BLASUBCUTANEOUSPOWDERPriority Review
Approved
Nov 2019
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
REBLOZYL (luspatercept) by Bristol Myers Squibb. Approved for erythroid maturation agent [epc]. First approved in 2019.
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REBLOZYL (luspatercept) is a subcutaneous erythroid maturation agent developed by Bristol Myers Squibb and approved by the FDA on November 8, 2019. It functions as an erythropoiesis-stimulating agent that promotes red blood cell maturation in patients with anemia. The drug is indicated for treating anemia in patients with beta-thalassemia and myelodysplastic syndromes, representing a novel mechanism for addressing ineffective erythropoiesis.
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Mechanism of Action
Pharmacologic Class:
Erythroid Maturation Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Real-World Study to Evaluate Luspatercept in Adults With Transfusion-Dependent Beta-Thalassemia in the Middle East
Started Feb 2026
200 enrolled
β-thalassemia
Luspatercept + Darbepoetin in MDS
Started Dec 2025
60 enrolled
MDS (Myelodysplastic Syndrome)
Treatment Patterns and Outcomes in Patients With Lower-risk Myelodysplastic Syndromes Treated With Luspatercept in China
Started Apr 2025
80 enrolled
Myelodysplastic Syndromes
Luspatercept for Clonal Cytopenias of Uncertain Significance
Started Mar 2025
50 enrolled
CCUS Clonal Cytopenia of Undetermined SignificanceAnemiaLeukopenia+2 more
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Started Feb 2025
68 enrolled
Primary MyelofibrosisMyelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
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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.