US EditionInnovent Announces First Participant Dosed of IBI128 (Tigulixostat, XOI) in Phase 3 Clinical Study
The Phase 3 trial will enroll 600 gout patients to compare efficacy and safety of tigulixostat versus febuxostat amid rising gout prevalence and unmet treatment needs in China.
- On March 22, 2026, Innovent Biologics announced the first participant was dosed in a Phase 3 head-to-head study of IBI128 versus febuxostat, aiming to provide a better treatment option for Chinese gout patients.
- With hyperuricemia affecting 17.7% of China's population and gout prevalence at 3.2%, approximately 177 million people face disease burden; nearly 60% of patients are aged 18–35, driving demand for safer, more effective therapies.
- The randomized, double-blind, multi-center Phase 3 plans to enroll 600 Chinese patients, randomizing them 1:1 to tigulixostat 100 mg or febuxostat 40 mg for 24 weeks, with sUA < 360 µmol/L at week 24 as the primary endpoint.
- Dr. Lei Qian, Chief R&D Officer of General Biomedicine at Innovent Biologics, stated "gout patients urgently need innovative drugs that have potent uric acid-lowering effects and good safety," citing unmet medical needs in China.
- Phase 2 data published at the Asia-Pacific League of Associations for Rheumatology conference in 2025 showed the 100 mg dose achieved 81% sUA compliance at 16 weeks, significantly better than febuxostat, supporting Phase 3 progression.
23 Articles
23 Articles
Helena Independent Record
Innovent Announces First Participant Dosed of IBI128 (Tigulixostat, XOI) in Phase 3 Clinical Study
SAN FRANCISCO and SUZHOU, China, March 22, 2026 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other…
Innovent begins phase 3 dosing of gout treatment candidate
SAN FRANCISCO and SUZHOU, China, March 23, 2026 /PRNewswire/ -- Innovent Biologics, Inc. (\"Innovent\", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the xanthine oxidase inhibitor (XOI) Tigulixostat(R&D code: IBI128) have the first participan…
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