Dactinomycin
As of the edition of 20 October 2026, Dactinomycin is a protein: marketed, first approved in 1963 (CA).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2003
- Kind
- Protein
- Brand name
- Cosmegen
- First approved
- 31 December 1963 (CA)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Recordati Rare Diseases
- Registered trials
- 51, 3 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Pregnancy and women's health; Inherited and neonatal; Hormones; Skin and connective tissue
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 | 4 | 0 | 3 | 0 |
| Phase 2 | 21 | 10 | 6 | 2 |
| Phase 3 | 25 | 13 | 6 | 1 |
| Phase 4 | 1 | 0 | 0 | 0 |
| All trials | 51 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Recordati Rare Diseases | Applicant | 1963 to now |
| Merck & Co. | Applicant |