Drug

Febuxostat

Approved · EMA

Emerging researchLate-stage developmentCooling momentum

Also known as Uloric, 2-(3-cyano-4-isobutoxyphenyl)-4-methyl- 1,3-thiazole-5-carboxylic acid, Febuxostatum.

RxNorm73689 ChEMBLCHEMBL1164729UNII101V0R1N2E

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Study on the Efficacy and Safety of Extracorporeal High-Frequency Hyperthermia in the Treatment of Refractory Gout

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Comparative Study Evaluating the Outcome of Febuxostat Versus Vitamin E in Hyperuricemia Patients With Non-alcoholic Steatohepatitis Without Cirrhosis

Clinical trial2026-05-30Primary completion · ClinicalTrials.gov

A Single-center, Non-randomized, Open-label, Self-controlled Phase I Drug-drug Interaction Clinical Study to Evaluate the Pharmacokinetics of JMKX003142 With Amiodarone, and Febuxostat in Chinese Healthy Subjects

Clinical trial2026-04-30Primary completion · ClinicalTrials.gov

A Prospective, Multicenter, Randomized Investigator Initiative Clinical Trial Study on the Effects of Febuxostat Dose Tapering in Gout Patients Optimally Controlled for 5 Years or More

Clinical trial2026-04-29Results expected Q1 2027 · ClinicalTrials.gov

Drug Safety Update: Febuxostat: updated advice for the treatment of patients with a history of major cardiovascular disease

Regulatory2023-05-25MHRA

Drug Safety Update: Febuxostat (Adenuric): increased risk of cardiovascular death and all-cause mortality in clinical trial in patients with a history of major cardiovascular disease

Regulatory2019-07-17MHRA

Approval: Febuxostat Krka (EMA)

Regulatory2019-03-28EMA

Cardiovascular Safety of Febuxostat or Allopurinol in Patients with Gout.

Research2018-03-12The New England journal of medicine

Approval: Febuxostat Viatris (previously Febuxostat Mylan) (EMA)

Regulatory2017-06-15EMA

Cardiovascular safety of febuxostat and allopurinol in patients with gout and cardiovascular comorbidities.

Research2012-06-13American heart journal

Women with gout: efficacy and safety of urate-lowering with febuxostat and allopurinol.

Research2012-02-01Arthritis care & research

Treating hyperuricemia of gout: safety and efficacy of febuxostat and allopurinol in older versus younger subjects.

Research2011-12-01Nucleosides, nucleotides & nucleic acids

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Febuxostat

Aliases & brands

Uloric2-(3-cyano-4-isobutoxyphenyl)-4-methyl- 1,3-thiazole-5-carboxylic acidFebuxostatum

RxNorm CUI

73689

ChEMBL ID

CHEMBL1164729

UNII

101V0R1N2E

Regulatory jurisdictions

emamhra

Regulatory timeline

6 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2008-04-21

Latest approval

2019-03-28

Authorities

EMA · MHRA

Total events

emaEuropean Medicines Agency· 3 events

2019-03-28Approval

Approval: Febuxostat Krka (EMA)

Indication: Febuxostat Krka is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus… Show full indication

Febuxostat Krka is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat Krka is indicated in adults.

Evidence ↗

2017-06-15Approval

Approval: Febuxostat Viatris (previously Febuxostat Mylan) (EMA)

Indication: Febuxostat Viatris is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus… Show full indication

Febuxostat Viatris is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat Viatris is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS).   Febuxostat Viatris is indicated in adults.

Evidence ↗

2008-04-21Approval

Approval: Adenuric (EMA)

Indication: 80 mg strength: Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty… Show full indication

80 mg strength: Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Adenuric is indicated in adults. 120 mg strength: Adenuric is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Adenuric is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS). Adenuric is indicated in adults.

Evidence ↗

mhraMedicines and Healthcare products Regulatory Agency· 3 events

2023-05-25Safety communicationSafety

Drug Safety Update: Febuxostat: updated advice for the treatment of patients with a history of major cardiovascular disease

Evidence ↗

2019-07-17Safety communicationSafety

Drug Safety Update: Febuxostat (Adenuric): increased risk of cardiovascular death and all-cause mortality in clinical trial in patients with a history of major cardiovascular disease

Evidence ↗

2014-12-11Safety communicationSafety

Drug Safety Update: Febuxostat (Adenuric▼): stop treatment if signs or symptoms of serious hypersensitivity

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).