Methoxy polyethylene glycol-epoetin beta
As of the edition of 20 October 2026, Methoxy polyethylene glycol-epoetin beta is a protein: marketed, first approved in 2007 (EU); acts on EPOR; US protection ended in 2019.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2007
- Kind
- Protein
- Brand name
- Mircera
- First approved
- 20 July 2007 (EU)
- Approvals on record
- 20 in 2 regions
- Holder of the most recent approval
- CSL Behring; 2 holders in all
- Registered trials
- 79, 9 stopped early
- Disease areas
- Blood and lymph; Pregnancy and women's health; Urinary and reproductive; Lungs and airways; Immune system; Cancer
US protection
US protection ended in 2019.
US protection ended in 2019, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by CSL Behring. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Methoxy polyethylene glycol-epoetin beta.
Target
| Gene | Protein | UniProt |
|---|---|---|
| EPOR | Erythropoietin receptor | P19235 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 9 | 9 | 0 | 0 |
| Phase 2 | 9 | 9 | 0 | 0 |
| Phase 3 | 47 | 40 | 0 | 7 |
| Phase 4 | 14 | 11 | 0 | 2 |
| All trials | 79 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Applicant and Lead sponsor of trials | 2001 to now |
| CSL Behring | Applicant | 2007 to now |