USFDAJun 23, 2026, 08:02 AM
Galectin Reaches FDA Agreement on Belapectin Phase 3 Primary Endpoint
AI Summary
Galectin Therapeutics announced positive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA), reaching agreement on the primary endpoint and regulatory path for belapectin. This clarity supports the advancement of belapectin for treating metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension. The company plans to submit the Phase 3 protocol in Q3 2026 and is actively seeking strategic and financial partners to support development and commercialization.
Key Highlights
- Galectin Therapeutics reached agreement with FDA on primary endpoint and regulatory path for belapectin.
- Company intends to file the Phase 3 protocol in Q3 2026.
- Actively exploring strategic and financial partnership opportunities for belapectin.
- Primary endpoint for Phase 3 is a composite liver outcome, including prevention of large esophageal varices (>5 mm).
- FDA accepted the proposed blinded central review process for endoscopic assessment of esophageal varices.
- Phase 3 trial will evaluate a single 2 mg dose of belapectin.
- FDA confirmed the proposed study framework is appropriate for a full approval pathway for MASH cirrhosis.
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