Jaguar Health receives $250,000 FDA grant for canine diarrhea drug study

SAN FRANCISCO - Jaguar Health, Inc. (NASDAQ:JAGX), a pharmaceutical company with revenue growth of 15.95% over the last twelve months and a current market capitalization of $4.68 million, has received notice of a $250,000 grant from the U.S. Food and Drug Administration’s Center for Veterinary Medicine to support a confirmatory study for its canine diarrhea treatment, the company announced Thursday. According to InvestingPro analysis, while the company maintains a strong gross profit margin of 81.88%, it faces challenges with cash burn and profitability.

The grant would fund research required for full FDA approval of Canalevia (crofelemer delayed-release tablets) for treating chemotherapy-induced diarrhea (CID) in dogs. The drug is currently conditionally approved under the name Canalevia-CA1.

Jaguar has not yet accepted the award, which is contingent upon compliance with FDA terms and conditions.

"When an animal drug receives conditional approval, the CVM requires that a confirmatory trial take place within 5 years to provide the substantial evidence of effectiveness required for full approval," said Dr. Michael Guy, Jaguar’s Vice President of Preclinical and Nonclinical Studies.

According to the company, enrollment has begun in the ongoing effectiveness study of Canalevia-CA1 for CID in dogs. Jaguar plans to request approval to use the grant for this modified field study.

The company is also in discussions with potential animal health partners to expand Canalevia’s indication from CID to general diarrhea in dogs and to obtain approval in the European Union.

Canalevia contains crofelemer, a plant-based prescription drug that modulates chloride channels in the gastrointestinal tract to reduce diarrhea. Unlike antibiotics, which can contribute to bacterial resistance when overused, Canalevia offers an alternative treatment approach.

According to industry data cited in the press release, there are approximately 90 million dogs in the U.S., with an estimated 11 million suffering from general diarrhea annually. The company notes that diarrhea is one of the most common reasons dogs are seen by veterinarians. InvestingPro research reveals additional insights about Jaguar Health’s financial position and market potential, with 12 exclusive ProTips and comprehensive analysis available in the Pro Research Report, helping investors make informed decisions about this pharmaceutical company’s growth trajectory.

In other recent news, Jaguar Health reported a 35% increase in net revenue for the second quarter of 2025 compared to the previous quarter, and a 10% rise year-over-year. Despite this revenue boost, the company continues to face operational losses while working to expand its product pipeline. In another development, Jaguar Health’s subsidiary, Napo Pharmaceuticals, plans to meet with the U.S. Food and Drug Administration regarding the clinical development of crofelemer for treating microvillus inclusion disease, a rare pediatric disorder. Initial results from a trial in Abu Dhabi indicated that crofelemer reduced the need for total parenteral nutrition by up to 27% in the first patient. Additionally, Jaguar Health extended the role of Lucid Capital Markets in its At the Market Offering Agreement until the end of 2025. Lucid will continue to serve as a manager alongside Ladenburg Thalmann & Co. Inc., unless the agreement is further extended. These developments reflect Jaguar Health’s ongoing strategic initiatives and regulatory engagements.

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