Itraconazole
As of the edition of 20 October 2026, Itraconazole is a small molecule: marketed, first approved in 1990 (BR).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1992
- Kind
- Small molecule
- Brand name
- Sporanox
- First approved
- 11 January 1990 (BR)
- Approvals on record
- 12 in 6 regions
- Holder of the most recent approval
- Pfizer; 7 holders in all
- Registered trials
- 415, 26 stopped early
- Disease areas
- Cancer; Infections; Lungs and airways; Immune system; Skin and connective tissue; Urinary and reproductive
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 | 17 | 12 | 2 | 1 |
| Phase 1 | 336 | 280 | 30 | 17 |
| Phase 2 | 35 | 18 | 10 | 4 |
| Phase 3 | 12 | 7 | 3 | 0 |
| Phase 4 | 15 | 7 | 4 | 4 |
| All trials | 415 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Applicant and Lead sponsor of trials | 1990 to now |
| Pfizer | Later holder and Lead sponsor of trials | 2006 to now |
| Stiefel | Later holder | 2010 to now |
| Sebela | Acquired holder | 2017 to now |