Overview
Luspatercept is a recombinant fusion protein comprised of a modified extracellular domain of activin receptor type IIB fused to the FC domain of human IgG1. It was first approved for use in the United States in November 2019 under the brand name Reblozyl® for the treatment of anemia in patients with beta thalassemia who require regular blood transfusions. Luspatercept is novel in that it ameliorates anemia via action on late-stage erythropoiesis, in contrast to typical erythropoiesis-stimulating agents (ESAs), such as darbepoetin alfa and epoetin alfa, which act only on early-stage erythropoiesis. Luspatercept's novel mechanism of action, then, is uniquely suited for the treatment of conditions in which late-stage erythropoiesis is defective, such as beta thalassemia and other myelodysplastic diseases.
Indication
Luspatercept is indicated for the treatment of:
Associated Conditions
- Anemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/14 | N/A | Active, not recruiting | |||
2025/05/11 | Not Applicable | Not yet recruiting | The First Affiliated Hospital of Zhejiang Chinese Medical University | ||
2025/04/15 | Phase 3 | Not yet recruiting | |||
2025/02/28 | N/A | Active, not recruiting | |||
2025/01/23 | Phase 2 | Recruiting | |||
2024/09/19 | N/A | Active, not recruiting | |||
2024/08/30 | N/A | Withdrawn | |||
2024/07/24 | Phase 2 | Recruiting | |||
2024/05/22 | Phase 4 | Not yet recruiting | |||
2024/02/12 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Celgene Corporation | 59572-711 | SUBCUTANEOUS | 25 mg in 1 1 | 4/2/2020 | |
| Celgene Corporation | 59572-775 | SUBCUTANEOUS | 75 mg in 1 1 | 4/2/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/25/2020 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| REBLOZYL POWDER FOR SOLUTION FOR INJECTION 75 MG/VIAL | SIN16471P | INJECTION, POWDER, FOR SOLUTION | 75.0 MG/vial | 4/6/2022 | |
| REBLOZYL POWDER FOR SOLUTION FOR INJECTION 25 MG/VIAL | SIN16470P | INJECTION, POWDER, FOR SOLUTION | 25 MG/vial | 4/6/2022 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Luspatercept for Injection | celgene corporation, a bristol-myers squibb company | 国药准字SJ20220002 | 生物制品 | 注射剂 | 1/25/2022 |
| Luspatercept for Injection | celgene corporation, a bristol-myers squibb company | 国药准字SJ20220003 | 生物制品 | 注射剂 | 1/25/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| REBLOZYL luspatercept 25 mg powder for injection vial | 334510 | Medicine | A | 8/30/2021 | |
| REBLOZYL luspatercept 75 mg powder for injection vial | 334511 | Medicine | A | 8/30/2021 |
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