Author: Jaguar Health, Inc.

Jaguar’s requesting advice from EMA on EU approval pathway for general diarrhea of FDA conditionally approved Canalevia^®

A novel non-antibiotic approach to diarrhea treatment is important because there are no FDA-approved drugs to treat general diarrhea in dogs, the second most common reason for visits to veterinary emergency hospitals

SAN FRANCISCO, CA / ACCESS Newswire / December 2, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar), today announced that its Italian subsidiary, Napo Therapeutics S.p.A., has submitted a request to the European Medicines Agency (EMA) to have the EMA’s Committee for Veterinary Medicinal Products (CVMP) provide scientific advice regarding the company’s plan to pursue approval of Canalevia (crofelemer delayed-release tablets) in the European Union for treatment of general diarrhea in dogs based on data from a study Jaguar completed in 200 dogs in 2017. The request asks that the CVMP review the company’s plan and related data during the CVMP’s scheduled meeting in March 2026.

The EMA is the EU’s equivalent of the U.S. Food and Drug Administration (FDA). Canalevia, under the name Canalevia-CA1, is conditionally approved by the FDA as an oral prescription drug for the treatment of chemotherapy-induced diarrhea (CID) in dogs.

“In the study of 200 dogs with general diarrhea, the pre-specified primary endpoint was not met. However, an updated analysis using a simplified endpoint – defining treatment success as no further episodes of diarrhea after the first treatment – showed that dogs treated with Canalevia had significantly better outcomes than those receiving placebo, including fewer watery stools and improved fecal scores,” said Dr. Michael Guy, D.V.M., M.S., Ph.D., Jaguar’s Vice President of Preclinical and Nonclinical Studies.

“We provided the CVMP with a summary of the updated analysis of the data from our completed study, which we look forward to having the CVMP review,” Dr. Guy said. “Following the start of the procedure in mid-January, the EMA will have 60 days (extendable to 90) to indicate if they agree that this updated analysis would support approval of Canalevia for treatment of general diarrhea in dogs in the EU. If the EMA agrees that the updated analysis would support approval, the company will submit a Marketing Authorization Application to the EMA for Canalevia for general diarrhea in dogs. If the application is approved, Canalevia will be marketable for treatment of general diarrhea in dogs in all 27 EU member countries.”

Data from the European Pet Food Industry Federation indicates that there were 69,359,000 dogs in the EU in 2023. According to the American Veterinary Medical Association, there were an estimated 89.7 million dogs in the US in 2024, with nearly half (45.5%) of US households owning a dog in 2024.

“We’ve been pleased with the marketplace reception of crofelemer for treatment of CID in dogs in the US and see a meaningful opportunity in the much larger market of general diarrhea in dogs, both in the US and the EU. We estimate that US veterinarians see approximately 6 million annual cases of acute and chronic diarrhea in dogs,” said Lisa Conte, Jaguar’s Founder and CEO. “Our primary objective for Canalevia is to secure a partner to help fund and execute development and commercialization globally for treatment of general diarrhea in dogs, while we continue to support availability for CID in dogs in the US. We have made business development around general diarrhea in dogs a key focus and potential catalyst for Jaguar in 2025.”

Diarrhea is one of the most common reasons dogs are seen by general practice veterinarians and is the second most common reason for visits to veterinary emergency hospitals, yet there is currently no FDA-approved drug to treat general, non-infectious diarrhea in dogs. Devastating diarrhea-related dehydration can occur rapidly for the animal, and the lack of easy access to outdoor facilities is a significant problem for families living in urban settings with dogs.

About Canalevia^® and Canalevia^®-CA1

Canalevia contains crofelemer, Jaguar’s novel, oral plant-based drug sustainably harvested from the Croton lechleri tree, that modulates chloride channels in the gastrointestinal tract to reduce diarrhea. Importantly, Canalevia is not an antibiotic drug. The overuse and misuse of antibiotics, both in humans and animals, contribute to the development of bacteria that are resistant to antibiotics.

Canalevia-CA1 (crofelemer delayed-release tablets), available from multiple leading veterinary distributors in the US, including Chewy, is the first and only oral plant-based prescription product that is FDA conditionally approved to treat chemotherapy-induced diarrhea (CID) in dogs. Canalevia-CA1 is a canine-specific formulation of crofelemer, an active pharmaceutical ingredient isolated and purified from the Croton lechleri tree. Canalevia-CA1 is currently conditionally approved by the FDA under application number 141-552. Conditional approval allows for commercialization of the product while Jaguar continues to collect the substantial evidence of effectiveness required for full approval. Jaguar has also received Minor Use in a Major Species (MUMS) Designation from the FDA for Canalevia-CA1 to treat CID in dogs. FDA has established a “small number” threshold for minor use in each of the seven major species covered by the MUMS act. The small number threshold is currently 80,000 for dogs, representing the largest number of dogs that can be affected by a disease or condition over the course of a year and still have the use qualify as a minor use.

