Health
FDA Approves Renewal of Canalevia-CA1, Jaguar Health's Drug for Chemotherapy-Induced Diarrhea (CID) in Dogs
Conditional approval extended through December 2026 for the treatment of CID in dogs CID confirmatory effectiveness trial expected to conclude in February 2026, ahead of FDA's June deadline - 51 dogs enrolled to date; ~49 more expected SAN FRANCISCO, ...
About this update from Jaguar Health, Inc.
[{"type":"list","items":[{"val":[{"type":"text","content":"Conditional approval extended through December 2026 for the treatment of CID in dogs","length":84,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":84,"olType":false},{"type":"list","items":[{"val":[{"type":"text","content":"CID confirmatory effectiveness trial expected to conclude in February 2026, ahead of FDA's June deadline - 51 dogs enrolled to date; ~49 more expected","length":154,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":154,"olType":false},{"type":"text","content":"SAN FRANCISCO, CA / ACCESS Newswire / December 10, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that the U.S. Food and Drug Administration (FDA) has granted renewal of the conditional approval for Canalevia-CA1 (crofelemer delayed-release tablets). Canalevia-CA1, the company's prescription drug for the treatment of chemotherapy-induced diarrhea (CID) in dogs, is available from multiple leading veterinary distributors in the U.S., including Chewy. The renewal of conditional approval is in effect until December 21, 2026.","length":540,"tagName":"p"},{"type":"text","content":""Canalevia-CA1 is an important prescription drug for the veterinary community and the thousands of dogs experiencing CID. We're very pleased about this conditional approval renewal, which, per FDA regulations, is for the fifth and final allowable year of conditional approval for Canalevia-CA1 for the CID indication in dogs. When an animal drug receives conditional approval, the FDA 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, our full effectiveness study of Canalevia-CA1 for the treatment of CID in dogs is underway, and this recent conditional approval renewal was granted because we were able to demonstrate active progress toward generating this required data."","length":948,"tagName":"p"},{"type":"text","content":""Diarrhea is a highly neglected and unmet medical need in dogs and people undergoing cancer treatment," said Lisa Conte, Jaguar's president and CEO. "Jaguar is deeply committed to supporting the quality of...