Luspatercept is under clinical development by Merck and currently in Phase III for Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF). According to GlobalData, Phase III drugs for Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF) have an 80% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Luspatercept’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Luspatercept overview

Luspatercept-AMT (Reblozyl) is a recombinant fusion protein, it is produced in chinese hamster ovary cells by recombinant DNA technology, acts as an erythroid maturation agent. It is formulated as lyophilized powder for solution for subcutaneous route of administration. Reblozyl is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions,and for the treatment of adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response or are ineligible for erythropoietin-based therapy, and adult patients with transfusion-dependent anemia associated with beta thalassemia.

Luspatercept (ACE-536) is under development for the treatment of anemia due to myelodysplastic syndrome, non-transfusion dependent (NTD) beta thalassemia, alpha-thalassemia, beta-thalassemia, anemia in myelofibrosis, post polycythemia vera myelofibrosis, post essential thrombocythemia myelofibrosis. The drug candidate is a recombinant fusion protein administered subcutaneously as a solution. Luspatercept is a modified activin receptor type IIB fusion protein. It is a GDF11 and GDF-8 inhibitor. It was also under development for sickle cell disease.

Merck overview

Merck is a biopharmaceutical company focused on the discovery, development, manufacturing and marketing of prescription medicines, biologic therapies, vaccines, and animal health products. It offers prescription products for therapy areas related to cardiovascular, cancer, immune disorders, infectious, respiratory, and diabetes. The company provides animal health products such as vaccines, poultry products, livestock products and aquaculture products. Merck sells medicines to drug wholesalers, retailers, hospitals, government agencies and managed health care providers; and animal health products to veterinarians, distributors and animal producers. The company and its subsidiaries operate in the Americas, Europe, the Middle East, Africa, Asia Pacific, and Latin America. Merck is known as MSD outside the US and Canada and is headquartered in Kenilworth, New Jersey, the US.

For a complete picture of Luspatercept’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.