About Conditional Approval and Full Approval

Canalevia-CA1 initially received conditional approval in December 2021 from the FDA for the treatment of CID in dogs. FDA’s conditional approval allows a drug company to legally promote, advertise and sell the animal drug for the labeled uses before proving it meets the “substantial evidence” standard of effectiveness for full approval. The conditional approval is valid for one year, with up to four annual renewals, for a total of five years of conditional approval. To receive a renewal from the FDA, the company must show active progress toward proving “substantial evidence of effectiveness” for full approval. After collecting the remaining effectiveness data, the company then applies to the FDA for full approval. The FDA reviews the application and, if appropriate, fully approves the drug.

About Chemotherapy-induced Diarrhea (CID) in Dogs

According to the American Veterinary Medical Association, approximately 1 in 4 dogs will at some stage in their life develop cancer. Nearly half of dogs over 10 will develop cancer.¹ According to the National Cancer Institute at the National Institutes of Health, roughly 6 million new cancer diagnoses are made in dogs yearly in the US.

Due to the increasing number of chemotherapeutic agents, chemotherapy is fast becoming the most widely used cancer treatment in veterinary medicine. Studies have found the incidence of CID to be one of the three most prevalent side effects in dogs undergoing cancer treatment,² and managing side-effects such as diarrhea can be important to maintain successful cancer treatment. More than half of the US veterinarians who responded to a Jaguar-sponsored survey reported that CID interferes with their patients’ chemotherapy treatment plans, indicating an unmet need for an effective product for the treatment of CID.

Canalevia-CA1 is a tablet that can be given orally twice a day and can be used for home treatment of CID in dogs.

Important Safety Information About Canalevia^®-CA1

For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.

About the Jaguar Health Family of Companies

Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar’s Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

For more information about:

Jaguar Health, visit https://jaguar.health

Napo Pharmaceuticals, visit napopharma.com

Napo Therapeutics, visit napotherapeutics.com

Magdalena Biosciences, visit magdalenabiosciences.com

Canalevia-CA1, visit canalevia.com

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements.” These include statements regarding Jaguar’s expectation that it may identify a partner to fund and execute development and commercialization of crofelemer for the treatment of general, non-infectious diarrhea in dogs in the US and/or globally, Jaguar’s expectation that it may be possible to obtain approval of Canalevia in the EU for treatment of general diarrhea in dogs based on the results of the study Jaguar completed in 200 dogs with general diarrhea, Jaguar’s expectation that, if the submitted summary of the updated analysis of the data from the company’s completed study is acceptable to the EMA, the company will then submit a MAA for Canalevia for general diarrhea in dogs, and Jaguar’s expectation that, if the MAA is approved, Canalevia will be marketable for treatment of general diarrhea in dogs in all 27 EU member countries. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

¹ “Cancer in Pets.” American Veterinary Medical Association, 2021, https://www.avma.org/resources/pet-owners/petcare/cancer-pets

² Mason SL, Grant IA, Elliott J, Cripps P, Blackwood L. Gastrointestinal toxicity after vincristine or cyclophosphamide administered with or without maropitant in dogs: a prospective randomised controlled study. J Small Anim Pract. 2014;55:391-398

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

This new IP supports crofelemer’s global exclusivity in rare pediatric intestinal failure coincident with published clinical data showing reductions in parenteral support requirements with crofelemer – supporting Jaguar’s strategy to secure non-dilutive partnership funding

Recent publication by members of Jaguar’s Scientific Advisory Board and other intestinal failure key opinion leaders: “Targeted Literature Review and Assessment of Evidence in Microvillus Inclusion Disease (MVID)”

SAN FRANCISCO, CA / ACCESS Newswire / November 24, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced that the Australian Patent Office has issued a new patent to Jaguar family company Napo Pharmaceuticals (Napo) for methods for treating short bowel syndrome (SBS), bile acid diarrhea, and diarrhea associated with small intestine resection or gallbladder removal, in patients with an inhibitor of chloride-ion transport such as crofelemer, Jaguar’s novel plant-based prescription drug.

“This new patent expands the international IP protection supporting crofelemer’s development in short bowel syndrome with intestinal failure (SBS-IF),” said Lisa Conte, founder, president, and CEO. “Together with emerging proof-of-concept data showing reductions in parenteral support, this strengthens the foundation for our planned business development efforts to advance crofelemer in rare pediatric intestinal failure disorders.”

