Enrollment Initiated in Jaguar Health Study of its FDA Conditionally Approved Canalevia-CA1 Prescription Drug for Dogs
Jaguar Health (NASDAQ:JAGX) announced progress in its field study of Canalevia-CA1, an FDA conditionally approved prescription drug for treating chemotherapy-induced diarrhea (CID) in dogs. The company has enrolled four dogs across six veterinary oncology clinics, with more clinics potentially joining.
Jaguar is actively seeking partnerships to achieve three key objectives for Canalevia: obtain EU approval for general diarrhea treatment based on existing study data, maintain U.S. availability for CID treatment, and expand U.S. indication to include general diarrhea. The company plans to submit documentation to the European Medicines Agency (EMA) highlighting updated analysis of their completed study, potentially leading to approval across all 27 EU member countries.
The market opportunity is significant, with 104 million dogs in Europe and approximately 6 million annual cases of acute and chronic diarrhea seen by U.S. veterinarians. The drug, derived from the Croton lechleri tree, is currently available through major U.S. veterinary distributors, including Chewy.
Jaguar Health (NASDAQ:JAGX) ha annunciato progressi nel suo studio sul campo di Canalevia-CA1, un farmaco con approvazione condizionata FDA per il trattamento della diarrea indotta dalla chemioterapia (CID) nei cani. La societ脿 ha arruolato quattro cani in sei cliniche veterinarie oncologiche, con la possibilit脿 che altre cliniche si uniscano.
Jaguar sta attivamente cercando partnership per raggiungere tre obiettivi chiave per Canalevia: ottenere l'approvazione nell'UE per il trattamento generale della diarrea basandosi sui dati di studio esistenti, mantenere la disponibilit脿 negli Stati Uniti per il trattamento della CID, ed espandere l'indicazione negli USA includendo la diarrea generale. L'azienda prevede di inviare documentazione all'Agenzia Europea per i Medicinali (EMA) con un'analisi aggiornata del loro studio completato, che potrebbe portare all'approvazione in tutti e 27 i paesi membri dell'UE.
Le opportunit脿 di mercato sono significative, con 104 milioni di cani in Europa e circa 6 milioni di casi annuali di diarrea acuta e cronica osservati dai veterinari statunitensi. Il farmaco, derivato dall'albero Croton lechleri, 猫 attualmente disponibile tramite i principali distributori veterinari USA, incluso Chewy.
Jaguar Health (NASDAQ:JAGX) anunci贸 avances en su estudio de campo de Canalevia-CA1, un medicamento aprobado condicionalmente por la FDA para tratar la diarrea inducida por quimioterapia (CID) en perros. La compa帽铆a ha inscrito a cuatro perros en seis cl铆nicas veterinarias oncol贸gicas, con la posibilidad de que se unan m谩s cl铆nicas.
Jaguar est谩 buscando activamente asociaciones para lograr tres objetivos clave para Canalevia: obtener la aprobaci贸n en la UE para el tratamiento general de la diarrea bas谩ndose en datos de estudios existentes, mantener la disponibilidad en EE.UU. para el tratamiento de CID y ampliar la indicaci贸n en EE.UU. para incluir la diarrea general. La empresa planea presentar documentaci贸n a la Agencia Europea de Medicamentos (EMA) con un an谩lisis actualizado de su estudio completado, lo que podr铆a conducir a la aprobaci贸n en los 27 pa铆ses miembros de la UE.
La oportunidad de mercado es significativa, con 104 millones de perros en Europa y aproximadamente 6 millones de casos anuales de diarrea aguda y cr贸nica atendidos por veterinarios en EE.UU. El medicamento, derivado del 谩rbol Croton lechleri, est谩 actualmente disponible a trav茅s de los principales distribuidores veterinarios de EE.UU., incluyendo Chewy.
Jaguar Health (NASDAQ:JAGX)電� 臧滌潣 頇旐暀鞖旊矔 鞙犽皽 靹れ偓(CID) 旃橂毳� 鞙勴暅 FDA 臁瓣贝攵� 鞀轨澑 觳橂癌鞎届澑 Canalevia-CA1 順勳灔 鞐瓣惮鞐愳劀 歆勳爠鞚� 氚滍憸頄堨姷雼堧嫟. 須岇偓電� 6臧滌潣 靾橃潣 膦呾枒 韥措Μ雼夓棎靹� 4毵堧Μ鞚� 臧滊ゼ 霌彪頄堨溂氅�, 雿� 毵庫潃 韥措Μ雼夓澊 彀胳棳頃� 臧�電レ劚鞚� 鞛堨姷雼堧嫟.
