Ascletis Submits Two Obesity Drug Applications to U.S. FDA

Chinese pharmaceutical company Ascletis has filed applications with the U.S. Food and Drug Administration (FDA) for the development of two new drugs aimed at treating obesity.

The first application is for ASC36, a once-monthly injection that acts as an amylin receptor agonist. The second application concerns ASC36_35 FDC, a co-formulation of ASC36 and the GLP-1R/GIPR agonist ASC35, also intended for monthly subcutaneous administration.

ASC36_35 FDC demonstrated approximately 51% greater relative body weight reduction compared to placebo in previous studies. This drug candidate targets three validated pathways: the amylin receptor, the GLP-1 receptor, and the GIP receptor.

Obesity continues to be a significant global health challenge, spurring demand for novel treatment strategies. Ascletis' development efforts are focused on addressing this need with new drug candidates designed to target multiple mechanisms of action.