Innovent Secures FDA Approval to Begin Clinical Trials of Oral GLP-1R Agonist IBI3032
Tuesday, August 05, 2025
Innovent Biologics has received approval from the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application to begin Phase 1 clinical trials of IBI3032, a novel oral GLP-1 receptor (GLP-1R) agonist. This marks a significant milestone in the company’s efforts to expand its cardiovascular and metabolic (CVM) pipeline globally.
IBI3032 is a small-molecule drug developed in-house by Innovent. It targets the GLP-1 receptor with a preference for the cAMP signalling pathway. Preclinical studies have shown that IBI3032 delivers improved pharmacokinetics and physicochemical properties when compared to similar treatments. In animal models, it achieved 5 to 10 times greater oral exposure at equivalent doses, demonstrating stronger efficacy and good tolerability. Results were consistent in both GLP-1R knock-in obese mice and obese monkeys, where lower doses delivered comparable therapeutic effects.
Phase 1 clinical trials are expected to begin in the second half of 2025, with studies planned to take place in both China and the United States. The trials will include healthy volunteers and individuals who are overweight or obese.
IBI3032 is part of Innovent’s broader CVM portfolio, which includes mazdutide as a lead compound. The addition of IBI3032 is seen as an important step in advancing the company’s efforts in metabolic disease research, including the potential treatment of obesity, type 2 diabetes (T2D), hypertension and obstructive sleep apnoea (OSA).
The therapy works by selectively activating GLP-1 receptors, helping to delay gastric emptying, suppress appetite and stimulate insulin secretion—key mechanisms in the treatment of metabolic disorders. IBI3032 was discovered using a structure-based drug design (SBDD) approach, paired with optimisation of its physical and chemical properties to improve performance over existing options.
Alongside FDA approval, IBI3032’s IND application has also been accepted by China’s National Medical Products Administration (NMPA). A multi-regional Phase 1 clinical trial is now planned to begin in the second half of 2025, highlighting Innovent’s commitment to advancing innovative treatments across international markets.
Source: prnewswire.com
