Epirubicin
As of the edition of 20 October 2026, Epirubicin is a small molecule: marketed, first approved in 1986 (ES); acts on TOP2A.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1999
- Kind
- Small molecule
- Brand name
- Ellence
- First approved
- 1 October 1986 (ES)
- Approvals on record
- 7 in 4 regions
- Holder of the most recent approval
- Pfizer; 2 holders in all
- Registered trials
- 323, 34 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Digestive system; Blood and lymph; Immune system; 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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| TOP2A | DNA topoisomerase 2-alpha | P11388 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 18 | 4 | 2 | 3 |
| Phase 1 | 20 | 15 | 3 | 1 |
| Phase 2 | 166 | 76 | 32 | 23 |
| Phase 3 | 111 | 61 | 15 | 7 |
| Phase 4 | 8 | 3 | 2 | 0 |
| All trials | 323 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator, Applicant, Acquired holder and Lead sponsor of trials | 1999 to now |