Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | MIRCERA | — | 2018-06-07 – 2024-04-30 | fda.gov ↗ |
| Approved | US (FDA) | MIRCERA | — | 2007-11-14 | fda.gov ↗ |
| Approved | EU (EMA) | Mircera | — | 2007-07-20 | europa.eu ↗ |
Trials 74 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00360347 | Nov 2001 → Apr 2003 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 29 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT03552393 | Aug 2018 → Jul 2021 | anemia, chronic kidney disease | Hoffmann-La Roche | Completed | Met primary |
| Phase 2 | NCT01194154 | Sep 2010 → Mar 2015 | chronic kidney disease | Hoffmann-La Roche | Completed | Missed primary |
| Phase 2 | NCT01093820 | Apr → Sep 2010 | acute myocardial infarction | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 2 | NCT00717366 | Jul 2008 → Mar 2016 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT00327535 | May 2006 → May 2007 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT00072059 | Jul 2003 → Feb 2005 | anemia, lung cancer | Jonsson Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00048048 | Mar 2002 → Oct 2003 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT00048035 | Mar 2002 → Jun 2005 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT00364832 | Oct 2001 → Jul 2005 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 347 trials · 5 met primary · 1 missed | ||||||
| Phase 3 | NCT00773331 | Jul 2009 → Dec 2010 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00680563 | Apr 2009 → Jan 2010 | anemia | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 3 | NCT00882713 | Feb 2009 → Oct 2010 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00737477 | Sep 2008 → Jul 2011 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00773968 | Sep 2008 → Mar 2010 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00661388 | Aug 2008 → Dec 2010 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00717821 | Aug 2008 → Jul 2011 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00660023 | Aug 2008 → Nov 2010 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00699348 | Jul 2008 → Jul 2010 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00642967 | Jun 2008 → Aug 2010 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00661505 | May 2008 → Jun 2010 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00576628 | May 2008 → Mar 2010 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00560404 | Apr 2008 → Dec 2010 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00576303 | Apr 2008 → Jun 2010 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00642304 | Mar 2008 → Dec 2009 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00462384 | Feb 2008 → Apr 2011 | anemia | Hoffmann-La Roche | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT00550680 | Jan 2008 → Sep 2009 | anemia due to chronic disorder | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00559637 | Jan 2008 → Jun 2010 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00605293 | Jan 2008 → Jan 2010 | anemia | Hoffmann-La Roche | Completed | Missed primary |
| Phase 3 | NCT00559273 | Dec 2007 → Oct 2009 | anemia due to chronic disorder | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00605345 | Dec 2007 → Jul 2009 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00546481 | Nov 2007 → Dec 2009 | anemia | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT00642850 | Nov 2007 → Jul 2009 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00560547 | Oct 2007 → Oct 2009 | anemia | Hoffmann-La Roche | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00517413 | Oct 2007 → May 2010 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00545571 | Oct 2007 → Oct 2009 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00442702 | Sep 2007 → Aug 2010 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00517881 | Jun 2007 → Nov 2009 | anemia | Hoffmann-La Roche | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00492427 | Jun 2007 → Jan 2008 | — | Chugai Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT00491868 | Jun 2007 → May 2008 | — | Chugai Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT00442793 | May 2007 → May 2010 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00454246 | Apr 2007 → Feb 2008 | anemia | Hoffmann-La Roche | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT00413894 | Mar 2007 → Oct 2008 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00422513 | Mar → Dec 2007 | anemia | Hoffmann-La Roche | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT00442416 | Feb 2007 → Jan 2008 | anemia | Hoffmann-La Roche | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT00433615 | Feb 2007 → Nov 2008 | anemia | Chugai Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT00433849 | Feb 2007 → Oct 2008 | — | Chugai Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT00433693 | Feb 2007 → Mar 2008 | — | Chugai Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT00433888 | Jan 2007 → Jul 2008 | — | Chugai Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT00394953 | Dec 2006 → Nov 2008 | anemia | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT00090753 | Oct 2004 → Dec 2009 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00081484 | Jun 2004 → Mar 2006 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00081471 | Jun 2004 → Jul 2006 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00077623 | Mar 2004 → Sep 2005 | anemia | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT00077766 | Mar 2004 → Aug 2005 | anemia | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT00077597 | Feb 2004 → Jun 2006 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00077610 | Feb 2004 → Aug 2005 | anemia | Hoffmann-La Roche | Completed | Met primary |
| Phase 417 trials · 2 met primary | ||||||
| Phase 4 | NCT05719376 | Feb 2023 → May 2026 | chronic renal failure syndrome | Yonsei University | Unknown | No outcome recorded |
| Phase 4 | NCT01807481 | Mar 2013 → Feb 2015 | — | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01519947 | May 2012 → May 2015 | anemia due to chronic disorder | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT02049346 | Mar 2012 → Apr 2013 | anemia due to chronic disorder | Hamad Medical Corporation | Completed | No outcome recorded |
| Phase 4 | NCT02232113 | Feb 2012 → Jan 2013 | anemia, nutritional deficiency disease | Taipei Veterans General Hospital, Taiwan | Completed | No outcome recorded |
| Phase 4 | NCT01342640 | Jul 2011 → Nov 2012 | anemia | Hoffmann-La Roche | Completed | Met primary |
| Phase 4 | NCT01306409 | Jan → Jul 2011 | anemia | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 4 | NCT01156363 | Oct 2010 → Jan 2013 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT01191983 | Aug 2010 → Apr 2018 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT01066000 | Oct 2009 → Sep 2011 | anemia | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 4 | NCT00922116 | Apr 2009 → Nov 2010 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00922610 | Feb 2009 → Jul 2010 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00773513 | Dec 2008 → Jul 2017 | anemia due to chronic disorder | Hoffmann-La Roche | Completed | Met primary |
| Phase 4 | NCT00737464 | Aug 2008 → Sep 2009 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00737711 | Jul 2008 → Oct 2009 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00642668 | Jun 2008 → Dec 2009 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00576602 | Dec 2007 → Jul 2008 | anemia | Hoffmann-La Roche | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy10 trials | ||||||
| Phase 1 | NCT02731469 Comparator | Jun 2016 → Mar 2017 | — | Biocad | Completed | No outcome recorded |
| Phase 2 | NCT07854561 Background | Aug 2026 → Feb 2027 expected | anemia due to chronic disorder | Chinese University of Hong Kong | Recruiting | No outcome recorded |
| Phase 2 | NCT05265325 Comparator | May 2023 → Feb 2024 | anemia | Kind Pharmaceuticals LLC | Completed | No outcome recorded |
| Phase 2 | NCT03519243 Comparator | Oct 2017 → Dec 2018 | anemia | Biocad | Completed | No outcome recorded |
| Phase 2 | NCT02044653 Comparator | Apr 2014 → Apr 2017 | anemia, chronic kidney disease | Genexine, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT07119372 Comparator | Mar 2025 → May 2026 overdue | anemia, end stage renal failure | Biocad | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06520826 Comparator | Nov 2024 → Jun 2026 overdue | anemia due to chronic disorder | USRC Kidney Research | Active not recruiting | Met primary |
| Phase 3 | NCT04707768 Comparator | Jun 2021 → Jan 2023 | anemia due to chronic disorder | Akebia Therapeutics | Completed | Met primary |
| Phase 3 | NCT04155125 Comparator | Jul 2020 → Mar 2022 | anemia due to chronic disorder | PT Kalbe Genexine Biologics | Completed | Met primary |
| — | NCT01666301 Comparator | Feb 2010 → Apr 2012 | — | Ospedale Regionale di Locarno | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2023-04-11 | Genexine, Inc. | Results Genexine’s long-acting anemia treatment GX-E4 phase 3 clinical trial interim result is presented at WCN2023, confirmed non-inferiority compared to Mircera. genexine.com ↗
Its non-inferiority results compared to Mircera (Methoxy Polyethylene Glycol-epoetin beta) were presented at the World Congress of Nephrology (WCN2023). |
| 2021-11-04 | Rockwell Medical Technologies, Inc. | Results Rockwell Medical Presents Triferic® Real World Evidence Update at ASN Kidney Week 2021 rockwellmed.com ↗
Mircera ® (methoxy polyethylene glycol-epoetin beta) dose remained stable in the standard of care group but was reduced 37 percent (from post-adoption baseline) in the Triferic group. |
| 2018-03-20 | Chugai Pharmaceutical | Regulatory Long-Acting Erythropoiesis Stimulating Agent “MIRCERA ® Injection Syringe 12.5μg” Approved in Japan chugai-pharm.co.jp ↗ |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-04-11 | Genexine, Inc. | Genexine’s long-acting anemia treatment GX-E4 phase 3 clinical trial interim result is presented at WCN2023, confirmed non-inferiority compared to Mircera. genexine.com ↗ |
