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Reblozyl (LUSPATERCEPT)
Reblozyl works by binding to growth/differentiation factor 11, promoting the maturation of red blood cells.
Reblozyl (luspatrecept) is a small molecule erythroid maturation agent developed by Celgene Corp, targeting growth/differentiation factor 11. It is FDA-approved for the treatment of myelodysplastic syndrome and beta thalassemia. Reblozyl works by promoting the maturation of red blood cells, increasing their production and reducing anemia. The commercial status of Reblozyl is patented, and it is currently owned by Celgene Corp. Key safety considerations include monitoring for thrombotic events and tumor progression.
At a glance
| Generic name | LUSPATERCEPT |
|---|---|
| Sponsor | Celgene Corp |
| Drug class | Erythroid Maturation Agent [EPC] |
| Target | Growth/differentiation factor 11 |
| Modality | Recombinant protein |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 2019 |
| Annual revenue | 2327 |
Mechanism of action
Luspatercept-aamt is recombinant fusion protein that binds several endogenous TGF- superfamily ligands, thereby diminishing Smad2/3 signaling. Luspatercept-aamt promoted erythroid maturation through differentiation of late-stage erythroid precursors (normoblasts) in mice. In models of -thalassemia and MDS, luspatercept-aamt decreased abnormally elevated Smad2/3 signaling and improved hematology parameters associated with ineffective erythropoiesis in mice.
Approved indications
- Myelodysplastic syndrome
- beta Thalassemia
Common side effects
- Bone Pain
- Arthralgia
- Headache
- Fatigue
- Cough
- Abdominal Pain
- Diarrhea
- Dizziness
- Hypertension
- Influenza
- Viral Upper Respiratory Infection
- ALT increase
Key clinical trials
- A Trial Comparing Three Different Treatment Options for Adults With Low-Risk Myelodysplasia and Anemia (A MyeloMATCH Treatment Trial) (PHASE2)
- MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) (PHASE2)
- Luspatercept for Clonal Cytopenias of Uncertain Significance (PHASE2)
- A Study to Determine the Efficacy and Safety of Luspatercept in Adult Participants and to Evaluate the Safety and Pharmacokinetics in and Adolescent Participants With Alpha (α)-Thalassemia (PHASE2)
- ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions (PHASE3)
- Luspatercept + Darbepoetin in MDS (PHASE2)
- A Study of Incidence, Treatment Patterns, and Outcomes in Transfusion-dependent Lower-risk Myelodysplastic Syndromes in Spain
- Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA (PHASE1,PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Reblozyl CI brief — competitive landscape report
- Reblozyl updates RSS · CI watch RSS
- Celgene Corp portfolio CI