Jaguar Health, Inc. has submitted a New Animal Drug Application (NADA) to the U.S. Food and Drug Administration's Center for Veterinary Medicine for full approval of crofelemer to treat chemotherapy-induced diarrhea (CID) in dogs. The submission marks a significant step in the company's efforts to secure full regulatory clearance for its veterinary medicine.

Crofelemer, marketed under the brand name Canalevia-CA1, is currently conditionally approved for the treatment of CID in dogs. The NADA submission seeks to transition the drug from conditional to full approval, which would solidify its market position.

The application was filed with the FDA's Center for Veterinary Medicine, the regulatory body overseeing animal health products. Full approval would require the company to meet all necessary efficacy and safety standards outlined by the agency.

Jaguar Health's move underscores its commitment to advancing treatments for canine oncology patients. The company aims to address a critical need for effective therapies managing chemotherapy side effects in dogs.

Jaguar Health, Inc. (NASDAQ: JAGX) has initiated a process to explore and review a range of strategic alternatives focused on maximizing stockholder value. This review aligns with the anticipated completion of clinical work supporting the filing of a New Drug Application (NDA) for its crofelemer-based prescription drug candidate for rare intestinal failure diseases. The Board of Directors is considering options that may include mergers, reverse mergers, acquisitions, partnerships, joint ventures, licensing arrangements, or other strategic transactions involving biotech or non-biotech companies. The company emphasized that there is no assurance this exploration will result in a completed transaction.

Lisa Conte, Jaguar's founder, president, and CEO, stated that the company remains committed to its development program for crofelemer. She believes identifying a suitable strategic alternative will support the goal of maximizing the value of the intestinal failure development program for all stakeholders, including patients, the healthcare community, and shareholders.

The strategic review coincides with clinical progress for crofelemer. In an ongoing investigator-initiated proof-of-concept trial for pediatric patients with intestinal failure due to microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF), the drug demonstrated a reduction of parenteral support of up to 37%. A late-breaking abstract with updates on this trial is scheduled for presentation at the European Society for Pediatric Gastroenterology, Hepatology & Nutrition (ESPGHAN) Annual Meeting in June 2026.

Market Opportunity and Indication

Patients with intestinal failure cannot absorb sufficient nutrients or fluids and often require lifelong intravenous nutritional support. While lifesaving, this support is associated with serious complications. A third-party market research report estimates the global value of the nutritional support market for MVID, an ultrarare congenital disorder with no approved therapies, is approximately $1.1 billion in 2026, rising to approximately $1.5 billion in 2033.

Jaguar Health, Inc. develops novel proprietary prescription drugs sustainably derived from plants for people with complicated gastrointestinal disease states. Its family companies, Napo Pharmaceuticals, Inc. and Napo Therapeutics S.p.A., focus on the development and commercialization of novel crofelemer powder for oral solution. Magdalena Biosciences, a joint venture with Filament Health Corp., focuses on developing novel prescription medicines derived from plants for mental health indications.