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febuxostat

Trade name: uloric

Small moleculeapproved

Approved

Feb 13, 2009

Febuxostat (ULORIC) is a novel, xanthine oxidase/dehydrogenase (XO/XDH) inhibitor being developed by Teijin, TAP Pharmaceuticals, and Ipsen for the treatment of gout. The currently available XO inhibitor, allopurinol, has been associated with serious instances of severe hypersensitivity, in some cases leading to fatalities. There is some suggestion that febuxostat is less prone to excacerbate systemic inflammatory events in animal studies. Febuxostat, a xanthine oxidase inhibitor, achieves its therapeutic effect by decreasing serum uric acid. Febuxostat is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations. Febuxostat is used for the treatment of hyperuricemia in patients with gout. — NCATS

Clinical trial activity

93 trials · 90 clinical orgs · 20 marketing orgs

Phase 1
18
Phase 2
43
Phase 3
19
Phase 4
19

Earliest trial started Jan 1, 2001 (NCT00174967)

Timeline

2000s

  1. Jan 1, 2001

    Takeda — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2002

    Takeda — Earliest Phase 3 Sponsor(trial)

  3. Feb 13, 2009

    Takeda — Earliest FDA Approval

  4. Feb 13, 2009

    Takeda — NDA Organization

2010s

  1. Jan 1, 2012

    Earliest Phase 1 Sponsor(trial)

  2. Mar 30, 2016

    Roxane Laboratories — Marketing Organization

  3. Jul 1, 2016

    Alembic — Marketing Organization

  4. Mar 29, 2017

    Lupin — Marketing Organization

  5. Jul 28, 2017

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  6. Jul 28, 2017

    Neogen — Marketing Organization

  7. Dec 21, 2018

    Zydus Discovery DMCC — Marketing Organization

  8. Dec 31, 2018

    Beijing Sl Pharma Co Ltd — Marketing Organization

  9. Feb 4, 2019

    Torrent Pharmaceuticals Limited — Marketing Organization

  10. Jun 26, 2019

    MSN Laboratories — Marketing Organization

  11. Jul 1, 2019

    Mylan — Marketing Organization

  12. Jul 1, 2019

    Sun Pharmaceuticals — Marketing Organization

  13. Oct 15, 2019

    West-Ward Pharmaceutical — Marketing Organization

  14. Oct 15, 2019

    Hikma — Marketing Organization

  15. Dec 30, 2019

    Indoco Remedies — Marketing Organization

2020s

  1. Jun 2, 2020

    Sunshine Lake Pharma Co., Ltd. — Marketing Organization

  2. Oct 22, 2020

    Dr. Reddy's Laboratories — Marketing Organization

  3. Dec 7, 2021

    Alkem Labs Ltd — Marketing Organization

  4. Mar 28, 2022

    Prinston Inc — Marketing Organization

  5. Oct 25, 2023

    Aurobindo Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedFeb 13, 2009

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)COC1=C(C=C(C=C1)C2=NC(C)=C(S2)C(O)=O)C#N
Mol. weight
316.375 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • 2-(3-cyano-4-isobutoxyphenyl)-4-methyl- 1,3-thiazole-5-carboxylic acid
  • 2-(3-cyano-4-isobutoxyphenyl)-4-methyl- 1,3-thiazole-5-carboxylic acid
  • adenuric
  • adenuric
  • adenuric
  • februxostat
  • februxostat
  • februxostat
  • februxostat
  • februxostat
  • februxostat
  • feburic
  • febuxostat
  • febuxostat
  • febuxostat
  • febuxostat
  • febuxostat
  • febuxostat
  • febuxostat
  • febuxostat
  • febuxostat
  • febuxostat
  • fébuxostat
  • fébuxostat
  • febuxostatum
  • febuxostatum
  • tmx-67
  • tmx-67
  • tmx-67
  • uloric
  • uloric
  • uloric
  • uloric
  • uloric

