FDA Approves Renewal of Canalevia-CA1, Jaguar Health's Drug for Chemotherapy-Induced Diarrhea (CID) in Dogs
Rhea-AI Summary
Jaguar Health (NASDAQ:JAGX) announced the FDA renewed the conditional approval for Canalevia-CA1 (crofelemer delayed-release tablets) for chemotherapy-induced diarrhea (CID) in dogs, effective through December 21, 2026. The company said this renewal represents the fifth and final allowable year of conditional approval.
A confirmatory effectiveness trial is underway and is expected to conclude in February 2026, ahead of the FDA's June deadline; the study has enrolled 51 dogs to date with approximately 49 more expected. Canalevia-CA1 is available from multiple leading U.S. veterinary distributors, including Chewy.
Positive
- Conditional approval renewed through Dec 21, 2026
- Confirmatory effectiveness trial expected to conclude Feb 2026
- 51 dogs enrolled in the confirmatory trial to date
- Product available via major U.S. veterinary distributors including Chewy
- Renewal is the fifth and final allowable year of conditional approval
Negative
- Full approval depends on the confirmatory trial producing substantial evidence
- Study enrollment incomplete (about 49 dogs remaining expected)
Key Figures
Market Reality Check
Peers on Argus 2 Up 1 Down
JAGX was up 6.36% while close peers like QNRX (-15.86%) and AZTR (-3.33%) were down, indicating a company-specific move rather than a sector-wide biotech trend.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 08 | Stockholder meeting results | Positive | +1.9% | All proposals approved plus MVID clinical and regulatory progress updates. |
| Dec 02 | EU pathway update | Positive | -1.3% | EMA submission for EU approval pathway for Canalevia diarrhea indication. |
| Nov 24 | Patent and data update | Positive | +5.0% | New Australian patent and proof-of-concept SBS and MVID data for crofelemer. |
| Nov 20 | Clinical trial protocol | Positive | -8.2% | Amended FDA protocol for placebo-controlled MVID trial toward expedited pathway. |
| Nov 17 | Earnings and update | Neutral | +1.4% | Q3 2025 results with small revenue growth but sizable net loss and R&D updates. |
Recent news often saw modest price reactions, with both positive and negative moves, and a mixed alignment between favorable updates and share performance.
Over the last month, Jaguar Health reported Q3 2025 results with ~$3.1M net revenue and a significant net loss, alongside ongoing crofelemer clinical progress. Subsequent updates focused on patents for short bowel syndrome, amended protocols for an expedited MVID pathway, EMA engagement for Canalevia in EU dogs, and stockholder approval of financing-related proposals. Today’s FDA conditional renewal for Canalevia-CA1 and progress on the confirmatory CID trial build directly on this regulatory and clinical trajectory.
Regulatory & Risk Context
Jaguar has an effective S-3 shelf registration filed on 2025-10-03, with at least one related 424B3 usage on 2025-11-25. This active shelf provides flexibility to issue registered securities in the future, which can facilitate financing but may also introduce potential equity overhang for existing shareholders.
Market Pulse Summary
This announcement extends Canalevia-CA1’s conditional approval for chemotherapy-induced diarrhea in dogs through December 21, 2026 and confirms that the CID confirmatory effectiveness trial is underway, with 51 dogs enrolled and completion targeted for February 2026 ahead of a June 2026 FDA deadline. In recent months Jaguar has combined clinical and regulatory progress with significant financing transactions. Investors may watch trial completion, any move toward full approval, and future use of the active S-3 shelf.
Key Terms
conditional approval regulatory
AI-generated analysis. Not financial advice.
Conditional approval extended through December 2026 for the treatment of CID in dogs
CID confirmatory effectiveness trial expected to conclude in February 2026, ahead of FDA's June deadline - 51 dogs enrolled to date; ~49 more expected
SAN FRANCISCO, CA / ACCESS Newswire / December 10, 2025 / Jaguar Health, Inc.(NASDAQ:JAGX) today announced that the U.S. Food and Drug Administration (FDA) has granted renewal of the conditional approval for Canalevia-CA1 (crofelemer delayed-release tablets). Canalevia-CA1, the company's prescription drug for the treatment of chemotherapy-induced diarrhea (CID) in dogs, is available from multiple leading veterinary distributors in the U.S., including Chewy. The renewal of conditional approval is in effect until December 21, 2026.
"Canalevia-CA1 is an important prescription drug for the veterinary community and the thousands of dogs experiencing CID. We're very pleased about this conditional approval renewal, which, per FDA regulations, is for the fifth and final allowable year of conditional approval for Canalevia-CA1 for the CID indication in dogs. When an animal drug receives conditional approval, the FDA requires that a confirmatory trial take place within 5 years to provide the substantial evidence of effectiveness required for full approval of the drug for the indication," said Dr. Michael Guy, D.V.M., M.S., Ph.D., Jaguar's Vice President of Preclinical and Nonclinical Studies. "As announced, our full effectiveness study of Canalevia-CA1 for the treatment of CID in dogs is underway, and this recent conditional approval renewal was granted because we were able to demonstrate active progress toward generating this required data."
"Diarrhea is a highly neglected and unmet medical need in dogs and people undergoing cancer treatment," said Lisa Conte, Jaguar's president and CEO. "Jaguar is deeply committed to supporting the quality of life of people and animals undergoing cancer treatment."
About Conditional Approval and Full Approval
Canalevia-CA1 initially received conditional approval in December 2021 from the FDA for the treatment of CID in dogs. FDA's conditional approval allows a drug company to legally promote, advertise and sell the animal drug for the labeled uses before proving it meets the "substantial evidence" standard of effectiveness for full approval. The conditional approval is valid for one year, with up to four annual renewals, for a total of five years of conditional approval. To receive a renewal from the FDA, the company must show active progress toward proving "substantial evidence of effectiveness" for full approval. After collecting the remaining effectiveness data, the company then applies to the FDA for full approval. The FDA reviews the application and, if appropriate, fully approves the drug.
About Canalevia®-CA1
Canalevia-CA1 contains crofelemer, Jaguar's novel, oral plant-based drug sustainably harvested from the Croton lechleri tree, that modulates chloride channels in the gastrointestinal tract to reduce diarrhea. Importantly, 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. Canalevia-CA1, currently conditionally approved by the FDA under application number 141-552, is a tablet that can be given orally twice a day for up to three days and can be used for home treatment of CID in 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 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 (crofelemer delayed-release tablets) 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 napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Magdalena Biosciences, visit magdalenabiosciences.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 the company's ongoing trial will provide the substantial evidence of effectiveness required for full approval of the drug for treatment of CID in dogs and will conclude in February 2026 with an approximate total of 100 dogs having participated. 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:
hello@jaguar.health
Jaguar-JAGX
SOURCE: Jaguar Health, Inc.
View the original press release on ACCESS Newswire
FAQ
What did Jaguar Health (JAGX) announce about Canalevia-CA1 on December 10, 2025?
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