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Innovent Announces First Participant Dosed of IBI128 (Tigulixostat, XOI) in Phase 3 Clinical Study
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 participant dosed in a Phase 3 clinical study in head-to-head comparison of febuxostat, aiming to provide a better treatment op
About this update from Innovent Biologics, Inc.
[{"type":"text","content":"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 major diseases, announced that the xanthine oxidase inhibitor (XOI) Tigulixostat(R&D code: IBI128) have the first participant dosed in a Phase 3 clinical study in head-to-head comparison of febuxostat, aiming to provide a better treatment option for Chinese gout patients. In a previous Phase 2 clinical study, tigulixostat showed a more significant urate-lowering effect and a good safety profile compared with the febuxostat group. The Phase 2 clinical data were published at the Asia-Pacific League of Associations for Rheumatology (APLAR) conference in 2025.","length":904,"tagName":"p"},{"type":"text","content":"This study adopts a randomized, double-blind, multi-center Phase 3 design, and plans to enroll 600 Chinese patients who meet the 2015 ACR/EULAR gout diagnostic criteria, and randomize them in a 1:1 ratio to receive tigulixostat 100 mg or febuxostat 40 mg for 24 weeks. The treatment period of the trial was one year. The primary endpoint was the proportion of patients with serum uric acid (sUA) < 360 μmol/L at week 24.","length":423,"tagName":"p","attribs":{}},{"type":"text","content":"The Principal Investigator of the Study, Professor Zou Hejian from Huashan Hospital, Fudan University, said: "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. As a metabolic disease with the fastest growth rate in prevalence in China, gout also has multiple unmet medical needs, including the safety risks of existing drugs, such as cardiovascular risks, hypersensitivity reactions limiting clinical application, and the risk of acute kidney injury caused by excessive uric acid excretion load; the lack of efficacy, such as insufficient drug compliance rate and medication restrictions for patients with renal impairment. Tigul...