Ascletis Gains FDA IND Clearance for Once-Monthly Obesity Drug ASC35 Phase I Trial

Ascletis Pharma Inc. has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical trial for its novel obesity drug, ASC35. The clearance, announced June 23, 2026, allows the company to proceed with human trials for the once-monthly GLP-1/GIP receptor dual agonist. ASC35 is being developed as a long-acting treatment for obesity and type 2 diabetes. Preclinical studies demonstrated ASC35's potential for superior weight loss compared to semaglutide in non-human primates. This advancement marks a key step in Ascletis's strategy to address significant unmet medical needs in chronic metabolic diseases.