Drugs / belapectin
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02575404 | May 2016 → Jan 2021 | head and neck squamous cell carcinoma, melanoma, non-small cell lung carcinoma | Providence Health & Services | Completed | No outcome recorded |
| Phase 1 | NCT02117362 | May 2014 → Nov 2018 | metastatic melanoma | Providence Health & Services | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04987996 | Jul 2023 → Jul 2027 | head and neck squamous cell carcinoma, metastatic melanoma | Providence Health & Services | Withdrawn | No outcome recorded |
| Phase 2 | NCT02407041 | Sep 2015 → Mar 2018 | psoriasis | Galectin Therapeutics Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04365868 | Jun 2020 → Mar 2025 | cirrhosis of liver, esophageal varices, metabolic dysfunction-associated steatohepatitis | Galectin Therapeutics Inc. | Terminated | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT04332432 Comparator | Jun 2020 → Mar 2022 | — | Galectin Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01899859 Comparator | Jul 2013 → Feb 2015 | metabolic dysfunction-associated steatohepatitis | Galectin Therapeutics Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02421094 Comparator | Sep 2015 → Sep 2016 | metabolic dysfunction-associated steatohepatitis | Galectin Therapeutics Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02462967 Comparator | Jun 2015 → Oct 2017 | portal hypertension | Galectin Therapeutics Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 35
| Date | Issuer | Release |
|---|---|---|
| 2026-05-27 | Galectin Therapeutics Inc. | Results Galectin Therapeutics Presents New EASL 2026 Oral and Poster Analyses Demonstrating Belapectin’s Potential to Modify Disease Progression in Advanced MASH Cirrhosis galectintherapeutics.com ↗
Belapectin 2 mg/kg produced a statistically significant reduction in new varices at 18 months in the per-protocol population (p=0.04), with significantly fewer patients experiencing worsening of liver stiffness as measured by FibroScan® |
| 2026-05-11 | Galectin Therapeutics Inc. | Results Galectin Therapeutics Announces Publication of NAVIGATE Phase 2b Trial Results for Belapectin in the Journal of Hepatology galectintherapeutics.com ↗
Results demonstrated that belapectin 2 mg/kg was associated with a numerical reduction in the development of new varices compared to placebo in the full analysis set, with a statistically significant reduction observed in the per-protocol population. |
| 2025-12-19 | Galectin Therapeutics Inc. | Regulatory Galectin Therapeutics Provides Regulatory Update Following FDA Written Response and Announces an Additional $10 Million Line of Credit from Richard E. Uihlein Sufficient to Cover Expected Expenditures Through March 2027 galectintherapeutics.com ↗
The FDA converted the Company’s initial request for an in-person or teleconference meeting to a written response. |
| 2025-11-10 | Galectin Therapeutics Inc. | Results Galectin Therapeutics Presented NAVIGATE Trial Results at the American Association for the Study of Liver Diseases (AASLD) 2025 Annual Meeting galectintherapeutics.com ↗
New biomarker analyses from the NAVIGATE trial demonstrated consistent antifibrotic effects of belapectin 2 mg/kg |
| 2025-05-12 | Galectin Therapeutics Inc. | Results Galectin Therapeutics Presented NAVIGATE Trial Results at the European Association for the Study of the Liver (EASL) 2025 Congress galectintherapeutics.com ↗
Belapectin 2 mg/kg demonstrated a statistically significant reduction in new varices at 18 months in the per-protocol population (p=0.04). |
| 2025-04-15 | Galectin Therapeutics Inc. | Results Galectin Therapeutics to Present at the European Association for the Study of the Liver (EASL) 2025 Congress galectintherapeutics.com ↗
Belapectin at 2 mg/kg/LBW Reduces Varices Development in MASH Cirrhosis with Portal Hypertension: Results from the NAVIGATE Trial |
| 2025-02-18 | Galectin Therapeutics Inc. | Results Galectin Therapeutics Reports Significant Reduction in New Varices with Belapectin in U.S. Patient Population from the NAVIGATE Trial galectintherapeutics.com ↗
