Jaguar Health Submits Amended Protocol to FDA for Crofelemer MVID Trial

Reuters11-20

Jaguar Health Submits Amended Protocol to FDA for Crofelemer MVID Trial

Jaguar Health Inc. announced that it has submitted an amended protocol to the U.S. Food and Drug Administration (FDA) for its ongoing placebo-controlled clinical trial of crofelemer for the treatment of microvillus inclusion disease (MVID), a rare pediatric disorder with no approved treatments. The company took this step following feedback from an FDA meeting held on October 2, 2025, with the goal of supporting a possible expedited approval pathway for crofelemer. Jaguar Health expects that, if the study results are positive, the amended protocol could help enable a faster FDA review and approval process. No grant or funding announcement involving multiple organizations was mentioned.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Jaguar Health Inc. published the original content used to generate this news brief via ACCESS Newswire (Ref. ID: 1104582) on November 20, 2025, and is solely responsible for the information contained therein.

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