As announced, and as presented November 8, 2025 at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting, the initial results of the ongoing and independent proof-of-concept trial of crofelemer in the UAE demonstrate disease progression modification through reduction of total parenteral support (PS) in pediatric intestinal failure patients that ranged from 12 to 37%. Specifically, in the two SBS-IF patients who have completed treatment, the results show crofelemer reduced PS between 12.5 to 15.6% at the highest dose over the 12-week treatment period, together with reduced loose watery stools frequency. For the initial MVID patient who has completed treatment, PS needs were reduced by up to 27% at the highest dose over the initial 12-week treatment period and up to 37% during the extension period upon reinitiation of crofelemer treatment, and showed reduced frequency of loose watery stools. These findings support continued evaluation of crofelemer to reduce PS needs for pediatric intestinal failure patients.

“The intestines of patients with intestinal failure due to short bowel syndrome often do not function properly, as is always the case with patients with intestinal failure due to the ultrarare genetic disorder microvillus inclusion disease (MVID). Intestinal failure is a debilitating, lifelong condition that often requires patients to receive life-sustaining fluids, electrolytes and nutrients through intravenous administration, which consists of total parenteral nutrition (TPN) with supplemental intravenous fluids, which together constitute parenteral support (PS). Most intestinal failure patients require PS up to 7 days a week, and sometimes for 20 hours or more per day,” Conte said.

While crucial for intestinal failure patients, PS is associated with significant toxicities to patients, similar to some toxicities associated with chemotherapy, often causing serious health problems including infections, metabolic complications, liver and kidney function problems – as well as a risk of neurodevelopmental delay. These symptoms may emerge at any time in intestinal failure patients, and often become life-threatening.

SBS affects approximately 10,000 to 20,000 people in the US, according to the Crohn’s & Colitis Foundation, and it is estimated that the population of SBS patients in Europe is approximately the same size. MVID is a devastating ultrarare pediatric disorder, with an estimated worldwide prevalence of 100-200 patients, characterized by severe malabsorption that requires life-sustaining parenteral support to meet the nutritional, fluid and electrolyte requirements of the child, and for which there are currently no approved treatments. MVID has a lethal natural history along with significant co-morbidities.

An article by Pravin Chaturvedi, PhD, Jaguar’s Chief Scientific Officer and Chair of the Jaguar and Napo Scientific Advisory Board, Michela Pantaleoni of Jaguar family company Napo Therapeutics in Italy, along with other members of the company’s Scientific Advisory Board and intestinal failure key opinion leaders, has been published in Clinical Nutrition Open Science, the official peer-reviewed open-access journal of ESPEN, the European Society for Clinical Nutrition and Metabolism. The article, “Targeted Literature Review and Assessment of Evidence in Microvillus Inclusion Disease (MVID),” synthesizes reported evidence on MVID’s clinical manifestations, treatment, and outcomes, highlighting the disease burden and identifying key gaps in current knowledge.

In addition to supporting the ongoing IIT in the UAE, Napo is also conducting a placebo-controlled clinical trial of crofelemer in pediatric SBS-IF patients at sites in the US and EU, and a placebo-controlled clinical trial of crofelemer in pediatric MVID patients at sites in the US, EU, and Middle East. The company is also providing crofelemer powder for oral solution for use in two expanded access programs in intestinal failure patients with MVID in the US, and for an IIT of crofelemer to treat intestinal failure in adult SBS-IF patients in the US.

As with all potential follow-on indications, Jaguar and Napo prioritize IP protection. Napo currently holds approximately 195 patents and approximately 56 patents pending. To date, crofelemer is the only oral plant-based prescription medicine approved under the FDA’s Botanical Guidance, which provides an important additional exclusivity advantage due to the inherent practicalities limiting the pathway by which a generic version of the drug could be produced.

About Crofelemer

Crofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as “dragon’s blood,” of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities.

About the Jaguar Health Family of Companies

Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome.

For more information about:

Jaguar Health, visit https://jaguar.health

Napo Pharmaceuticals, visit www.napopharma.com

Napo Therapeutics, visit napotherapeutics.com

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements.” In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

Crofelemer can potentially extend lives of MVID patients – infants and children who face the lethal natural history of the disease

Parenteral support reduction of up to 37% is groundbreaking; No approved treatments exist for MVID in any region

SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / November 20, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that, in support of a possible expedited approval pathway for crofelemer for treatment of intestinal failure in patients with the ultrarare genetic disorder microvillus inclusion disease (MVID), the company has submitted an amended protocol to the U.S. Food and Drug Administration (FDA) for the company’s ongoing placebo-controlled clinical trial of crofelemer in pediatric MVID patients.

