Last reviewed · How we verify
Mircera
At a glance
| Generic name | Mircera |
|---|---|
| Also known as | Methoxy polyethylene glycol-epoetin beta, Methoxy Polyethylene glycol-epoetin beta, RO0503821 |
| Sponsor | Samsung Medical Center |
| Target | Erythropoietin receptor |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Approved indications
- Anemia in chronic kidney disease
Common side effects
- Hypertension
- Diarrhea
- Nasopharyngitis
- Upper Respiratory Tract Infection
- Headache
- Muscle Spasms
- Procedural Hypotension
- Fluid Overload
- Vomiting
- Back Pain
- Cough
- Hypotension
Serious adverse events
- Serious Gastrointestinal Hemorrhage
- Serious Hemorrhagic Adverse Reactions (all types)
- Coronary Artery Disease
- Anemia
- Septic Shock
Key clinical trials
- Vafseo Outcomes In-Center Experience (PHASE3)
- A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA. (PHASE3)
- A Study of Subcutaneous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia. (PHASE3)
- A Study of MIRCERA in Participants With Chronic Kidney Disease Stage 3-4 and Not on Dialysis
- Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis (PHASE3)
- Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects (PHASE3)
- A Study of Intermittent Oral Dosing of ASP1517 in Non-Dialysis Chronic Kidney Disease Patients With Anemia (PHASE3)
- A Study of AND017 to Treat Anemia in Chronic Kidney Disease Patients on Dialysis (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Mircera CI brief — competitive landscape report
- Mircera updates RSS · CI watch RSS
- Samsung Medical Center portfolio CI