MIRCERA (methoxy polyethylene glycol-epoetin beta)
MIRCERA is indicated for the treatment of Anemia; Chronic Kidney Disease.
How MIRCERA Works
Mircera acts as an erythropoietin receptor activator that stimulates red blood cell production by interacting with erythroid progenitor cells. It serves as a replacement for endogenous erythropoietin, a primary growth factor for erythroid development that is typically produced by the kidneys but becomes deficient in patients with chronic kidney disease. This agent is designed with a longer half-life and greater in vivo activity compared to natural erythropoietin to effectively address the primary cause of anemia in these patients.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2007-11-14
- Revenue
- $106M (Q4-2024)
- Routes
- INJECTION
- Dosage Forms
- SOLUTION
MIRCERA Approval History
What MIRCERA Treats
2 indicationsMIRCERA is approved for 2 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anemia
- Chronic Kidney Disease
MIRCERA Boxed Warning
ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete boxed warning Chronic Kidney Disease: • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascula...
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete boxed warning Chronic Kidney Disease: • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL ( 5.1 ). • No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks ( 5.1 ). • Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions ( 5.1 ). Cancer: • Mircera is not indicated and is not recommended for the treatment of anemia due to cancer chemotherapy. A dose-ranging study of Mircera was terminated early because of more deaths among patients receiving Mircera than another ESA ( 5.2 ). • ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers ( 5.2 ). Chronic Kidney Disease [see Warnings and Precautions ( 5.1 )] • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL. • No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. • Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions. Cancer [see Warnings and Precautions ( 5.2 )] • Mircera is not indicated and is not recommended for the treatment of anemia due to ca
MIRCERA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MIRCERA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
20 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04155125 | GXE4KGBio-001 | Ph 3 | completed | A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient |
| NCT03552393 results posted | NH19708 2016-004779-39 | Ph 2 | 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. |
| NCT00642967 | ML21146 2007-005757-28 | Ph 3 | completed | A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis |
| NCT00717821 | ML21145 | Ph 3 | completed | A Study of Once Monthly Intravenous or Subcutaneous Mircera in Participants With Chronic Kidney Disease on Hemodialysis. |
| NCT03519243 results posted | BCD-131-2 | Ph 2 | completed | Comparative Study of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in CKD Patients on Dialysis |
| NCT00773513 results posted | BH21260 2007-005129-31 | Ph 4 | 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 ALTITUD results posted | ML25754 | Ph 4 | 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 |
| NCT00661505 results posted | ML21096 | Ph 3 | completed | A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia |
| NCT02044653 | GX-E2_P2 | Ph 2 | completed | Study to Evaluate the Efficacy and Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease (CKD) |
| NCT02049346 | 11021/11 | Ph 4 | completed | Comparison Among Erythropoietin Stimulating Agents |
| NCT00717366 results posted | NH19707 2007-007758-70 | Ph 2 | completed | Study to Determine Optimum Intravenous Starting Dose of MIRCERA for Treatment of Pediatric Participants With Anemia and Chronic Kidney Disease on Hemodialysis |
| NCT00642668 results posted | ML21348 | Ph 4 | completed | A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia |
| NCT00737477 MISTRAL results posted | ML21421 2008-001747-18 | Ph 3 | completed | A Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis |
| NCT01194154 results posted | ML22916 2009-015114-22 | Ph 2 | completed | A Study of Methoxy Polyethylene Glycol-epoetin Beta (Mircera) in Participants With Chronic Kidney Disease (PRIMAVERA) |
| NCT00605293 results posted | ML21060 2007-002065-12 | Ph 3 | 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 |
| NCT00559637 MERCUR results posted | ML20888 2007-000126-46 | Ph 3 | completed | A Study of Subcutaneous Mircera in Participants With Chronic Kidney Disease Not Treated With ESA or on Dialysis |
| NCT00773968 ORION results posted | ML21439 2008-003173-40 | Ph 3 | completed | A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal Anemia |
| NCT00462384 results posted | ML20659 | Ph 3 | terminated | A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Participants With Chronic Kidney Disease. |
| NCT00550680 results posted | ML20952 2006-006349-15 | Ph 3 | completed | A Study of Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia |
| NCT00660023 results posted | ML20752 2006-005621-28 | Ph 3 | completed | A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MIRCERA FDA Label Details
Indications & Usage
FDA Label (PDF)MIRCERA is indicated for the treatment of Anemia; Chronic Kidney Disease.
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR ...
Pro Intelligence Preview
Deep insights for MIRCERA
Revenue Insights
- • Q4-2024: $106M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • 22 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment