By Fineline Cube 
China-based Innovent Biologics (HKG: 1801) announced that its self-developed oral small molecule GLP-1 receptor agonist (GLP-1RA), IBI3032, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). Additionally, the clinical trial application for IBI3032 has been accepted by China’s National Medical Products Administration (NMPA).
Development and Mechanism
IBI3032 was developed using a globally established molecular scaffold, with full intellectual property rights retained by Innovent. The drug preferentially activates the cAMP signaling pathway. Preclinical data demonstrated that its oral exposure was 5-10 times higher than similar products. It also showed superior efficacy and good tolerability in both GLP-1R KI DIO mice and obese cynomolgus monkey models.
Clinical Trial Plans
Innovent Biologics plans to initiate Phase I clinical trials for IBI3032 in both the U.S. and China during the second half of 2025. The trials will include eligible participants such as healthy subjects and overweight/obese individuals.
Therapeutic Potential
IBI3032 is expected to complement injectable GLP-1 formulations and has potential applications in indications such as hypertension and obstructive sleep apnea (OSA). The company stated that the progress of this project signifies a further enhancement of its global development capabilities.
Development Strategy
IBI3032 was developed using a structure-based drug design (SBDD) strategy, resulting in superior pharmacokinetic and physicochemical properties compared to similar products. It is intended for the treatment of metabolic diseases like obesity and type 2 diabetes.-Fineline Info & Tech