Xtandi
Xtandi ingredients
| Active ingredient | Strength |
|---|---|
| Enzalutamide | 40 mg/1, 80 mg/1 |
What Xtandi is used for
The FDA lists the approved uses on the official label (below). In the EU, enzalutamide is approved as Xtandi for:
Xtandi is indicated for: as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy (see section 5.1). the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1). the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1). the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Xtandi
- Generic name
- Enzalutamide
- Made by
- Astellas Pharma US, Inc.
- Forms
- Capsule, Tablet
- Given
- Oral
- Drug class
- Androgen Receptor Inhibitor
- FDA approval
- New drug application (NDA) NDA213674
- On the US market since
- 2012
Official information
- Xtandi prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Enzalutamide)
In India
- Enzalutamide: 18 brands in India
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Xtandi?
Xtandi (Enzalutamide) is a cancer medicine made by Astellas Pharma US, Inc., approved by the US FDA.
What are the ingredients of Xtandi?
Xtandi contains Enzalutamide (40 mg/1, 80 mg/1).
Is Xtandi approved in Europe?
The same active substance is approved in the EU as Xtandi.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA