The U.S. Food and Drug Administration (FDA) has issued Investigational New Drug (IND) approval for Innovent Biologics’ IBI3032. In particular, IBI3032 is an oral glucagon-like peptide (GLP-1) receptor agonist, similar to blockbuster drugs Ozempic and Mounjaro. Overall, this development marks an important shift forward for Innovent’s foray into treating metabolic disease globally.
IBI3032 Enters U.S. Clinical Trials
In particular, IBI3032 is a novel small-molecule drug that targets the GLP-1 receptor using cAMP (cyclic adenosine monophosphate)-biased signaling. Cyclic adenosine monophosphate, a molecule, acts as a vital second messenger sending messages from outside to inside cells. It also performs a number of other cellular functions.
Notably, the drug showed 5–10 times higher oral exposure in preclinical models versus in peer compounds. Moreover, it achieved strong efficacy and tolerability in obese mouse and monkey studies.
According to Innovent, the FDA’s clearance allows the company to initiate concurrent Phase 1 trials in the U.S. and China. In addition, the trial will enroll both healthy volunteers and individuals with overweight or obesity, beginning in the second half of 2025. Overall, this dual-region approach reflects Innovent’s ambition to become a global player in cardiometabolic therapies.
Mazdutide’s Success in China
Earlier in June 2025, China’s NMPA (National Medical Products Administration) approved Innovent’s mazdutide, the country’s first dual GCG/GLP-1 RA. The bureau gave it green light for chronic weight management, reinforcing the company’s growing reputation in metabolic innovation.
Consequently, Innovent is positioning IBI3032 as the next-generation candidate in Innovent’s cardiometabolic pipeline. The oral formulation gives it a distinct edge over injectable therapies, offering more flexibility and convenience for patients.
“We are excited to advance this candidate into clinical development,” noted Dr. Lei Qian, Chief R&D Officer for General Biomedicines Pipeline at Innovent Biologics.
“This IND approval reflects Innovent’s strong R&D capabilities and, most importantly, our commitment to global innovation. We hope that in the near future, IBI3032 can offer more effective and convenient treatment options to benefit patients around the world,” Qian added.
Expanding a Robust R&D Portfolio
Founded in 2011, Innovent has 16 approved products and over 30 pipeline candidates across oncology, autoimmune, and metabolic diseases. Overall, the company’s strategic focus now includes multi-regional clinical development, visible in the IBI3032 and mazdutide programs.
In fact, the firm’s metabolic portfolio is expanding rapidly. In addition to GLP-1 therapies, Innovent is exploring combination approaches that may address multiple risk factors simultaneously.
Competitive Advantages
Although the GLP-1 market is already competitive, Innovent’s oral delivery method provides a critical advantage. For now, injectable GLP-1 agonists, like those from Novo Nordisk and Eli Lilly, have dominated the space. However, oral alternatives offer better patient adherence and potentially broader use cases.
Furthermore, Innovent’s proprietary mechanism may offer differentiated outcomes. Preclinical data shows IBI3032’s selective receptor signaling could improve safety while maintaining efficacy.
Global Ambitions for IBI3032
Looking ahead, Innovent plans to launch Phase 1 trials in late 2025. Results from these studies will guide future Phase 2/3 plans. If successful, IBI3032 may support the company’s ambition to launch globally competitive, first-in-class metabolic therapies.