Additional analysis of data from the NAVIGATE trial showed statistically significant 68.1% (p=0.02) reduction in the incidence of new varices with belapectin vs placebo in per-protocol patients (completers) enrolled in the U.S. |
| 2025-01-10 | Galectin Therapeutics Inc. | Results Galectin Therapeutics to Present at the 2025 MASH-TAG Conference galectintherapeutics.com ↗
Belapectin administered at 2mg/kg/LBW for 18 months reduced the incidence of varices development in patients with MASH cirrhosis and portal hypertension: Top line results from the NAVIGATE trial |
| 2024-12-20 | Galectin Therapeutics Inc. | Results Galectin Therapeutics Announces Top-Line Results of NAVIGATE Clinical Trial Evaluating Belapectin in Patients with Cirrhotic Portal Hypertension Caused by MASH galectintherapeutics.com ↗
In the pre-specified per-protocol population, belapectin showed a statistically significant reduction (p-value < 0.05) in development of esophageal varices in 2mg/kg cohort compared to placebo |
| 2024-11-18 | Galectin Therapeutics Inc. | Results Galectin Therapeutics Presents Three Abstracts at the American Association for the Study of Liver Diseases (AASLD) 2024 Liver Meeting galectintherapeutics.com ↗
Approximately a third of patients with MASH cirrhosis and portal hypertension (PH) screened for the NAVIGATE trial had the incidental finding of varices on EGD, highlighting the need for screening EGDs in these patients |
| 2024-06-04 | Galectin Therapeutics Inc. | Results Galectin Therapeutics to Present at the European Association for the Study of the Liver (EASL) 2024 Congress galectintherapeutics.com ↗
This year we show that collagen content in liver biopsies of MASH cirrhotic patients fails to correlate with measures of portal pressure, a main marker of disease progression. |
| 2024-04-09 | Galectin Therapeutics Inc. | Results Galectin Therapeutics Reports the Positive Outcome of the Fifth Data and Safety Monitoring Board Meeting for NAVIGATE Phase 2b/3 Study of Belapectin in Patients with Cirrhotic Portal Hypertension Caused by Metabolic Dysfunction-Associated SteatoHepatitis galectintherapeutics.com ↗
Based on its deliberation, which included an unblinded review of the data collected thus far, the DSMB concluded that NAVIGATE can continue as designed, without modifications. |
| 2022-10-12 | Galectin Therapeutics Inc. | Regulatory Galectin Therapeutics Receives FDA Approval to Proceed with Combination Immunotherapy Trial in Head and Neck Cancer galectintherapeutics.com ↗
Galectin Therapeutics also received a Study May Proceed letter for a Phase 2 clinical trial entitled “A Phase 2 Study of the Efficacy and Safety of Belapectin in Combination with Pembrolizumab (Keytruda®) as First-Line Treatment in subjects with Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck.” |
| 2022-10-06 | Galectin Therapeutics Inc. | Results Galectin Therapeutics Reports the Positive Outcome of the Second Data and Safety Monitoring Board Meeting for NAVIGATE, its Seamless, Adaptive Phase 2b/3 Study of Belapectin in Patients with Liver Cirrhosis Caused by Non-Alcoholic Steatohepatitis galectintherapeutics.com ↗
Based on its deliberation, the DSMB concluded that NAVIGATE can continue as designed, without modifications. |
| 2022-04-14 | Galectin Therapeutics Inc. | Results Galectin Therapeutics Reports the Positive Outcome of the First Data and Safety Monitoring Board for NAVIGATE, its Seamless, Adaptive Phase 2b/3 Study of Belapectin in Patients with Liver Cirrhosis Caused by Non-Alcoholic Steatohepatitis galectintherapeutics.com ↗
Based on its deliberation, the DSMB concluded that NAVIGATE can continue as designed, without modifications. |
| 2021-07-09 | Galectin Therapeutics Inc. | Results Galectin Therapeutics Announces Positive Top-Line Results from a Phase 1b Clinical Trial Extension of Belapectin in Combination with KEYTRUDA® in Advanced Metastatic Melanoma and Head and Neck Cancer galectintherapeutics.com ↗
today announced top-line clinical data from the extension cohort of an investigator-initiated Phase 1b clinical trial of Belapectin, a galectin-3 inhibitor, in combination with KEYTRUDA® (pembrolizumab) in patients with metastatic melanoma and head and neck cancer1. |