| 2021-11-04 | Rockwell Medical Technologies, Inc. | Rockwell Medical Presents Triferic® Real World Evidence Update at ASN Kidney Week 2021 rockwellmed.com ↗ |
| 2018-03-20 | Chugai Pharmaceutical | Long-Acting Erythropoiesis Stimulating Agent “MIRCERA ® Injection Syringe 12.5μg” Approved in Japan chugai-pharm.co.jp ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 88 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | methoxypolyethylene glycol-epoetin beta | “We aimed to compare the effectiveness of methoxy polyethylene glycol-epoetin beta, given intravenously at 2-week or 4-week intervals, with epoetin treatment one to three times...” PMID 17950856 ↗ Oct 200764“Mircera (methoxypolyethylene glycol-epoetin beta), subcutaneous injection; regimen: once every 4 weeks up to Week 48 inclusive; starting from Week 52, all subjects will be...” NCT07119372 ↗ “Epoetin alfa (EPOGEN), Methoxy polyethylene glycol-epoetin beta (Mircera), or Darbepoetin alfa (Aranesp)” NCT06520826 ↗ “Mircera(methoxy polyethylene glycol-epoetin beta)” NCT05719376 ↗ |
| Known as | C.E.R.A. | “Participants with chronic renal anaemia who were on dialysis and previously treated with intravenous (IV) or subcutaneous (SC) epoetin alfa, epoetin beta or darbepoetin alfa...” NCT00517413 ↗7“This single arm study will assess the efficacy, safety and tolerability of subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) for maintenance of hemoglobin levels...” NCT00517881 ↗ “Participants received methoxy polyethylene glycol-epoetin beta (Continuous Erythropoietin Receptor Activator [C.E.R.A.]) subcutaneously every four weeks for 44 weeks.” NCT00576628 ↗ “C.E.R.A. (methoxy polyethylene glycol-epoetin beta), a continuous erythropoietin receptor activator” PMID 18037099 ↗ Dec 2007 “methoxy polyethylene glycol-epoetin beta [C.E.R.A.]” NCT00642304 ↗ |
| Known as | Mircera | “This comparative, open-label, multicenter, parallel-group study evaluated the effect of altitude on the dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta)...” NCT01519947 ↗48“Participants with chronic renal anaemia who were on dialysis and previously treated with intravenous (IV) or subcutaneous (SC) epoetin alfa, epoetin beta or darbepoetin alfa...” NCT00517413 ↗ “Eligible participants will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of...” NCT00442416 ↗ “Participants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) once every two weeks intravenously for 52 weeks.” NCT00077610 ↗ “Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis” NCT01342640 ↗ “Epoetin alfa (EPOGEN), Methoxy polyethylene glycol-epoetin beta (Mircera), or Darbepoetin alfa (Aranesp)” NCT06520826 ↗ “once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels” NCT00661505 ↗ “RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera])” NCT00048048 ↗ “methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]” NCT00546481 ↗ “A Study of Mircera in Anemic Patients With Multiple Myeloma” NCT00360347 ↗ “Drug: methoxy polyethylene glycol-epoetin beta (Mircera)” NCT00077623 ↗ |
| Known as | Pegzerepoetin alfa | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707314 ↗ |
| Known as | R744 | “Clinical Study of R744 to Hemodialysis Patients” NCT00491868 ↗ |
| Known as | Ro 50-3821 | “Ro 50-3821 may stimulate red blood cell production and treat anemia” NCT00072059 ↗ |
| Known as | RO0503821 | “Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) intravenously (IV) using a dose conversion factor of 0.25/150 microgram...” NCT00048035 ↗8“Eligible participants will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of...” NCT00442416 ↗ “Eligible participants will be administered with RO0503821 (\[methoxy polyethylene glycol-epoetin beta\] {Mircera}) intravenously (IV), every 2 weeks during Weeks 1 through 52.” NCT00077766 ↗ “Eligible participants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) subcutaneously, once every two weeks for 52 weeks.” NCT00077623 ↗ “Participants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) once every two weeks intravenously for 52 weeks.” NCT00077610 ↗ “methoxy polyethylene glycol-epoetin beta (MIRCERA \[RO0503821\]) IV once every month up to 52 weeks.” NCT00394953 ↗ “RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\])” NCT00364832 ↗ “RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera])” NCT00048048 ↗ “methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]” NCT00546481 ↗ |
| Action | Activate | “a continuous erythropoietin receptor activator” PMID 18037099 ↗ Dec 20071“Erythropoietin receptor agonist” CHEMBL3707314 ↗ |
| Modality | Protein / enzyme biologic | “CERA is an erythropoietin with a long-half life.” PMID 24431909 ↗ Dec 2013 |
| Route | Intravenous | “Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) intravenously (IV)” NCT00048035 ↗ |
| Target | EPOR | “Erythropoietin receptor agonist” CHEMBL3707314 ↗ |