Galectin Therapeutics IncFDA alignment on Phase 3 trial design and regulatory path for belapectin

Galectin Therapeutics has reached agreement with the FDA on the primary endpoint and regulatory path for a planned Phase 3 trial of belapectin in patients with MASH cirrhosis and portal hypertension. The company intends to file the Phase 3 protocol in the third quarter of 2026 and is actively exploring strategic and financial partnership opportunities to support continued development and commercialization. The trial will assess a single 2 mg dose of belapectin in a randomized, double-blind, placebo-controlled design, with a composite liver outcome as the primary endpoint that includes prevention of large esophageal varices. The FDA accepted the company's proposed blinded central endoscopy review methodology, which builds on the approach used in the global Phase 2b/3 NAVIGATE trial. Galectin expects the planned Phase 3 study, together with existing clinical data, to potentially support a full approval application under a traditional regulatory pathway.
Galectin Therapeutics IncFDA alignment on Phase 3 trial design and regulatory path for belapectin