Product
Luspatercept
Aliases
ACE-536, BMS-986346, Luspatercept Injection [Reblozyl], Reblozyl (1 other aliases)
Name
luspatercept
INN Name
Luspatercept
Target
TD LR-MDS
FDA Approved
Yes
Ema approved
Status
0
27 clinical trials
1 organization
1 abstract
27 indications
1 document
Indication
ThalassemiaIndication
Myelodysplastic SyndromesIndication
Beta-thalassemiaIndication
Myelodysplastic SyndromeIndication
AnaemiaIndication
Primary MyelofibrosisIndication
Blood transfusionIndication
Beta ThalassemiaIndication
MDSIndication
NOSIndication
Granulosa Cell Tumor of the OvaryIndication
5q deletion syndromeIndication
Transfusion-dependent AnemiaIndication
Myeloproliferative NeoplasmIndication
Autoimmune Hemolytic AnemiaIndication
Immune ThrombocytopeniaIndication
CNIndication
Autoimmune NeutropeniaIndication
Cold Agglutinin DiseaseIndication
MyelodysplasiaIndication
LeukemiaIndication
myeloidIndication
AcuteClinical trial
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Determine the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo in Adults With Non-Transfusion Dependent Beta (β)-Thalassemia (The BEYOND™ Study)Status: Completed, Estimated PCD: 2022-11-28
Clinical trial
A Phase 3b, Open-label, Single-arm, Rollover Study to Evaluate Long-term Safety in Subjects Who Have Participated in Other Luspatercept (ACE-536) Clinical TrialsStatus: Recruiting, Estimated PCD: 2028-05-12
Clinical trial
Reblozyl® (Luspatercept) Post-Marketing Surveillance in Korean Patients With Myelodysplastic Syndrome or Beta ThalassemiaStatus: Recruiting, Estimated PCD: 2028-12-30
Clinical trial
A Phase 2, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Luspatercept (ACE-536) in Chinese Adult Subjects Who Require Regular Red Blood Cell Transfusions Due to Beta (β)-ThalassemiaStatus: Recruiting, Estimated PCD: 2025-02-03
Clinical trial
A Phase 2, Study for the Treatment of Anemia With Alpha (α)-Thalassemia to Determine the Efficacy and Safety of Luspatercept (BMS-986346/ACE-536) in Adults and Evaluate the Safety and Pharmacokinetics in AdolescentsStatus: Recruiting, Estimated PCD: 2025-11-05
Clinical trial
A Phase-2 Study To Determine Efficacy and Safety of Luspatercept in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis and Anemia With or Without Red Blood Cell-Transfusion DependenceStatus: Completed, Estimated PCD: 2022-07-18
Clinical trial
A Phase 3, Double-Blind, Placebo Controlled Multicenter Study to Determine the Efficacy and Safety of Luspatercept (ACE-536) in Adults With Transfusion Dependent Beta (B)-ThalassemiaStatus: Completed, Estimated PCD: 2021-01-05
Clinical trial
A Phase 2, Multicenter, Single-Arm Bridging Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes(MDS) in Chinese and Japanese Subjects With Ring Sideroblasts Who Require Red Blood Cell TransfusionsStatus: Active (not recruiting), Estimated PCD: 2023-09-29
Clinical trial
A Phase 2, Multicenter, Single-arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in Japanese Subjects Who Are Not Requiring Red Blood Cell TransfusionStatus: Completed, Estimated PCD: 2022-07-01
Clinical trial
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) ESA in Native Subjects Who Require Red Blood Cell TransfusionsStatus: Active (not recruiting), Estimated PCD: 2023-03-31
Abstract
Efficacy and safety results from the COMMANDS trial: A phase 3 study evaluating luspatercept vs epoetin alfa in erythropoiesis-stimulating agent (ESA)‑naive transfusion-dependent (TD) patients (pts) with lower‑risk myelodysplastic syndromes (LR-MDS).Org: University of Texas M.D. Anderson Cancer Center, Medical Clinic and Policlinic 1, Hematology and Cellular Therapy, University Hospital Leipzig, University of Florence, AOUC, Yale School of Medicine and Yale Cancer Center, Yale University, Monash University and Monash Health,
Clinical trial
Safety and Efficacy Study of the Tapering Dose of Luspatercept in Patients With Lower-risk Myelodysplastic SyndromesStatus: Recruiting, Estimated PCD: 2026-06-30
Clinical trial
