Idarubicin
As of the edition of 20 October 2026, Idarubicin is a small molecule: marketed, first approved in 1990 (US); acts on TOP2A; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Small molecule
- Brand name
- Idamycin
- First approved
- 27 September 1990 (US)
- Approvals on record
- 9 in 4 regions
- Holder of the most recent approval
- Pfizer; 2 holders in all
- Registered trials
- 218, 25 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Inherited and neonatal; Digestive system; Heart and blood vessels
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| TOP2A | DNA topoisomerase 2-alpha | P11388 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 1 | 3 | 0 |
| Phase 1 | 34 | 20 | 7 | 7 |
| Phase 2 | 107 | 57 | 25 | 15 |
| Phase 3 | 53 | 26 | 8 | 3 |
| Phase 4 | 14 | 7 | 1 | 0 |
| All trials | 218 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Earlier holder | 1990 to now |