Jaguar Health Completes Canalevia-CA1 Dog Trial, Eyes Full FDA Approval in Q2
Jaguar Health completed its canine crofelemer effectiveness study for chemotherapy-induced diarrhea and expects topline results within a month to secure full FDA approval before its Conditional License expires December 21, 2026. It will file Q2 2026 data alongside a 28-day neratinib trial showing a 30% diarrhea reduction.
1. Completion of Canalevia-CA1 Effectiveness Study
Jaguar Health has concluded enrollment in its multicenter effectiveness study of crofelemer delayed-release tablets for chemotherapy-induced diarrhea in dogs. Topline results are expected within one month, which will determine the filing for full FDA approval before the conditional license expires on December 21, 2026.
2. Positive Neratinib Trial Findings
A separate 28-day study in dogs treated with neratinib showed crofelemer reduced the incidence and severity of diarrhea by 30% with statistical significance, supporting the drug's therapeutic potential alongside targeted TKI treatments.
3. Regulatory and Submission Timeline
The FDA renewed Canalevia-CA1’s conditional approval through its fifth and final year, requiring successful confirmatory data to secure a full veterinary drug approval. Jaguar plans to submit both its CID effectiveness data and neratinib trial results in Q2 2026 under NADA application 141-552.
4. Market Opportunity and Veterinary Impact
With an estimated 90 million dogs in the US and over one in four receiving cancer treatment, managing chemotherapy-induced diarrhea represents a substantial unmet need. Jaguar estimates more than 11 million dogs suffer from general diarrhea annually, highlighting potential commercial upside.