Jaguar Health Announces Promising Clinical Trial Results and Advances Regulatory Pathway for Crofelemer in Treating Rare Pediatric Disorder MVID

Jaguar Health Inc. $(JAGX)$ has announced progress in the development of its novel crofelemer powder formulation for oral solution, intended for the treatment of microvillus inclusion disease (MVID), an ultrarare pediatric disorder. Following a recent Type C Meeting with the U.S. Food and Drug Administration (FDA), the company reported constructive discussions regarding the clinical trial pathway for potential approval of crofelemer for this indication. Results from an ongoing investigator-initiated proof-of-concept trial in the United Arab Emirates demonstrate an approximate 37% reduction in total parenteral support among participants. Jaguar Health has previously received orphan drug designations for crofelemer for MVID from both the FDA and the European Medicines Agency. Further discussions with regulatory agencies in the European Union and the Middle East/North Africa region are planned. The company indicated that selected amendments will be made to the clinical study based on FDA feedback, and additional results will be presented as the trial progresses.

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: 1081626) on October 06, 2025, and is solely responsible for the information contained therein.