Generic medicine information · Oncology · Prescription-only

Enzalutamide: the oral prostate-cancer medicine, its originator Xtandi and listed products

Enzalutamide is an oral androgen receptor inhibitor taken once daily. In the United States it is approved as Xtandi for castration-resistant prostate cancer (CRPC), metastatic castration-sensitive prostate cancer (mCSPC) and non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.[1]

This page explains the medicine using official sources and lists 7 products as listed from Bangladesh drug listings and Medicine for World. The originator Xtandi is described from the official label. It is not a complete global list, and regulatory status differs by product and country.[4]

Availability enquiries are handled by Medicine for World. Submission of an enquiry does not confirm regulatory eligibility, supply or delivery. Ownership and commercial disclosure

Zaluta 40 mg enzalutamide product packaging
Zaluta · Xtandi — Product photos as listed[4]
  • 7 listed productsBrand names as listed; several manufacturers
  • Originator: XtandiAstellas · US approval 2012, EU approval 2013
  • Regulatory status variesConfirm with your national authority
  • Prescription-only cancer medicineSeizure, falls and fractures need attention
Quick facts

Enzalutamide at a glance

Generic name (INN)
Enzalutamide[1]
Medicine class
Androgen receptor inhibitor (non-steroidal antiandrogen) for prostate cancer, taken by mouth[1]
Dosage forms
Capsules and tablets, taken once daily[1]
Strengths (US label)
Capsules 40 mg; tablets 40 mg and 80 mg[1]
Originator
Xtandi · Astellas[1][3]
Approvals
United States: 31 August 2012 · European Union: 21 June 2013[2][3]
Recommended dose (US label)
160 mg once daily, with or without food[1]
Products in this directory
7 listed products; manufacturer stated for 4 of them[4]
Supply status
Prescription-only medicine[1]

What is enzalutamide?

Enzalutamide is the international non-proprietary name of an oral androgen receptor inhibitor. According to the US prescribing information, Xtandi is indicated for castration-resistant prostate cancer (CRPC), metastatic castration-sensitive prostate cancer (mCSPC) and non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis (high-risk BCR).[1]

In the European Union, where it is authorised as Xtandi (21 June 2013), the listed uses in adult men are high-risk biochemical recurrent hormone-sensitive disease, metastatic hormone-sensitive disease, high-risk non-metastatic CRPC and metastatic CRPC (before chemotherapy or after docetaxel).[3] Xtandi was first approved in the United States on 31 August 2012.[2] Approved uses and available strengths differ between countries.

In the AFFIRM trial of men with metastatic CRPC after docetaxel, median overall survival was 18.4 months with Xtandi versus 13.6 months with placebo (hazard ratio 0.63).[1] Whether enzalutamide is suitable, and at which dose, is decided by the treating doctor. Full warnings are in the official product information:

Directory

7 products currently included in this directory

The products below are included for identification and availability-enquiry purposes. Inclusion does not mean that a product is authorised, approved, therapeutically equivalent or available in every country. Confirm regulatory status with the relevant national medicines authority.

Products are listed in alphabetical order. The list is not a ranking and makes no claim that one product is better than another.[4]

7 of 7 products

  • Zaluta 40 mg enzalutamide product packaging

    Zaluta

    Product information listed
    Active ingredient as listed
    Enzalutamide
    Manufacturer as listed
    Beacon Pharmaceuticals PLC (manufacturing country listed: Bangladesh)
    Product strength (not a dose recommendation)
    40 mg
    Dosage form
    Tablet
    Pack information
    Not stated in the listing
    Information source
    Product listing dataset[4]
    Information last checked
    October 13, 2026
    Regulatory status
    Not independently verified for this page
  • Prozenza 40 mg enzalutamide product packaging