MVID patients are born without the ability to absorb the basic nutrients of life, and are therefore subject to a lethal natural history and a lifetime of parenteral support which is associated with toxicities and comorbidities. The ability of crofelemer to decrease the volume of parenteral support is potentially life extending for these patients and is thus disease progression modifying. Crofelemer provides an opportunity for improved quality of life, potentially reducing the time MVID patients spend on parenteral nutrition and/or supplemental intravenous fluids by up to 37% a day from what is often up to 20 hours a day, 7 days a week to support the daily electrolyte and nutrient needs of the patient.

“In light of the initial groundbreaking results of the investigator-initiated trial (IIT) of crofelemer in the United Arab Emirates for treatment of MVID and in support of our efforts to make crofelemer available to children with MVID as quickly and efficiently as possible, as announced, the company met with the FDA on October 2, 2025 to seek their advice regarding our ongoing clinical trial of crofelemer for MVID treatment. Based on the feedback from the FDA during this meeting, we have proposed an amendment to our protocol for this study and submitted the amended protocol to the FDA for their review. Our expectation is that the amended protocol, along with the results of this study, if positive, will support a faster FDA review and approval of crofelemer for MVID,” said Pravin Chaturvedi, PhD, Jaguar’s Chief Scientific Officer and Chair of the Jaguar and Napo Scientific Advisory Board.

Jaguar has also discussed the potential for approval of crofelemer for MVID with the European Medicines Agency, the EU’s equivalent of the FDA, based on a study in potentially a small number of patients given the burden of MVID. “That’s how unprecedented crofelemer’s mechanism of action and these results are in intestinal failure patients with MVID,” said Lisa Conte, Jaguar’s founder, president, and CEO. “MVID is a devastating ultrarare pediatric disorder, with an estimated worldwide prevalence of only 100-200 patients, so a trial of crofelemer in just a small number of MVID patients is expected to be statistically meaningful.”

As presented on November 8, 2025, at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting, the initial groundbreaking results of an ongoing and independent IIT of crofelemer in the UAE for treatment of pediatric intestinal failure, which includes patients with intestinal failure due to MVID and short bowel syndrome (SBS-IF), demonstrate disease progression modification through reduction of total parenteral support (PS) in pediatric intestinal failure patients that ranged from 12 to 37%. For the initial MVID patient who has completed treatment, PS needs were reduced by up to 27% at the highest dose over the initial 12-week treatment period and up to 37% during the extension period upon reinitiation of crofelemer treatment, and also showed reduced frequency of loose watery stools. This finding supports continued evaluation of crofelemer to reduce PS needs for pediatric MVID patients.

MVID causes intestinal failure, a situation where the patient’s intestines are unable to absorb the fluids, electrolytes and nutrients required to survive and thrive. Intestinal failure is a debilitating, morbid and lifelong condition that often requires patients to receive life-sustaining fluids, electrolytes and nutrients through intravenous administration, which consists of total parenteral nutrition (TPN) with supplemental intravenous fluids, which together constitute parenteral support (PS). Most intestinal failure patients require PS up to 7 days a week, and sometimes for 20 hours or more per day. While crucial for these patients, PS is associated with significant toxicities to patients, similar to some toxicities associated with chemotherapy, often causing serious health problems including infections, metabolic complications, liver and kidney function problems – as well as a risk of neurodevelopmental delay. These symptoms may emerge at any time in intestinal failure patients, and often become life-threatening.

In addition to supporting the IIT in the UAE and conducting the placebo-controlled clinical trial of crofelemer in pediatric MVID patients at sites in the U.S., E.U., and Middle East, the company is also providing crofelemer powder for oral solution for use in two expanded access programs in the U.S. to treat intestinal failure in pediatric patients with MVID.

About the Jaguar Health Family of Companies

Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including MVID and short bowel syndrome.

