Enzalutamide is a Small Molecule owned by Pfizer, and is involved in 110 clinical trials, of which 73 were completed, 36 are ongoing, and 1 is planned.

Enzalutamide is the first triple-acting, androgen receptor antagonist. It inhibits the activity of prostate cancer cell androgen receptors, which may result in a reduction in prostate cancer cell proliferation and, correspondingly, a reduction in the serum prostate specific antigen (PSA) level. Androgen receptor over-expression in prostate cancer represents a key mechanism associated with prostate cancer hormone resistance.

The revenue for Enzalutamide is expected to reach a total of $54.4bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Enzalutamide NPV Report.

Enzalutamide was originated by University of California and is currently owned by Pfizer. Astellas Pharma is the other company associated in development or marketing of Enzalutamide.

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.

Astellas Pharma Overview

Astellas Pharma (Astellas) discovers, develops, manufactures, and commercializes a wide range of pharmaceuticals. The company’s product portfolio comprises marketed products for the treatment of a wide range of urological diseases, infectious diseases, cancer, nephrology, and metabolic diseases, immunodeficiency diseases, and transplantation. Its pipeline possesses drug candidates for the treatment of urothelial cancer; gastric cancer; gastroesophageal junction cancer; anemia associated with chronic kidney disease (CKD) in dialysis; Rheumatoid arthritis and non-dialysis patients; menopause-related vasomotor symptoms (MR-VMS) such as hot flashes and night sweats; and acute myeloid leukemia (AML), among others. It operates in the Americas, Australia, Europe, and Asia and Oceania through a network of subsidiaries and affiliates. Astellas is headquartered in Tokyo, Japan.

The company reported revenues of (Yen) JPY1,296,163 million for the fiscal year ended March 2022 (FY2022), an increase of 3.7% over FY2021. In FY2022, the company’s operating margin was 12.4%, compared to an operating margin of 11.7% in FY2021. In FY2022, the company recorded a net margin of 9.6%, compared to a net margin of 9.7% in FY2021. The company reported revenues of JPY380,394 million for the second quarter ended September 2022, a decrease of 0.4% over the previous quarter.

Quick View – Enzalutamide

Report Segments
  • Innovator (NME)
Drug Name
  • Enzalutamide
Administration Pathway
  • Oral
Therapeutic Areas
  • Infectious Disease
  • Oncology
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.