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鞁滌灔 旮绊殞電� 靸侂嫻頃橂┌, 鞙犽熃鞐� 1鞏� 400毵� 毵堧Μ鞚� 臧�鞕� 氙戈淡 靾橃潣靷摛鞚� 鞐瓣皠 鞎� 600毵� 瓯挫潣 旮夓劚 氚� 毵岇劚 靹れ偓 靷毳� 氤搓碃 鞛堨姷雼堧嫟. 鞚� 鞎诫鞚� Croton lechleri 雮橂鞐愳劀 於旍稖霅橃棃鞙茧┌, 順勳灛 Chewy毳� 韽暔頃� 欤检殧 氙戈淡 靾橃潣 鞙犿喌鞐呾泊毳� 韱淀暣 鞝滉车霅橁碃 鞛堨姷雼堧嫟.
Jaguar Health (NASDAQ:JAGX) a annonc茅 des progr猫s dans son 茅tude de terrain concernant Canalevia-CA1, un m茅dicament sur ordonnance approuv茅 conditionnellement par la FDA pour le traitement de la diarrh茅e induite par la chimioth茅rapie (CID) chez les chiens. L'entreprise a inscrit quatre chiens dans six cliniques v茅t茅rinaires en oncologie, avec la possibilit茅 que d'autres cliniques rejoignent l'茅tude.
Jaguar cherche activement des partenariats pour atteindre trois objectifs cl茅s pour Canalevia : obtenir l'approbation europ茅enne pour le traitement g茅n茅ral de la diarrh茅e sur la base des donn茅es d'茅tudes existantes, maintenir la disponibilit茅 aux 脡tats-Unis pour le traitement de la CID, et 茅tendre l'indication am茅ricaine pour inclure la diarrh茅e g茅n茅rale. La soci茅t茅 pr茅voit de soumettre des documents 脿 l'Agence europ茅enne des m茅dicaments (EMA) mettant en avant une analyse actualis茅e de leur 茅tude achev茅e, ce qui pourrait conduire 脿 une approbation dans les 27 pays membres de l'UE.
Le potentiel de march茅 est important, avec 104 millions de chiens en Europe et environ 6 millions de cas annuels de diarrh茅e aigu毛 et chronique pris en charge par les v茅t茅rinaires am茅ricains. Le m茅dicament, d茅riv茅 de l'arbre Croton lechleri, est actuellement disponible via les principaux distributeurs v茅t茅rinaires am茅ricains, dont Chewy.
Jaguar Health (NASDAQ:JAGX) gab Fortschritte in seiner Feldstudie zu Canalevia-CA1 bekannt, einem von der FDA bedingt zugelassenen verschreibungspflichtigen Medikament zur Behandlung von Chemotherapie-induziertem Durchfall (CID) bei Hunden. Das Unternehmen hat vier Hunde in sechs veterin盲ronkologischen Kliniken eingeschrieben, weitere Kliniken k枚nnten hinzukommen.
Jaguar sucht aktiv Partnerschaften, um drei Hauptziele f眉r Canalevia zu erreichen: die EU-Zulassung f眉r die allgemeine Behandlung von Durchfall basierend auf bestehenden Studiendaten, die Aufrechterhaltung der Verf眉gbarkeit in den USA f眉r die CID-Behandlung und die Erweiterung der US-Indikation auf allgemeinen Durchfall. Das Unternehmen plant, der Europ盲ischen Arzneimittelagentur (EMA) Unterlagen mit einer aktualisierten Analyse ihrer abgeschlossenen Studie vorzulegen, was zu einer Zulassung in allen 27 EU-Mitgliedstaaten f眉hren k枚nnte.
Die Marktchance ist erheblich, mit 104 Millionen Hunden in Europa und etwa 6 Millionen j盲hrlichen F盲llen von akutem und chronischem Durchfall, die von US-Tier盲rzten behandelt werden. Das Medikament, das aus dem Croton lechleri Baum gewonnen wird, ist derzeit 眉ber gro脽e US-Tiervertriebe, darunter Chewy, erh盲ltlich.
- Plant-based Canalevia-CA1 is already FDA conditionally approved and commercially available through major distributors
- Large market opportunity with 104 million dogs in Europe and 6 million annual U.S. diarrhea cases
- Potential expansion to general diarrhea treatment could significantly increase market reach
- Study data shows significantly better outcomes for Canalevia-treated dogs compared to placebo
- Previous clinical trial did not meet its primary endpoint, requiring revised endpoint analysis
- EMA approval for general diarrhea treatment is still pending and not guaranteed
- Company still needs to secure strategic partnerships for global commercialization
Insights
Jaguar Health advances Canalevia-CA1 for dog diarrhea with study enrollment and partnership discussions to expand global market potential.