For more information about:

Jaguar Health, visit https://jaguar.health

Napo Pharmaceuticals, visit www.napopharma.com

Napo Therapeutics, visit napotherapeutics.com

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements.” These include statements regarding Jaguar’s expectation that the amended protocol the company submitted to the FDA for the company’s ongoing trial of crofelemer for the treatment of intestinal failure in MVID patients will support a possible expedited approval pathway for crofelemer for this indication, Jaguar’s expectation that the ability of crofelemer to decrease the volume of PS is life extending and disease progression modifying for MVID patients, and that crofelemer provides an opportunity for improved quality of life for MVID patients by reducing the time MVID patients spend on parenteral nutrition and/or supplemental intravenous fluids by up to 37% a day, Jaguar’s expectation that the amended protocol, along with the results of the company’s study, if positive, will support a faster FDA review and approval of crofelemer for treatment of MVID, and Jaguar’s expectation that crofelemer could also be approved by the European Medicines Agency for MVID based on a study in potentially a small number of patients. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Contact:

hello@jaguar.health

Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

Initial results of ongoing investigator-initiated proof-of-concept trial demonstrate crofelemer can potentially extend the lives of infants born with intestinal failure due to microvillus inclusion disease (MVID), reducing the volume of the total parenteral support (PS) necessary for them to survive, though with associated toxicity; Groundbreaking PS reduction of up to 37%; No approved treatments exist for MVID

Company completed meeting with FDA October 2, 2025 for advice on possible expedited approval pathway to advance its ongoing placebo-controlled trial of crofelemer for potential approval for treatment of MVID

REMINDER: Today Jaguar to host investor webcast at 8:30 a.m. Eastern regarding Q3 2025 financials and company updates; Click here to register

SAN FRANCISCO, CA / ACCESS Newswire / November 17, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”) today reported its consolidated third-quarter 2025 financial results.

2025 THIRD QUARTER COMPANY FINANCIAL RESULTS:

• Net Revenue: The combined net revenue for the Company’s prescription products (Mytesi^®, Gelclair^®, and Canalevia^®-CA1), including license revenue, was approximately $3.1 million in the third quarter of 2025, representing an increase of approximately 4% over the combined net revenue in the second quarter of 2025, which totaled approximately $3.0 million, and equaled the combined net revenue for the third quarter of 2024.

• Mytesi Prescription Volume: Mytesi prescription volume increased by approximately 0.9% in the third quarter of 2025 over the second quarter of 2025, and Mytesi prescription volume in the third quarter of 2025 decreased by 3.6% compared to the volume in the third quarter of 2024. Prescription volume differs from invoiced sales volume, which reflects, among other factors, varying buying patterns among specialty pharmacies in the closed network as they manage their inventory levels.

• License Revenue: For the third quarter of 2025, the Company recognized license fees of $42,858 from a securities purchase agreement with a European partner. As of September 30, 2025, the total deferred revenue associated with this contract amounts to approximately $595,000.

• Neonorm^™: Revenues for the non-prescription Neonorm products were minimal for the third quarters of 2025 and 2024.

		Three Months Ending
Financial Highlights		September 30,
(in thousands, except per share amounts)		2025				2024				$ change				% change
Net product revenue		$	3,083			$	3,108				(25	)			-1	%
Loss from operations		$	(7,238	)		$	(7,262	)			24				0	%
Net loss attributable to common stockholders		$	(9,502	)		$	(9,854	)			352				-4	%
Net loss per share, basic and diluted		$	(6.28	)		$	(26.29	)			20				-76	%

		Three Months Ending
		September 30,
(in thousands)		2025				2024				$ change				% change
		(unaudited)
Net loss attributable to common stockholders		$	(9,502	)		$	(9,854	)			(352	)			4	%
Adjustments:
Interest income (expense)			6				(162	)			(168	)			104	%
Property and equipment depreciation			17				17				(0	)			-2	%
Amortization of intangible assets			463				457				(6	)			-1	%
Share-based compensation expense			135				305				170				56	%
Loss on extinguishment of debt			–				–				–				-100	%
Non-GAAP EBITDA			(8,881	)			(9,237	)			(357	)			4	%

Note Regarding Use of Non-GAAP Measures

The Company supplements its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA, which are considered non-GAAP under applicable SEC rules. Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects the basis upon which Company management assesses and operates the business. These non-GAAP financial measures are not in accordance with GAAP and should not be viewed in isolation or as substitutes for GAAP net sales and GAAP net loss and are not substitutes for, or superior to, measures of financial performance in conformity with GAAP.

The Company defines non-GAAP EBITDA as net loss before interest expense and other expense, depreciation of property and equipment, amortization of intangible assets, share-based compensation expense and provision for or benefit from income taxes. The Company defines non-GAAP Recurring EBITDA as non-GAAP EBITDA adjusted for certain non-recurring revenues and expenses. Company management believes that non-GAAP EBITDA and non-GAAP Recurring EBITDA are meaningful indicators of Jaguar’s performance and provide useful information to investors regarding the Company’s results of operations and financial condition.

