MIRCERA
LOE Approachingmethoxy polyethylene glycol-epoetin beta
BLAINJECTIONSOLUTION
Approved
Nov 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
MIRCERA (methoxy polyethylene glycol-epoetin beta) is half-life, in contrast to erythropoietin. First approved in 2007.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MIRCERA (methoxy polyethylene glycol-epoetin beta) is a long-acting erythropoiesis-stimulating agent (ESA) approved for treating anemia in chronic kidney disease (CKD) patients. It works by mimicking erythropoietin, a hormone that stimulates red blood cell production in response to hypoxia, compensating for the impaired endogenous erythropoietin production seen in CKD. The drug's extended half-life enables less frequent dosing compared to shorter-acting ESAs.
LOE Approaching
As MIRCERA approaches loss of exclusivity, commercial teams are likely consolidating and shifting focus toward biosimilar defense and managed-care contracting strategies.
Mechanism of Action
half-life, in contrast to erythropoietin. A primary growth factor for erythroid development, erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia. In responding to hypoxia, erythropoietin interacts with erythroid progenitor cells to increase red cell…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis
Started Mar 2025
228 enrolled
AnemiaChronic Kidney DiseaseChronic Kidney Disease Patients on Hemodialysis+1 more
A Prospective Interventional Study Assessing the Clinical and Operational Effectiveness of Transitioning From Mircera to Daprodustat for the Treatment of Anemia in End Stage Kidney Disease
Started Jul 2023
161 enrolled
AnemiaRenal Insufficiency, ChronicRenal Anemia
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
Started Jun 2021
456 enrolled
Anemia Associated With Chronic Kidney Disease (CKD)
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.
Started Aug 2018
40 enrolled
AnemiaRenal Insufficiency, Chronic
Comparative Study of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in CKD Patients on Dialysis
Started Oct 2017
75 enrolled
Anemia
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.