methoxy polyethylene glycol-epoetin beta
Trade name: Mircera
Approved
Nov 14, 2007
Methoxy polyethylene glycol-epoetin beta, sold under the brand name Mircera, is a long-acting erythropoietin receptor activator (CERA) used for the treatment of anaemia associated with chronic kidney disease. It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA). — Wikipedia
Clinical trial activity
85 trials · 22 clinical orgs · 2 marketing orgs
Earliest trial started Oct 1, 2001 (NCT00364832)
Timeline
2000s
2010s
- Jan 1, 2012
Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Studied for
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 4
- Dialysis · Phase 3
- Hemodialysis, Home · Phase 3
- Hepatitis C, Chronic · Phase 4
- Inflammation · Phase 4
- Kidney Diseases · Phase 4
- Kidney Failure, Chronic · Phase 4
- Lung Neoplasms · Phase 2
- Malnutrition · Phase 4
- Myocardial Infarction · Phase 2
- Renal Insufficiency, Chronic · Phase 3
- Reticulocyte Count · Phase 1
Mechanism of action
- Erythropoietin receptorAGONIST
Erythropoietin receptor agonist
Supplements levels of the natural hormone erythropoietin and stimulates the production of red blood cells. Anemia is caused by a deficiency of red blood cells. The PEGylated protein is a continuous erythropoietin receptor activator with a slower association and faster dissociation from the receptor, increased in vivo activity and an increased in vivo half-life compared to erythropoietin.
- ErythropoietinSupplementation
EPO supplementation
Approval history
- approvedNov 14, 2007
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaMethoxy polyethylene glycol-epoetin beta ↗
- NCATSLR3UXN0193 ↗
- ChEMBLCHEMBL3707314 ↗
- WikipediaCarbon dioxide ↗
Also known as
- cera
- cera
- cera
- cera (erythropoietin receptor activator)
- continuous erythropoietin receptor activator
- epo beta
- epoetin beta
- epoetin-beta
- epoetin beta pegol
- epoetin beta rdna
- epoietin beta
- methoxy polyethylene glycol epoetin beta
- methoxy polyethylene glycol-epoetin beta
- methoxy polyethylene glycol-epoetin beta
- methoxy polyethylene glycol-epoetin beta
- methoxy polyethylene glycol-epoetin beta
- methoxy polyethylene glycol-epoetin beta
- methoxy polyethylene glycol-epoetin beta
- methoxy polyethylene glycol-epoetin beta
- methoxy polyethylene glycol-epoetin-beta
- mircera
- mircera
- mircera
- mircera
- mircera
- pegylated epoetin beta
- pegzerepoetin alfa
- r744
- r744
- ro0503821
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07119372 | Phase 3 | Mar 1, 2025 | Biocad |
| NCT04707768 | Phase 3 | Jul 21, 2021 | Akebia Therapeutics |
| NCT04155125 | Phase 3 | Jan 1, 2020 | Genexine, Inc., Novotech |
| NCT03552393 | Phase 2 | May 8, 2018 | Roche |
| NCT03519243 | Phase 2 | Oct 24, 2017 | Biocad |
| NCT02731469 | Phase 1 | Aug 1, 2016 | Biocad |
| NCT02832323 | N/A | Jun 22, 2016 | University of Western Brittany |
| NCT02044653 | Phase 2 | Aug 1, 2014 | Genexine, Inc., Kyung Hee University |
| NCT02064426 | Phase 2 | Mar 1, 2014 | Bayer |
| NCT01975818 | Phase 2 | Oct 1, 2013 | Bayer |
| NCT01807481 | Phase 4 | Mar 1, 2013 | Sungkyunkwan University |
| NCT01519947 | Phase 4 | May 1, 2012 | Roche |
| NCT02049346 | Phase 4 | Mar 1, 2012 | Hamad Medical Corporation |
| NCT01584921 | Phase 1 | Mar 1, 2012 | University of Copenhagen |
| NCT02232113 | Phase 4 | Feb 1, 2012 | Taipei Medical University, Taipei Veteran General hospital |
| NCT01342640 | Phase 4 | Jul 1, 2011 | Roche |
| NCT01306409 | Phase 4 | Jan 1, 2011 | Roche, University of Basel, University of Bern |
| NCT01156363 | Phase 4 | Oct 1, 2010 | Roche |
| NCT01194154 | Phase 2 | Sep 30, 2010 | Roche |
| NCT01191983 | Phase 4 | Aug 30, 2010 | Roche |
Organizations
Research & Development (22)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Roche | For profit | 61 | 60 | 3 | 2001 |
| Chugai | For profit | 6 | 6 | 1 | 2007 |
| Biocad | For profit | 3 | 3 | 3 | 2016 |
| Bayer | For profit | 2 | 2 | 1 | 2013 |
| Genexine, Inc. | For profit | 2 | 2 | 2 | 2014 |
| University of Bern | Academic/Hospital | 2 | 2 | 2 | 2010 |
| Affymax | For profit | 1 | 1 | 1 | 2007 |
| Akebia Therapeutics | For profit | 1 | 1 | 1 | 2021 |
| Hamad Medical Corporation | For profit | 1 | 1 | 1 | 2012 |
| Hospital Universitario Fundación Alcorcón | Academic/Hospital | 1 | 1 | 1 | 2008 |
| Kyung Hee University | Academic/Hospital | 1 | 0 | 1 | 2014 |
| Mario Negri Institute | Academic/Hospital | 1 | 1 | 1 | 2009 |
| National Cancer Institute (NCI) | Government | 1 | 0 | 1 | 2003 |
| Novotech | For profit | 1 | 0 | 1 | 2020 |
| Sungkyunkwan University | Academic/Hospital | 1 | 1 | 1 | 2013 |
| Taipei Medical University | Academic/Hospital | 1 | 0 | 1 | 2012 |
| Taipei Veteran General hospital | Government | 1 | 1 | 1 | 2012 |
| Takeda | For profit | 1 | 0 | 1 | 2007 |
| University of Basel | Academic/Hospital | 1 | 0 | 1 | 2011 |
| University of California, Los Angeles | Academic/Hospital | 1 | 1 | 1 | 2003 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Roche | For profit | MKTG | Nov 14, 2007 |
| Roche | For profit | NDA | Nov 14, 2007 |
| Vifor Inc. | For profit | NDA2 | Nov 14, 2007 |