Jaguar Health Targets Mid-2027 NDA with Liquid Crofelemer Trial Extension, ESPGHAN Abstracts

Jaguar Health’s crofelemer is the first and only FDA-approved oral botanical drug, derived from sustainably harvested Croton lechleri latex under an ethnobotanical platform developed with indigenous Amazon communities over multiple decades. The drug’s complex proanthocyanidin mixture was chemically characterized and approved as a delayed-release tablet for noninfectious HIV/AIDS diarrhea, establishing a botanical guidance precedent.

Napo Pharmaceuticals, a Jaguar Health family company, is advancing a novel crofelemer powder for oral solution targeting ultrarare congenital disorders microvillus inclusion disease (MVID) and short bowel syndrome with intestinal failure (SBS-IF). This investigational liquid formulation aims to reduce dependence on total parenteral nutrition by leveraging crofelemer’s first-in-class anti-secretory mechanism in pediatric patients.

Jaguar Health initiated an extension phase of its pivotal multicenter pediatric MVID trial for liquid crofelemer and plans a New Drug Application submission by mid-2027. The company also secured acceptance of two late-breaking abstracts on oral crofelemer therapy at the 58th ESPGHAN annual meeting, building on prior proof-of-concept results presented at NASPGHAN 2025.

These milestones underscore Jaguar Health’s specialized competency in botanical CMC, sustainable harvesting, and mechanism-based bioassays, creating practical barriers to generic replication. Successful advancement through trial extension and regulatory engagement could unlock a niche orphan drug market and enhance the company’s valuation prospects.