Participation Instructions for Webcast

When: Monday, November 17, 2025 at 8:30 a.m. Eastern

Participant Registration & Access Link: Click Here

Replay Instructions for Webcast

Replay of the webcast on the investor relations section of Jaguar’s website: (click here)

About Crofelemer

Crofelemer is the only oral FDA-approved prescription drug under botanical guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals, a Jaguar family company, has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for Indigenous communities.

About the Jaguar Health Family of Companies

Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo’s crofelemer is FDA-approved under the brand name Mytesi^® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar’s Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

For more information about:

Jaguar Health, visit https://jaguar.health

Napo Pharmaceuticals, visit www.napopharma.com

Napo Therapeutics, visit napotherapeutics.com

Magdalena Biosciences, visit magdalenabiosciences.com

Canalevia-CA1, visit canalevia.com

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About Mytesi^®

Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).

See full Prescribing Information at Mytesi.com. Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.

About Gelclair^®

INDICATIONS

GELCLAIR^® has a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis (may be caused by chemotherapy or radiation therapy), irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, or disease. Also, indicated for diffuse aphthous ulcers.

IMPORTANT SAFETY INFORMATION

• Do not use GELCLAIR if there is a known or suspected hypersensitivity to any of its ingredients.

• No adverse effects have been reported in clinical trials, although postmarketing reports have included infrequent complaints of burning sensation in the mouth.

• If GELCLAIR is swallowed accidentally, no adverse effects are anticipated.

• If no improvement is seen within 7 days, a physician should be consulted.

You are encouraged to report negative side effects of prescription medical products to the FDA.

Visit www.fda.gov/safety/medwatch or call 1-855-273-0468.

Please see full Prescribing Information at:

https://www.gelclairhcp.com/pdf/prescribing-information-instructions-for-use.pdf

Important Safety Information About Canalevia^®-CA1

For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.

See full Prescribing Information at Canalevia.com.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements.” These include statements regarding Jaguar’s expectation that it will hold an investor webcast on November 17, 2025, and Jaguar’s expectation that crofelemer can potentially extend lives of MVID patients, reducing the volume of the PS necessary for them to survive. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Source: Jaguar Health, Inc.

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

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Company plans to file its Earnings Report on November 14, 2025 on Form 10-Q for the quarter ended September 30, 2025

SAN FRANCISCO, CA / ACCESS Newswire / November 14, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that the company will conduct an investor webcast on Monday, November 17, 2025, at 8:30 a.m. Eastern to review third-quarter 2025 financials and provide corporate updates.

Participation Instructions for Jaguar Investor Webcast

When: Monday, November 17, 2025 at 8:30 AM Eastern Time

Participant Registration & Access Link: Click Here

About the Jaguar Health Family of Companies
Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo’s crofelemer is FDA-approved under the brand name Mytesi^® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar’s Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

For more information about:

Jaguar Health, visit https://jaguar.health

Napo Pharmaceuticals, visit www.napopharma.com

Napo Therapeutics, visit napotherapeutics.com

Magdalena Biosciences, visit magdalenabiosciences.com

Canalevia-CA1, visit canalevia.com

Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram

Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements.” These include statements regarding the expectation that Jaguar will file its 10-Q on November 14, 2025 for the quarter ended September 30, 2025, and the expectation that Jaguar will hold an investor webcast on November 17, 2025. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

CONTACT:
hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

Crofelemer can potentially extend and save lives of microvillus inclusion disease patients, reducing the volume of the total parenteral support (PS) necessary for them to survive

Groundbreaking PS reduction of up to 37% is unprecedented; No approved treatments exist for MVID

SAN FRANCISCO, CA / ACCESS Newswire / November 13, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today provided a recap of the November 8, 2025 presentation at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting describing the initial groundbreaking results of an independent investigator-initiated trial (IIT) of crofelemer in the UAE for treatment of pediatric intestinal failure, which includes patients with ‘intestinal failure’ due to microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF).

“The intestines of patients with the ultrarare genetic disorder MVID do not function properly, as is often the case with patients having intestinal failure due to short bowel syndrome. The intestines of these patients are unable to absorb the fluids, electrolytes and nutrients required to survive and thrive. Intestinal failure is a debilitating, lifelong condition that often requires patients to receive life-sustaining fluids, electrolytes and nutrients through intravenous administration, which consists of total parenteral nutrition (TPN) with supplemental intravenous fluids, which together constitute parenteral support (PS). Most intestinal failure patients require PS up to 7 days a week, and sometimes for 20 hours or more per day,” said Lisa Conte, Jaguar’s founder, president, and CEO.

