Jaguar Health Files NADA After 77% Efficacy, 40% Complete CID Resolution in Dogs
JAGX•Jaguar Health submitted its New Animal Drug Application to the FDA for full approval of Canalevia®-CA1 as a treatment for chemotherapy-induced diarrhea in dogs. In the pivotal trial, 77% of owners rated the treatment effective and 40% of dogs achieved complete resolution versus 10.5% without any treatment.
1. NADA Submission
Jaguar Health has submitted a New Animal Drug Application to the FDA’s Center for Veterinary Medicine requesting full approval of Canalevia-CA1 for the treatment of chemotherapy-induced diarrhea in dogs. This submission follows a conditional approval period and includes data from pivotal efficacy and delayed-release tablet studies.
2. Pivotal Effectiveness Study
In the pivotal effectiveness trial, dogs receiving Canalevia-CA1 twice daily achieved normal average daily stool scores by day three of treatment. Owners reported 77% treatment effectiveness and 40% complete symptom resolution, compared with 10.5% spontaneous resolution in untreated dogs.
3. Market Opportunity
Industry data show that roughly one in four dogs develops cancer, yielding approximately six million new canine cancer diagnoses annually in the U.S. Diarrhea is a leading side effect of chemotherapy, yet no non-infectious diarrhea therapies are currently FDA-approved for dogs, indicating strong market potential for Canalevia-CA1.
4. Safety and Next Steps
Canalevia-CA1’s safety profile includes decreased appetite, reduced activity, dehydration, abdominal pain and vomiting as the most common adverse reactions. Jaguar Health now awaits FDA review, which could pave the way for unrestricted veterinary use and broaden its commercial portfolio.
