Innovent Announces First Participant Dosed of IBI128 in Phase 3 Gout Study

New XOI drug aims to provide better treatment option for Chinese gout patients

Mar. 23, 2026 at 1:39am by Ben Kaplan

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Innovent Biologics, a biopharmaceutical company, announced the first participant has been dosed in a Phase 3 clinical study of its xanthine oxidase inhibitor (XOI) drug IBI128 (tigulixostat). The randomized, double-blind study will compare IBI128 to febuxostat in 600 Chinese gout patients, with the primary endpoint being the proportion of patients achieving serum uric acid levels below 360 μmol/L at week 24.

Why it matters

Gout is a growing problem in China, with an estimated 177 million people with hyperuricemia and over 10 million gout patients. Current gout treatments face challenges with safety and efficacy, so a new drug like IBI128 that can effectively lower uric acid levels with a good safety profile could provide an important new treatment option for Chinese gout patients.

The details

The Phase 3 study will randomize patients 1:1 to receive either IBI128 100 mg or febuxostat 40 mg for 24 weeks, with a total treatment period of 1 year. The study is being led by Professor Zou Hejian from Huashan Hospital, Fudan University. In a previous Phase 2 study, IBI128 showed a more significant urate-lowering effect and better safety compared to febuxostat.

  • The first participant was dosed in the Phase 3 study in March 2026.
  • The treatment period of the Phase 3 trial is 1 year.

The players

Innovent Biologics

A world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines, including for the treatment of gout.

Professor Zou Hejian

The Principal Investigator of the Phase 3 IBI128 study, from Huashan Hospital, Fudan University.

Dr. Lei Qian

The Chief R&D Officer of General Biomedicine at Innovent Biologics.

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What they’re saying

“Current gout treatment has dual challenges of drug safety concerns and insufficient efficacy. The Phase 2 data of IBI128 have shown significant advantages in lowering uric acid. This Phase 3 study, through head-to-head design and long-term observation, is expected to provide high-level evidence-based evidence for clinical practice.”

— Professor Zou Hejian, Principal Investigator of the Study, Huashan Hospital, Fudan University

“Gout is one of the largest chronic diseases in China, which has long brought a sustained health burden to millions of patients. However, compared with chronic diseases such as diabetes and hypertension, the current therapeutic options are still relatively limited. Gout patients urgently need innovative drugs that have potent uric acid-lowering effects and good safety, and the development of IBI128 reflects Innovent Biologics' proactive response, as an innovation-driven biopharmaceutical company, to address this significant unmet medical need.”

— Dr. Lei Qian, Chief R&D Officer of General Biomedicine, Innovent Biologics

What’s next

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The takeaway

This new Phase 3 study of Innovent's IBI128 drug highlights the growing need for innovative and effective treatments for the rising rates of gout in China, as current options face challenges with safety and efficacy. If successful, IBI128 could provide an important new therapy to help manage this chronic and debilitating condition.