While crucial for these patients, total parenteral support is associated with significant toxicities to patients, similar to some toxicities associated with chemotherapy, often causing serious health problems including infections, metabolic complications, liver and kidney function problems – as well as a risk of neurodevelopmental delay. These symptoms may emerge at any time in intestinal failure patients, and often become life-threatening.

As presented at NASPGHAN, the results of this ongoing and independent proof-of-concept trial of crofelemer demonstrate disease progression modification through reduction of total parenteral support (PS) in pediatric intestinal failure patients that ranged from 12 to 37%. Specifically, in the two SBS-IF patients who have completed treatment, the results show crofelemer reduced PS between 12.5 to 15.6% at the highest dose over the 12-week treatment period, together with reduced loose watery stools frequency. For the initial MVID patient who has completed treatment, PS needs were reduced by up to 27% at the highest dose over the initial 12-week treatment period and up to 37% during the extension period upon reinitiation of crofelemer treatment, and also showed reduced frequency of loose watery stools. These findings support continued evaluation of crofelemer to reduce PS needs for pediatric intestinal failure patients.

The presentation on November 8, 2025 at NASPGHAN, was titled Exploratory Single-Arm, Open-Label Non-Randomized Trial Evaluating the Safety and Effectiveness of Crofelemer in Pediatric Patients with Intestinal Failure. The study’s primary investigator, Dr. Mohamad Miqdady, Division Chief of the Pediatric Gastroenterology, Hepatology & Nutrition Division at Sheikh Khalifa Medical City (SKMC), a tertiary care center in Abu Dhabi in the UAE, described these initial findings in pediatric intestinal failure patients with crofelemer treatment.

A recognized leader in pediatric gastroenterology, Dr. Miqdady is Professor of Pediatric Gastroenterology at Khalifa University’s medical school, and completed his Fellowship in Pediatric Gastroenterology at Baylor College of Medicine and Texas Children’s Hospital in Houston. He is a member of Napo’s Scientific Advisory Board.

MVID is a devastating ultrarare pediatric disorder, with an estimated worldwide prevalence of 100-200 patients, characterized by severe malabsorption that requires life-sustaining parenteral support to meet the nutritional, fluid and electrolyte requirements of the child, and for which there are currently no approved treatments. MVID has a lethal natural history along with significant co-morbidities. Short bowel syndrome (SBS) affects approximately 10,000 to 20,000 people in the U.S., according to the Crohn’s & Colitis Foundation, and it is estimated that the population of SBS patients in Europe is approximately the same size.

In addition to supporting the IIT in the UAE, Napo is also conducting the placebo-controlled clinical trial of crofelemer in pediatric MVID patients at sites in the U.S., E.U., and Middle East under appropriate regulatory approvals in each of these geographies. The company is also providing crofelemer powder for oral solution for use in two expanded access programs in intestinal failure patients the U.S. to treat adult and pediatric intestinal failure patients with short bowel syndrome and MVID, respectively.

The mission of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) is to be a world leader in research, education, clinical practice and advocacy for pediatric gastroenterology, hepatology and nutrition in health and disease. NASPGHAN strives to improve the care of infants, children and adolescents with digestive disorders by promoting advances in clinical care, research and education.

About the Jaguar Health Family of Companies

Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome.

For more information about:

Jaguar Health, visit https://jaguar.health

Napo Pharmaceuticals, visit www.napopharma.com

Napo Therapeutics, visit napotherapeutics.com

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements.” These include statements regarding Jaguar’s expectation that crofelemer can potentially extend and save lives of MVID patients, reducing the volume of the PS necessary for them to survive. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

Results of ongoing investigator-initiated proof-of-concept trial of crofelemer in United Arab Emirates (UAE) demonstrate disease progression modification and reduction of total parenteral support (PS) in pediatric intestinal failure patients ranging between 12% to 37%

SAN FRANCISCO, CA / ACCESS Newswire / November 6, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today issued a reminder that an abstract describing partial results of the independent and ongoing investigator-initiated trial (IIT) of crofelemer in the UAE for treatment of pediatric intestinal failure, which includes patients with intestinal failure due to microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF), will be presented this coming Saturday, November 8, 2025, at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting taking place November 5-8, 2025 in Chicago.

The results of the ongoing investigator-initiated proof-of-concept trial in the UAE demonstrate reduction of total parenteral support (PS) (comprised of total parenteral nutrition and supplementary IV fluids) in pediatric intestinal failure patients ranging between 12% to 37%.

