This section highlights FDA-related milestones and regulatory updates for drugs developed by Galmed Pharmaceuticals (GLMD).
Over the past two years, Galmed Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Aramchol, AM-001, MGL-3196, and Aramchol. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Aramchol meglumine FDA Regulatory Events
Aramchol meglumine is a drug developed by Galmed Pharmaceuticals for the following indication: Modifying treatment for nonalcoholic steatohepatitis, or NASH, a more advanced condition of non-alcoholic fatty liver disease.
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:
- Aramchol meglumine
- Announced Date:
- June 2, 2026
- Indication:
- Modifying treatment for nonalcoholic steatohepatitis, or NASH, a more advanced condition of non-alcoholic fatty liver disease.
Announcement
Tissue Dynamics Ltd. and Galmed Pharmaceuticals Ltd. announced results from a preclinical study evaluating a combination of Aramchol Meglumine, an SCD1 inhibitor, and a selective PPARα agonist.
AI Summary
Tissue Dynamics Ltd. and Galmed Pharmaceuticals Ltd. reported promising preclinical results for a new combination therapy using Aramchol Meglumine, an SCD1 inhibitor, together with a selective PPARα agonist. In a human cardiac organoid model, the companies found a previously unrecognized metabolic pathway that appears to drive cardiac fibrosis, a condition that causes harmful scarring in the heart. This biology was seen in human tissue models but is not easily detected in standard animal studies.
In inflammatory human cardiac organoids, the drug combination cut fibrotic burden by about four times compared with controls, with strong statistical significance. Importantly, the treatment also preserved cardiac muscle structure and metabolic function, suggesting it may reduce scarring without damaging heart tissue. The companies said these findings support further study of the approach as a potential treatment for heart fibrosis.
Read Announcement
AM-001 FDA Regulatory Events
AM-001 is a drug developed by Galmed Pharmaceuticals for the following indication: Aramchol Meglumine.
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:
- AM-001
- Announced Date:
- November 18, 2025
- Indication:
- Aramchol Meglumine
Announcement
Galmed Pharmaceuticals Ltd. announced meaningful top-line results from Galmed's AM-001 Study, a Phase 1 Bioavailability (BA) Study of Aramchol meglumine.
AI Summary
Galmed Pharmaceuticals reported top-line results from its AM-001 Phase 1 bioavailability study of Aramchol meglumine. The study compared Aramchol meglumine granules to Aramchol free acid tablets in 30 healthy volunteers. The results showed much higher bioavailability for the meglumine granules: the 400 mg granule dose delivered about five times the Aramchol exposure and the 200 mg granule about three times the exposure versus the 300 mg free acid tablet. The company described the pharmacokinetic profile as unexpected and more favorable.
These findings support a once-daily 400 mg dose as the likely optimal regimen for upcoming trials. Once-daily dosing could improve long-term patient adherence and clinical effectiveness. Galmed also expects the new formulation to cut the drug’s cost of goods substantially (around half), potentially making chronic treatment more affordable and appealing to payers. The data will guide dose selection for planned Phase 2 oncology studies in H1 2026.
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MGL-3196 FDA Regulatory Events
MGL-3196 is a drug developed by Galmed Pharmaceuticals for the following indication: For the Treatment of NASH and Liver Fibrosis.
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:
- MGL-3196
- Announced Date:
- March 20, 2025
- Indication:
- For the Treatment of NASH and Liver Fibrosis
Announcement
Galmed Pharmaceuticals Ltd. announced the grant of a new patent related to its lead compound, Aramchol.
AI Summary
Galmed Pharmaceuticals Ltd. announced a new patent for its lead compound, Aramchol, which covers a combination therapy using Aramchol and Resmetirom for treating non-alcoholic steatohepatitis (NASH) and liver fibrosis. This patent extends Aramchol’s market exclusivity until September 2039, securing a 15-year exclusivity runway. The combination therapy is designed to address the multiple challenges of NASH, a disease marked by liver fat buildup, metabolic issues, and fibrosis.
The company believes that pairing Aramchol—a first-in-class stearoyl-CoA desaturase-1 (SCD1) modulator—with Resmetirom, which targets liver fat, will provide a more effective treatment option for patients. This strategic patent strengthens Galmed’s intellectual property portfolio and positions the company to fully capitalize on the commercial potential of these novel NASH therapies in the future.
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Aramchol FDA Regulatory Events
Aramchol is a drug developed by Galmed Pharmaceuticals for the following indication: NonAlcoholic SteatoHepatitis (NASH) and Fibrosis.
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:
- Aramchol
- Announced Date:
- September 25, 2024
- Indication:
- NonAlcoholic SteatoHepatitis (NASH) and Fibrosis
Announcement
Galmed Pharmaceuticals Ltd. announced that the one-year results of the Open-Label part (ARCON ) of its global Phase 3 trial of Aramchol in 150 patients with NASH and fibrosis (ARMOR) have been published in Hepatology.
AI Summary
Galmed Pharmaceuticals Ltd. announced the one-year results for the open-label part (ARCON) of its global Phase 3 ARMOR trial, involving 150 patients with NASH and fibrosis. The study findings were published in the journal Hepatology and confirm a significant anti-fibrotic effect when using Aramchol 300mg BID. Researchers used three objective methods to assess improvements: NASH CRN, paired ranked reading, and an Artificial Intelligence (AI) quantitative digital analysis. The AI digital pathology method, in particular, provided a sensitive measurement of fibrosis regression, demonstrating the drug’s potential in significantly reducing liver fibrosis.
These results highlight Aramchol’s unique mechanism, targeting the enzyme SCD-1, which not only helps burn fat but also improves glycemic control. Galmed sees this as a promising step toward effective treatment options for patients with NASH and fibrosis.
Read Announcement
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