Jaguar Health has initiated a critical phase in advancing its canine diarrhea treatment by enrolling four dogs in its field study for Canalevia-CA1. This FDA conditionally approved drug for chemotherapy-induced diarrhea (CID) in dogs represents a strategic asset in the $89.7 million U.S. dog population market.
The company has articulated a three-pronged strategy that significantly enhances its commercial potential: 1) Obtain European approval for general diarrhea in dogs using existing data; 2) Maintain U.S. availability for the CID indication; and 3) Expand the U.S. label to include the much larger general diarrhea market. With six veterinary oncology clinics participating and more in discussions, Jaguar is building the necessary clinical infrastructure to support regulatory submissions.
The company's reanalysis of its 200-dog study data using an alternative endpoint (dogs with no diarrhea episodes after first treatment) revealed clinically significant results showing superior outcomes versus placebo. This revised data analysis strategy could provide a faster path to EU approval, potentially unlocking access to a 104 million dog European market.
What's particularly notable is the company's focus on securing animal health partners to accelerate commercialization. With approximately six million annual cases of acute and chronic diarrhea in U.S. dogs and no FDA-approved treatment for general non-infectious diarrhea, Canalevia addresses a substantial unmet need. The company's plant-based approach also offers a strategic advantage amid growing concerns about antibiotic resistance.
The ongoing field study to collect real-world evidence represents the pathway to potentially convert the conditional FDA approval to full approval, which would strengthen Jaguar's negotiating position with potential partners and expand market adoption among veterinary practices.
Company strategy: In discussions with multiple potential animal health company partners to collaborate to bring Canalevia庐, conditionally approved for CID, to regulatory approval and commercialization for general diarrhea globally
Diarrhea is one of the most common reasons owners bring their dog to the veterinarian and the second most common reason for visits to the veterinary emergency hospital, yet there are currently no FDA-approved drugs to treat general diarrhea in dogs
Jaguar CEO Lisa Conte presenting July 17 at to provide updates on near-term catalysts; Click to register
SAN FRANCISCO, CA / / July 10, 2025 / () (Jaguar), under its Jaguar Animal Health tradename for the veterinary market, today announced that four dogs have now been enrolled in Jaguar's ongoing field study of , the company's U.S. Food and Drug Administration (FDA) conditionally approved prescription drug for the treatment of chemotherapy-induced diarrhea (CID) in dogs, and enrollment is continuing. Six veterinary oncology clinics have signed on to take part in this study, and Jaguar is in discussions with other veterinary oncology clinics regarding possible participation.
"Jaguar's primary objective for Canalevia (crofelemer delayed-release tablets) is to identify a partner with which to collaborate to achieve our three parallel goals for the drug: Obtain approval in the European Union for Canalevia for treatment of general diarrhea in dogs based on existing Jaguar study data; maintain continuity of availability in the U.S. of Canalevia for treatment of CID in dogs; and to expand the U.S. indication from CID in dogs to treatment of general diarrhea in dogs," said Lisa Conte, Jaguar's Founder and CEO. "I'm pleased to report that Jaguar is currently in discussions with multiple potential animal health company partners to collaborate to bring Canalevia to regulatory approval and commercialization for general diarrhea globally."
Canalevia contains crofelemer, a plant-based botanical prescription drug 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.
"In the EU, as we , it may be possible to obtain approval of Canalevia for treatment of general diarrhea in dogs based on the results of a study Jaguar completed in 200 dogs with general diarrhea," Conte said. "While this completed trial did not meet its stated primary endpoint, the study results are clinically significant when analyzed using an alternate, simplified endpoint, defining treatment success as any dog that had no episodes of diarrhea following the first treatment with either Canalevia or placebo. Using this revised endpoint, the study data shows that dogs treated with Canalevia had significantly better outcomes - with fewer watery stools and significant improvement in fecal scores compared to placebo-treated dogs."
Jaguar plans to submit a dossier to the European Medicines Agency (EMA) to outline the results of the updated analysis of the company's completed study of Canalevia in dogs with general diarrhea. If acceptable to the EMA, the company will then submit a Marketing Authorization Application (MAA) for Canalevia for general diarrhea in dogs. If the application is approved, Canalevia will be marketable for treatment of general diarrhea in dogs in all 27 EU member countries.
Data from the European Pet Food Industry Federation concluded that there were 104 million dogs in Europe in 2022. "We've been pleased with the marketplace reception of crofelemer for treatment of CID in dogs in the U.S. and believe there is clearly an unmet medical need for a product for the much larger market of treatment of general diarrhea in dogs - both in the U.S. and the EU," said Conte. "We estimate that U.S. veterinarians see approximately six million annual cases of acute and chronic diarrhea in dogs, and we look forward to identifying a partner to fund and execute development and commercialization of crofelemer for the treatment of general diarrhea in the U.S. and/or globally. Forging a partnership for this purpose is a key focus of our business development efforts in 2025 and has been designated as a key potential catalyst for the company this year."