MVID is a devastating ultrarare pediatric disorder, with an estimated worldwide prevalence of 100-200 patients, characterized by severe malabsorption that requires life-sustaining parenteral support to meet the nutritional, fluid and electrolyte requirements of the child, and for which there are currently no approved treatments. MVID has a lethal natural history along with significant co-morbidities. SBS affects approximately 10,000 to 20,000 people in the U.S., according to the Crohn’s & Colitis Foundation, and it is estimated that the population of SBS patients in Europe is approximately the same size.

“We are very pleased with the initial findings from this pilot open-label study in pediatric intestinal failure patients with MVID and SBS. The unique mechanism of action of crofelemer and the reductions achieved in the average weekly parenteral support volumes buttress the ongoing investigation of crofelemer in pediatric intestinal failure patients. The ability to reduce PS needs is disease progression modification that has a groundbreaking impact on patient well-being as well as quality of life. We will continue to evaluate the longer-term safety and durability of these reductions in intestinal failure patients over the coming weeks,” said Pravin Chaturvedi, PhD, Napo’s and Jaguar’s Chief Scientific Officer and Chair of the Scientific Advisory Board.

In addition to supporting the IIT in the UAE and conducting the placebo-controlled clinical trial of crofelemer in pediatric MVID patients at sites in the U.S., E.U., and Middle East under appropriate regulatory approvals in each of these geographies, the company is providing crofelemer powder for oral solution for use in two expanded access programs in the U.S., authorized by the FDA, to treat pediatric intestinal failure patients with MVID. The company is also supporting an IIT in the U.S. of crofelemer in adult SBS-IF patients.

About the Jaguar Health Family of Companies

Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome.

For more information about:

Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit www.napopharma.com
Napo Therapeutics, visit napotherapeutics.com

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements.” These include statements regarding Jaguar’s expectation that an abstract describing partial results of the ongoing IIT in the UAE will be presented at the 2025 NASPGHAN Annual Meeting. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

Results of ongoing investigator-initiated proof-of-concept trial of crofelemer in United Arab Emirates (UAE) demonstrate disease progression modification and reduction of total parenteral support (PS) in pediatric intestinal failure patients ranging between 12% to 37%

SAN FRANCISCO, CA / ACCESS Newswire / November 6, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today issued a reminder that an abstract describing partial results of the independent and ongoing investigator-initiated trial (IIT) of crofelemer in the UAE for treatment of pediatric intestinal failure, which includes patients with intestinal failure due to microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF), will be presented this coming Saturday, November 8, 2025, at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting taking place November 5-8, 2025 in Chicago.

The results of the ongoing investigator-initiated proof-of-concept trial in the UAE demonstrate reduction of total parenteral support (PS) (comprised of total parenteral nutrition and supplementary IV fluids) in pediatric intestinal failure patients ranging between 12% to 37%.

MVID is a devastating ultrarare pediatric disorder, with an estimated worldwide prevalence of 100-200 patients, characterized by severe malabsorption that requires life-sustaining parenteral support to meet the nutritional, fluid and electrolyte requirements of the child, and for which there are currently no approved treatments. MVID has a lethal natural history along with significant co-morbidities. SBS affects approximately 10,000 to 20,000 people in the U.S., according to the Crohn’s & Colitis Foundation, and it is estimated that the population of SBS patients in Europe is approximately the same size.

“We are very pleased with the initial findings from this pilot open-label study in pediatric intestinal failure patients with MVID and SBS. The unique mechanism of action of crofelemer and the reductions achieved in the average weekly parenteral support volumes buttress the ongoing investigation of crofelemer in pediatric intestinal failure patients. The ability to reduce PS needs is disease progression modification that has a groundbreaking impact on patient well-being as well as quality of life. We will continue to evaluate the longer-term safety and durability of these reductions in intestinal failure patients over the coming weeks,” said Pravin Chaturvedi, PhD, Napo’s and Jaguar’s Chief Scientific Officer and Chair of the Scientific Advisory Board.

In addition to supporting the IIT in the UAE and conducting the placebo-controlled clinical trial of crofelemer in pediatric MVID patients at sites in the U.S., E.U., and Middle East under appropriate regulatory approvals in each of these geographies, the company is providing crofelemer powder for oral solution for use in two expanded access programs in the U.S., authorized by the FDA, to treat pediatric intestinal failure patients with MVID. The company is also supporting an IIT in the U.S. of crofelemer in adult SBS-IF patients.

About the Jaguar Health Family of Companies

Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome.

For more information about:

Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit www.napopharma.com
Napo Therapeutics, visit napotherapeutics.com

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements.” These include statements regarding Jaguar’s expectation that an abstract describing partial results of the ongoing IIT in the UAE will be presented at the 2025 NASPGHAN Annual Meeting. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire