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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

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

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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