Jaguar Health Submits New Animal Drug Application
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 23 2026
0mins
Jaguar Health announced that the company has completed submission of its New Animal Drug Application, NADA, to the U.S. Food and Drug Administration's Center for Veterinary Medicine for full approval of crofelemer for the treatment of chemotherapy-induced diarrhea, CID, in dogs. "We're very happy to have completed submission of this NADA," said Dr. Michael Guy, D.V.M., M.S., Ph.D., Jaguar's Vice President of Preclinical and Nonclinical Studies. "As announced, the statistically significant results of our recently completed pivotal effectiveness study of Canalevia-CA1 for the treatment of CID in dogs demonstrated that dogs suffering from CID who 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 was regarded as normal. Moreover, in a survey at the end of the study, 77% of the owners of dogs participating in the study reported that they believed Canalevia-CA1 was an effective treatment for their dog's CID. Additionally, around 40% of dog owners reported that Canalevia-CA1 completely resolved their dog's CID. In comparison, only 10.5% of owners reported complete resolution in their dog's CID without the use of any CID treatments."
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy JAGX?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on JAGX
About JAGX
Jaguar Health, Inc. is a commercial stage pharmaceuticals company. The Company is developing 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. Its marketed drug Mytesi, (crofelemer 125 mg delayed-release tablets), is a first-in-class oral botanical drug product approved by the FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Its Canalevia-CA1, crofelemer delayed-release tablets drug, is an oral plant-based prescription product that is FDA conditionally approved to treat chemotherapy-induced diarrhea in dogs. It has an exclusive distribution agreement for the sale of Gelclair. It is developing a pipeline of prescription drug product candidates to address unmet needs in gastrointestinal health.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Virtual Investor Conferences Forum Highlights
- On-Demand Presentations: The Life Sciences Virtual Investor Forum held on June 24-25, 2026, is now available for on-demand viewing for 90 days, enhancing investor engagement and understanding of participating companies.
- Company Participation: Companies such as MetaVia Inc. (NASDAQ: MTVA) and CytoSorbents Corporation (NASDAQ: CTSO) are accepting one-on-one management meeting requests, facilitating direct communication between investors and management teams.
- Investor Materials Access: Attendees can download investor materials from the companies' resource sections, which not only increases transparency but also provides potential investors with essential decision-making support.
- Interactive Platform Benefits: Virtual Investor Conferences offer real-time investor engagement solutions that replicate the components of on-site conferences, improving the efficiency of connections between companies and investors, thereby fostering stronger investor relations.
See More
Jaguar Completes Study on Crofelemer for Canine Chemotherapy-Induced Diarrhea
- Drug Application Submission: Jaguar has submitted a New Animal Drug Application (NADA) to the FDA for crofelemer, aiming for full approval for treating chemotherapy-induced diarrhea in dogs, marking a significant advancement in veterinary drug development.
- Clinical Study Results: The recently completed pivotal effectiveness study showed that dogs treated with Canalevia-CA1 had normal average stool after three days, with 77% of owners reporting the drug's effectiveness, indicating strong market demand and competitive potential.
- Market Demand Analysis: Over half of veterinarians surveyed indicated that CID interferes with their canine patients' chemotherapy plans, highlighting a pressing need for effective treatment solutions, positioning Jaguar's product to fill this gap.
- Safety Information: Canalevia-CA1 is approved for oral use in dogs only, with FDA conditional approval emphasizing the need to rule out infectious diarrhea before use, ensuring the product's safety and efficacy.
See More
Jaguar Completes NADA Submission for Canalevia-CA1 in Dogs
- Clinical Study Results: Jaguar's recently completed pivotal effectiveness study of crofelemer demonstrated that dogs treated with Canalevia-CA1 had normal average daily stools after three days, indicating significant efficacy in treating chemotherapy-induced diarrhea (CID) and addressing the urgent market need for effective treatment options.
- Positive Owner Feedback: At the end of the study, 77% of dog owners reported that they believed Canalevia-CA1 was an effective treatment, with approximately 40% stating that their dog's CID was completely resolved, highlighting the drug's potential to improve canine quality of life and drive market demand.
- FDA Application Progress: Jaguar has submitted a New Animal Drug Application (NADA) to the U.S. FDA seeking full approval for Canalevia-CA1, marking a significant milestone in the company's veterinary drug development efforts and potentially laying the groundwork for future market expansion.
