Jaguar Health has established the first study site for its field study of Canalevia-CA1, marking a significant step toward full FDA approval of the only conditionally approved prescription drug for treating chemotherapy-induced diarrhea (CID) in dogs. The prospective, randomized, open-label field study aims to collect real-world data demonstrating clinical effectiveness across multiple U.S. veterinary sites.
The San Francisco-based pharmaceutical company is pursuing dual objectives with its crofelemer-based therapy: securing full FDA approval for CID treatment and expanding the drug's indication to address general, non-infectious diarrhea in dogs. Lisa Conte, Jaguar's founder and CEO, emphasized the market opportunity, stating that U.S. veterinarians see approximately six million annual cases of acute and chronic diarrhea in dogs.
Addressing Significant Unmet Medical Need
Cancer represents a substantial health burden for companion animals, with approximately 1 in 4 dogs developing cancer at some stage in their lives and nearly 50% of dogs over age 10 affected by the disease. According to the National Cancer Institute, roughly 6 million new cancer diagnoses are made in dogs each year in the U.S., creating a substantial population requiring supportive cancer care.
"Dogs get cancer at roughly the same rate as people," Conte explained, highlighting the parallel between human and veterinary oncology needs. The increasing adoption of chemotherapeutic agents by veterinary oncologists has made chemotherapy the most widely used cancer treatment in veterinary medicine, with CID identified as one of the three most prevalent side effects in dogs undergoing cancer treatment.
Expanding Market Opportunities
Beyond cancer treatment, Jaguar has identified a broader market opportunity in treating general canine diarrhea. The company has established a new Investigational New Animal Drug (INAD) file with the FDA's Center for Veterinary Medicine for crofelemer to treat general, non-infectious diarrhea in dogs. This represents a significant unmet need, as diarrhea is one of the most common reasons for veterinary office visits and the second most common reason for emergency veterinary visits, yet no FDA-approved drugs currently exist for treating general diarrhea in dogs.
The potential market is substantial, with an estimated 89.7 million dogs in the United States in 2024 and nearly half (45.5%) of U.S. households owning a dog. Conte noted that "devastating diarrhea-related dehydration can occur rapidly for the animal, and the lack of control in urban settings where owners don't have easy access to outdoor facilities is a significant problem for families with dogs."
Partnership Strategy and Development Pipeline
Jaguar is actively pursuing partnerships to fund development and commercialization of crofelemer for general, non-infectious diarrhea treatment in dogs, both in the U.S. and globally. This business development effort has been designated as a key potential catalyst for the company in 2025.
The company's development strategy extends beyond veterinary applications. Conte outlined parallel human health initiatives, including pathways discussed with the FDA to bring crofelemer to metastatic breast cancer patients, potentially qualifying for orphan drug status, and an expanded access program for cancer therapy-related diarrhea in breast cancer patients.
Clinical Evidence and Regulatory Pathway
Canalevia-CA1 initially received conditional approval in December 2021 from the FDA for treating CID in dogs. The conditional approval pathway allows legal promotion and sale while the company continues collecting substantial evidence of effectiveness required for full approval. Companies can renew conditional approval annually for up to five years, provided they demonstrate active progress toward proving effectiveness.
The ongoing field study will randomly assign dogs undergoing chemotherapy treatment to receive either Canalevia-CA1 or serve as controls, generating real-world evidence to support full FDA approval. More than half of U.S. veterinarians responding to a Jaguar-sponsored survey reported that CID interferes with their patients' chemotherapy treatment plans, indicating clear clinical need for effective treatment options.
Plant-Based Innovation
Canalevia-CA1 represents a unique therapeutic approach as a canine-specific formulation of crofelemer, derived from the red bark sap of the Croton lechleri tree in the Amazon Rainforest. Crofelemer is the only oral FDA-approved prescription drug developed under botanical guidance, and Napo Pharmaceuticals, a Jaguar family company, has established a sustainable harvesting program under fair trade practices to ensure quality, ecological integrity, and support for Indigenous communities.
The drug is administered as an oral tablet twice daily and is available from multiple leading veterinary distributors in the U.S., including Chewy. Canalevia-CA1 has also received Minor Use in a Major Species (MUMS) designation from the FDA, with the current small number threshold set at 80,000 dogs annually.
