Overview
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 response or intolerance to allopurinol. Gout is a form of arthritis that is caused by the accumulation of uric acid crystal in or around a joint, leading to inflammation and further deposition of uric acid crystal deposition in bones, joints, tissues, and other organs in the long term. Gout is closely associated with hyperuricemia. Febuxostat works by inhibiting the activity of an enzyme that is responsible for the synthesis of uric acid, thereby reducing serum uric acid levels. In February 2019, a black box warning for febuxostat was added, based on the findings of a post-market clinical study (the CARES trial) where there was an increased risk of cardiovascular (CV) fatal outcomes in patients with gout and known cardiovascular disease treated with febuxostat, when compared to those treated with allopurinol. The manufacturer and the FDA advise health professionals to limit the use of febuxostat to second-line therapy in patients who have inadequate response or intolerance to allopurinol, and to avoid the use of febuxostat in patients with cardiovascular diseases.
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 hyperuricemia.
Associated Conditions
- Chronic, symptomatic Hyperuricemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/05/31 | Phase 1 | Completed | |||
2025/05/29 | Phase 2 | Recruiting | Mostafa Bahaa | ||
2025/02/19 | Phase 4 | Recruiting | |||
2024/10/22 | Not Applicable | Not yet recruiting | |||
2024/10/02 | Phase 4 | Not yet recruiting | |||
2024/09/19 | Phase 2 | Active, not recruiting | Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd | ||
2024/07/29 | Early Phase 1 | Not yet recruiting | |||
2024/07/15 | Phase 2 | Completed | |||
2024/05/16 | Phase 3 | Not yet recruiting | |||
2023/11/18 | Phase 3 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Golden State Medical Supply, Inc. | 51407-294 | ORAL | 80 mg in 1 1 | 12/27/2023 | |
DR REDDY'S LABORATORIES LIMITED | 55111-797 | ORAL | 80 mg in 1 1 | 9/18/2019 | |
Tris Pharma Inc | 27808-207 | ORAL | 80 mg in 1 1 | 7/11/2022 | |
Aphena Pharma Solutions - Tennessee, LLC | 71610-411 | ORAL | 40 mg in 1 1 | 4/22/2020 | |
Zydus Lifesciences Limited | 70771-1553 | ORAL | 80 mg in 1 1 | 10/4/2023 | |
Golden State Medical Supply, Inc. | 51407-293 | ORAL | 40 mg in 1 1 | 12/27/2023 | |
Aurobindo Pharma Limited | 59651-114 | ORAL | 80 mg in 1 1 | 11/3/2023 | |
DR REDDY'S LABORATORIES LIMITED | 55111-796 | ORAL | 40 mg in 1 1 | 9/18/2019 | |
Ascend Laboratories, LLC | 67877-669 | ORAL | 80 mg in 1 1 | 9/6/2022 | |
Takeda Pharmaceuticals America, Inc. | 64764-677 | ORAL | 80 mg in 1 1 | 4/27/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 6/15/2017 | ||
Authorised | 6/15/2017 | ||
Authorised | 4/21/2008 | ||
Authorised | 3/28/2019 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
FEBURIC® FILM COATED TABLETS 80MG | SIN14959P | TABLET, FILM COATED | 80.00 mg | 2/19/2016 | |
FEBUGOUT F.C. TABLETS 80MG | SIN17054P | TABLET, FILM COATED | 80mg | 7/25/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Febuxostat Tablets | 国药准字H20249299 | 化学药品 | 片剂 | 11/5/2024 | |
Febuxostat Tablets | 国药准字H20223640 | 化学药品 | 片剂 | 8/30/2022 | |
Febuxostat Tablets | 国药准字H20249847 | 化学药品 | 片剂 | 12/25/2024 | |
Febuxostat Tablets | 国药准字H20249848 | 化学药品 | 片剂 | 12/25/2024 | |
Febuxostat Tablets | 国药准字H20253470 | 化学药品 | 片剂 | 2/25/2025 | |
Febuxostat Tablets | 国药准字H20247281 | 化学药品 | 片剂 | 11/7/2024 | |
Febuxostat Tablets | 国药准字HJ20180050 | 化学药品 | 片剂 | 8/21/2023 | |
Febuxostat Tablets | 国药准字H20130058 | 化学药品 | 片剂 | 3/3/2023 | |
Febuxostat Tablets | 国药准字H20233931 | 化学药品 | 片剂 | 7/25/2023 | |
Febuxostat Tablets | 国药准字H20233932 | 化学药品 | 片剂 | 7/25/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
FEBURIC TABLETS 80 MG | N/A | N/A | N/A | 3/22/2012 | |
FEBUXOSTAT FPH TABLETS 80MG | N/A | fortune pharmacal co ltd | N/A | N/A | 10/8/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
ADENURIC febuxostat 80 mg tablets blister pack | 205556 | A Menarini Australia Pty Ltd | Medicine | A | 12/18/2014 |
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