Galectin Therapeutics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Galectin Therapeutics (GALT).
Over the past two years, Galectin Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Belapectin. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Belapectin (Formerly GR-MD-02) FDA Regulatory Timeline and Events
Belapectin (Formerly GR-MD-02) is a drug developed by Galectin Therapeutics for the following indication: Non-alcoholic steatohepatitis (NASH) with cirrhosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Belapectin (Formerly GR-MD-02)
- Announced Date:
- May 11, 2026
- Indication:
- Non-alcoholic steatohepatitis (NASH) with cirrhosis
Announcement
Galectin Therapeutics announced the publication of results from its NAVIGATE Phase 2b clinical trial evaluating belapectin in patients with MASH cirrhosis and portal hypertension in AASLD flagship journal Hepatology.
AI Summary
Galectin Therapeutics announced that results from its NAVIGATE Phase 2b trial of belapectin were published in Hepatology, the AASLD flagship journal. The manuscript, titled "Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in Patients with MASH Cirrhosis: The Randomized, Placebo-Controlled NAVIGATE Trial," is available online as an open-access publication.
Key findings show a numerical reduction in the incidence of new esophageal varices with belapectin 2 mg/kg versus placebo, with a statistically significant reduction in the per-protocol population. The study also reported supportive improvements in non-invasive markers of portal hypertension and fibrosis, including liver stiffness measurement (LSM) and the ELF score, and a favorable safety and tolerability profile.
Belapectin targets galectin-3, a mediator of fibrosis and inflammation, and is being developed to address complications of MASH cirrhosis. NAVIGATE was a global, randomized, placebo-controlled trial in patients with MASH cirrhosis and portal hypertension without varices at baseline, treated and followed for 18 months. The full manuscript is freely accessible online.
Read Announcement- Drug:
- Belapectin (Formerly GR-MD-02)
- Announced Date:
- November 10, 2025
- Indication:
- Non-alcoholic steatohepatitis (NASH) with cirrhosis
Announcement
Galectin Therapeutics presented a poster and will deliver an oral presentation of the NAVIGATE study analysis at the AASLD 2025 Annual Meeting.
AI Summary
Galectin Therapeutics presented a poster and will deliver an oral presentation of the NAVIGATE study analysis at the AASLD 2025 Annual Meeting. NAVIGATE is a Phase 2b, randomized, double-blind trial of 355 patients with compensated MASH cirrhosis and portal hypertension that compared IV belapectin (2 mg/kg and 4 mg/kg) versus placebo every other week for 18 months.
New biomarker analyses showed consistent antifibrotic effects with belapectin 2 mg/kg. Fewer patients on 2 mg/kg experienced ≥30% or ≥5 kPa increases in liver stiffness by FibroScan versus placebo, indicating slower fibrosis progression. Across ELF score categories, 2 mg/kg reduced new varices most in patients with ELF >11.3 (22.7% vs 42.9%). Pro-C3 fell by >50% from baseline at 18 months with 2 mg/kg versus placebo. More patients on 2 mg/kg had ≥20% reductions in YKL-40, while PRO‑C4 increases (≥20%) were more common with placebo (13% vs 3%).
For those who completed 36 months, the reduction in new varices was sustained, and the safety profile of belapectin was comparable to placebo.
Read Announcement- Drug:
- Belapectin (Formerly GR-MD-02)
- Announced Date:
- October 7, 2025
- Indication:
- Non-alcoholic steatohepatitis (NASH) with cirrhosis
Announcement
Galectin Therapeutics announced participation in the AASLD Liver Meeting 2025.
Read Announcement- Drug:
- Belapectin (Formerly GR-MD-02)
- Announced Date:
- December 20, 2024
- Indication:
- Non-alcoholic steatohepatitis (NASH) with cirrhosis
Announcement
Galectin Therapeutics, Inc. announced results from its global clinical trial NAVIGATE evaluating belapectin in patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH) cirrhosis and portal hypertension.
AI Summary
Galectin Therapeutics, Inc. announced encouraging results from its global NAVIGATE trial that evaluated belapectin in patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension. The study was conducted at over 130 sites around the world. In the pre-specified per-protocol population, patients receiving belapectin at 2 mg/kg showed a 48.9% reduction in the development of esophageal varices compared to placebo (p < 0.05). Although the intent-to-treat population showed a favorable trend, the results did not reach statistical significance overall. Belapectin was well tolerated, with adverse event rates similar to those in the placebo group. Additional data, including results from a 36-month treatment period and further biomarker analysis, are expected to be shared in early 2025. These findings support further clinical development of belapectin as a promising treatment option for this challenging patient population.
Read Announcement- Drug:
- Belapectin (Formerly GR-MD-02)
- Announced Date:
- November 18, 2024
- Indication:
- Non-alcoholic steatohepatitis (NASH) with cirrhosis
Announcement
- Galectin Therapeutics, Inc. nnounced the presentation of three posters on the ongoing NAVIGATE trial in patients with MASH cirrhosis and portal hypertension at the American Association for the Study of Liver Diseases (AASLD)'s annual meeting 2024 Liver Meeting, being held November 15-19, 2024 in San Diego, California.
AI Summary
Galectin Therapeutics, Inc. announced that three posters presenting key data from its ongoing NAVIGATE trial will be featured at the AASLD 2024 Liver Meeting in San Diego, California, running from November 15-19, 2024. The NAVIGATE trial focuses on patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension, evaluating the potential of belapectin to prevent esophageal varices in this high-risk group.
The posters will highlight several important findings including the development of a centralized system for the consistent evaluation of esophageal and gastric varices, detailed baseline patient characteristics, and the discovery that about one-third of patients screened for the trial had esophageal varices. These results point to the need for reliable screening and targeted treatments in patients with MASH cirrhosis and portal hypertension, underscoring the trial’s significance in addressing this unmet medical need.
Read Announcement
Galectin Therapeutics FDA Events - Frequently Asked Questions
As of now, Galectin Therapeutics (GALT) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Galectin Therapeutics (GALT) has reported FDA regulatory activity for Belapectin (Formerly GR-MD-02).
The most recent FDA-related event for Galectin Therapeutics occurred on May 11, 2026, involving Belapectin (Formerly GR-MD-02). The update was categorized as "Publication," with the company reporting: "Galectin Therapeutics announced the publication of results from its NAVIGATE Phase 2b clinical trial evaluating belapectin in patients with MASH cirrhosis and portal hypertension in AASLD flagship journal Hepatology."
Currently, Galectin Therapeutics has one therapy (Belapectin (Formerly GR-MD-02)) targeting the following condition: Non-alcoholic steatohepatitis (NASH) with cirrhosis.
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:GALT last updated on 5/11/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
