Sotatercept is under clinical development by Merck and currently in Pre-Registration for Pulmonary Arterial Hypertension. According to GlobalData, Pre-Registration drugs for Pulmonary Arterial Hypertension have a 75% phase transition success rate (PTSR) indication benchmark for progressing into Marketed. GlobalData’s report assesses how Sotatercept’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.

Sotatercept overview

Sotatercept (ACE-011) is under development for the treatment of pulmonary arterial hypertension and pulmonary hypertension due to left heart disease. The drug candidate is administered subcutaneously and intravenously. Sotatercept is a dimeric fusion protein containing the extracellular domain of the activin receptor 2A (ACVR2A) fused to the Fc domain of human IgG1. It was also under development for the treatment of chemotherapy induced anemia (CIA), end stage renal disease (ESRD), solid tumor, osteoporosis and renal anemia in patients with chronic kidney disease on hemodialysis, multiple myeloma, metabolic bone disorders,Diamond-Blackfan anemia (inherited erythroblastopenia),  myelodysplastic syndrome and sickle cell disease and anemia in patients with myelofibrosis, beta-thalassemia.

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 Sotatercept’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 20 February 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

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.