- Market Demand Context: According to the American Veterinary Medical Association, approximately 1 in 4 dogs will develop cancer at some point in their lives, and CID is one of the most common side effects of cancer treatment, indicating a substantial market opportunity for Canalevia-CA1 to meet unmet treatment needs.
See More
Agenda Announced for Life Sciences Virtual Investor Forum
- Forum Schedule: The Life Sciences Virtual Investor Forum, taking place on June 24-25, 2026, will bring together innovators from various companies, providing an efficient platform for direct engagement between investors and companies, expected to attract numerous individual and institutional investors.
- Easy Participation: Investors can register for free and run an online system check to expedite participation and receive event updates, with live company presentations and one-on-one meeting arrangements enhancing the investor experience during the forum.
- Company Showcase: The forum will feature multiple publicly traded companies, including MetaVia Inc. and CytoSorbents Corporation, covering various life sciences sectors, which is expected to provide investors with rich industry insights and investment opportunities.
- Investor Relations Enhancement: Virtual Investor Conferences aim to improve communication efficiency between companies and investors by offering real-time interactive engagement solutions, helping companies better showcase their strategies and business development plans.
See More
Jaguar Health Initiates Strategic Review to Enhance Shareholder Value
- Strategic Review Initiated: Jaguar Health has announced the commencement of a strategic alternatives review aimed at maximizing shareholder value ahead of its planned NDA filing for the crofelemer-based drug candidate, reflecting the company's proactive stance towards future growth.
- Diverse Options Considered: The company is exploring various strategic transaction options, including mergers, partnerships, and licensing deals, to enhance its market competitiveness through collaborations with both biotech and non-biotech firms.
- Clinical Study Progress: In an ongoing pediatric study, crofelemer has demonstrated a reduction in parenteral support needs by up to 37%, providing strong support for the drug's clinical application, with updated trial data expected to be presented at the ESPGHAN Annual Meeting in June 2026.
- Market Potential Assessment: A third-party report estimates that the MVID nutritional support market will reach $1.1 billion by 2026 and grow to $1.5 billion by 2033, indicating significant growth potential in this sector, which could present new opportunities for Jaguar Health's strategic review.
See More
Jaguar Health Reports Q1 Earnings Results
- Earnings Performance: Jaguar Health reported a Q1 GAAP EPS of -$13.60, indicating significant challenges in profitability that could undermine investor confidence.
- Revenue Surge: The company achieved revenue of $20.27 million in Q1, a substantial increase from $2.21 million in Q1 2025, reflecting a notable rise in market demand for its products or services.
- Market Reaction: Despite the impressive revenue growth, the ongoing losses may raise concerns about the company's future financial health, potentially impacting stock performance.
- Need for Strategic Adjustment: In light of the substantial losses, Jaguar Health may need to reassess its business model and cost structure to achieve sustainable profitability and enhance its competitive position in the market.
See More
Virtual Investor Conferences Forum Highlights
- On-Demand Presentations: The Life Sciences Virtual Investor Forum held on June 24-25, 2026, is now available for on-demand viewing for 90 days, enhancing investor engagement and understanding of participating companies.
- Company Participation: Companies such as MetaVia Inc. (NASDAQ: MTVA) and CytoSorbents Corporation (NASDAQ: CTSO) are accepting one-on-one management meeting requests, facilitating direct communication between investors and management teams.
- Investor Materials Access: Attendees can download investor materials from the companies' resource sections, which not only increases transparency but also provides potential investors with essential decision-making support.
- Interactive Platform Benefits: Virtual Investor Conferences offer real-time investor engagement solutions that replicate the components of on-site conferences, improving the efficiency of connections between companies and investors, thereby fostering stronger investor relations.
See More
Jaguar Completes Study on Crofelemer for Canine Chemotherapy-Induced Diarrhea
- Drug Application Submission: Jaguar has submitted a New Animal Drug Application (NADA) to the FDA for crofelemer, aiming for full approval for treating chemotherapy-induced diarrhea in dogs, marking a significant advancement in veterinary drug development.
- Clinical Study Results: The recently completed pivotal effectiveness study showed that dogs treated with Canalevia-CA1 had normal average stool after three days, with 77% of owners reporting the drug's effectiveness, indicating strong market demand and competitive potential.
