Danazol
As of the edition of 20 October 2026, Danazol is a small molecule: marketed, first approved in 1972 (CA); acts on AR and PGR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Danocrine
- First approved
- 31 December 1972 (CA)
- Approvals on record
- 8 in 5 regions
- Holder of the most recent approval
- Eurofarma Laboratorios; 4 holders in all
- Registered trials
- 27, 2 stopped early
- Disease areas
- Blood and lymph; Immune system; Pregnancy and women's health; Urinary and reproductive; Digestive system; Eye
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.
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 Danazol.
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 | 1 | 1 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 24 | 9 | 1 | 2 |
| Phase 3 | 1 | 1 | 0 | 0 |
| All trials | 27 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Applicant | 1972 to now |
| Eurofarma Laboratorios | Applicant | 2023 to now |