Fluconazole
As of the edition of 20 October 2026, Fluconazole is a small molecule: marketed, first approved in 1988 (FR).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Diflucan
- First approved
- 8 March 1988 (FR)
- Approvals on record
- 26 in 7 regions
- Holder of the most recent approval
- Bayer; 4 holders in all
- Registered trials
- 164, 10 stopped early
- Disease areas
- Infections; Urinary and reproductive; Immune system; Nervous system; Cancer; Pregnancy and women's health
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 42 | 33 | 2 | 0 |
| Phase 1 | 58 | 50 | 3 | 4 |
| Phase 2 | 20 | 17 | 0 | 3 |
| Phase 3 | 31 | 25 | 3 | 2 |
| Phase 4 | 13 | 7 | 3 | 1 |
| All trials | 164 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Lead sponsor of trials | 1989 to now |
| Baxter Healthcare | Applicant | 2004 to now |
| Bayer | Later holder and Lead sponsor of trials | 2010 to now |