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# Alcohol Use Disorder Drug Gets Fast Track
- URL: https://www.fdaweb.com/alcohol-use-disorder-drug-gets-fast-track/
- Published: 2025-08-19T12:00:00.000Z
- Updated: 2026-09-14T15:19:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159717

FDA has granted Altimmune a fast track designation for pemvidutide and its use for treating alcohol use disorder. The company is currently evaluating pemvidutide in the Phase 2 RECLAIM trial. The primary endpoint is a reduction in the number of heavy drinking days, with secondary measures including improvements in World Health Organization risk drinking levels and biomarkers of alcohol consumption.

The company says pemvidutide has a dual mechanism of action — acting on both GLP-1 and glucagon receptors — that could reduce alcohol cravings while addressing liver fat and inflammation. In preclinical studies, the therapy produced a rapid and significant reduction in alcohol intake, it says.

Pemvidutide is also in development for metabolic dysfunction-associated steatohepatitis (MASH), alcohol-associated liver disease, and obesity, according to the company. In earlier trials, the drug demonstrated significant weight loss, improvements in liver fat and fibrosis, and favorable tolerability. A 48-week readout from the ongoing IMPACT Phase 2b MASH trial is expected in late 2025.