ASCLETIS-B (01672) announced the selection of ASC36, a potential best-in-class monthly subcutaneous amylin receptor agonist, as its clinical development candidate. The company plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in Q2 2026 for ASC36 as an obesity treatment.

Developed using ASCLETIS-B's proprietary AI-assisted structure-based drug discovery (AISBDD) and ultra-long-acting platform (ULAP) technologies, ASC36 is a peptide-based amylin receptor agonist. The optimized design of ASC36 achieves an extended apparent half-life (time for blood concentration to drop to 50% of Cmax) and higher bioavailability per milligram of peptide, enabling monthly subcutaneous dosing with an injection volume ≤1mL. These design advantages also enhance manufacturing scalability.

In head-to-head primate studies, ASC36's depot formulation demonstrated an average observed half-life of ~15 days—three times longer than petrelintide—supporting its potential for monthly obesity treatment in humans. In diet-induced obese (DIO) rat studies (a model with high predictive value for human efficacy), ASC36 achieved 10.01% weight loss versus petrelintide's 5.25% at equimolar doses, representing a 91% improvement. Superior weight-loss efficacy per milligram may further reduce production costs at scale.