Ketoconazole
As of the edition of 20 October 2026, Ketoconazole is a small molecule: marketed, first approved in 1982 (US); acts on CYP11B1 and CYP17A1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Nizoral
- First approved
- 1 January 1982 (US)
- Approvals on record
- 10 in 5 regions
- Holder of the most recent approval
- Esteve Pharmaceuticals; 9 holders in all
- Withdrawn from market
- 1 January 2011 (in some regions)
- Registered trials
- 140, 17 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Infections; Skin and connective tissue; Immune system; Blood and lymph
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Ketoconazole.
See the 2 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 7 | 3 | 0 | 1 |
| Phase 1 | 88 | 77 | 6 | 5 |
| Phase 2 | 25 | 14 | 1 | 8 |
| Phase 3 | 13 | 8 | 0 | 3 |
| Phase 4 | 7 | 5 | 2 | 0 |
| All trials | 140 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Applicant, Later holder and Lead sponsor of trials | 1985 to now |
| Stiefel | Later holder | 2007 to now |
| Esteve Pharmaceuticals | Applicant | 2014 to now |
| Kramer | Acquired holder | 2019 to now |
| Ina Pharmaceutics | Acquired holder | 2025 to now |
| Rising Pharma | Acquired holder | 2025 to now |