REBLOZYL (luspatercept-aamt) · Bristol-Myers Squibb
REBLOZYL (luspatercept-aamt) is an erythroid maturation agent indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. It is also used for adults with very low- to intermediate-risk myelodysplastic syndromes (MDS), including those who are erythropoiesis stimulating agent (ESA)-naïve or those with ring sideroblasts who have failed ESA therapy. The medication serves to manage chronic anemia in these populations but is not indicated for use as a substitute for RBC transfusions when immediate correction is required.
How REBLOZYL Works
Luspatercept-aamt is a recombinant fusion protein that binds to specific endogenous TGF-β superfamily ligands, thereby diminishing Smad2/3 signaling. In conditions like beta thalassemia and MDS, this signaling is abnormally elevated, leading to ineffective red blood cell production. By reducing Smad2/3 signaling, the drug promotes erythroid maturation and increases the percentage of late-stage erythroid precursors in the bone marrow. This mechanism enhances erythropoiesis and improves hematology parameters associated with ineffective erythroid development.
Details
- Status
- Prescription
- First Approved
- 2019-11-08
- Patent Cliff
- 2031
- Revenue
- $666M (Q4-2025)
- Routes
- SUBCUTANEOUS
- Dosage Forms
- POWDER
REBLOZYL Approval History
What REBLOZYL Treats
5 indicationsREBLOZYL is approved for 5 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anemia
- Beta Thalassemia
- Myelodysplastic Syndromes
- Myelodysplastic Syndromes with Ring Sideroblasts
- Myelodysplastic/Myeloproliferative Neoplasm with Ring Sideroblasts and Thrombocytosis
REBLOZYL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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.
What's emerging in REBLOZYL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications REBLOZYL treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to REBLOZYL
3 of 14FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Bristol-Myers Squibb's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07331818 LUSPARA | LUSPARA - EuroBloodNet | Ph 2 | not yet recruiting | Luspatercept in Patients Affected With Rare Inherited Anemias |
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.
REBLOZYL FDA Label Details
Indications & Usage
FDA Label (PDF)REBLOZYL is an erythroid maturation agent indicated for the treatment of: • Anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions . • Anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions . • Anemia failing an erythropoiesis stimulating agent and requiring 2 or more RBC units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblas...
Pro Intelligence Preview
Deep insights for REBLOZYL
Revenue Insights
- • Q4-2025: $666M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 14 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.