A Phase 3b, Open-label Study Evaluating the Efficacy and Safety of Luspatercept (BMS-986346/ACE-536) Initiated at Maximum Approved Dose in LR-MDS With IPSS-R Very Low-, Low-, or Intermediate-risk Who Require RBC Transfusions (MAXILUS)Status: Recruiting, Estimated PCD: 2026-01-01
Clinical trial
A Phase IIIb, Open-label, Single Arm Study to Evaluate the Efficacy and Safety of Luspatercept in Patients With Lower-risk MDS and Ring-sideroblastic Phenotype (MDS-RS)Status: Recruiting, Estimated PCD: 2024-12-31
Clinical trial
A Randomized Phase I/ II Multicenter Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESAStatus: Recruiting, Estimated PCD: 2027-05-19
Clinical trial
Phase II Study to Determine the Efficacy and Safety of Luspatercept (ACE-536) in Patients With Myelodysplastic/Myeloproliferative Neoplasms With Ring Sideroblasts and Thrombocytosis (MDS/MPN-RS-T) and Myelodysplastic/Myeloproliferative Neoplasms, Unclassifiable With Ring Sideroblasts (MDS/MPN-U With RS)Status: Terminated, Estimated PCD: 2023-04-17
Clinical trial
A Multicenter, Phase Ib/II Study That Combines Luspatercept and Lenalidomide (L2) in Lower-risk, Non-del(5q) MDS PatientsStatus: Recruiting, Estimated PCD: 2029-08-01
Clinical trial
Luspatercept in Metastatic Adult Granulosa Cell Tumor (AGCT) of the OvaryStatus: Completed, Estimated PCD: 2022-08-22
Clinical trial
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate-Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-Stimulating Agent (ESA)-Naive Participants Who Are Non-Transfusion Dependent (NTD): The "ELEMENT-MDS" TrialStatus: Recruiting, Estimated PCD: 2027-06-25
Clinical trial
A Phase II, Open-label, Single Arm Study to Evaluate the Efficacy of Luspatercept in Erythropoiesis-stimulating Agent Naive Lower-risk MDS Patients With or Without Ring Sideroblasts Who do Not Require RBC TransfusionsStatus: Recruiting, Estimated PCD: 2026-07-31
Clinical trial
A Pilot, Open-Label Study of Luspatercept for Patients With Lower Risk Myelodysplastic Syndromes (MDS)Status: Recruiting, Estimated PCD: 2026-06-02
Clinical trial
Efficacy and Safety of Luspatercept for the Treatment of Anemia Due to Myelodysplastic Syndromes With del5q, Refractory/Resistant/Intolerant to Prior Treatments, Who Require Red Blood Cell TransfusionsStatus: Recruiting, Estimated PCD: 2024-04-03
Clinical trial
Roxadustat Combined With Luspatercept Versus Luspatercept Monotherapy in the Treatment of Refractory Myelodysplastic Syndrome With Ring Sideroblasts (MDS-RS): A Prospective Randomized Controlled StudyStatus: Not yet recruiting, Estimated PCD: 2024-08-01
Clinical trial
A Phase 2, Single Arm Study of Luspatercept for the Treatment of Anemia in Lower Risk Myelodysplastic Syndromes (MDS) or Non-Proliferative Myelodysplastic Syndromes/ Myeloproliferative Neoplasms (MDS/MPN)Status: Recruiting, Estimated PCD: 2025-05-01
Clinical trial
Evaluation of the Diagnostic/Therapeutic Course of Patients With Autoimmune Cytopenias (Autoimmune Hemolytic Anemia AIHA, Immune Thrombocytopenia ITP, Chronic Idiopathic/Autoimmune Neutropenia CIN/AIN) and Identification of Predictive and Prognostic Markers.Status: Recruiting, Estimated PCD: 2026-09-01
Clinical trial
Efficacy and Safety of Luspatercept in Adult Patients With Transfusion-dependent Anemia Due to Very Low-, Low- and Intermediate-risk (IPSS-R) Myelodysplastic Syndrome With Ring Sideroblasts: a Retrospective Multicenter Study by FISiM-ETSStatus: Completed, Estimated PCD: 2022-12-31
Clinical trial
Connect® Myeloid: The Myelofibrosis (MF), Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease RegistryStatus: Recruiting, Estimated PCD: 2031-03-31
Clinical trial
A Phase 4 Study to Evaluate Safety and Effectiveness of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) With Ring Sideroblasts Who Require Red Blood Cell Transfusions in Participants Who Have Had Unsatisfactory Response to or Are Ineligible to Erythropoietin Based Therapy and in Participants With Transfusion Dependent Anemia Due to Beta-ThalassemiaStatus: Recruiting, Estimated PCD: 2026-04-13
Document
DailyMed Label: ReblozylOrganization
Celgene Corporation