Sotatercept is under clinical development by Merck & Co and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Sotatercept’s likelihood of approval (LoA) and phase transition for Pulmonary Arterial Hypertension took place on 19 Oct 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 19 Oct 2022 increased Sotatercept’s LoA and PTSR for Myelofibrosis.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Sotatercept Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Sotatercept overview

Sotatercept (ACE-011) is under development for the treatment of anemia in patients with myelofibrosis, beta-thalassemia,  and pulmonary arterial hypertension. 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.

Merck & Co overview

Merck & Co (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 women’s diseases, 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.

Quick View Sotatercept LOA Data

Report Segments
  • Innovator
Drug Name
  • Sotatercept
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Cardiovascular
  • Genito Urinary System And Sex Hormones
  • Hematological Disorders
  • Musculoskeletal Disorders
  • Oncology
  • Toxicology
Key Developers
  • Sponsor Company: Merck & Co
  • Originator: Acceleron Pharma
Highest Development Stage
  • Phase III


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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.