| 2021-04-13 | Galectin Therapeutics Inc. | Results Journal for ImmunoTherapy of Cancer Publishes Phase 1 Clinical Research Showing Belapectin, Galectin Therapeutics’ Galectin-3 Inhibitor, Enhances Tumor Response in Combination with Anti-PD-1 Therapy galectintherapeutics.com ↗
In the study, as previously disclosed, an objective response was observed in 50% of MM (7/14) and 33% of HNSCC (2/6) patients. |
| 2021-03-08 | Galectin Therapeutics Inc. | Results OncoImmunology Publishes Pre-clinical Research Showing Galectin Therapeutics’ Belapectin Galectin-3 Inhibitor Reduces Tumor Progression in Combination with Anti-OX40 Therapy galectintherapeutics.com ↗
today announced that a paper published in the peer-reviewed journal OncoImmunology demonstrates how belapectin, a potent galectin-3 inhibitor, in combination with an anti-OX40 (CD134) monoclonal antibody, significantly reduces tumor progression compared to either agent alone. |
| 2020-04-30 | Galectin Therapeutics Inc. | Regulatory Galectin Therapeutics Submits Seamless Adaptively-Designed Phase 2b/3 NASH-RX Protocol in NASH Cirrhosis galectintherapeutics.com ↗
today announced that it has submitted to the U.S. Food and Drug Administration (FDA) its protocol for a seamless adaptively-designed Phase 2b/3 clinical study, the NASH-RX trial |
| 2019-12-09 | Galectin Therapeutics Inc. | Results Galectin Therapeutics’ Phase 2 NASH Cirrhosis Clinical Trial Results on Belapectin (GR-MD-02) Published in Gastroenterology galectintherapeutics.com ↗
The paper outlines that in a phase 2b study of 162 patients with NASH, cirrhosis, and portal hypertension, one year of biweekly infusion of belapectin was safe but not associated with significant reduction in HVPG or fibrosis, compared with placebo. |
| 2019-11-05 | Galectin Therapeutics Inc. | Results Additional Ad Hoc Analysis of ELF Data from Galectin Therapeutics NASH-CX Phase 2 Clinical Trial to be Highlighted in Poster Presentation at the 2019 AASLD Liver Meeting galectintherapeutics.com ↗
Baseline enhanced liver fibrosis (ELF) score taken at the beginning of NASH-CX trial accurately predicted which patients were at higher risk of liver-related outcomes |
| 2019-08-05 | Galectin Therapeutics Inc. | Regulatory Galectin Therapeutics Submits Phase 3 NASH-RX Protocol in Nash Cirrhosis to FDA galectintherapeutics.com ↗
The Galectin team is excited about the submission of the Phase 3 NASH-RX protocol, and the other requested information including the draft Phase 4 synopsis to the FDA. |
| 2019-03-22 | Galectin Therapeutics Inc. | Results Providence Cancer Institute to Present Findings on GR-MD-02 at the 2019 Keystone Symposia on Molecular and Cellular Biology galectintherapeutics.com ↗
Galectin-3 Inhibition with GR-MD-02 Synergizes with T Cell-Targeting Immunotherapy, Leading to Reduced Immune Suppression and Improved Overall Survival. |
| 2018-09-20 | Galectin Therapeutics Inc. | Results Galectin Therapeutics, Inc. Announces Positive Preliminary Results from Phase 1b Clinical Trial of GR-MD-02 and KEYTRUDA® in Advanced Melanoma and Expansion of the Trial galectintherapeutics.com ↗
Combination immunotherapy of GR-MD-02 and KEYTRUDA for all cohorts reported shows an Objective Response Rate of 50% (seven of fourteen patients). |
| 2018-05-11 | Galectin Therapeutics Inc. | Results Galectin Therapeutics Reports 2018 First Quarter Financial Results and Provides Business Update galectintherapeutics.com ↗
First, a statistically significant correlation was identified between the decrease in portal pressure (HVPG, or hepatic venous pressure gradient) and the improvement in hepatocyte ballooning treatment with GR-MD-02 at 2 mg/Kg. |
| 2018-04-18 | Galectin Therapeutics Inc. | Results Galectin Therapeutics to Present at 2nd Annual NASH Summit 2018 galectintherapeutics.com ↗
There were statistically significant and clinically relevant positive effects of GR-MD-02 on portal hypertension (hepatic venous pressure gradient or HVPG) and other liver biopsy parameters in patients with NASH cirrhosis without esophageal varices following one year of therapy. |
| 2018-04-16 | Galectin Therapeutics Inc. | Results Galectin Therapeutics Late-Breaker Presentation at The International Liver Congress Reinforces and Extends the Positive Effects of GR-MD-02 in Patients With NASH Cirrhosis galectintherapeutics.com ↗
