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 and MGL-3196. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Aramchol - FDA Regulatory Timeline and 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.
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MGL-3196 - FDA Regulatory Timeline and 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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