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

Luspatercept for Anemia in Lower Risk MDS or Non-proliferative MDS/MPN Neoplasms

Phase 2

Recruiting

Conditions: Myelodysplastic Syndromes
Myeloproliferative Neoplasm
Anemia

Interventions: Drug: Luspatercept

First Posted Date: 2023-02-17

Last Posted Date: 2025-05-07

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 70

Registration Number: NCT05732961

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States

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

Phase 2

Recruiting

Conditions: Anemia

Interventions: Biological: Luspatercept
Drug: Placebo

First Posted Date: 2022-12-27

Last Posted Date: 2025-05-14

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 249

Registration Number: NCT05664737

Locations: 🇨🇦
Local Institution - 0008, Halifax, Nova Scotia, Canada
🇨🇳
The First People's Hospital of Foshan, Foshan, Guangdong, China
🇨🇳
Local Institution - 0029, Guangzhou, Guangdong, China

and more 33 locations

A Study to Evaluate Luspatercept (ACE-536) in Chinese Participants Who Require Regular Red Blood Cell Transfusions Due to Beta (β)-Thalassemia.

Phase 2

Active, not recruiting

Conditions: Beta-thalassemia

Interventions: Drug: Placebo
Drug: Luspatercept

First Posted Date: 2022-10-05

Last Posted Date: 2025-02-11

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 90

Registration Number: NCT05567458

Locations: 🇨🇳
Local Institution - 0002, Maoming, Guangdong, China
🇨🇳
Local Institution - 0005, Shenzhen, Guangdong, China
🇨🇳
Local Institution - 0007, Liuzhou, Guangxi, China

and more 7 locations

Efficacy and Safety of Luspatercept: a Study by Fondazione Italiana Sindromi Mielodisplastiche

Completed

Conditions: Myeloid Dysplasia

Interventions: Drug: Luspatercept

First Posted Date: 2022-08-30

Last Posted Date: 2025-03-04

Lead Sponsor: Fondazione Italiana Sindromi Mielodisplastiche-ETS

Target Recruit Count: 215

Registration Number: NCT05520749

Locations: 🇮🇹
Istituto Clinico Humanitas, Milan, Rozzano, Italy

The Safety and Efficiency of Luspatercept in Chinese Adults With Transfusion Dependent β-thalassemia: a Real-world Study

Phase 4

Conditions: Transfusion-dependent Anemia
Thalassemia Major

Interventions: Drug: Luspatercept Injectable Product

First Posted Date: 2022-07-18

Last Posted Date: 2022-07-18

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 20

Registration Number: NCT05462548

Locations: 🇨🇳
The second affiliated hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

Efficacy and Safety in Transfusion Independent Non-severe Aplastic Anemia

Phase 2

Conditions: Aplastic Anemia

Interventions: Drug: Luspatercept

First Posted Date: 2022-06-01

Last Posted Date: 2022-06-01

Lead Sponsor: Bing Han

Target Recruit Count: 90

Registration Number: NCT05399732

Locations: 🇨🇳
Peking union medical college hospital, Beijing, China

Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions

Phase 2

Recruiting

Conditions: Myelodysplastic Syndromes
Anemia

Interventions: Drug: Luspatercept Injection

First Posted Date: 2022-05-20

Last Posted Date: 2024-01-31

Lead Sponsor: University of Leipzig

Target Recruit Count: 213

Registration Number: NCT05384691

Locations: 🇩🇪
Universitätsmedizin Greifswald Klinik Innere Medizin C / Hämatologie und Onkologie, Greifswald, Germany
🇩🇪
OncoSearch Institut für klinische Studien GbR, Erlangen, Germany
🇩🇪
VK&K Studien GbR, Landshut, Germany

and more 19 locations

Assessment of Effectiveness and Safety of Luspatercept in Patients Suffering From Lower-risk Myelodysplastic Syndrome.

Phase 3

Recruiting

Conditions: Myelodysplastic Syndromes

Interventions: Drug: Luspatercept

First Posted Date: 2022-01-06

Last Posted Date: 2023-10-12

Lead Sponsor: GWT-TUD GmbH

Target Recruit Count: 70

Registration Number: NCT05181592

Locations: 🇩🇪
Onkologische Schwerpunktpraxis Heidelberg, Heidelberg, Germany
🇩🇪
Gemeinschaftspraxis Hämatologie/Onkologie Magdeburg, Magdeburg, Germany
🇪🇸
Hospital General Universitario Gregorio Marañón, Madrid, Spain

and more 14 locations

Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA

Phase 1

Recruiting

Conditions: MDS
Myelodysplastic Syndromes

Interventions: Drug: Luspatercept Injection [Reblozyl]
Drug: Eprex

First Posted Date: 2022-01-06

Last Posted Date: 2025-05-09

Lead Sponsor: Groupe Francophone des Myelodysplasies

Target Recruit Count: 150

Registration Number: NCT05181735

Locations: 🇫🇷
Clinique de l'Europe, Amiens, France
🇫🇷
Hôpital privé du Confluent, Nantes, France
🇫🇷
Centre Hospitalier de Versailles, Le Chesnay, France

and more 35 locations

Luspatercept With or Without Hydroxyurea for the Treatment of Myelodysplastic/Myeloproliferative Neoplasms With Ring Sideroblasts and Thrombocytosis or Unclassifiable With Ring Sideroblasts

Phase 2

Terminated

Conditions: Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Not Otherwise Specified
Myelodysplastic/Myeloproliferative Neoplasm, Not Otherwise Specified

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Biological: Luspatercept
Drug: Hydroxyurea
Other: Questionnaire Administration

First Posted Date: 2021-08-13

Last Posted Date: 2024-02-22

Lead Sponsor: Mayo Clinic

Target Recruit Count: 3

Registration Number: NCT05005182

Locations: 🇺🇸
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy