Denosumab is under clinical development by Amgen and currently in Phase II for Metastatic Melanoma. According to GlobalData, Phase II drugs for Metastatic Melanoma have a 36% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Denosumab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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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.

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 metastatic melanoma. 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 for the treatment of cardiovascular conditions, oncology/hematology, inflammation, bone health, neurological disorders and nephrology conditions. The company analyzes the difficulties of disease and understands the fundamentals of human biology to develop products harnessing advanced human genetics. Amgen sells products primarily to pharmaceutical wholesale distributors in the US. It also markets certain products directly to consumers through direct-to-consumer channels and through partnerships with other companies. The company has a presence in Asia Pacific, Europe, the Middle East, the Americas and Australia. Amgen is headquartered in Thousand Oaks, California, the US.

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

This content was updated on 10 June 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.