Jaguar Health Completes Submission of New Animal Drug Application for Full FDA Approval of Crofelemer for Treatment of Chemotherapy-Induced Diarrhea (CID) in Dogs

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Jaguar's recently completed pivotal effectiveness study of crofelemer for the treatment of CID in dogs demonstrates positive, statistically significant results SAN FRANCISCO, CA / ACCESS Newswire / June 23, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that the company has completed submission of its New Animal Drug Application (NADA) to the U.S. Food and Drug Administration's Center for Veterinary Medicine for full approval of crofelemer for the treatment of chemotherapy-induced diarrhea (CID) in dogs. Crofelemer, under the name Canalevia®-CA1, is currently conditionally approved for this indication in dogs. "We're very happy to have completed submission of this NADA," said Dr. Michael Guy, D.V.M., M.S., Ph.D., Jaguar's Vice President of Preclinical and Nonclinical Studies. "As announced, the statistically significant results of our recently completed pivotal effectiveness study of Canalevia-CA1 for the treatment of CID in dogs demonstrated that dogs suffering from CID who 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 was regarded as normal. Moreover, in a survey at the end of the study, 77% of the owners of dogs participating in the study reported that they believed 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 10.5% of owners reported complete resolution in their dog's CID without the use of any CID treatments." The effectiveness study, which was undertaken at veterinary oncology clinics around the U.S., is a core component of Jaguar's submitted NADA, along with the positive results of a study of crofelemer delayed-release tablets for treatment of cancer therapy-related diarrhea in dogs receiving neratinib - a targeted tyrosine kinase inhibitor (TKI) chemotherapy agent. 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. 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...

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