Mechlorethamine
As of the edition of 20 October 2026, Mechlorethamine is a small molecule: marketed, first approved in 1982 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Mustargen
- First approved
- 1 January 1982 (US)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Recordati Rare Diseases; 2 holders in all
- Registered trials
- 18, 3 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Skin and connective tissue; Nervous system
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 0 | 1 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 12 | 8 | 0 | 2 |
| Phase 3 | 3 | 0 | 2 | 0 |
| All trials | 18 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Later holder | 2013 to now |
| Recordati Rare Diseases | Acquired holder | 2013 to now |
| Helsinn Birex Pharmaceuticals | Acquired holder | 2019 to now |
| Merck & Co. | Earlier holder |