Jaguar Health Seeks Breakthrough Designation for Crofelemer in MVID Treatment

Jaguar Health, Inc. has initiated discussions with the FDA to consider a Breakthrough Therapy Designation for crofelemer, aimed at pediatric patients with Microvillus Inclusion Disease (MVID). This ultra-rare disorder results in intestinal failure requiring lifelong parenteral support.

Currently, no effective therapies exist beyond parenteral support. Crofelemer, however, has shown promising results in reducing support needs in ongoing studies, with findings to be presented at the ESPGHAN 2026 meeting.

Jaguar's subsidiary, Napo Pharmaceuticals, highlights the urgent need for expedited therapeutic pathways. Crofelemer already holds orphan drug designations in the U.S. and EU for MVID and short bowel syndrome.