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Drug

Methoxy polyethylene glycol-epoetin beta

Established medicine
ClassErythropoietin receptor agonistResearchOngoing clinical research

Also known as CERA, Mircera, PEGZEREPOETIN ALFA, epoetin beta-methoxy polyethylene glycol.

RxNorm729596ChEMBLCHEMBL3707314ATCB03XA03UNIILR3UXN0193
1
Active clinical trials
Erythropoietin receptor
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Randomized, Open-label, Comparative Clinical Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis

Clinical trial2026-05-01Primary completion · ClinicalTrials.gov

A Randomized, Open Label Study to Compare the Effect of Once Monthly Administration of Subcutaneous Mircera Versus Epoetin Alfa on Maintenance of Hemoglobin Levels, Safety and Tolerability in Dialysis Patients With Chronic Renal Anemia.

Clinical trial2025-09-11Results posted · ClinicalTrials.gov

A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anaemia in Pre-dialysis Patients Not Currently Treated With ESA.

Clinical trial2025-09-11Results posted · ClinicalTrials.gov

Open-Label Randomised Controlled Trial of Efepoetin Alfa for Treatment of Anaemia Associated With Chronic Kidney Disease Patients Not on Dialysis (ND-CKD). A Non- Inferiority Trial Compared to Methoxy Polyethylene Glycol-Epoetin Beta (MIRCERA)

Clinical trial2023-06-30Completed · ClinicalTrials.gov

An Open-Label, Single-Arm, Multicenter Study to Ascertain the Optimal Starting Dose of MIRCERA® Given Subcutaneously for the Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.

Clinical trial2022-03-07Results posted · ClinicalTrials.gov

Randomized Open-Label Comparative Study of the Efficacy and Safety of BCD-131 (JSC BIOCAD, Russia) and Mircera (F. Hoffmann-La Roche Ltd, Switzerland) in Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis

Clinical trial2021-03-04Results posted · ClinicalTrials.gov

A Randomized, Controlled, Open-Label, Multi-Centre, Parallel-Group Study To Assess All-Cause Mortality And Cardiovascular Morbidity In Patients With Chronic Kidney Disease On Dialysis And Those Not On Renal Replacement Therapy Under Treatment With MIRCERA® Or Reference ESAs.

Clinical trial2019-08-20Results posted · ClinicalTrials.gov

Comparative Study to Evaluate the Effect of the Altitude on Dosage Requirements of Methoxy Polyethylene Glycol-Epoetin Beta to Correct Hemoglobin Levels in Chronic Renal Anemia in Pre-Dialysis and Dialysis Patients

Clinical trial2019-06-19Results posted · ClinicalTrials.gov

A Single Arm Open Label Study to Assess Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneously C.E.R.A. for the Maintenance of Hemoglobin Levels in Patients With Chronic Renal Anemia Not on Dialysis

Clinical trial2018-06-26Results posted · ClinicalTrials.gov

A Single Arm Open Label Multicenter Interventional Study to Assess the Efficacy, Safety, and Tolerability of Every 4 Weeks Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anemia in Diabetic Nephropathy With Chronic Kidney Disease Stages III-IV Not on Dialysis, Not Currently Treated With ESA.

Clinical trial2018-04-23Completed · ClinicalTrials.gov

An Open-label, Randomized, Multi-centre, Multiple Dose Trial to Investigate the Efficacy and Safety of Subcutaneous Injections of RO0503821 at Different Dosing Intervals in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy

Clinical trial2018-01-02Results posted · ClinicalTrials.gov

Approval: Mircera (EMA)

Regulatory2007-07-20EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Methoxy polyethylene glycol-epoetin beta
Aliases & brands
CERAMirceraPEGZEREPOETIN ALFAepoetin beta-methoxy polyethylene glycol
RxNorm CUI
729596
ChEMBL ID
CHEMBL3707314
ATC codes
B03XA03
UNII
LR3UXN0193
Primary mechanism
Erythropoietin receptor agonist
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Erythropoietin receptor
EPOR · P19235
AGONISTErythropoietin receptor agonist

