Galectin Therapeutics FDA Meeting Supports Belapectin for MASH Cirrhosis
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 23 2026
0mins
Galectin Therapeutics announced feedback from its recent in person Type C meeting with the FDA, supporting the advancement of belapectin for the treatment of patients with metabolic dysfunction-associated steatohepatitis, or MASH, cirrhosis and portal hypertension. Alignment was reached on a composite liver outcome as the primary endpoint, including prevention of development of large esophageal varices, a clinically meaningful manifestation of worsening portal hypertension and disease progression in patients with compensated MASH cirrhosis. The company plans to incorporate the development of large esophageal varices as one component of composite clinical outcome endpoints in the planned Phase 3 study. FDA accepted the company's proposed blinded central review process for endoscopic assessment of esophageal varices. This methodology builds upon the approach successfully implemented in the global Phase 2b/3 NAVIGATE trial and is designed to ensure standardized, objective, and consistent assessment of endoscopic outcomes across study sites. Based on the robust efficacy observed with the 2 mg dose across prior clinical studies, the company plans to evaluate a single 2 mg dose of belapectin in its planned Phase 3 trial. The company believes that the planned Phase 3 study, together with the totality of existing clinical data, has the potential to support a full approval application for belapectin in patients with MASH cirrhosis and portal hypertension. Given the similarity of the intended study population to the NAVIGATE trial, including patients with MASH cirrhosis and portal hypertension, and the evaluation of a single belapectin dose, the Company currently expects the planned Phase 3 trial to be of a size generally comparable to the NAVIGATE trial. Consistent with FDA guidance, the company understands that approval in the MASH cirrhosis population will require a traditional pathway, unlike earlier-stage MASH populations where accelerated approval based on histologic endpoints may be available. The FDA confirmed that the proposed composite outcome endpoints, including the development of large varices, and study framework are appropriate for a full approval pathway. Based on FDA's recent communication regarding use of a single, adequate and well-controlled confirmatory trial for marketing approval, the company believes the planned phase 3 trial provides a clear regulatory path toward a broad indication focused on preventing progression of MASH cirrhosis. Galectin is advancing Phase 3 planning and is actively pursuing potential strategic and financial partners. Phase 3 protocol submission is anticipated in the third quarter of 2026.
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About GALT
Galectin Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to developing therapies to improve the lives of patients with chronic liver disease and cancer. The Company’s drug candidates are based on its method of targeting galectin proteins, which are key mediators of biologic and pathologic functions. The Company’s lead drug, belapectin, is a carbohydrate-based drug that inhibits the galectin-3 protein, which is directly involved in multiple inflammatory, fibrotic, and malignant diseases for which it has Fast Track designation by the U.S. Food and Drug Administration. The lead development program is in metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis, or NASH) with cirrhosis, the most advanced form of MASH-related fibrosis. The Company's additional development programs are in the treatment of combination immunotherapy for advanced head and neck cancers and other malignancies.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Trial Design: The trial will evaluate a single 2 mg dose of belapectin, aiming to prevent esophageal varices, using the same centralized, blinded endoscopy review process as in a previous trial, with a similar expected size, and plans to submit the final protocol to the FDA in Q3 2026.
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- Strategic Partnership Exploration: CEO Joel Lewis noted that the agreement provides “important clarity” and renewed confidence, as Galectin actively seeks strategic partnerships to support the development of belapectin, although approval will follow the traditional full-approval pathway.
See More
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- Phase 3 Trial Plans: The company intends to submit the Phase 3 protocol in Q3 2026, conducting a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Belapectin in preventing disease progression in patients with MASH cirrhosis and portal hypertension, indicating potential benefits for patients.
- Clinical Endpoint Alignment: The FDA and Galectin agreed on a composite clinical endpoint that includes prevention of disease progression and the development of large esophageal varices greater than 5 mm, which is a meaningful indicator of worsening portal hypertension and MASH cirrhosis.
- Dose Evaluation Plan: Based on efficacy observed in prior clinical studies, the company plans to evaluate a single 2mg dose of Belapectin in the Phase 3 trial, aiming to advance clinical progress and attract strategic and financial partnership opportunities.
See More
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- Trial Design Confirmation: The FDA has agreed to key components of the Phase 3 program, including its design and primary endpoint, paving the way for potential full approval of belapectin, despite the previous Phase 2b/3 trial failing to meet its primary endpoint.
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See More
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- Phase 3 Trial Plans: The company intends to submit the Phase 3 protocol in Q3 2026 to assess the safety and efficacy of belapectin in preventing disease progression in MASH cirrhosis patients, demonstrating a commitment to addressing substantial unmet medical needs.
- Clinical Assessment Methodology: The FDA accepted the company's proposed blinded central endoscopy review process, ensuring standardized and consistent assessment of esophageal varices across global studies, thereby enhancing the scientific rigor of the clinical trial.
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