Luspatercept

Generic Name: Luspatercept

Brand Names: Reblozyl

Drug Type: Biotech

CAS Number: 1373715-00-4

Unique Ingredient Identifier: AQK7UBA1LS

Background: 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

A Study to Evaluate Treatment Patterns and Effectiveness of Luspatercept

Active, not recruiting

Conditions: Myelodysplastic Syndromes (MDS)

Interventions: Drug: Luspatercept
Drug: Erythropoiesis-stimulating agent (ESA)

First Posted Date: 2025-05-14

Last Posted Date: 2025-05-14

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 430

Registration Number: NCT06971185

Locations: 🇺🇸
Bristol Myers Squibb, Princeton, New Jersey, United States

Treatment of Transfusion-dependent Nonsevere Aplastic Anemia With Luspatercept: a Multicenter Prospective Clinical Study

Not Applicable

Not yet recruiting

Conditions: Transfusion-dependent Non-severe Aplastic Anemia

Interventions: Drug: Luspatercept
Drug: Luspatercept combine with Deferasirox

First Posted Date: 2025-05-11

Last Posted Date: 2025-05-11

Lead Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University

Target Recruit Count: 90

Registration Number: NCT06964971

Locations: 🇨🇳
The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China

AZA+Lus VS AZA Monotherapy in HR-MDS

Phase 3

Not yet recruiting

Conditions: Higher-risk Myelodysplastic Syndrome

Interventions: Drug: Azacitidine (AZA)
Drug: Luspatercept

First Posted Date: 2025-04-15

Last Posted Date: 2025-04-15

Lead Sponsor: Peking Union Medical College Hospital

Target Recruit Count: 86

Registration Number: NCT06927232

A Study to Evaluate Luspatercept Treatment Patterns and Outcomes in Erythropoiesis-Stimulating Agents-Naïve Patients With Lower-Risk Myelodysplastic Syndromes in the United States

Active, not recruiting

Conditions: Myelodysplastic Syndromes

Interventions: Drug: Luspatercept
Drug: Erythropoiesis-stimulating agents

First Posted Date: 2025-02-28

Last Posted Date: 2025-02-28

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 400

Registration Number: NCT06851065

Locations: 🇺🇸
RTI Health Solutions, Raleigh, North Carolina, United States

Luspatercept for Clonal Cytopenias of Uncertain Significance

Phase 2

Recruiting

Conditions: CCUS Clonal Cytopenia of Undetermined Significance
Anemia
Leukopenia
Thrombocytopenia
Neutropenia

Interventions: Drug: Luspatercept

First Posted Date: 2025-01-23

Last Posted Date: 2025-04-25

Lead Sponsor: Weill Medical College of Cornell University

Target Recruit Count: 50

Registration Number: NCT06788691

Locations: 🇺🇸
Weill Cornell Medical College, New York, New York, United States

A Real-World Study of Β-Thalassemia Major Treatment with Luspatercept in Taiwan

Recruiting

Conditions: β-Thalassemia Major

Interventions: Drug: Luspatercept

First Posted Date: 2024-09-19

Last Posted Date: 2024-12-13

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 90

Registration Number: NCT06596642

Locations: 🇨🇳
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan
🇨🇳
National Cheng Kung University Hospital, Tainan, Taiwan
🇨🇳
MacKay Memorial Hospital, Taipei, Taiwan

and more 2 locations

A Retrospective Study to Describe Real-World Treatment Patterns and Clinical Outcomes Among Patients With Myelodysplastic Syndromes

Withdrawn

Conditions: Myelodysplastic Syndromes (MDS)

Interventions: Drug: Epoetin Alfa
Drug: Luspatercept

First Posted Date: 2024-08-30

Last Posted Date: 2024-10-09

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 86

Registration Number: NCT06581055

Locations: 🇨🇳
National Taiwan University Hospital (NTUH), Taipei, Taiwan

Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis

Phase 1

Recruiting

Conditions: Primary Myelofibrosis
Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis