Epoetin beta
As of the edition of 20 October 2026, Epoetin beta is a protein: marketed, first approved in 1997 (EU); acts on EPOR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Protein
- Brand name
- NeoRecormon
- First approved
- 16 July 1997 (EU)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Roche; 2 holders in all
- Registered trials
- 51, 7 stopped early
- Disease areas
- Blood and lymph; Urinary and reproductive; Pregnancy and women's health; Cancer; Immune system; Heart and blood vessels
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 |
|---|---|---|
| EPOR | Erythropoietin receptor | P19235 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 7 | 4 | 0 | 2 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 14 | 13 | 0 | 1 |
| Phase 3 | 10 | 7 | 0 | 0 |
| Phase 4 | 19 | 14 | 0 | 4 |
| All trials | 51 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Applicant and Lead sponsor of trials | 1997 to now |