Company Advances Towards Full FDA Approval of Crofelemer for Chemotherapy-Induced Diarrhea

SAN FRANCISCO, CA / ACCESS Newswire / April 29, 2026 / Jaguar Health, Inc. (NASDAQ: JAGX) (Jaguar) today announced topline results from the completion of its effectiveness trial of crofelemer (FDA conditionally approved Canalevia-CA1) for the treatment of chemotherapy-induced diarrhea (CID) in dogs. The statistically significant results demonstrated that dogs suffering from CID that were treated with Canalevia-CA1 twice daily at the onset of diarrhea had, at the end of 3 days of treatment, an average daily stool that is regarded as normal. Moreover, an owner's survey at the end of the study reported that 83% of owners indicate that Canalevia-CA1 was an effective treatment for their dog's CID. Additionally, around 40% of dog owners reported that Canalevia-CA1 completely resolved their dog's CID. In comparison, only 12.5% of owners reported they saw an improvement in their dog's CID without the use of any chemotherapy-induced diarrhea treatments. The Company expects to file the data from the complete analysis of this trial in support of full regulatory approval of crofelemer for CID and also submit for scientific publication.

"We are quite pleased with the study results, supporting the paradigm shifting antisecretory mechanism of action of crofelemer in CID, typically a chloride ion mediated secretory diarrhea common across all mammals. Our vision at the company is to expand the opportunity to treat a broader collection of symptomatic diarrhea causes in companion animals with an anti-secretory approach," said Lisa Conte, Jaguar Founder and CEO.

This study, "Clinical Field Study to Collect Real-World Data (RWD) to Demonstrate Real-World Evidence (RWE) of Effectiveness for Canalevia^®-CA1 (Crofelemer delayed-release tablets) 125 mg for the Treatment of Chemotherapy-Induced Diarrhea (CID) in Dogs" is the pivotal study in substantiating treatment effectiveness in the upcoming Animal Drug application.

Important Safety Information About Canalevia^®-CA1

For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 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. 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." 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:

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SOURCE: Jaguar Health, Inc.