Innovent Announces Phase 3 Trial for Gout Drug Tigulixostat

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

Mar. 23, 2026 at 12:54am by Ben Kaplan

Got story updates? Submit your updates here. ›

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

Why it matters

Gout is a growing health issue in China, with an estimated 177 million people suffering from hyperuricemia and over 10 million with gout. Current gout treatments face challenges with safety and efficacy, so new treatment options like tigulixostat that can effectively lower uric acid levels while maintaining good safety are needed to address this significant unmet medical need.

The details

The Phase 3 study will randomize patients 1:1 to receive either tigulixostat 100 mg or febuxostat 40 mg for 24 weeks, with a total treatment period of one year. The study is being led by Professor Zou Hejian from Huashan Hospital, Fudan University, who noted that tigulixostat showed advantages in uric acid lowering and safety in previous Phase 2 trials. Innovent's Chief R&D Officer Dr. Lei Qian stated the company is building a comprehensive gout pipeline to address different patient needs, including tigulixostat as well as an IL-1RAP monoclonal antibody and a GLP-1/GCG dual agonist.

  • The Phase 3 study began dosing the first participant in March 2026.
  • The treatment period of the trial is one year.

The players

Innovent Biologics

A 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 tigulixostat study and a professor at Huashan Hospital, Fudan University.

Dr. Lei Qian

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

Got photos? Submit your photos here. ›

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

The judge in the case will decide on Tuesday whether or not to allow Walker Reed Quinn out on bail.

The takeaway

This Phase 3 trial of tigulixostat represents an important step in addressing the growing gout epidemic in China by developing a new treatment option that can effectively lower uric acid levels while maintaining good safety, which are key unmet needs for current gout therapies.