    Prozenza

    Product information listed
    Active ingredient as listed
    Enzalutamide
    Manufacturer as listed
    Ziska Pharmaceuticals Ltd. (manufacturing country listed: Bangladesh)
    Product strength (not a dose recommendation)
    40 mg
    Dosage form
    Tablet
    Pack information
    Not stated in the listing
    Information source
    Product listing dataset[4]
    Information last checked
    October 13, 2026
    Regulatory status
    Not independently verified for this page
  • Enzamide 40 mg enzalutamide product packaging

    Enzamide

    Product information listed
    Active ingredient as listed
    Enzalutamide
    Manufacturer as listed
    Everest Pharmaceuticals Ltd. (manufacturing country listed: Bangladesh)
    Product strength (not a dose recommendation)
    40 mg
    Dosage form
    Tablet
    Pack information
    Not stated in the listing
    Information source
    Product listing dataset[4]
    Information last checked
    October 13, 2026
    Regulatory status
    Not independently verified for this page
  • Enzalunix 40 mg enzalutamide product packaging

    Enzalunix

    Product information listed
    Active ingredient as listed
    Enzalutamide
    Manufacturer as listed
    Beacon Pharmaceuticals Limited (manufacturing country listed: Bangladesh)
    Product strength (not a dose recommendation)
    40 mg
    Dosage form
    Tablet
    Pack information
    120 tablets per pot (manufacturer page)
    Information source
    Product listing dataset[4]
    Information last checked
    October 13, 2026
    Regulatory status
    Not independently verified for this page
  • Glenza 40 mg enzalutamide product packaging

    Glenza

    Product information listed
    Active ingredient as listed
    Enzalutamide
    Manufacturer as listed
    Manufacturer not stated in the listing
    Product strength (not a dose recommendation)
    40 mg
    Dosage form
    Not stated in the listing
    Pack information
    Not stated in the listing
    Information source
    Product listing dataset[4]
    Information last checked
    October 13, 2026
    Regulatory status
    Not independently verified for this page
  • BDENZA 40 mg enzalutamide product packaging

    BDENZA

    Product information listed
    Active ingredient as listed
    Enzalutamide
    Manufacturer as listed
    Manufacturer not stated in the listing
    Product strength (not a dose recommendation)
    40 mg
    Dosage form
    Not stated in the listing
    Pack information
    Not stated in the listing
    Information source
    Product listing dataset[4]
    Information last checked
    October 13, 2026
    Regulatory status
    Not independently verified for this page
  • Indenza 160 mg/40 mg enzalutamide product packaging

    Indenza

    Product information listed
    Active ingredient as listed
    Enzalutamide
    Manufacturer as listed
    Manufacturer not stated in the listing
    Product strength (not a dose recommendation)
    160 mg / 40 mg
    Dosage form
    Not stated in the listing
    Pack information
    Not stated in the listing
    Information source
    Product listing dataset[4]
    Information last checked
    October 13, 2026
    Regulatory status
    Not independently verified for this page

Product listing data last checked October 13, 2026.

Originator

Originator medicine: Xtandi (Astellas)

Xtandi is the originator enzalutamide medicine, marketed in the United States and the European Union by Astellas. It was first approved by the US FDA on 31 August 2012 and authorised in the European Union on 21 June 2013 (Astellas Pharma Europe B.V.). The originator itself is not part of the Medicine for World listing on this page; its card links to the official US prescribing information. Other products represented as containing enzalutamide are made by other manufacturers and sold under their own brand names.[1][2][3]

The originator is shown here separately from the other listed products.

Brand name
Xtandi[1][3]
Active substance
Enzalutamide[1]
Company
Astellas (EU authorisation holder: Astellas Pharma Europe B.V.)[1][3]
Strengths in the US label
Capsules 40 mg; tablets 40 mg and 80 mg[1]
First approvals
United States 31 August 2012 · European Union 21 June 2013[2][3]
Pack in the US label
Capsules and tablets[1]
Comparison

Enzalutamide generic vs originator medicine

This comparison covers identity and listing information only. It does not establish regulatory approval, pharmaceutical equivalence, bioequivalence, quality, safety or clinical effectiveness.

