Health
Jaguar Health Receives Notice of $250,000 FDA Grant to Fund Confirmatory Trial to Support FDA Approval of Canalevia for Treatment of Chemotherapy-Induced Diarrhea (CID) in Dogs
Company strategy: In discussions with multiple potential animal health company partners to expand the indication and commercialize Canalevia for treatment of general diarrhea globally SAN FRANCISCO, CA / ACCESS Newswire / September 25, 2025 /Jaguar ...
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Company strategy: In discussions with multiple potential animal health company partners to expand the indication and commercialize Canalevia for treatment of general diarrhea globally","length":183,"tagName":"p"},{"type":"text","content":"SAN FRANCISCO, CA / ACCESS Newswire / September 25, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar"), under its Jaguar Animal Health tradename for the veterinary market, today announced that it has received notice from the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) of a $250,000 grant. Canalevia, under the name Canalevia-CA1, is currently conditionally approved for chemotherapy-induced diarrhea (CID) in dogs. The grant would support a confirmatory study required for full FDA approval of Canalevia (crofelemer delayed-release tablets) for the treatment of CID in dogs. Acceptance of the award is dependent upon the company's compliance with FDA terms and conditions. The company has not yet accepted the award.","length":765,"tagName":"p"},{"type":"text","content":""When an animal drug receives conditional approval, the CVM requires that a confirmatory trial take place within 5 years to provide the substantial evidence of effectiveness required for full approval of the drug for the indication," said Dr. Michael Guy, D.V.M., M.S., Ph.D., Jaguar's Vice President of Preclinical and Nonclinical Studies. "As announced, enrollment has begun in our ongoing full effectiveness study of Canalevia-CA1 for the treatment of CID in dogs. Although we submitted the application for this grant in June 2024, notifications of successful grant awards were delayed due to the new federal administration and funding modifications by the National Institutes of Health. We are planning to request approval from the CVM to use the grant to support this ongoing, slightly modified, field study in dogs undergoing chemotherapy."","length":870,"tagName":"p"},{"type":"text","content":""Looking forward, as announced, Jaguar is in discussions with multiple potential animal health company partners regarding collaborating on the development, approval, and commercialization of Canalevia for the expanded indication of treatment of general diarrhea in dogs," said Lisa Conte, Jaguar's Founder and CEO. "Our objective is to partner with an animal health...