Home / Health / Obesity Drug ASC35 Clears FDA for Phase I Trial
Obesity Drug ASC35 Clears FDA for Phase I Trial
24 Jun
Summary
- ASC35, a dual GLP-1R/GIPR agonist, targets obesity treatment.
- FDA clearance allows for a Phase I study of ASC35's safety.
- The drug utilizes Ascletis' proprietary SALD formulation technology.
Ascletis Pharma has received clearance from the US Food and Drug Administration (FDA) to begin a Phase I clinical study for ASC35, a new therapeutic candidate for obesity. ASC35 is a novel, once-monthly subcutaneous injection that acts as a dual agonist for GLP-1R and GIPR.
The planned study will assess the safety, tolerability, and pharmacokinetic profile of ASC35. This research follows the drug's independent discovery and development utilizing Ascletis' AI-assisted drug discovery platform.
The investigational drug employs Ascletis' proprietary Self-Assembling Lipid Depot (SALD) formulation technology, which enables ultra-long-acting delivery. This technology is designed for patient convenience, offering a once-monthly injection.
This FDA clearance represents a significant step for Ascletis' peptide pipeline focused on obesity treatment. The company aims to address a substantial unmet need in the growing obesity market with potentially superior weight loss efficacy and a patient-friendly administration profile.
