Jaguar Health Reports FDA Fee Waivers for Mytesi and Canalevia-CA1
Jaguar Health says Napo Pharmaceuticals received a PDUFA fee waiver for Mytesi, while Canalevia-CA1 also received an FDA fee waiver for the 2027 fiscal year.
Jaguar Health, Inc. (NASDAQ:JAGX) said on September 22, 2026 that the U.S. Food and Drug Administration (FDA) had approved fee waivers for two medicines linked to its business. Napo Pharmaceuticals received a waiver for the Prescription Drug User Fee Act (PDUFA) fee associated with Mytesi for the 2027 fiscal year, while Jaguar received a separate waiver from the FDA’s Center for Veterinary Medicine for Canalevia-CA1.
Mytesi contains crofelemer in delayed-release tablet form and is approved for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS receiving antiretroviral therapy. The medicine is commercialized in the U.S. by Future Pak, LLC.
Canalevia-CA1 is a conditionally approved prescription drug for chemotherapy-induced diarrhea in dogs. It is also commercialized in the U.S. by Future Pak, LLC. The FDA approval remains conditional pending a full demonstration of effectiveness under application number 141-552.
The company’s information states that Mytesi is not indicated for infectious diarrhea. Infectious causes should be ruled out before treatment because failing to consider them could prevent patients from receiving appropriate therapy and could allow their disease to worsen.
In clinical studies, adverse reactions reported for Mytesi at a rate greater than placebo included upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%) and increased bilirubin (3.1%).
Canalevia-CA1 is intended for oral use in dogs and is not for use in humans. The information provided states that infectious causes of diarrhea should be excluded before use, and lists decreased appetite, decreased activity, dehydration, abdominal pain and vomiting among the most common adverse reactions. The product should not be used in dogs with a known hypersensitivity to crofelemer and must be kept away from children and other animals. Federal law restricts its use to or on the order of a licensed veterinarian.
Jaguar said its family companies, Napo Pharmaceuticals, Inc. and Napo Therapeutics S.p.A., are working on crofelemer powder for oral solution for rare and orphan gastrointestinal disorders involving intestinal failure. The programme includes microvillus inclusion disease and short bowel syndrome.
Jaguar said it expects to file a New Drug Application for crofelemer for microvillus inclusion disease in mid-2027. The company identified this as a forward-looking statement and said such statements are predictions subject to risks, uncertainties and assumptions, including factors beyond its control.
The active ingredient in Mytesi is described as a botanical drug extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon rainforest. Napo said it has established a sustainable harvesting programme for crofelemer.
Napo Pharmaceuticals received an FDA waiver for the PDUFA fee linked to Mytesi for the 2027 fiscal year.
Jaguar received a separate FDA Center for Veterinary Medicine fee waiver for Canalevia-CA1 for the 2027 fiscal year.
Mytesi is approved for noninfectious diarrhea in adults with HIV/AIDS receiving antiretroviral therapy.
Canalevia-CA1 is conditionally approved for chemotherapy-induced diarrhea in dogs and remains subject to a full demonstration of effectiveness.
Jaguar said it expects to file an NDA for crofelemer for microvillus inclusion disease in mid-2027, subject to the risks and uncertainties described by the company.
Jaguar Health, Inc. (NASDAQ:JAGX) said that the U.S. Food and Drug Administration (FDA) granted Napo Pharmaceuticals’ request for a waiver of the fee associated with the Prescription Drug User Fee Act (PDUFA) for Mytesi for the 2027 fiscal year. Jaguar also said it was granted a waiver by the Center for Veterinary Medicine of the FDA for Canalevia-CA1 for the 2027 fiscal year.
Mytesi (crofelemer delayed-release tablets) is an FDA-approved prescription drug indicated for the symptomatic relief of noninfectious diarrhoea in adult patients with HIV/AIDS on antiretroviral therapy. It is not indicated for the treatment of infectious diarrhoea, and infectious causes should be ruled out before treatment because patients may otherwise not receive appropriate therapy and their disease may worsen.
The source states that, in clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%) and increased bilirubin (3.1%).
Canalevia-CA1 is a conditionally approved prescription drug for the treatment of chemotherapy-induced diarrhoea in dogs. It is for oral use in dogs only and is not for use in humans. The source states that infectious causes of diarrhoea should be ruled out before use, and that the most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain and vomiting. It is conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.
The source states that both Mytesi and Canalevia-CA1 are currently commercialised in the U.S. by Future Pak, LLC. Canalevia-CA1 is described as Jaguar’s conditionally approved prescription drug for chemotherapy-induced diarrhoea in dogs.
Jaguar family companies Napo Pharmaceuticals, Inc. and Napo Therapeutics S.p.A. focus on the development and commercialisation of crofelemer powder for oral solution for rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome. Jaguar states that the company expects to file a New Drug Application for crofelemer for microvillus inclusion disease in mid-2027. The source describes this as a forward-looking statement and says such statements are predictions subject to risks, uncertainties and assumptions, some of which are beyond Jaguar’s control.
The source states that crofelemer is extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon rainforest, and that Napo has established a sustainable harvesting programme. It also says that Canalevia-CA1 should not be used in dogs with a known hypersensitivity to crofelemer, should be kept out of reach of children and other animals, and is restricted by federal law to use by or on the order of a licensed veterinarian.