Jaguar Health Extends Conditional Approval for Canalevia-CA1 Until December 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 10 2025
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Source: Newsfilter
- Conditional Approval Renewal: Jaguar Health announced that the FDA has renewed the conditional approval for Canalevia-CA1 until December 21, 2026, indicating the company's positive progress in addressing the urgent market need for effective treatments for chemotherapy-induced diarrhea (CID) in dogs.
- Clinical Trial Progress: With 51 dogs currently enrolled, the confirmatory effectiveness trial is expected to conclude in February 2026, which will provide the necessary data for FDA full approval, further solidifying the company's position in the veterinary pharmaceuticals market.
- Market Demand Fulfillment: A survey indicated that over half of veterinarians reported CID affecting their patients' chemotherapy plans, and the introduction of Canalevia-CA1 will help address this unmet medical need, enhancing the quality of life for canine cancer patients.
- Drug Characteristics: Canalevia-CA1 is a plant-based drug that modulates chloride channels in dogs' gastrointestinal tracts to reduce diarrhea, and importantly, it does not involve the use of antibiotics, aligning with current safety standards in veterinary medicine.
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Analyst Views on JAGX
About JAGX
Jaguar Health, Inc. is a commercial stage pharmaceuticals company. The Company is developing prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Its marketed drug Mytesi, (crofelemer 125 mg delayed-release tablets), is a first-in-class oral botanical drug product approved by the FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Its Canalevia-CA1, crofelemer delayed-release tablets drug, is an oral plant-based prescription product that is FDA conditionally approved to treat chemotherapy-induced diarrhea in dogs. It has an exclusive distribution agreement for the sale of Gelclair. It is developing a pipeline of prescription drug product candidates to address unmet needs in gastrointestinal health.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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