Jaguar Health Completes Effectiveness Trial to Support FDA Approved Crofelemer for Treatment of Chemotherapy-Induced Diarrhea (CID) in Dogs
Rhea-AI Summary
Jaguar Health (NASDAQ:JAGX) completed its effectiveness study of Canalevia-CA1 (crofelemer) for chemotherapy-induced diarrhea (CID) in dogs and expects topline results within a month. The FDA renewed conditional approval through Dec 21, 2026; Jaguar plans to file effectiveness results in Q2 2026 to seek full approval.
A prior 28-day neratinib study showed a 30% reduction in incidence and severity of diarrhea, reported as statistically significant.
Positive
- Effectiveness study completed for CID in dogs
- FDA conditional approval renewed through Dec 21, 2026
- Planned Q2 2026 filing of effectiveness results seeking full approval
- Neratinib study: 30% reduction in diarrhea incidence and severity
Negative
- Conditional approval expires Dec 21, 2026, requiring full approval to continue commercialization
- Regulatory dependency: full veterinary approval contingent on positive effectiveness study filing
News Market Reaction – JAGX
In the Apr 8 session, JAGX declined 2.56%, reflecting a moderate negative market reaction. Argus tracked a trough of -23.4% from its starting point during tracking. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Fda approval Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jan 02 | FDA grant support | Positive | +7.1% | FDA CVM awarded a $240,000 grant backing Canalevia-CA1 effectiveness study. |
| Dec 10 | Conditional renewal | Positive | +13.7% | FDA renewed conditional approval for Canalevia-CA1 through December 21, 2026. |
| Sep 25 | Grant & expansion | Positive | -4.7% | Notice of a $250,000 FDA grant and plans to expand Canalevia indications. |
| Jul 10 | Study enrollment | Positive | +0.0% | Enrollment progress in field study of conditionally approved Canalevia-CA1 in dogs. |
| Jun 11 | Site initiation | Positive | -0.5% | First study site established for Canalevia-CA1 field study targeting CID in dogs. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
FDA-related Canalevia-CA1 updates have generally been positive but produced mixed trading reactions, with more instances of divergence than alignment.
Over the past year, Jaguar has steadily advanced Canalevia-CA1 toward full FDA approval for chemotherapy-induced diarrhea in dogs. Events included a $250,000 FDA grant notice on Sep 25, 2025, initiation and expansion of the field study from Jun 11 through Jul 10, 2025, and renewal of conditional approval through Dec 21, 2026 on Dec 10, 2025. A further $240,000 FDA grant was announced on Jan 1, 2026. Today’s completion of the effectiveness trial fits this progression toward full approval.
Key Terms
chemotherapy-induced diarrhea medical
tyrosine kinase inhibitor medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Topline results expected within a month and may complement positive results of a study of crofelemer for treatment of cancer therapy-induced diarrhea (CTD) in dogs receiving neratinib - a targeted tyrosine kinase inhibitor (TKI)
SAN FRANCISCO, CA / ACCESS Newswire / April 8, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that the Company has completed the company's ongoing effectiveness study of crofelemer delayed-release tablets for the treatment of chemotherapy-induced diarrhea (CID) in dogs. Crofelemer, under the name Canalevia-CA1, is currently conditionally approved for the sole indication of treating CID in dogs. The approval for Canalevia CA-1 will expire on December 21, 2026.
"We're very pleased that enrollment has concluded for this study, which is being undertaken at veterinary oncology clinics around the US. 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, D.V.M., M.S., Ph.D., Jaguar's Vice President of Preclinical and Nonclinical Studies.
In the second quarter of 2026 Jaguar plans to submit and file the results of the company's effectiveness study and the positive results of a study of crofelemer delayed-release tablets for treatment of CTD in dogs receiving neratinib - a targeted tyrosine kinase inhibitor (TKI) chemotherapy agent.
"The 28-day study in dogs receiving neratinib was designed to evaluate the scientific rationale for the use of crofelemer tablets in reducing the severity and incidence of diarrhea in cancer patients receiving neratinib, a targeted therapy known to cause significant diarrhea," said Dr. Guy "The study demonstrated that crofelemer dosing resulted in a
The results of the neratinib study were presented at the American Association for Cancer Research Virtual Annual Meeting II in June 2020 and published in the peer-reviewed journal PLOS ONE in January 2024. The study, titled Effects of orally administered crofelemer on the incidence and severity of neratinib-induced diarrhea in female dogs, was conducted by Jaguar family company Napo Pharmaceuticals in collaboration with Puma Biotechnology, Inc. and can be viewed by clicking here.
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 Association concluded that there were approximately 90 million dogs in the US in 2025, 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 90 million dogs in Europe in 2023.
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.
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. Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including MVID and short bowel syndrome.
For more information about:
Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit www.napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Canalevia-CA1, visit canalevia.com
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that it will submit an administrative NADA for crofelemer in the second quarter of 2026 that will include the results of the company's ongoing confirmatory study of crofelemer for treatment for CID in dogs and the results of the study of crofelemer for treatment of CID in dogs receiving neratinib. 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:
Jaguar-JAGX
SOURCE: Jaguar Health, Inc.
View the original press release on ACCESS Newswire