Innovent Receives Approval for IND Application of Oral GLP-1R Agonist IBI3032
Tuesday, August 05, 2025
Innovent Biologics has received approval from the United States Food and Drug Administration (FDA) for its investigational new drug (IND) application to begin Phase 1 clinical trials of IBI3032, an oral GLP-1 receptor agonist.
GLP-1 receptor agonists are gaining global attention for their role in treating conditions such as type 2 diabetes and obesity. Oral formulations are seen as a convenient and flexible alternative to injectable therapies, with additional potential in managing related conditions such as hypertension and obstructive sleep apnoea (OSA).
IBI3032 was discovered using a structure-based drug design approach, coupled with efforts to optimise its physicochemical characteristics. The compound works by activating GLP-1 receptors to slow gastric emptying, reduce appetite, and enhance insulin secretion, supporting its use in insulin-related metabolic disorders.
The trials are expected to start in the second half of 2025.
IBI3032 is a small-molecule, orally administered GLP-1 receptor agonist developed in-house by Innovent. It targets the cAMP signalling pathway and has shown improved pharmacokinetic and physicochemical properties in preclinical studies. Compared to other compounds in its class, IBI3032 demonstrated significantly higher oral exposure in animal models at equivalent doses, with enhanced efficacy and good tolerability.
The upcoming Phase 1 trials will be conducted in both China and the United States, involving healthy volunteers and participants who are overweight or obese. This trial forms part of Innovent’s broader cardiovascular and metabolic (CVM) pipeline, which includes mazdutide as a key asset.
Regulatory acceptance for the Phase 1 study has now been granted by both the FDA and China’s National Medical Products Administration (NMPA). The approval marks a key milestone in Innovent’s efforts to advance its pipeline of globally relevant therapies.
Source: prnewswire.com
