Febuxostat
- Generic Name
- Febuxostat
- Brand Names
- Adenuric, Uloric, Febuxostat Viatris (previously Febuxostat Mylan), Febuxostat Krka
- Drug Type
- Small Molecule
- Chemical Formula
- C16H16N2O3S
- CAS Number
- 144060-53-7
- Unique Ingredient Identifier
- 101V0R1N2E
- Background
Febuxostat is a non-purine xanthine oxidase (XO) inhibitor. In early 2008, febuxostat was granted marketing authorization by the European Commission for the treatment of chronic hyperuricemia and gout. In the following year, the FDA for approved febuxostat for use in the chronic management of hyperuricemia in adult patients with gout who have an inadequate r...
- Indication
Febuxostat is indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. It is not recommended for the treatment of asymptomatic hyperuricemia or secondary hyperuricem...
- Associated Conditions
- Chronic, symptomatic Hyperuricemia
- Associated Therapies
- -
Phase III Trial of Febuxostat in Korea Gout Patients
- First Posted Date
- 2009-01-13
- Last Posted Date
- 2009-01-13
- Lead Sponsor
- SK Chemicals Co., Ltd.
- Target Recruit Count
- 181
- Registration Number
- NCT00821392
Efficacy and Safety of Oral Febuxostat in Participants With Gout
- First Posted Date
- 2007-02-01
- Last Posted Date
- 2012-02-02
- Lead Sponsor
- Takeda
- Target Recruit Count
- 2269
- Registration Number
- NCT00430248
Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.
- First Posted Date
- 2005-09-15
- Last Posted Date
- 2012-02-02
- Lead Sponsor
- Takeda
- Target Recruit Count
- 1072
- Registration Number
- NCT00174915
Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010
- First Posted Date
- 2005-09-15
- Last Posted Date
- 2010-07-27
- Lead Sponsor
- Takeda
- Target Recruit Count
- 1086
- Registration Number
- NCT00175019
Dose-Response, Safety and Efficacy of Febuxostat in Subjects With Gout
- First Posted Date
- 2005-09-15
- Last Posted Date
- 2011-07-29
- Lead Sponsor
- Takeda
- Target Recruit Count
- 153
- Registration Number
- NCT00174967
Long-Term Safety of Febuxostat in Subjects With Gout.
- First Posted Date
- 2005-09-15
- Last Posted Date
- 2011-01-27
- Lead Sponsor
- Takeda
- Target Recruit Count
- 116
- Registration Number
- NCT00174941
Febuxostat Versus Allopurinol Control Trial in Subjects With Gout
- First Posted Date
- 2005-01-31
- Last Posted Date
- 2012-02-02
- Lead Sponsor
- Takeda
- Target Recruit Count
- 760
- Registration Number
- NCT00102440
Drug Development Updates
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