Diarrhea is one of the most common reasons dogs are seen by general practice veterinarians and is the second most common reason for visits to veterinary emergency hospitals, yet there is currently no FDA-approved drug to treat general, non-infectious diarrhea in dogs. According to the American Veterinary Medical Association, there were an estimated 89.7 million dogs in the United States in 2024, with nearly half (
Canalevia-CA1, a canine-specific formulation of crofelemer, Jaguar's novel, oral plant-based drug sustainably harvested from the Croton lechleri tree, is available from multiple leading veterinary distributors in the U.S., including .
The objective of the ongoing, prospective, randomized, open-label field study in dogs undergoing chemotherapy treatment across the U.S. is to collect real-world data to demonstrate real-world evidence of the clinical effectiveness for Canalevia-CA1 for the treatment of CID in dogs to support potential full FDA approval of the drug for this indication. Dogs enrolled in this study will be randomly assigned to receive a prescription of Canalevia-CA1 as a treatment for CID or be randomly selected to the control group.
Participation Instructions for Jaguar's Virtual Presentation at the Emerging Growth Conference
When: Thursday, July 17, 2025 from 2:55 - 3:05 PM Eastern
Where: Online ()
Registration link for conference:
Replay: An archived webcast of the presentation will be made available on and on the .
About Conditional Approval and Full Approval
Canalevia-CA1 initially received 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. The drug company can ask the FDA to renew the conditional approval annually for up to four more years, 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 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, and almost
Due to the increasing number of chemotherapeutic agents being adopted by veterinary oncologists and primary care veterinarians, 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 U.S. 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.
Canalevia-CA1 is a tablet that can be given orally twice a day and can be used for home treatment of CID in dogs.
About Canalevia庐-CA1
Canalevia-CA1 (crofelemer delayed-release tablets) is the first and only oral plant-based prescription product that is FDA conditionally approved to treat chemotherapy-induced diarrhea (CID) in dogs. Canalevia-CA1 is a canine-specific formulation of crofelemer, an active pharmaceutical ingredient isolated and purified from the Croton lechleri tree. Canalevia-CA1 is currently conditionally approved by the FDA under application number 141-552. Conditional approval allows for commercialization of the product while Jaguar continues to collect the substantial evidence of effectiveness required for full approval. Jaguar has also received Minor Use in a Major Species (MUMS) designation from the FDA for Canalevia-CA1 to treat CID in dogs. FDA has established a "small number" threshold for minor use in each of the seven major species covered by the MUMS act. The small number threshold is currently 80,000 for dogs, representing the largest number of dogs that can be affected by a disease or condition over the course of a year and still have the use qualify as a minor use.
About Crofelemer
Crofelemer is the only oral FDA-approved prescription drug under botanical guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals, a Jaguar family company, has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities.
Important Safety Information About Canalevia庐-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. Napo's crofelemer is FDA-approved under the brand name Mytesi庐 for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. 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 (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.
For more information about:
Jaguar Health, visit
Napo Pharmaceuticals, visit
Napo Therapeutics, visit
Magdalena Biosciences, visit
Canalevia-CA1, visit
Visit the Make Cancer Less Shitty patient advocacy program on , , &
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that Jaguar management will present at the July 2025 Emerging Growth Conference, Jaguar's expectation that it will identify a partner to fund and execute development and commercialization of crofelemer for the treatment of general, non-infectious diarrhea in dogs in the U.S and/or globally, Jaguar's expectation that it may be possible to obtain approval of Canalevia in the EU for treatment of general diarrhea in dogs based on the results of a study Jaguar completed in 200 dogs with general diarrhea, Jaguar's expectation that it will submit a dossier to the EMA to outline the results of the updated analysis of the company's completed study of Canalevia in dogs with general diarrhea, Jaguar's expectation that, if the submitted dossier is acceptable to the EMA, the company will then submit a MAA to the EMA for Canalevia for general diarrhea in dogs, and Jaguar's expectation that the field study of Canalevia-CA1 for the treatment of CID in dogs will support potential full FDA approval of the drug for this indication. 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,
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
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SOURCE: Jaguar Health, Inc.
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FAQ
What is the current status of Jaguar Health's (JAGX) Canalevia-CA1 study?
What are the main objectives for Canalevia's expansion according to Jaguar Health (JAGX)?
How large is the potential market for Canalevia in Europe and the US?
What makes Canalevia different from other diarrhea treatments for dogs?
What are the next regulatory steps for Jaguar Health's Canalevia in Europe?
