Methoxy Polyethylene Glycol-Epoetin Beta
drugOn this page
Also known as MirceraPegzerepoetin alfaR-744R744
Summary
Methoxy Polyethylene Glycol-Epoetin Beta (CHEMBL3707314) is an approved protein (ATC B03XA03); indicated across 4 conditions including anemia and chronic kidney disease.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Protein
- ATC class: B03XA03
- Indications: 4 conditions
- Clinical trials: 42
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL3707314 |
| Name | Methoxy Polyethylene Glycol-Epoetin Beta |
| Type | Protein |
| Max phase | 4 |
| ATC | B03XA03 |
Also known as: Methoxy polyethylene glycol-epoetin beta, Mircera, Pegzerepoetin alfa, R-744, R744, METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
4 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| anemia | 4 | MONDO:0002280 | EFO:0004272 |
| chronic kidney disease | 4 | MONDO:0005300 | EFO:0003884 |
| kidney disorder | 2 | MONDO:0005240 | EFO:0003086 |
1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 42.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE3 | 25 |
| Not specified | 7 |
| PHASE4 | 5 |
| PHASE2 | 5 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT00642668 | PHASE4 | COMPLETED | A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia |
| NCT00773513 | PHASE4 | COMPLETED | A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs) |
| NCT01519947 | PHASE4 | COMPLETED | A Study of The Effect of Altitude on Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Dose Requirements in Participants With Chronic Renal Anemia in Pre-Dialysis or Dialysis |
| NCT01807481 | PHASE4 | UNKNOWN | Phase IV Study to Evaluate the Efficacy and Safety of Mircera in PD |
| NCT02049346 | PHASE4 | COMPLETED | Comparison Among Erythropoietin Stimulating Agents |
| NCT00090753 | PHASE3 | COMPLETED | A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia |
| NCT00422513 | PHASE3 | TERMINATED | A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease. |
| NCT00433615 | PHASE3 | COMPLETED | Clinical Study of R744 to Predialysis Patients |
| NCT00433693 | PHASE3 | COMPLETED | Correction Study of R744 in Renal Anemia Patients on Hemodialysis |
| NCT00433849 | PHASE3 | COMPLETED | Clinical Study of R744 to Peritoneal Dialysis Patients |
| NCT00433888 | PHASE3 | COMPLETED | Switch and Maintenance Study of Intravenous Injections of R744 to Hemodialysis Patients (Phase Ⅲ Study) |
| NCT00442702 | PHASE3 | COMPLETED | A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis. |
| NCT00454246 | PHASE3 | TERMINATED | A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis. |
| NCT00462384 | PHASE3 | TERMINATED | A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Participants With Chronic Kidney Disease. |
| NCT00491868 | PHASE3 | COMPLETED | Clinical Study of R744 to Hemodialysis Patients |
| NCT00492427 | PHASE3 | COMPLETED | Clinical Study of R744 to Predialysis Patients( Phase III, Comparative Study in Comparison With Epoetin Beta) |
| NCT00545571 | PHASE3 | COMPLETED | MIRACLE Study: A Study of Once-Monthly Intravenous Mircera in Hemodialysis Participants With Chronic Renal Anemia |
| NCT00546481 | PHASE3 | COMPLETED | A Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients. |
| NCT00550680 | PHASE3 | COMPLETED | A Study of Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia |
| NCT00559273 | PHASE3 | COMPLETED | A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis |
| NCT00559637 | PHASE3 | COMPLETED | A Study of Subcutaneous Mircera in Participants With Chronic Kidney Disease Not Treated With ESA or on Dialysis |
| NCT00560547 | PHASE3 | WITHDRAWN | A Study of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia. |
| NCT00605293 | PHASE3 | COMPLETED | A Study of Intravenous Mircera (C.E.R.A or Methoxy Polyethylene Glycol-epoetin Beta) for the Maintenance Treatment of Hemodialysis Participants With Chronic Renal Anemia |
| NCT00642967 | PHASE3 | COMPLETED | A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis |
| NCT00660023 | PHASE3 | COMPLETED | A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis |
| NCT00661505 | PHASE3 | COMPLETED | A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia |
| NCT00717821 | PHASE3 | COMPLETED | A Study of Once Monthly Intravenous or Subcutaneous Mircera in Participants With Chronic Kidney Disease on Hemodialysis. |
| NCT00737477 | PHASE3 | COMPLETED | A Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis |
| NCT00773968 | PHASE3 | COMPLETED | A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal Anemia |
| NCT04155125 | PHASE3 | COMPLETED | A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient |
| NCT00717366 | PHASE2 | COMPLETED | Study to Determine Optimum Intravenous Starting Dose of MIRCERA for Treatment of Pediatric Participants With Anemia and Chronic Kidney Disease on Hemodialysis |
| NCT01194154 | PHASE2 | COMPLETED | A Study of Methoxy Polyethylene Glycol-epoetin Beta (Mircera) in Participants With Chronic Kidney Disease (PRIMAVERA) |
| NCT02044653 | PHASE2 | COMPLETED | Study to Evaluate the Efficacy and Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease (CKD) |
| NCT03519243 | PHASE2 | COMPLETED | Comparative Study of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in CKD Patients on Dialysis |
| NCT03552393 | PHASE2 | COMPLETED | Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously for Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis. |
| NCT01417377 | Not specified | COMPLETED | An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Anemic Patients With Chronic Kidney Disease (NORM) |
| NCT01756612 | Not specified | COMPLETED | A Study to Assess Hemoglobin Level Depending on the Comorbidity Index in Chronic Kidney Disease (CKD) Participants Not in Dialysis Treated With Methoxy Polyethylene Glycol-Epoetin Beta (COMETE) |
| NCT02238080 | Not specified | COMPLETED | An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Chronic Kidney Disease Participants on Dialysis |
| NCT02263833 | Not specified | COMPLETED | An Observational, Prospective, Safety Study of Mircera (Monopegylated Epoetin Beta) in Clinical Practice |
| NCT02540213 | Not specified | COMPLETED | Observational Study of MIRCERA in Users of Self-Application and Multidose Systems |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).
Related Atlas pages
- Diseases: anemia, chronic kidney disease