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Luspatercept

Alternative Names: luspatercept, reblozyl, ace-536, ace536, ace 536, luspatercept-aamt, luspatercept–aamt
Latest Update: 2024-06-22
Latest Update Note: Clinical Trial Update

Product Description

Luspatercept, a recombinant fusion protein that binds transforming growth factor β superfamily ligands to reduce SMAD2 and SMAD3 signaling, showed promising results in a phase 2 study. Luspatercept reduced the severity of anemia in patients with lower-risk myelodysplastic syndromes with ring sideroblasts who had been receiving regular red-cell transfusions and who had disease that was refractory to or unlikely to respond to erythropoiesis-stimulating agents or who had discontinued such agents owing to an adverse event.  (Sourced from: https://www.nejm.org/doi/full/10.1056/nejmoa1908892)

Mechanisms of Action: TGFb Inhibitor

Novel Mechanism: No

Modality: Fusion Protein

Route of Administration: Subcutaneous

FDA Designation: Priority Review - Anemia|Myelodysplastic Syndrome *

Approval Status: Approved

Approved Countries: Australia | Austria | Belgium | Brazil | Canada | Chile | Croatia | Cyprus | Czech | Denmark | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Korea | Latvia | Lithuania | Luxembourg | Malaysia | Netherlands | Norway | Peru | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | Spain | Sweden | Taiwan | Turkey | United Arab Emirates | United States | Uruguay

Approved Indications: Anemia | beta-Thalassemia | Myelodysplastic Syndrome | Thalassemia | Thrombocytosis | Oncology Unspecified

Known Adverse Events: Abdominal Pain | Dizziness | Headache | Pain Unspecified | Vertigo | Arthralgia | Dyspnea | Diarrhea

Company: Bristol-Myers Squibb
Company Location: NEW YORK NY 10016
Company CEO: Giovanni Caforio
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Luspatercept

Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, United States

Active Clinical Trial Count: 45

Highest Development Phases

Phase 3: Anemia|Myelodysplastic Syndrome|Myelofibrosis|Myeloproliferative Disorders|Polycythemia|Polycythemia Vera|Preleukemia|Thrombocythemia, Essential|beta-Thalassemia

Phase 2: Anemia, Dyserythropoietic, Congenital|Anemia, Refractory|Anemia, Sideroblastic|Thalassemia|alpha-Thalassemia

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

ACE-536-B-THAL-004

P2

Not yet recruiting

beta-Thalassemia

2034-02-26

Phase 2 Study of Luspatercept in Adults with Alpha (α)-thalassemia

P2

Active, not recruiting

Thalassemia

2030-09-28

CA056-025

P3

Recruiting

Myelodysplastic Syndrome

2030-03-11

CASE2920

P2

Recruiting

Myelodysplastic Syndrome

2029-08-01

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