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07181265Phase 1Oct 30, 2025Jemincare
NCT07170475Phase 1Jun 27, 2025Fujita Health University
NCT06995339Phase 2May 30, 2025Tanta University
NCT06834230Phase 4Mar 3, 2025Saga University
NCT06653686N/ANov 30, 2024Jinlin University
NCT06622603Phase 4Oct 15, 2024Ajou University, Chungnam National University, Eulji University, Gachon University, Seoul National University
NCT06233162Phase 1Sep 3, 2024Bio-innova Co., Ltd
NCT06525974Early Phase 1 (Phase 1)Sep 1, 2024Tanta University
NCT06501534Phase 2Jul 10, 2024Innovent Biologics (Suzhou) Co. Ltd.
NCT06414837Phase 3Jun 30, 2024Hengrui Therapeutics, Inc.
NCT06997952Phase 1May 24, 2024Ain Shams University
NCT06603142Phase 2/Phase 3 (Phase 3)Apr 22, 2024Government of China
NCT06139393Phase 3Nov 30, 2023Hengrui Therapeutics, Inc.
NCT05815901Phase 3Mar 14, 2023Inha University, JW Pharmaceutical
NCT05513976Phase 2Sep 15, 2022Hengrui Therapeutics, Inc.
NCT05574036Phase 2Aug 25, 2022Tanta University
NCT05474560N/AAug 1, 2022Ain Shams University
NCT05347498Phase 1Apr 30, 2022Hengrui Therapeutics, Inc.
NCT05109936Phase 3Jan 1, 2022Rouen Normandy University
NCT05007392Phase 3Dec 31, 2021Eisai
Showing 20 of 93 trials
Page 1 / 5

Organizations

Research & Development (90)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
TakedaFor profit201852001
Hengrui Therapeutics, Inc.For profit7732017
Ain Shams UniversityAcademic/Hospital4432016
Ardea BiosciencesFor profit4332012
Huazhong University of Science and TechnologyAcademic/Hospital4422013
AstraZenecaFor profit3312014
Menarini GroupFor profit3332012
Tanta UniversityAcademic/Hospital3322022
Arthrosi TherapeuticsFor profit2222019
CymaBay Therapeutics, Inc.For profit2212011
Seoul National UniversityAcademic/Hospital2222021
SK ChemicalsFor profit2222006
SRL MedisearchFor profit2022010
TWi Biotechnology, Inc.For profit2212013
University of UtahAcademic/Hospital2222011
Ajou UniversityAcademic/Hospital1012024
Altasciences Company Inc.For profit1012019
AstellasFor profit1112011
Benha UniversityAcademic/Hospital1112017
Bio-innova Co., LtdFor profit1112024
90 organizations
Page 1 / 5

Marketing (29)

OrganizationOrg typeRelationshipDate
AlembicFor profitMKTGJul 1, 2016
AlembicFor profitSYNJul 1, 2019
Alkem Labs LtdFor profitMKTGDec 7, 2021
Aurobindo PharmaFor profitMKTGOct 25, 2023
Beijing Sl Pharma Co LtdFor profitMKTGDec 31, 2018
Dr. Reddy's LaboratoriesFor profitSYNOct 22, 2020
Dr. Reddy's LaboratoriesFor profitMKTGOct 22, 2020
HikmaFor profitMKTGOct 15, 2019
HikmaFor profitSYNOct 15, 2019
Indoco RemediesFor profitSYNDec 30, 2019
Indoco RemediesFor profitMKTGDec 30, 2019
LupinFor profitMKTGMar 29, 2017
MSN LaboratoriesFor profitMKTGJun 26, 2019
MSN LaboratoriesFor profitSYNDec 30, 2019
Macleods Pharmaceuticals, LtdFor profitMKTGJul 28, 2017
MylanFor profitSYNMay 13, 2016
MylanFor profitMKTGJul 1, 2019
NeogenFor profitMKTGJul 28, 2017
Prinston IncFor profitMKTGMar 28, 2022
Roxane LaboratoriesFor profitMKTGMar 30, 2016
Sun PharmaceuticalsFor profitMKTGJul 1, 2019
Sunshine Lake Pharma Co., Ltd.For profitMKTGJun 2, 2020
Sunshine Lake Pharma Co., Ltd.For profitSYNJun 2, 2020
TakedaFor profitNDAFeb 13, 2009
Torrent Pharmaceuticals LimitedFor profitMKTGFeb 4, 2019
Torrent Pharmaceuticals LimitedFor profitSYNDec 19, 2023
West-Ward PharmaceuticalFor profitMKTGOct 15, 2019
Zydus Discovery DMCCFor profitMKTGDec 21, 2018
Zydus Discovery DMCCFor profitSYNJan 9, 2023