Jaguar Health Seeks EMA Approval for Canalevia in European Union to Treat General Diarrhea in Dogs
Key Insights
Jaguar Health's Italian subsidiary has submitted a request to the European Medicines Agency (search) seeking scientific advice for EU approval of Canalevia (search) to treat general diarrhea in dogs based on a 200-dog study from 2017.
The plant-based drug crofelemer showed significantly better outcomes than placebo in an updated analysis, with dogs experiencing fewer watery stools and improved fecal scores after treatment.
The EMA will have 60-90 days to review the data and determine if it supports approval, potentially opening access to a market of 69.4 million dogs across 27 EU member countries.
Jaguar Health has taken a significant step toward expanding access to its plant-based diarrhea treatment for dogs in Europe, with its Italian subsidiary Napo Therapeutics (search) S.p.A. submitting a request to the European Medicines Agency (search) (EMA) for scientific advice on pursuing EU approval of Canalevia (search) for general diarrhea in dogs.
The submission, announced December 2, 2025, seeks guidance from the EMA's Committee for Veterinary Medicinal Products (CVMP) on the company's plan to obtain approval based on data from a study completed in 200 dogs in 2017. The CVMP is scheduled to review the company's plan and related data during its March 2026 meeting.
Study Results Show Promise Despite Initial Setback
While the original 200-dog study did not meet its pre-specified primary endpoint, an updated analysis using a simplified endpoint definition showed encouraging results. Dr. Michael Guy, Jaguar's Vice President of Preclinical and Nonclinical Studies, explained that the revised analysis defined treatment success as no further episodes of diarrhea after the first treatment.
"Dogs treated with Canalevia (search) had significantly better outcomes than those receiving placebo, including fewer watery stools and improved fecal scores," Guy stated. The company has provided the CVMP with a summary of this updated analysis for review.
Regulatory Timeline and Market Opportunity
Following the procedure's start in mid-January, the EMA will have 60 days, extendable to 90, to indicate whether the updated analysis would support approval of Canalevia (search) for treating general diarrhea in dogs in the EU. If the EMA agrees, Jaguar will submit a Marketing Authorization Application, which if approved, would make Canalevia marketable across all 27 EU member countries.
The potential market is substantial, with data from the European Pet Food Industry Federation indicating 69,359,000 dogs in the EU in 2023. This compares to an estimated 89.7 million dogs in the US in 2024, with nearly half (45.5%) of US households owning a dog.
Addressing an Unmet Medical Need
The pursuit of EU approval addresses a significant gap in veterinary medicine. Diarrhea represents one of the most common reasons dogs visit general practice veterinarians and is the second most common reason for visits to veterinary emergency hospitals. Despite this prevalence, no FDA-approved drug currently exists to treat general, non-infectious diarrhea in dogs.
"We estimate that US veterinarians see approximately 6 million annual cases of acute and chronic diarrhea in dogs," said Lisa Conte, Jaguar's Founder and CEO. The company sees meaningful opportunity in this larger market compared to its current indication for chemotherapy-induced diarrhea.
Plant-Based Non-Antibiotic Approach
Canalevia (search) contains crofelemer, a novel oral plant-based drug sustainably harvested from the Croton lechleri tree. The compound modulates chloride channels in the gastrointestinal tract to reduce diarrhea without using antibiotics, addressing concerns about antibiotic resistance development in both humans and animals.
The drug is currently conditionally approved by the FDA under the name Canalevia (search)-CA1 for treating chemotherapy-induced diarrhea in dogs. This conditional approval, received in December 2021, allows commercialization while the company continues collecting substantial evidence of effectiveness required for full approval.
Business Development Focus
Jaguar has made business development around general diarrhea in dogs a key focus and potential catalyst for 2025. "Our primary objective for Canalevia (search) is to secure a partner to help fund and execute development and commercialization globally for treatment of general diarrhea in dogs, while we continue to support availability for CID in dogs in the US," Conte explained.
The company reports being pleased with the marketplace reception of crofelemer for treating chemotherapy-induced diarrhea in dogs in the US, with the product available through multiple leading veterinary distributors including Chewy.
Cancer Context Underscores Need
The importance of effective diarrhea treatment extends beyond general cases to cancer care. According to the American Veterinary Medical Association, approximately 1 in 4 dogs will develop cancer at some stage, with nearly half of dogs over 10 developing the disease. The National Cancer Institute reports roughly 6 million new cancer diagnoses in dogs yearly in the US.
Studies have identified chemotherapy-induced diarrhea as one of the three most prevalent side effects in dogs undergoing cancer treatment. More than half of US veterinarians in a Jaguar-sponsored survey reported that such diarrhea interferes with their patients' chemotherapy treatment plans, highlighting the unmet need for effective treatments.