FDA · United States
fluconazole — FDA regulatory status
fluconazole (APO-FLUCONAZOLE) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- APO-FLUCONAZOLE
- Originator
- Pfizer Australia Pty Ltd
- Mechanism
- Cytochrome P450 51 inhibitor
- Target
- Lanosterol 14-alpha demethylase
- Structured fields
- 8
Sponsor / originator context: Pfizer Australia Pty Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Cytochrome P450 51 inhibitor. Target: Lanosterol 14-alpha demethylase. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 61 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| APHP230824 | Phase 3 | PARItec | 2024-514244-81-00 |
| Anastrozole | Phase 3 | United Therapeutics Europe | NCT00077168, NCT00253422 |
| BO41843 | Phase 3 | HOFFMANN-LA ROCHE | 2023-506911-16-00 |
| C4391024 | Phase 3 | First Biotech (Australia) | 2024-512925-95-00 |
| CD101.IV.3.08 | Phase 3 | Mundipharma | 2024-514471-18-00 |
| CLEE011O12001 | Phase 3 | Novartis India | 2022-503001-38-01 |
| CLEE011O12301C | Phase 3 | Novartis India | 2023-510357-42-00 |
| CTRIAL-IE 12-01 | Phase 3 | Ningbo Cancer Hospital | 2024-516801-22-00 |
| D8534C00001 | Phase 3 | AstraZeneca | 2023-503990-39-00 |
| D8535C00001 | Phase 3 | AstraZeneca | 2023-504031-41-00 |
| D9722C00001 | Phase 3 | AstraZeneca | 2023-504180-16-00 |
| GEICAM/2011-03_S1007 | Phase 3 | Ningbo Cancer Hospital | 2024-515368-29-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 10519191 | Bile acid analogs as FXR/TGR5 agonists and methods of use thereof | US |
| 10323061 | Heteroaryl containing bile acid analogs as FXR/TGR5 agonists and methods of use thereof | US |
| 10266560 | Bile acid analogs as FXR/TGR5 agonists and methods of use thereof | US |
| 10246483 | Bile acid analogs as FXR/TGR5 agonists and methods of use thereof | US |
| 9669095 | Cyclosporin analogues for preventing or treating hepatitis C infection | US |
| 9616099 | Cyclosporin analogues for preventing or treating hepatitis C infection | US |
| 9603895 | Cyclosporin analogues for preventing or treating hepatitis C infection | US |
| 9221878 | Cyclosporin analogues for preventing or treating hepatitis C infection | US |
| 9156886 | Cyclosporin analogues for preventing or treating hepatitis C infection | US |
| 8685917 | Cyclosporin analogues | US |
| 8481483 | Cyclosporin analogues | US |
| 8367053 | Cyclosporin analogues | US |
Related hubs
FAQ
What is the FDA approval status of fluconazole?
fluconazole currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get fluconazole regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to fluconazole?
This spoke lists 61 published programs associated with fluconazole in our pipeline index.