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Xtandi (enzalutamide)

Astellas Pharma · FDA-approved active Quality 61/100

Xtandi works by blocking the androgen receptor, a protein that helps prostate cancer cells grow.

Xtandi (enzalutamide) is a small molecule androgen receptor inhibitor developed by Astellas, targeting the androgen receptor to treat prostate cancer. It was FDA-approved in 2012 for the treatment of malignant tumor of prostate and metastasis from malignant tumor of prostate. Xtandi is currently owned by Astellas and has multiple generic manufacturers. As a patented medication, its commercial status is subject to change. Key safety considerations include potential side effects such as fatigue, diarrhea, and hypertension.

At a glance

Generic nameenzalutamide
SponsorAstellas Pharma
Drug classAndrogen Receptor Inhibitor [EPC]
TargetAndrogen receptor
Therapeutic areaOncology
PhaseFDA-approved
First approval2012
Annual revenue4500

Mechanism of action

Enzalutamide is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway. Enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors; and consequently, inhibits nuclear translocation of androgen receptors and their interaction with DNA. major metabolite, N-desmethyl enzalutamide, exhibited similar in vitro activity to enzalutamide. Enzalutamide decreased proliferation and induced cell death of prostate cancer cells in vitro, and decreased tumor volume in mouse prostate cancer xenograft model.

Approved indications

Common side effects

Drug interactions

Key clinical trials

Patents

PatentExpiryType
125023572033-09-11Method of Use
124471282033-09-11Method of Use
118396892033-09-11Formulation

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results
FDA Orange BookPatents + exclusivity
SEC EDGARRevenue + earnings

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