Jaguar Health Announces Statistically Significant Results from Effectiveness Trial of Crofelemer (FDA Approved Canalevia-CA1) for Treatment of Chemotherapy-Induced Diarrhea in Dogs
Rhea-AI Summary
Jaguar Health (NASDAQ:JAGX) reported statistically significant effectiveness from a pivotal field trial of crofelemer (conditionally approved Canalevia-CA1) for chemotherapy-induced diarrhea (CID) in dogs. Dogs treated twice daily showed an average daily stool regarded as normal after three days. Owner surveys: 83% found treatment effective; ~40% reported complete resolution. Comparator: 12.5% of owners reported improvement without CID treatments. Jaguar expects to file full trial data to support a full FDA approval and pursue scientific publication.
Positive
- Statistically significant effectiveness demonstrated in pivotal CID trial
- Owner-reported 83% effectiveness for Canalevia-CA1
- ~40% of owners reported complete resolution of CID symptoms
- Treatment produced normal average daily stool after 3 days of twice-daily dosing
- Company plans to file full trial data to support full FDA approval
Negative
- Drug currently conditionally approved by FDA pending full demonstration of effectiveness
- Most common adverse reactions include decreased appetite, decreased activity, dehydration, abdominal pain, vomiting
- Study relied on owner surveys and real-world data, which can increase variability in outcomes
News Market Reaction – JAGX
In the Apr 29 session, JAGX declined 6.64%, reflecting a notable negative market reaction. Argus tracked a peak move of +3608.7% during that session. Our momentum scanner triggered 6 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 |
|---|---|---|---|---|
| Apr 08 | Effectiveness trial update | Positive | -2.6% | Completion of effectiveness study and FDA renewal of conditional approval for CID. |
| Jan 02 | FDA funding grant | Positive | +7.1% | FDA CVM grant of $240,000 to support Canalevia-CA1 effectiveness study. |
| Dec 10 | Conditional approval renewal | Positive | +13.7% | FDA renewal of conditional approval for Canalevia-CA1 through Dec 21, 2026. |
| Sep 25 | FDA grant notice | Positive | -4.7% | Notice of potential $250,000 FDA grant to fund confirmatory Canalevia trial. |
| Jul 10 | Study enrollment progress | Positive | +0.0% | Enrollment progress in field study of conditionally approved Canalevia-CA1 for CID. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
FDA-related news for Canalevia-CA1 has often been positive, but price reactions have been mixed, with both strong gains and notable selloffs around prior regulatory milestones.
Over the past year, Jaguar’s key milestones around Canalevia-CA1 for chemotherapy-induced diarrhea in dogs have included study initiation, FDA grant support, conditional approval renewal through December 21, 2026, and completion of the effectiveness trial. Price reactions to these fda approval-tagged updates have alternated between gains and pullbacks, showing no consistent directional pattern. Today’s statistically significant effectiveness results fit into this sequence as another step toward full FDA approval using the same underlying program.
Key Terms
chemotherapy-induced diarrhea medical
cid medical
antisecretory medical
mechanism of action medical
real-world data medical
real-world evidence medical
conditionally approved regulatory
adverse reactions medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Company Advances Towards Full FDA Approval of Crofelemer for Chemotherapy-Induced Diarrhea
SAN FRANCISCO, CA / ACCESS Newswire / April 29, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced topline results from the completion of its effectiveness trial of crofelemer (FDA conditionally approved Canalevia-CA1) for the treatment of chemotherapy-induced diarrhea (CID) in dogs. The statistically significant results demonstrated that dogs suffering from CID that were treated with Canalevia-CA1 twice daily at the onset of diarrhea had, at the end of 3 days of treatment, an average daily stool that is regarded as normal. Moreover, an owner's survey at the end of the study reported that
"We are quite pleased with the study results, supporting the paradigm shifting antisecretory mechanism of action of crofelemer in CID, typically a chloride ion mediated secretory diarrhea common across all mammals. Our vision at the company is to expand the opportunity to treat a broader collection of symptomatic diarrhea causes in companion animals with an anti-secretory approach," said Lisa Conte, Jaguar Founder and CEO.
This study, "Clinical Field Study to Collect Real-World Data (RWD) to Demonstrate Real-World Evidence (RWE) of Effectiveness for Canalevia®-CA1 (Crofelemer delayed-release tablets) 125 mg for the Treatment of Chemotherapy-Induced Diarrhea (CID) in Dogs" is the pivotal study in substantiating treatment effectiveness in the upcoming Animal Drug application.
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
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.
Contact:
hello@jaguar.health
Jaguar-JAGX
SOURCE: Jaguar Health, Inc.
View the original press release on ACCESS Newswire