Ascletis Announces First Participant Dosed in a Global Phase III Clinical Program of Once-Daily Oral Small Molecule GLP-1 Receptor Agonist ASC30 for Chronic Weight Management
PR Newswire
HONG KONG, Aug. 30, 2026
- Expected to enroll approximately 4,600 participants with obesity or overweight across two pivotal trials (AURORA-1 and AURORA-2) in the U.S., Europe, and Canada. - Global Phase III clinical program to investigate efficacy and safety of three maintenance doses (20 mg, 40 mg, and 60 mg) over 72 weeks in participants with obesity or overweight without type 2 diabetes (AURORA-1) and with type 2 diabetes (AURORA-2).- Topline data from the AURORA Phase III clinical program are expected in the third quarter of 2028, with a U.S. Food and Drug Administration (FDA) New Drug Application (NDA) submission expected by the end of 2028 and European Medicines Agency (EMA) Marketing Authorisation Application (MAA) submission expected in early 2029.- ASC30 has the potential to become the second oral small molecule GLP-1 receptor agonist available in the U.S. and Europe, if approved.HONG KONG, Aug. 30, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announced that the first participant has been dosed in a global Phase III clinical program of ASC30 for chronic weight management. ASC30 is an investigational, proprietary once-daily oral small molecule glucagon-like peptide-1 receptor (GLP-1R) agonist being developed for chronic weight management and diabetes.
