Canalevia^® (crofelemer delayed-release tablets), under the name Canalevia-CA1, is conditionally approved by the FDA for treatment of chemotherapy-induced diarrhea in dogs

Jaguar is exploring the possibility of approval of Canalevia for treatment of general diarrhea in dogs in the EU based on the statistically significant data from a completed study

Diarrhea is one of the most common reasons owners bring their dog to the veterinarian and the second most common reason for visits to the veterinary emergency hospital, yet there are currently no FDA-approved drugs to treat general diarrhea in dogs

Company strategy: In discussions with multiple potential animal health company partners to collaborate to bring Canalevia to regulatory approval and commercialization for general diarrhea globally

SAN FRANCISCO, CA / ACCESS Newswire / June 25, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar), under its Jaguar Animal Health tradename for the veterinary market, today announced that the company plans to pursue approval from the European Medicines Agency's (EMA) Committee for Veterinary Medicinal Products (CVMP) for Canalevia (crofelemer delayed-release tablets) in the European Union for treatment of general diarrhea in dogs. Canalevia, under the name Canalevia-CA1, is conditionally approved by the U.S. Food and Drug Administration (FDA) as a prescription drug for the treatment of chemotherapy-induced diarrhea (CID) in dogs.

"Jaguar's primary objective for Canalevia is to identify a partner with which to collaborate to achieve our three parallel goals for the drug: Obtain approval in the EU for Canalevia for treatment of general diarrhea in dogs based on existing Jaguar study data; maintain continuity of availability in the U.S. of Canalevia for treatment of CID in dogs; and to expand the U.S. indication from CID in dogs to treatment of general diarrhea in dogs," said Lisa Conte, Jaguar's Founder and CEO. "I'm pleased to report that Jaguar is currently in discussions with multiple potential animal health company partners to collaborate to bring Canalevia to regulatory approval and commercialization for general diarrhea globally."

Canalevia contains crofelemer, a plant-based botanical prescription drug 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.

"In the EU, it may be possible to obtain approval of Canalevia for treatment of general diarrhea in dogs based on the results of a study Jaguar completed in 200 dogs with general diarrhea," Conte said. "Whil