Jaguar Health Inc. Pursues EMA Approval for Canalevia to Treat General Diarrhea in Dogs Across EU

Reuters
25 Jun
Jaguar Health Inc. Pursues EMA Approval for Canalevia to Treat General Diarrhea in Dogs Across EU

SAN FRANCISCO, CA / June 25, 2025 / Jaguar Health, Inc. $(JAGX)$ has announced its plan to pursue regulatory approval for Canalevia (crofelemer delayed-release tablets) in the European Union for treating general diarrhea in dogs. Currently conditionally approved by the U.S. FDA for chemotherapy-induced diarrhea in dogs, Jaguar aims to expand Canalevia's indications and availability. The company intends to submit a dossier to the European Medicines Agency's $(EMA)$ Committee for Veterinary Medicinal Products (CVMP), followed by a Marketing Authorization Application $(MAA)$ if the results are favorable. Successful approval would allow Canalevia to be marketed for general diarrhea treatment in dogs across all 27 EU member countries. Jaguar is actively in discussions with multiple potential animal health company partners to collaborate on achieving these regulatory and commercialization goals globally.

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