Dr. Chalasani’s late-breaker presentation highlighted and extended the study’s primary findings in patients without esophageal varices and those with mild portal hypertension. |
| 2018-04-04 | Galectin Therapeutics Inc. | Results Galectin Therapeutics to Present Late-Breaker Oral Presentation at The International Liver Congress 2018 galectintherapeutics.com ↗
The NASH-CX demonstrated statistically significant and clinically relevant positive effects of GR-MD-02 on portal pressure (hepatic venous pressure gradient or HVPG) and liver biopsy parameters in patients with NASH cirrhosis without esophageal varices following one year of therapy. |
| 2018-04-02 | Galectin Therapeutics Inc. | Results Galectin Therapeutics to Present at H.C. Wainwright Global Life Sciences Conference galectintherapeutics.com ↗
There were statistically significant and clinically relevant positive effects of GR-MD-02 on portal pressure (hepatic venous pressure gradient or HVPG) and liver biopsy parameters in patients with NASH cirrhosis without esophageal varices following one year of therapy. |
| 2018-03-09 | Galectin Therapeutics Inc. | Results Galectin Therapeutics to Present at Two International Conferences in March galectintherapeutics.com ↗
In that study there were statistically significant and clinically relevant positive effects of GR-MD-02 on HVPG and other parameters in patients with NASH cirrhosis without esophageal varices following one year of therapy. |
| 2018-03-08 | Galectin Therapeutics Inc. | Results Galectin Therapeutics to Present at 2nd Annual H.C. Wainwright NASH Investor Conference galectintherapeutics.com ↗
There were statistically significant and clinically relevant positive effects of GR-MD-02 on HVPG and other parameters in patients with NASH cirrhosis without esophageal varices following one year of therapy. |
| 2018-02-28 | Galectin Therapeutics Inc. | Results Galectin Therapeutics to Present at 30th Annual ROTH Conference galectintherapeutics.com ↗
There were statistically significant and clinically relevant positive effects of GR-MD-02 on HVPG and other parameters in patients with NASH cirrhosis without esophageal varices following one year of therapy. |
| 2018-02-06 | Galectin Therapeutics Inc. | Results Galectin Therapeutics to Present at BIO CEO & Investor Conference galectintherapeutics.com ↗
GR-MD-02, a proprietary polysaccharide pharmaceutical preparation that inhibits galectin proteins, recently showed in a Phase 2b clinical trial (NASH-CX) that there were statistically significant and clinically relevant positive effects in patients with NASH cirrhosis without esophageal varices. |
| 2017-12-05 | Galectin Therapeutics Inc. | Results Galectin Therapeutics Announces Results from Phase 2b NASH-CX Trial galectintherapeutics.com ↗
Importantly, analysis of the secondary endpoint of complications of cirrhosis showed there was a statistically significant reduction in the development of new esophageal varices in patients without varices at baseline. |
| 2017-11-13 | Galectin Therapeutics Inc. | Results Combination Immunotherapy of Pembrolizumab with the Galectin-3 Inhibitor GR-MD-02 Shows Promising Early Results in Treatment of Advanced Melanoma from a Phase 1b Clinical Trial galectintherapeutics.com ↗
Five patients with advanced melanoma had objective responses after five courses of every three-week therapy, with three partial responses and two complete responses. |
All press releases naming this drug 50 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | belapectin | “GR-MD-02 (belapectin) is an inhibitor of galectin 3 that reduces liver fibrosis and portal hypertension in rats and was safe and well tolerated in phase 1 studies.” PMID 31812510 ↗ Dec 2019 |
| Known as | GR MD 02 | “GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3” NCT02462967 ↗ |
| Action | Inhibit | “Galectin-3 inhibitor” CHEMBL4297577 ↗1“galectin-3 inhibitor” NCT02117362 ↗ |
| Modality | Other / unclassified | “a complex carbohydrate drug” NCT02462967 ↗ |
| Route | Intravenous | “when administered intravenously” NCT01899859 ↗ |
| Target | LGALS3 | “Galectin-3 inhibitor” CHEMBL4297577 ↗ |