Innovent receives FDA Approval for IND application of oral GLP-1R agonist IBI3032
- owenhaskins
- 2 days ago
- 2 min read
Innovent Biologics has announced the FDA has approved the investigational new drug (IND) application to initiate a Phase 1 clinical trial of IBI3032, the company's novel oral GLP-1R agonist.
IBI3032 is a novel oral small molecule glucagon-like peptide-1 receptor agonist (GLP-1RA). By efficiently and selectively targeting GLP-1R, it activates downstream signal transduction, thereby delaying gastric emptying, inhibiting appetite, and promoting insulin secretion, and ultimately supporting the treatment of insulin-related metabolic diseases such as obesity and T2DB.
Discovered through a structure-based drug design (SBDD) strategy combined with systematic physicochemical property optimisation, IBI3032 has shown better PK and physicochemical properties compared to similar compounds.
IBI3032 is an orally administered small-molecule GLP-1 receptor agonist with bias for cAMP signalling pathway, discovered and developed by Innovent Biologics with proprietary rights. Preclinical data demonstrate its superior pharmacokinetic (PK) and physicochemical properties compared to peer compounds. In animal models, IBI3032 achieved five to ten times higher oral exposure at equivalent doses, with improved efficacy and good tolerability in both GLP-1R KI DIO mice and obese monkey models, achieving comparable therapeutic effects at lower doses.
The Phase 1 clinical trials of IBI3032 are planned to be conducted concurrently in China and the US. Dosing in healthy volunteers and overweight or obese participants is expected to begin in the second half of 2025. Innovent is building up its CVM pipeline with mazdutide as the cornerstone, and the initiation of the IBI3032 clinical study marks a significant step in the evolution of its CVM pipeline portfolio with global potential.
The IND application of IBI3032 was accepted by China's National Medical Products Administration (NMPA) and approved by the US Food and Drug Administration (FDA). A multi-regional Phase 1 clinical study of IBI3032 is planned for initiation in the second half of 2025.