Core Viewpoint - The FDA has granted Fast Track designation to pemvidutide for the treatment of Alcohol Use Disorder (AUD), highlighting the urgent need for effective treatments in this area [1][3][5] Group 1: Pemvidutide and Clinical Trials - Pemvidutide is currently undergoing a Phase 2 trial named RECLAIM, which is enrolling approximately 100 patients to evaluate its safety and efficacy in treating AUD [2][6] - The trial will randomize participants to receive either 2.4 mg of pemvidutide or a placebo weekly for 24 weeks, with the primary endpoint being the change in the average number of heavy drinking days [2] - Pemvidutide has shown potential in preclinical models to significantly reduce alcohol intake, supporting its use in treating AUD [3][7] Group 2: Market Need and Treatment Gap - An estimated 28 million adults in the U.S. suffer from AUD, yet only 2% are currently treated with medication, indicating a significant treatment gap [3][5] - Existing FDA-approved therapies for AUD have limited efficacy and do not adequately address comorbidities such as hepatic steatosis and hypertension [3][5] - The World Health Organization identifies harmful alcohol consumption as a leading cause of global death and disability, emphasizing the need for effective treatments [4] Group 3: Mechanism and Benefits of Pemvidutide - Pemvidutide acts as a dual receptor agonist for GLP-1 and glucagon, which may help in weight loss and reducing alcohol cravings [6][7] - In previous trials, pemvidutide demonstrated significant improvements in liver fat content, weight loss, and blood pressure, indicating its potential as a comprehensive treatment for AUD and related conditions [7] - The ongoing IMPACT Phase 2b trial is expected to provide further insights into pemvidutide's efficacy in treating Metabolic Dysfunction-Associated Steatohepatitis (MASH) and its potential benefits for AUD [7]