The Fort Worth Press - Jaguar Health Awarded $240,000 FDA Grant in Support of Canalevia-CA1 for Treatment of Chemotherapy-Induced Diarrhea (CID) in Dogs

"As announced on December 10, 2025, 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, Jaguar must complete and file a successful effectiveness study," said Dr. Michael Guy, D.V.M., M.S., Ph.D., Jaguar's Vice President of Preclinical and Nonclinical Studies.

Dogs undergoing chemotherapy are an important predictive model for the mechanism of action in humans experiencing diarrhea due to cancer treatment. Many cancer treatment agents provided to dogs are human drugs, or have the same mechanism of action as human cancer drugs, and these agents and mechanisms of action often have meaningful rates of diarrhea in dogs and humans.

A report by the American Veterinary Medical Foundation concluded that there were approximately 90 million dogs in the U.S. in 2024, of which Jaguar estimates more than 11 million suffer from general diarrhea each year. Data from the European Pet Food Industry Federation concluded that there were approximately 104 million dogs in Europe in 2022.

Canalevia is not an antibiotic drug. The overuse and misuse of antibiotics, both in humans and animals, contribute to the development of bacteria that are resistant to antibiotics.

Diarrhea is one of the most common reasons dogs are seen by general practice veterinarians and is the second most common reason for visits to veterinary emergency hospitals, yet there is currently no FDA-approved drug to treat general, non-infectious diarrhea in dogs. Devastating diarrhea-related dehydration can occur rapidly for the animal, and the lack of easy access to outdoor facilities is a significant problem for families living in urban settings with dogs.

About Chemotherapy-induced Diarrhea (CID) in Dogs

According to the American Veterinary Medical Association, approximately 1 in 4 dogs will at some stage in their life develop cancer. Nearly half of dogs over 10 will develop cancer.¹ According to the National Cancer Institute at the National Institutes of Health, roughly 6 million new cancer diagnoses are made in dogs yearly in the US.

Due to the increasing number of chemotherapeutic agents, chemotherapy is fast becoming the most widely used cancer treatment in veterinary medicine. Studies have found the incidence of CID to be one of the three most prevalent side effects in dogs undergoing cancer treatment,² and managing side-effects such as diarrhea can be important to maintain successful cancer treatment. More than half of the US veterinarians who responded to a Jaguar-sponsored survey reported that CID interferes with their canine patients' chemotherapy treatment plans, indicating an unmet need for an effective product for the treatment of CID.

Important Safety Information About Canalevia^®-CA1

For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.

About the Jaguar Health Family of Companies

Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

For more information about:

Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit www.napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Magdalena Biosciences, visit magdalenabiosciences.com
Canalevia-CA1, visit canalevia.com

Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements." In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

¹ "Cancer in Pets." American Veterinary Medical Association, 2021, https://www.avma.org/resources/pet-owners/petcare/cancer-pets

² Mason SL, Grant IA, Elliott J, Cripps P, Blackwood L. Gastrointestinal toxicity after vincristine or cyclophosphamide administered with or without maropitant in dogs: a prospective randomised controlled study. J Small Anim Pract. 2014;55:391-398

Contact:

[email protected]
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

S.Rocha--TFWP