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
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.
Canalevia-CA1 di Jaguar Health, un farmaco prescritto per il trattamento della diarrea indotta da chemioterapia (CID) nei cani, è stato presentato su PetVet Magazine. Questo farmaco, che contiene crofelemer come principio attivo, è il primo e unico trattamento approvato condizionatamente dalla FDA per il CID nei cani.
Canalevia-CA1 è una formulazione specifica per i cani derivata dall'albero Croton lechleri. Il farmaco affronta una problematica sanitaria significativa, poiché la diarrea legata alla terapia oncologica può influenzare l'efficacia del trattamento e potrebbe richiedere aggiustamenti della dose o la sospensione dei farmaci per il cancro. Lo stesso principio attivo è in fase di studio nel Trial OnTarget di Fase 3 di Jaguar per la diarrea legata alla terapia oncologica negli esseri umani.
Canalevia-CA1 de Jaguar Health, un medicamento recetado para tratar la diarrea inducida por quimioterapia (CID) en perros, ha sido destacado en PetVet Magazine. Este medicamento, que contiene crofelemer como ingrediente activo, es el primer y único tratamiento aprobado condicionalmente por la FDA para CID en perros.
Canalevia-CA1 es una formulación específica para perros derivada del árbol Croton lechleri. Este medicamento aborda una preocupación de salud significativa, ya que la diarrea relacionada con la terapia del cáncer puede afectar la eficacia del tratamiento y puede requerir ajustes en la dosis o la suspensión de medicamentos contra el cáncer. El mismo ingrediente activo está siendo estudiado en el ensayo OnTarget de Fase 3 de Jaguar para la diarrea relacionada con la terapia del cáncer en humanos.
자과르 헬스(Jaguar Health)의 카날레비아-CA1(Canalevia-CA1)는 개의 화학요법 유발 설사(CID) 치료를 위한 처방약으로 PetVet 매거진에 소개되었습니다. 이 약물은 효능 성분으로 크로 펠레머(crofelemer)를 함유하고 있으며, 이는 개의 CID 치료를 위한 첫 번째이자 유일한 FDA 조건부 승인 치료제입니다.
카날레비아-CA1은 크로톤 레클레리(Croton lechleri) 나무에서 유래한 개 전용 제형입니다. 이 약물은 건강 문제를 다루고 있으며, 암 치료와 관련된 설사는 치료의 효과에 영향을 미칠 수 있으며 약물의 용량 조정을 요구하거나 암 약물의 중단을 초래할 수 있습니다. 같은 효능 성분은 사람의 암 치료 관련 설사를 위한 자과르의 제3상 온타겟(OnTarget) 시험에서도 연구되고 있습니다.
Canalevia-CA1 de Jaguar Health est un médicament sur ordonnance pour le traitement de la diarrhée induite par la chimiothérapie (CID) chez les chiens, qui a été présenté dans PetVet Magazine. Ce médicament, qui contient du crofelemer en tant qu'ingrédient actif, est le premier et unique traitement approuvé sous conditions par la FDA pour le CID chez les chiens.
Canalevia-CA1 est une formulation spécifique aux chiens dérivée de l'arbre Croton lechleri. Ce médicament aborde une préoccupation de santé significative, car la diarrhée liée à la thérapie anticancéreuse peut affecter l'efficacité du traitement et peut nécessiter des ajustements de dosage ou l'arrêt des médicaments anticancéreux. Le même ingrédient actif est étudié dans l'essai OnTarget de phase 3 de Jaguar pour la diarrhée liée à la thérapie anticancéreuse chez l'homme.
Canalevia-CA1 von Jaguar Health ist ein verschreibungspflichtiges Medikament zur Behandlung von chemotherapiebedingtem Durchfall (CID) bei Hunden und wurde in der PetVet Magazin vorgestellt. Das Medikament enthält Crofelemer als Wirkstoff und ist die erste und einzige bedingt von der FDA zugelassene Behandlung für CID bei Hunden.
Canalevia-CA1 ist eine hundespezifische Formulierung, die vom Croton lechleri-Baum abgeleitet ist. Das Medikament befasst sich mit einer bedeutenden gesundheitlichen Problematik, da durch die Krebsbehandlung verursachter Durchfall die Wirksamkeit der Therapie beeinträchtigen kann und möglicherweise Dosisanpassungen oder die Unterbrechung von Krebsmedikamenten erforderlich macht. Der gleiche Wirkstoff wird in der Phase-3-OnTarget-Studie von Jaguar für mit der Krebstherapie verbundenen Durchfall bei Menschen untersucht.
- 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
- Only conditional FDA approval, pending full demonstration of effectiveness
- Reported adverse reactions including decreased appetite, activity, dehydration, abdominal pain, and vomiting
Insights
The FDA conditional approval for Canalevia-CA1 represents a modest development for Jaguar Health in the veterinary pharmaceutical space. While being first-to-market for chemotherapy-induced diarrhea (CID) in dogs creates a unique market position, several factors temper the immediate impact. The conditional approval status indicates that additional efficacy data is still required, which introduces some uncertainty about the product's long-term market position.
The connection to the company's human Phase 3 OnTarget trial studying crofelemer for cancer therapy-related diarrhea suggests potential synergies in research and development. However, the veterinary market size for CID treatment is relatively compared to human applications. The publication in PetVet Magazine, while providing visibility, is primarily a marketing milestone rather than a significant business catalyst.
From a market perspective, this development carries immediate financial implications for Jaguar Health. With a micro-cap status (
The product's unique position as the only FDA-approved treatment for canine CID could provide some pricing power, but market penetration will likely be gradual given the specialized nature of the indication and the need for veterinary prescription. The sustainable harvesting aspect of the active ingredient from Croton lechleri trees adds an ESG angle but is unlikely to significantly influence near-term financial performance.
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:
Jaguar-JAGX
SOURCE: Jaguar Health, Inc.
View the original press release on accesswire.com
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