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2007-07-20
Latest approval
2007-07-20
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2007-07-20Approval
Approval: Mircera (EMA)
Indication: Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients (see section 5.1). Treatment of symptomatic anaemia associated with chronic kidney… Show full indication

Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients (see section 5.1). Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (ESA) after their haemoglobin level was stabilised with the previous ESA (see section 5.1).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

66 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
66
registered trials across all phases
LATEST COMPLETION 2023
1
Active studies
1
Recruiting
57
Late-stage (III+)
55
Completed
10
Discontinued
PHASE DISTRIBUTIONn = 66
Phase 29Phase 342Phase 415

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Single Arm Open Label Multicenter Interventional Study to Assess the Efficacy, Safety, and Tolerability of Every 4 Weeks Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anemia in Diabetic Nephropathy With Chronic Kidney Disease Stages III-IV Not on Dialysis, Not Currently Treated With ESA.

CompletedPH IVHoffmann-La Rochen=1022018

A Randomized, Controlled, Open-Label, Multi-Centre, Parallel-Group Study To Assess All-Cause Mortality And Cardiovascular Morbidity In Patients With Chronic Kidney Disease On Dialysis And Those Not On Renal Replacement Therapy Under Treatment With MIRCERA® Or Reference ESAs.

CompletedPH IVKey trialHoffmann-La Rochen=2,8252017

A Prospective,Single-arm,Multicenter Study to Evaluate the Efficacy and Safety of Mircera in Peritoneal Patients Who Already Had Been Treated With ESA

Unknown statusPH IVSamsung Medical Centern=1012015

Comparative Study to Evaluate the Effect of the Altitude on Dosage Requirements of Methoxy Polyethylene Glycol-Epoetin Beta to Correct Hemoglobin Levels in Chronic Renal Anemia in Pre-Dialysis and Dialysis Patients

CompletedPH IVHoffmann-La Rochen=872015

Erythropoietins in Management of Anemia of End Stage Renal Disease: A Prospective Study From Qatar.

CompletedPH IVHamad Medical Corporationn=3272013

Recent completions

Trials that read out recently, adding to the completed evidence base.

Open-Label Randomised Controlled Trial of Efepoetin Alfa for Treatment of Anaemia Associated With Chronic Kidney Disease Patients Not on Dialysis (ND-CKD). A Non- Inferiority Trial Compared to Methoxy Polyethylene Glycol-Epoetin Beta (MIRCERA)

CompletedPH IIIPT Kalbe Genexine Biologicsn=3912023

An Open-Label, Single-Arm, Multicenter Study to Ascertain the Optimal Starting Dose of MIRCERA® Given Subcutaneously for the Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.

CompletedPH IIHoffmann-La Rochen=402021

Randomized Open-Label Comparative Study of the Efficacy and Safety of BCD-131 (JSC BIOCAD, Russia) and Mircera (F. Hoffmann-La Roche Ltd, Switzerland) in Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis

CompletedPH IIBiocadn=752018

A Single Arm Open Label Multicenter Interventional Study to Assess the Efficacy, Safety, and Tolerability of Every 4 Weeks Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anemia in Diabetic Nephropathy With Chronic Kidney Disease Stages III-IV Not on Dialysis, Not Currently Treated With ESA.

CompletedPH IVHoffmann-La Rochen=1022018

A Randomized, Controlled, Open-Label, Multi-Centre, Parallel-Group Study To Assess All-Cause Mortality And Cardiovascular Morbidity In Patients With Chronic Kidney Disease On Dialysis And Those Not On Renal Replacement Therapy Under Treatment With MIRCERA® Or Reference ESAs.

CompletedPH IVKey trialHoffmann-La Rochen=2,8252017

Phase II Clinical Trial to Explore the Optimal Fixed Starting Dose & Dosing Interval and to Evaluate the Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease and Receiving Hemodialysis (HD) / Peritoneal Dialysis (PD)

CompletedPH IIGenexine, Inc.n=2572017
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.