Jaguar Health's Napo Pharmaceuticals Seeks FDA Guidance on Crofelemer for Rare Pediatric Disease

Jaguar Health, through its subsidiary Napo Pharmaceuticals, is set to meet with the U.S. FDA to discuss regulatory pathways for crofelemer, aimed at treating microvillus inclusion disease (MVID). This pediatric disorder currently lacks approved drug treatments, and Napo is keen on exploring expedited regulatory options. The company's ongoing clinical trials show promising initial results, with crofelemer reducing parenteral nutrition needs by 27% in one patient.

The promising data from Abu Dhabi will be presented at the 2025 NASPGHAN Annual Meeting in Chicago. Jaguar supports ongoing investigator-initiated trials and is conducting further studies across multiple regions under regulatory guidance. If successful, crofelemer could emerge as a novel therapeutic option, potentially reducing complications associated with MVID.