Jaguar Health Inc. (NASDAQ: JAGX) announced completion of an effectiveness study for crofelemer delayed-release tablets to treat chemotherapy-induced diarrhea in dogs. The drug, marketed as Canalevia-CA1, currently holds conditional FDA approval that expires December 21, 2026.

The company conducted the study at veterinary oncology clinics across the United States. Topline results are expected within a month, according to the press release.

"The FDA granted renewal of the conditional approval for Canalevia-CA1 for a fifth and final year, through December 21, 2026, for the treatment of CID in dogs. In order to receive a full veterinary drug approval for the indication of CID beyond Dec. 21, 2026, Jaguar must complete and file a successful effectiveness study," said Dr. Michael Guy, the company's Vice President of Preclinical and Nonclinical Studies.

Jaguar plans to submit the effectiveness study results in the second quarter of 2026, along with results from a separate study examining crofelemer's effects on dogs receiving neratinib, a cancer therapy known to cause diarrhea. The neratinib study showed a 30% reduction in diarrhea incidence and severity, which was statistically significant.

The neratinib study results were presented at the American Association for Cancer Research Virtual Annual Meeting II in June 2020 and published in PLOS ONE in January 2024. The study was conducted by Napo Pharmaceuticals, a Jaguar family company, in collaboration with Puma Biotechnology Inc.

According to the American Veterinary Medical Association, approximately one in four dogs develop cancer during their lifetime. The National Cancer Institute estimates roughly 6 million new cancer diagnoses occur in dogs yearly in the United States.

Canalevia-CA1 is conditionally approved specifically for treating chemotherapy-induced diarrhea in dogs and requires a veterinarian's prescription.