Jaguar Health Establishes First Study Site for Canalevia-CA1 Field Study

Jaguar Health has established the first study site for its field study of Canalevia-CA1, a prescription drug for chemotherapy-induced diarrhea in dogs. The study aims to collect real-world data to support potential full FDA approval of the drug. Jaguar is also in discussions with potential partners to fund development and commercialization of crofelemer for the treatment of general, non-infectious diarrhea in dogs in the US and/or globally.

San Francisco, CA / June 13, 2025 - Jaguar Health, Inc., a commercial-stage pharmaceutical company, has established the first study site for its field study of Canalevia-CA1, a prescription drug for chemotherapy-induced diarrhea (CID) in dogs. The study aims to collect real-world data to support potential full FDA approval of the drug [1].

Jaguar Health also announced that it is in discussions with potential partners to fund the development and commercialization of crofelemer, the active ingredient in Canalevia-CA1, for the treatment of general, non-infectious diarrhea in dogs in the U.S. and/or globally. The company estimates that there is an unmet medical need for such a product, with approximately six million annual cases of acute and chronic diarrhea in dogs [2].

The objective of the prospective, randomized, open-label field study in dogs undergoing chemotherapy treatment across the U.S. is to collect real-world data to demonstrate the clinical effectiveness of Canalevia-CA1 for the treatment of CID in dogs. Dogs enrolled in the study will be randomly assigned to receive a prescription of Canalevia-CA1 as a treatment for CID or be randomly selected to the control group [1].

Jaguar Health has two parallel goals for Canalevia-CA1: to obtain full approval of the drug for treatment of CID in dogs and to expand the indication of crofelemer from CID to treatment of general, non-infectious diarrhea in dogs. The company has established a new Investigational New Animal Drug (INAD) file with the FDA's Center for Veterinary Medicine for crofelemer to treat general, non-infectious diarrhea in dogs [1].

The lack of FDA-approved drugs to treat general, non-infectious diarrhea in dogs is a significant problem, as diarrhea is one of the most common reasons for veterinary office visits and the second most common reason for visits to the veterinary emergency room [1]. Canalevia-CA1 is a canine-specific formulation of crofelemer, an oral plant-based drug sustainably harvested from the Croton lechleri tree, and is available from multiple leading veterinary distributors in the U.S., including Chewy [1].

Canalevia-CA1 initially received conditional approval in December 2021 from the FDA for the treatment of CID in dogs. The conditional approval allows Jaguar Health to legally promote, advertise, and sell the drug for the labeled uses before proving it meets the "substantial evidence" standard of effectiveness for full approval [1].

References:
[1] https://www.nasdaq.com/press-release/first-study-site-established-jaguar-health-study-its-fda-conditionally-approved
[2] https://www.nasdaq.com/press-release/first-study-site-established-jaguar-health-study-its-fda-conditionally-approved