Innovent Biologics Secures FDA Nod to Begin Phase 1 Trials for Oral GLP-1 Agonist

Innovent Biologics Secures FDA Nod to Begin Phase 1 Trials for Oral GLP-1 Agonist

By, Admin 6 August 2025

A new player is entering the metabolic disorder arena—and it’s oral. Innovent Biologics has received FDA approval to begin Phase 1 clinical trials for IBI3032, its in-house developed oral GLP-1 receptor agonist.

Why This Matters

GLP-1 receptor agonists are transforming treatment for:

  • Type 2 diabetes
  • Obesity
  • Hypertension
  • Obstructive sleep apnea (OSA)

Unlike injectable options, oral therapies offer:

  • Easier administration
  • Better patient compliance
  • Potential for broader use in early interventions

Inside IBI3032: A Targeted Metabolic Approach

IBI3032 is a small-molecule GLP-1 receptor agonist, designed using structure-based drug discovery and optimized for oral delivery.

Mechanism of Action

  • Activates GLP-1 receptors
  • Slows gastric emptying
  • Reduces appetite
  • Boosts insulin secretion via the cAMP pathway

Preclinical Highlights

  • Higher oral bioavailability vs. other GLP-1 analogs
  • Strong efficacy in animal models
  • Favorable safety and pharmacokinetic profile

What’s Next: Dual Trials in US and China

Phase 1 trials will begin in the second half of 2025. Participants will include:

  • Healthy volunteers
  • Overweight and obese individuals

Both the FDA and China’s NMPA have approved the study—marking global regulatory support for Innovent’s pipeline.

Part of a Bigger Vision

This program complements Innovent’s broader cardiovascular and metabolic (CVM) strategy, where mazdutide remains a core asset.

With IBI3032 entering clinical trials, Innovent signals its ambition to compete globally in oral metabolic therapeutics.

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