Apalutamide is under clinical development by Johnson & Johnson 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 Apalutamide’s likelihood of approval (LoA) and phase transition for Metastatic Hormone Refractory (Castration Resistant, Androgen-Independent) Prostate Cancer took place on 09 Feb 2021, 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.

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

Apalutamide overview

Apalutamide (Erleada, Erlyand, Ansenke) is a nonsteroidal anti-androgen. It is formulated as film coated tablets, coated tablets and tablets for oral route of administration. Erleada is indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer in adults and metastatic hormone sensitive prostate cancer, non-muscle invasive bladder cancer, metastatic prostate cancer, and also indicated for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).

Erleada (JNJ-56021927, ARN-509) is under development for the treatment of recurrent/metastatic salivary gland carcinoma, metastatic castration-resistant prostate cancer, and localized prostate cancer. It is a new molecular entity (NME).

Johnson & Johnson overview

Johnson & Johnson (J&J) researches, develops, manufactures, and sells pharmaceutical products, medical devices, and consumer products. The company provides pharmaceuticals for immune diseases, cancer, neurological disorders, infectious, cardiovascular and metabolic diseases; consumer products in oral care, baby care, beauty, over-the-counter (OTC) medicines, women’s health and wound care categories; and medical devices for use in the cardiovascular, orthopaedic, general surgery and vision care fields. J&J distributes pharmaceutical and medical products to retailers, wholesalers, health care professionals and hospitals; and offers consumer products through retail outlets and distributors. The company offers its products in the US; Europe; Asia-Pacific and Africa; and Western Hemisphere (excluding the US). J&J is headquartered in New Brunswick, New Jersey, the US.

Quick View Apalutamide LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Apalutamide
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
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.