Mitotane
As of the edition of 20 October 2026, Mitotane is a small molecule: marketed, first approved in 1979 (CA); acts on CYP11A1 and CYP11B1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2004
- Kind
- Small molecule
- Brand name
- Lysodren
- First approved
- 31 December 1979 (CA)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Esteve Pharmaceuticals; 2 holders in all
- Registered trials
- 11, 2 stopped early
- Disease areas
- Cancer; Hormones; 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.
Companies that need a new molecule because of this drug
1 company-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Mitotane.
See the 1 company-target row 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 | 5 | 1 | 2 | 2 |
| Phase 3 | 4 | 2 | 1 | 0 |
| All trials | 11 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Esteve Pharmaceuticals | Applicant and Acquired holder | 1979 to now |