Wednesday, July 8, 2026
🇺🇸 FDA

Drug profile · INN

fluconazole

APO-FLUCONAZOLE

fluconazole (APO-FLUCONAZOLE) is a cytochrome p450 51 inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 20
Pipeline programs 61
News articles 0
Drug details — fluconazole
US status
approved
Class
—
Route
INJECTION
Patents
20
Programs
61
Data quality
0.89
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Quick answer

fluconazole (APO-FLUCONAZOLE) is a cytochrome p450 51 inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN fluconazole
Brand APO-FLUCONAZOLE
Mechanism Cytochrome P450 51 inhibitor
Target Lanosterol 14-alpha demethylase
Route INJECTION
Formulation INJECTABLE
Originator Pfizer Australia Pty Ltd

Mechanism of action

Cytochrome P450 51 inhibitor

Primary target: Lanosterol 14-alpha demethylase

Approval history

Authority Status Date
FDA approved —
TGA approved —

Pipeline programs

Search pipeline Sponsor programs
  1. APHP230824 Phase 3 · PARItec · Uncomplicated candidemia
  2. Anastrozole Phase 3 · United Therapeutics Europe · Breast Cancer
  3. BO41843 Phase 3 · HOFFMANN-LA ROCHE · ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED O
  4. C4391024 Phase 3 · First Biotech (Australia) · Advanced/Metastatic Breast Cancer
  5. CD101.IV.3.08 Phase 3 · Mundipharma · Invasive Fungal Diseases in Adults undergoing Allogeneic Blo
  6. CLEE011O12001 Phase 3 · Novartis India · HR-positive HER-2- negative Breast Cancer
  7. CLEE011O12301C Phase 3 · Novartis India · hormone receptor (HR)-positive, HER2-negative, early breast
  8. CTRIAL-IE 12-01 Phase 3 · Ningbo Cancer Hospital · Patients with 1-3 positive Nodes, Hormone Receptor-Positive

Related & competitor drugs

Browse all drugs
  1. clotrimazole Cytochrome P450 51 inhibitor
  2. efinaconazole Lanosterol 14-alpha demethylase inhibitor
  3. itraconazole Cytochrome P450 51 inhibitor
  4. ketoconazole Antiinfectives for systemic use (J02)
  5. miconazole nitrate Cytochrome P450 51 inhibitor
  6. posaconazole Antiinfectives for systemic use (J02)

Related patents

Browse patents Pfizer Australia Pty Ltd patent hub

  1. US 10519191

    Bile acid analogs as FXR/TGR5 agonists and methods of use thereof

    Expires Mon Dec 26 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  2. US 10323061

    Heteroaryl containing bile acid analogs as FXR/TGR5 agonists and methods of use thereof

    Expires Mon Jun 13 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  3. US 10266560

    Bile acid analogs as FXR/TGR5 agonists and methods of use thereof

    Expires Mon Apr 18 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  4. US 10246483

    Bile acid analogs as FXR/TGR5 agonists and methods of use thereof

    Expires Mon Mar 28 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  5. US 9669095

    Cyclosporin analogues for preventing or treating hepatitis C infection

    Expires Mon Jun 01 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  6. US 9616099

    Cyclosporin analogues for preventing or treating hepatitis C infection

    Expires Mon Apr 06 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  7. US 9603895

    Cyclosporin analogues for preventing or treating hepatitis C infection

    Expires Mon Mar 23 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  8. US 9221878

    Cyclosporin analogues for preventing or treating hepatitis C infection

    Expires Mon Dec 24 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  9. US 9156886

    Cyclosporin analogues for preventing or treating hepatitis C infection

    Expires Mon Oct 08 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  10. US 8685917

    Cyclosporin analogues

    Expires Mon Mar 27 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  11. US 8481483

    Cyclosporin analogues

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

    granted

  12. US 8367053

    Cyclosporin analogues

    Expires Mon Jan 31 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  13. US 8367618

    Cyclosporin analogues for preventing or treating hepatitis C infection

    Expires Mon Jan 31 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  14. US 8354383

    6,11-bridged biaryl macrolides

    Expires Mon Jan 10 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  15. US 8349312

    Proline substituted cyclosporin analogues

    Expires Mon Jan 03 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  16. US 7419962

    3,6-bicyclolides

    Expires Mon Aug 28 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  17. US 7229972

    3,6-Bicyclolides

    Expires Mon Jun 07 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  18. US 7049417

    6,11-4-Carbon bridged ketolides

    Expires Mon May 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

  19. US 6841664

    6,11-4-carbon bridged ketolides

    Expires Mon Jan 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

  20. US 6750204

    11-C-substituted ketolides

    Expires Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is fluconazole?

fluconazole (APO-FLUCONAZOLE) is a cytochrome p450 51 inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for fluconazole?

APO-FLUCONAZOLE is a marketed brand name for fluconazole. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of fluconazole?

fluconazole 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.

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