Jaguar Health Submits Amended Protocol for Crofelemer Clinical Trial in MVID Patients
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 24 2025
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Source: Newsfilter
- Clinical Trial Progress: Jaguar Health has submitted an amended protocol to expedite the approval of Crofelemer for microvillus inclusion disease (MVID) patients. The drug has the potential to reduce daily parenteral support needs by up to 37%, significantly improving patients' quality of life.
- FDA Meeting Feedback: The company met with the FDA on October 2, 2025, to discuss the progress of Crofelemer's clinical trial. Based on FDA feedback, Jaguar expects the amended protocol to support a faster review and approval process.
- International Collaboration: Jaguar has also engaged with the European Medicines Agency (EMA) regarding the potential approval of Crofelemer based on studies involving a small number of MVID patients. This indicates the drug's significant potential in treating extremely rare pediatric disorders.
- Initial Results Showcase: Initial results from an independent trial in the UAE show that Crofelemer can reduce parenteral support needs in MVID patients by 12% to 37%. This finding provides strong support for further evaluation of Crofelemer in MVID patients.
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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.
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