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Article about Canalevia-CA1, Jaguar Health's Prescription Drug Conditionally Approved by the FDA for the Treatment of Chemotherapy-Induced Diarrhea in Dogs, Published in PetVet Magazine

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Jaguar Health's prescription drug Canalevia-CA1 for treating chemotherapy-induced diarrhea (CID) in dogs has been featured in PetVet Magazine. The drug, which contains crofelemer as its active ingredient, is the first and only FDA-conditionally approved treatment for CID in dogs.

Canalevia-CA1 is a canine-specific formulation derived from the Croton lechleri tree. The drug addresses a significant health concern, as cancer therapy-related diarrhea can impact treatment effectiveness and may require dosing adjustments or discontinuation of cancer medications. The same active ingredient is being studied in Jaguar's Phase 3 OnTarget trial for cancer therapy-related diarrhea in humans.

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Positive

  • First and only FDA-conditionally approved treatment for chemotherapy-induced diarrhea in dogs
  • Potential market expansion with ongoing Phase 3 human trials for similar indication

Negative

  • Only conditional FDA approval, pending full demonstration of effectiveness
  • Reported adverse reactions including decreased appetite, activity, dehydration, abdominal pain, and vomiting

News Market Reaction

+0.90%
1 alert
+0.90% News Effect

On the day this news was published, JAGX gained 0.90%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Canalevia®-CA1 is a canine-specific formulation of crofelemer, Jaguar's novel, oral plant-based drug sustainably harvested from the Croton lechleri tree

Crofelemer, the active ingredient in Canalevia CA-1, is the subject of Jaguar's recently conducted Phase 3 OnTarget trial in humans for cancer therapy-related diarrhea

SAN FRANCISCO, CA / ACCESSWIRE / December 5, 2024 / Jaguar Health, Inc.(NASDAQ:JAGX) (Jaguar) today announced that an article about Canalevia-CA1 (crofelemer delayed-release tablets), Jaguar's prescription drug for the treatment of chemotherapy-induced diarrhea (CID) in dogs, has been published in PetVet Magazine and can be viewed by clicking here.

Canalevia-CA1 is conditionally approved by the U.S. Food and Drug Administration for the treatment of CID in dogs and is the first and only treatment for CID in dogs to receive any approval from the FDA.

"As the article states, whether a patient has two legs or four, cancer therapy-related diarrhea (CTD) can have a significant effect on morbidity and mortality. In human patients, managing CTD may require dosing holidays, dose reductions or discontinuations of cancer drugs, potentially resulting in less effective cancer treatment, treatment resistance or failures," 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."

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 and/or rare 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

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.

Source: Jaguar Health, Inc.

Contact:

hello@jaguar.health

Jaguar-JAGX

SOURCE: Jaguar Health, Inc.



View the original press release on accesswire.com

FAQ

What is Canalevia-CA1 (JAGX) approved to treat?

Canalevia-CA1 is conditionally approved by the FDA to treat chemotherapy-induced diarrhea (CID) in dogs.

What are the main side effects of Canalevia-CA1 (JAGX)?

The most common adverse reactions include decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.

Is Canalevia-CA1 (JAGX) fully approved by the FDA?

No, Canalevia-CA1 is conditionally approved by the FDA pending a full demonstration of effectiveness under application number 141-552.

What is the active ingredient in Canalevia-CA1 (JAGX)?

The active ingredient is crofelemer, a plant-based drug sustainably harvested from the Croton lechleri tree.
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