Chinese biopharmaceutical company Innovent Biologics Inc (HKEX:01801) announced on Sunday that the first participant has been dosed in a Phase 3 clinical study of the xanthine oxidase inhibitor (XOI) tigulixostat (R&D code: IBI128) in a head-to-head comparison with 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. Phase 2 data were published at the Asia-Pacific League of Associations for Rheumatology (APLAR) conference in 2025.

The new study adopts a randomised, double-blind, multi-centre Phase 3 design. It will enrol 600 Chinese patients who meet the 2015 ACR/EULAR gout diagnostic criteria, randomised in a 1:1 ratio to receive tigulixostat 100 mg or febuxostat 40 mg for 24 weeks.

Primary endpoint is the proportion of patients with serum uric acid (sUA) < 360 Mu mol/L at week 24.