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luspatercept

Generic: ACE-536·Brand: Reblozyl·Code: ACE-536

luspatercept: developed by 1 company · 13 clinical trials tracked.

luspatercept evidence translation

What we can confirm

13 tracked trials

What it means

Source-backed records connect luspatercept to CELG; that link alone does not prove the drug works.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

How could luspatercept → CELG affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence5 indications · 1 study sponsors

Related indications

low-to-intermediate risk myelodysplastic syndromes (MDS), transfusion-dependent beta-thalassemia, myelofibrosisAnemiaChronic Kidney DiseaseMyelodysplastic SyndromesThrombocytopenia
Development Pipeline (1)
CompanyPhase
CELGENE CORP /DE/ (CELG)
low-to-intermediate risk myelodysplastic syndromes (MDS), tr…
Phase 3
Clinical Trials (13)showing 10 most recent

A Prospective, Multicenter, Non-Interventional Study Assessing First-line Luspatercept in Anemic Patients With Very Low, Low, or Intermediate Risk Myelodysplastic Neoplasms Requiring Red Blood Cell Transfusions

Not yet recruiting

Primary endpoint: Percentage of participants achieving red blood cell transfusion independence (RBC-TI) for at least 8 consecutive weeks

Observational190 targetStarted 2026-08Completion 2030-081 site · GermanyBristol-Myers Squibb

A Multicenter Phase 2 Study of Luspatercept in Patients With Anemia Due to Chronic Kidney Disease

NCT07725497·Phase 2
Recruiting

Primary endpoint: Hemoglobin (HB) improvement

Interventionalopen30 targetStarted 2026-07Completion 2029-077 sites · United StatesMemorial Sloan Kettering Cancer Center

REal-World Application of Luspatercept in Adults With Transfusion-Dependent Beta-Thalassemia in the Middle East (RELATE): A Non-interventional Retrospective and Prospective Observational Study

Recruiting

Primary endpoint: Change in transfusion burden

Observational200 targetStarted 2026-06Completion 2031-0413 sites · Kuwait, Oman, Saudi Arabia, United Arab EmiratesBristol-Myers Squibb

Observational Retrospective Study on Incidence, First-line Treatment Patterns, and Clinical Outcomes in Transfusion-dependent Lower-risk Myelodysplastic Syndromes in Spain Using the BIG-PAC® Database

Primary endpoint: Incidence of transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS)

Observational1,300 targetStarted 2026-02Completion 2026-051 site · SpainBristol-Myers Squibb

A Phase II Study of Luspatercept Plus Darbepoetin Alfa in Non-mutated SF3B1 Lower-risk Myelodysplastic Syndromes

NCT07096297·Phase 2
Recruiting

Primary endpoint: Mean Rate of Red Blood Cell Transfusion Independence

Interventionalopen60 targetStarted 2025-12Completion 2030-083 sites · United StatesYale University

Efficacy of Luspatercept In Clonal Cytopenias of Uncertain Significance

NCT06788691·Phase 2
Recruiting

Primary endpoint: Number of patients achieving cytopenia responses as defined by HI-E, HI-P, HI-N, mHI-E responses

Interventionalopen50 targetStarted 2025-03Completion 2028-021 site · United StatesWeill Medical College of Cornell University

Luspatercept Treatment Patterns and Outcomes Among ESA-Naïve Patients With Lower-Risk MDS - A Retrospective Medical Record Review in the United States

Completed

Primary endpoint: Participant baseline demographics

Observational418 enrolledStarted 2024-08Completion 2025-031 site · United StatesBristol-Myers Squibb

Real World Use of Luspatercept in Lower Risk Myelodysplastic Syndromes and Beta-thalassemia Patients

Terminated

Primary endpoint: Participant age

Observational30 targetStarted 2023-11Completion 2025-051 site · GermanyBristol-Myers Squibb

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" Trial

NCT05949684·Phase 3·BMY
Active, not recruiting

Primary endpoint: Number of participants with lower-risk non-transfusion dependent myelodysplastic syndromes (NTD-MDS) who converted to Transfusion Dependence (TD) during any continuous 16-week interval within the 96-week treatment period

InterventionalRandomizedopen402 targetStarted 2023-10Completion 2031-0550 sites · Argentina, Australia, Brazil, Canada…Bristol-Myers Squibb

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)

NCT06045689·Phase 3·BMY
Active, not recruiting

Primary endpoint: Number of participants who achieve red blood cell transfusion independence (RBC-TI) for 8 weeks with a simultaneous mean hemoglobin (Hb) increase of ≥ 1 g/dL from Week 1 to Week 24

Interventionalopen106 targetStarted 2023-10Completion 2027-0950 sites · Belgium, Czechia, France, Germany…Bristol-Myers Squibb

Frequently asked questions

Who is developing luspatercept?

luspatercept is being developed by CELGENE CORP /DE/.

How many clinical trials involve luspatercept?

BioSniper tracks 13 clinical trials involving luspatercept.