Hong Kong, 11 Nov 2026—Ascletis Pharma Inc. announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for ASC30_39, a once-daily oral fixed-dose combination (FDC) tablet that unites the company’s small-molecule GLP-1 receptor agonist ASC30 with its selective amylin receptor agonist ASC39 for the treatment of obesity.

ASC30_39 is the first oral co-formulation combining a GLP-1 agonist and an amylin agonist to reach the IND stage, delivering two clinically validated, complementary mechanisms for weight management in a single tablet. Preclinical studies in dogs showed high oral bioavailability, robust systemic exposure, and a half-life of up to 12 hours, with pharmacokinetic profiles comparable to the respective monotherapies.

Both components were discovered through Ascletis’ AI-assisted structure-based drug discovery platform and formulated to ensure room-temperature stability and a compact pill size, indicating strong compatibility between ASC30 and ASC39.

Pipeline context: • ASC30 is in two global pivotal Phase III trials (AURORA-1 and AURORA-2) enrolling approximately 4,600 adults with obesity or overweight across the United States, Europe, and Canada. Top-line data are anticipated in Q3 2028. In prior studies, ASC30 showed a gastrointestinal tolerability profile with roughly half the vomiting incidence observed with orforglipron under similar dosing schedules. • ASC39, an oral small-molecule selective amylin receptor agonist, exhibits 40-fold selectivity for the human amylin 1 receptor versus the calcitonin receptor and achieved a 6.60 percent placebo-adjusted body-weight reduction after six days of daily dosing in diet-induced obese rats—comparable to the benchmark amylin analogue eloralintide.

Ascletis cautioned that there is no assurance of successful development, manufacturing, or commercialization of ASC30, ASC39, or the ASC30_39 FDC.