Enzalutamide is under clinical development by Pfizer and currently in the Phase I and Phase II 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 Enzalutamide’s likelihood of approval (LoA) and phase transition for Transitional Cell Carcinoma (Urothelial Cell Carcinoma) took place on 01 Sep 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.

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

Enzalutamide overview

Enzalutamide (Xtandi) is a phenylimidazolidine derivative, acts as anti neoplastic agent. It is formulated as soft gelatin capsules and tablets for oral route of administration. It is indicated for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel, indicated for the treatment of metastatic prostate cancer. It is also indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT).

Enzalutamide is under development for the treatment of non-metastatic castration-resistant prostate cancer, prostate cancer in patients with non-metastatic biochemical recurrence in the EU, China and Asia, and also for metastatic hormone-sensitive prostate cancer in the U.S, EU, Asia and Japan and for non-metastatic high risk hormone sensitive prostate cancer. The drug candidate is also under development for castration-resistant prostate cancer in the Japan as a tablet formulation. It is also under development for the treatment of androgen receptor positive (AR+) ovarian, epithelial ovarian cancer, primary peritoneal or fallopian tube cancer (following one, two and three prior therapies),  and pancreatic cancer. It is also under development for refractory/relapsed acute myeloid leukemia, multiple myeloma, acute lymphocytic leukemia, chronic myeloid leukemia, chronic lymphocytic leukemia, myelodysplastic syndrome, primary myelofibrosis, Hodgkin and Non-Hodgkin's lymphoma, 

It was also under development for metastatic castration-resistant prostate cancer in Japan as a first line therapy and HER2 positive triple negative breast cancer in the U.S., EU, Japan and Asia-Pacific and hepatocellular carcinoma in the U.S, EU and Asia. It was also under development for spindle cell squamous cell carcinoma and HER2 positive breast cancer as a second line therapy and androgen receptor positive salivary cancer and COVID-19.

Pfizer overview

Pfizer discovers, develops, manufactures and commercializes biopharmaceuticals. The company offers products to treat various conditions such as cardiovascular, metabolic and pain, cancer, inflammation, immune disorders and rare diseases. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contract manufacturing services. Pfizer sells its products through wholesalers, retailers, hospitals, clinics, government agencies and pharmacies. It has major manufacturing facilities in India, China, Japan, Ireland, Italy, Belgium, Germany, Singapore, and the US. The company provides its products in North America, South America, Asia-Pacific, Australia, Europe, Africa and the Middle East. Pfizer is headquartered in New York, the US.

Quick View Enzalutamide LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Enzalutamide
Administration Pathway
  • Oral
Therapeutic Areas
  • Infectious Disease
  • Oncology
Key Developers
  • Sponsor Company: Pfizer
  • Originator: University of California
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.