Denosumab is under clinical development by Amgen 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 Denosumab’s likelihood of approval (LoA) and phase transition for Male Infertility took place on 05 Jul 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

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

Denosumab overview

Denosumab (Prolia, Pralia), is a human IgG2 monoclonal antibody. It is formulated as solution for subcutaneous route of administration. Prolia is indicated for the treatment of Postmenopausal osteoporosis, fractures, bone loss in patients undergoing hormone ablation for cancer, pediatric glucocorticoid induced osteoporosis and pediatric osteogenesis imperfecta. Pralia also indicated for inhibition of the progression of bone erosion associated with rheumatoid arthritis. The drug candidate is under development for the treatment of male infertility, neuropathic arthropathy, pediatric glucocorticoid induced osteoporosis, erosive osteoarthritis of interphalangeal finger joints and langerhans cell histiocytosis. It was also under development for the treatment of rheumatoid arthritis, postmenopausal osteoporosis,  osteogenesis imperfecta and prevention of bone metastases.

Amgen overview

Amgen is a biotechnology company, which discovers, develops, manufactures, and markets innovative human medicines to treat patients suffering from serious diseases. It develops novel medicines in six focused disease areas including cardiovascular diseases, oncology/hematology, inflammation, bone health, neurological disorders and nephrology. The company develops products using advanced human genetics to unravel the difficulties of disease and understand the fundamentals of human biology. Amgen sells products primarily to pharmaceutical wholesale distributors in the US. It also markets certain products directly to consumers through direct-to-consumer channels such as print, television and online media. Amgen is headquartered in Thousand Oaks, California, the US.

Quick View Denosumab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Denosumab
Administration Pathway
  • Subcutaneous
Therapeutic Areas
  • Central Nervous System
  • Genetic Disorders
  • Immunology
  • Male Health
  • Musculoskeletal Disorders
  • Oncology
  • Toxicology
Key Developers
Highest Development Stage
  • Marketed

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.