*Febuxostat is an orally administered, non-purine, selective inhibitor of xanthine oxidase approved for the management of chronic hyperuricaemia in patients with gout. *In a randomized, double-blind, dose-ranging study in patients with gout and hyperuricaemia, significantly more recipients of febuxostat 40-120 mg/day than placebo had serum urate levels of < 6.0 mg/dL after 4 weeks of treatment. *Serum urate levels were reduced below 6.0 mg/dL at the last three monthly observations in a significantly greater proportion of patients with gout and hyperuricaemia receiving febuxostat 80 or 120 mg once daily than in those receiving allopurinol 300 mg once daily in a 52-week, randomized, double-blind trial (FACT). *Similarly, febuxostat 80, 120 or 240 mg once daily showed significantly greater urate-lowering efficacy than allopurinol 100 or 300 mg once daily in a 28-week, randomized, double-blind, placebo-controlled trial (APEX) in patients with gout and hyperuricaemia. *Long-term treatment with febuxostat for up to 4 years or more reduced the incidence of gout flares to (or close to) zero. *Febuxostat was generally well tolerated in clinical trials, including extension studies lasting > or = 4 years, with most treatment-related adverse events being mild to moderate in severity.