Xtandi
An oral therapy for advanced prostate cancer.
Where Enzalutamide is approved
All regulators →Of the three regulators tracked here, the first to approve Enzalutamide was the US, on 31 Aug 2012. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Enzalutamide patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Enzalutamide, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 5 listed patents; the last listed expires 23 Feb 2037 (US 12161628).
- Latest patent on the drug substance itself: 13 Aug 2027 (US 7709517).
- Exclusivity I-926: New indication: treatment of patients with non-metastatic castration-sensitive prostate cancer (nmcspc) with biochemical recurrence at high…, until 17 Nov 2026.
Reproduced from the FDA Orange Book and Purple Book (checked 5 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Enzalutamide
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Enzalutamide works
All drug targets →- Androgen Receptor antagonist AntagonistTarget: AR androgen receptor✓ In ChEMBL and the Guide to Pharmacology
- Triple-negative breast carcinomaPhase 3
- CancerPhase 2/3
- COVID-19Phase 2
- Bone metastasisPhase 2
- Breast cancerPhase 2
- Estrogen-receptor positive breast cancerPhase 2
- Fallopian tube cancerPhase 2
- Hepatocellular carcinomaPhase 2
- Mantle cell lymphomaPhase 2
- Non-small cell lung carcinomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1082407, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 6812, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Enzalutamide
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 5 technology appraisals of Enzalutamide. 5 are current, and 3 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Enzalutamide for treating non-metastatic prostate cancer after radical prostatectomy or radiotherapy (terminated appraisal) NICE TA994 | Terminated (no company submission) | 8 Aug 2024 | Current |
| Enzalutamide for treating hormone-sensitive metastatic prostate cancer NICE TA712 | Recommended | 7 Jul 2021 | Current |
| Enzalutamide for hormone-relapsed non-metastatic prostate cancer NICE TA580 | Not recommended | 15 May 2019 | Current |
| Enzalutamide for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated NICE TA377 | Recommended | 27 Jan 2016 | Current |
| Enzalutamide for metastatic hormone‑relapsed prostate cancer previously treated with a docetaxel‑containing regimen NICE TA316 | Recommended | 23 Jul 2014 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Enzalutamide
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 21 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Xtandi, Enzalutamide Accordpharma (generic), Enzalutamide Viatris (generic)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Enzalutamide
- ATC code
- L02BB04
- ChEMBL
- CHEMBL1082407
- DrugBank
- DB08899
- PubChem CID
- 15951529
- CAS number
- 915087-33-1
- FDA UNII
- 93T0T9GKNU
- Wikidata
- Q1996756
- Wikipedia
- Enzalutamide
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Xtandi is used for
XTANDI ® is indicated for the treatment of patients with: • castration-resistant prostate cancer (CRPC) • metastatic castration-sensitive prostate cancer (mCSPC) • non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with: • castration-resistant prostate cancer. ( 1 ) • metastatic castration-sensitive prostate cancer. ( 1 ) • non‑metastatic castration‑sensitive prostate cancer with biochemical recurrence at high risk for metastasis. ( 1 )
How it works
12.1 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. A 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 a mouse prostate cancer xenograft model.
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 8 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.