Wednesday, July 8, 2026

Drug profile · INN

febuxostat

febuxostat (ADENURIC) is a xanthine dehydrogenase inhibitor. Associated with A.Menarini Australia Pty Limited. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved Musculo-skeletal system (M04) M04AA03
US status approved
Patents linked 5
Pipeline programs 16
News articles 0
Drug details — febuxostat
US status
approved
Class
Musculo-skeletal system (M04)
Route
ORAL
Patents
5
Programs
16
Data quality
0.89

Quick answer

febuxostat (ADENURIC) is a xanthine dehydrogenase inhibitor. Associated with A.Menarini Australia Pty Limited. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN febuxostat
Brand ADENURIC
Mechanism Xanthine dehydrogenase inhibitor
Target Xanthine dehydrogenase/oxidase
Therapeutic class Musculo-skeletal system (M04)
Route ORAL
Formulation TABLET
ATC code M04AA03

Mechanism of action

Xanthine dehydrogenase inhibitor

Primary target: Xanthine dehydrogenase/oxidase

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved

Pipeline programs

  1. Febuxostat Phase 3 · Takeda · Cardiovascular Disease
  2. Febuxostat IR Phase 3 · Takeda · Gout
  3. FEBUXOSTAT, ALLOPURINOL Phase 2 · PARItec · Gout adult patients
  4. Febuxostat Phase 2 · Takeda · Hypertension
  5. Febuxostat Phase 2 · Takeda · Angina
  6. Febuxostat Phase 2 · Takeda · Hyperuricosuria
  7. Febuxostat Phase 2 · Takeda · Joint Damage
  8. Febuxostat Phase 2 · Takeda · Renal Impairment

Related & competitor drugs

  1. allopurinol Musculo-skeletal system (M04)
  2. colchicine Musculo-skeletal system (M04)
  3. denosumab Musculo-skeletal system (M05)
  4. eteplirsen Musculo-skeletal system (M09)
  5. ibandronic acid Musculo-skeletal system (M05)
  6. lesinurad Musculo-skeletal system (M04)
  1. US 9107912

    Methods for concomitant treatment of theophylline and febuxostat

    Expires Mon Aug 13 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 8742129

    Crystalline forms of febuxostat

    Expires Mon May 29 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 8609856

    Crystalline forms of Febuxostat

    Expires Mon Dec 12 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 8415481

    Crystalline form of febuxostat

    Expires Mon Apr 04 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 8372872

    Methods for concomitant treatment of theophylline and febuxostat

    Expires Mon Feb 07 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is febuxostat?

febuxostat (ADENURIC) is a xanthine dehydrogenase inhibitor. Associated with A.Menarini Australia Pty Limited. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for febuxostat?

ADENURIC is a marketed brand name for febuxostat. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of febuxostat?

febuxostat has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.