Dacarbazine
As of the edition of 20 October 2026, Dacarbazine 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 2003
- Kind
- Small molecule
- Brand name
- Dtic-Dome
- First approved
- 1 January 1982 (US)
- Approvals on record
- 7 in 6 regions
- Holder of the most recent approval
- medac Gesellschaft für klinische Spezialpräparate mbH; 6 holders in all
- Registered trials
- 146, 15 stopped early
- Disease areas
- Cancer; Immune system; Blood and lymph; Skin and connective tissue; Eye; Urinary and reproductive
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 | 6 | 2 | 1 | 0 |
| Phase 1 | 8 | 8 | 0 | 0 |
| Phase 2 | 95 | 51 | 21 | 12 |
| Phase 3 | 35 | 21 | 8 | 3 |
| Phase 4 | 2 | 0 | 1 | 0 |
| All trials | 146 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eurofarma Laboratorios | Applicant | 1998 to now |
| Pfizer | Applicant and Lead sponsor of trials | 2000 to now |
| Bayer | Applicant, Earlier holder and Lead sponsor of trials | 2005 to now |