- Market Demand Analysis: Over half of veterinarians surveyed indicated that CID interferes with their canine patients' chemotherapy plans, highlighting a pressing need for effective treatment solutions, positioning Jaguar's product to fill this gap.
- Safety Information: Canalevia-CA1 is approved for oral use in dogs only, with FDA conditional approval emphasizing the need to rule out infectious diarrhea before use, ensuring the product's safety and efficacy.
See More
Jaguar Completes NADA Submission for Canalevia-CA1 in Dogs
- Clinical Study Results: Jaguar's recently completed pivotal effectiveness study of crofelemer demonstrated that dogs treated with Canalevia-CA1 had normal average daily stools after three days, indicating significant efficacy in treating chemotherapy-induced diarrhea (CID) and addressing the urgent market need for effective treatment options.
- Positive Owner Feedback: At the end of the study, 77% of dog owners reported that they believed Canalevia-CA1 was an effective treatment, with approximately 40% stating that their dog's CID was completely resolved, highlighting the drug's potential to improve canine quality of life and drive market demand.
- FDA Application Progress: Jaguar has submitted a New Animal Drug Application (NADA) to the U.S. FDA seeking full approval for Canalevia-CA1, marking a significant milestone in the company's veterinary drug development efforts and potentially laying the groundwork for future market expansion.
- Market Demand Context: According to the American Veterinary Medical Association, approximately 1 in 4 dogs will develop cancer at some point in their lives, and CID is one of the most common side effects of cancer treatment, indicating a substantial market opportunity for Canalevia-CA1 to meet unmet treatment needs.
See More
Agenda Announced for Life Sciences Virtual Investor Forum
- Forum Schedule: The Life Sciences Virtual Investor Forum, taking place on June 24-25, 2026, will bring together innovators from various companies, providing an efficient platform for direct engagement between investors and companies, expected to attract numerous individual and institutional investors.
- Easy Participation: Investors can register for free and run an online system check to expedite participation and receive event updates, with live company presentations and one-on-one meeting arrangements enhancing the investor experience during the forum.
- Company Showcase: The forum will feature multiple publicly traded companies, including MetaVia Inc. and CytoSorbents Corporation, covering various life sciences sectors, which is expected to provide investors with rich industry insights and investment opportunities.
- Investor Relations Enhancement: Virtual Investor Conferences aim to improve communication efficiency between companies and investors by offering real-time interactive engagement solutions, helping companies better showcase their strategies and business development plans.
See More
Jaguar Health Initiates Strategic Review to Enhance Shareholder Value
- Strategic Review Initiated: Jaguar Health has announced the commencement of a strategic alternatives review aimed at maximizing shareholder value ahead of its planned NDA filing for the crofelemer-based drug candidate, reflecting the company's proactive stance towards future growth.
- Diverse Options Considered: The company is exploring various strategic transaction options, including mergers, partnerships, and licensing deals, to enhance its market competitiveness through collaborations with both biotech and non-biotech firms.
- Clinical Study Progress: In an ongoing pediatric study, crofelemer has demonstrated a reduction in parenteral support needs by up to 37%, providing strong support for the drug's clinical application, with updated trial data expected to be presented at the ESPGHAN Annual Meeting in June 2026.
- Market Potential Assessment: A third-party report estimates that the MVID nutritional support market will reach $1.1 billion by 2026 and grow to $1.5 billion by 2033, indicating significant growth potential in this sector, which could present new opportunities for Jaguar Health's strategic review.
See More
Jaguar Health Reports Q1 Earnings Results
- Earnings Performance: Jaguar Health reported a Q1 GAAP EPS of -$13.60, indicating significant challenges in profitability that could undermine investor confidence.
- Revenue Surge: The company achieved revenue of $20.27 million in Q1, a substantial increase from $2.21 million in Q1 2025, reflecting a notable rise in market demand for its products or services.
- Market Reaction: Despite the impressive revenue growth, the ongoing losses may raise concerns about the company's future financial health, potentially impacting stock performance.
- Need for Strategic Adjustment: In light of the substantial losses, Jaguar Health may need to reassess its business model and cost structure to achieve sustainable profitability and enhance its competitive position in the market.
See More