AttributeOther listed enzalutamide productsOriginator (Xtandi)
Active substanceEnzalutamide, as listed. Formulation details are not stated in several product listings.[4]Enzalutamide[1]
Brand nameEach manufacturer's own brand name (7 products listed, for example Zaluta, Prozenza, Enzamide)[4]Xtandi (US and EU)[1][3]
CompanyBeacon, Ziska and Everest where named; the manufacturer is not stated for four listings; manufacturing country listed: Bangladesh where stated[4]Astellas[1][3]
Dosage formTablet for the named Bangladesh brands; not stated for the other listings[4]Capsules and tablets (US label)[1]
Strength40 mg for the named brands; some listings give other values (for example 40 mg, 160 mg), as listed and not verified[4]Capsules 40 mg; tablets 40 mg and 80 mg (US label)[1]
PackNot stated in most listings (Enzalunix: 120 tablets per pot)[4]Not listed by Medicine for World[4]
Regulatory approvalVaries by product and country. Not independently verified for this page; Enzalunix is described by its maker as launched for export purposes only. Check with your national medicines authority.US FDA approval 31 August 2012 · EU authorisation 21 June 2013[2][3]
ClassificationProduct represented by its manufacturer or supplier as containing enzalutamide. Regulatory classification must be confirmed in the relevant jurisdiction.[4]Originator product[1][2]
What must be the sameSame active ingredient, strength, dosage form and route of administration as the originator, where the product is approved as a generic[5]Reference product[1]
BioequivalenceMust deliver the same amount of active ingredient at the same rate and extent as the originator[5][6]Reference product for the comparison[6]
Clinical trial dataDoes not have to repeat the originator's animal and clinical studies; shows equivalence to the originator instead[5][6]Full safety and efficacy programme submitted for approval[2][6]
Inactive ingredients and appearanceMay differ (for example colour or excipients); minor differences are generally allowed and rarely matter clinically[6]Its own formulation and appearance[1]
Manufacturing standardsMade under the same strict good-manufacturing-practice standards as the originator; plants are inspected[5]Same standards[5]
PriceTends to cost less, because the maker does not repeat the original studies[5]. No prices are shown on this page.Usually higher[5]
Market entryGenerally approved once the originator's patents and exclusivities have expired or been successfully challenged[5]Protected by patents and marketing exclusivity during that period[5]
Safety

Side effects and important warnings

The information below summarises the US prescribing information. It is not complete; read the full label and talk to your doctor.[1]

No boxed warning – but seizures, falls and fractures matter. The US label for Xtandi has no boxed warning and lists no contraindications. It warns about seizure (0.6% of patients across eight trials), posterior reversible encephalopathy syndrome (PRES), hypersensitivity, ischemic heart disease, falls and fractures, embryo-fetal toxicity, dysphagia or choking and digoxin assay interference. The EU product information lists hypersensitivity and pregnancy (or possible pregnancy) as contraindications.[1][3]

Adverse reactions in the PREVAIL trial (Xtandi n=871; placebo n=844)

Side effectShare of patients
Asthenic conditions (weakness, fatigue)47% (placebo 33%)
Back pain29% (placebo 22%)
Constipation23% (placebo 17%)
Hot flush18% (placebo 8%)
Hypertension14% (placebo 4.1%)
Fall13% (placebo 5%)
Non-pathological fracture9% (placebo 3%)

Other warnings in the label

  • Seizure occurred in 0.6% of patients across eight trials and in 2.2% (8 of 366) in a trial of patients with predisposing factors; the label says to stop permanently after a seizure
  • Posterior reversible encephalopathy syndrome (PRES): stop treatment if it occurs; the diagnosis needs brain imaging, preferably MRI
  • Hypersensitivity: facial, tongue and lip edema were reported (0.5%, 0.1%, 0.1%); pharyngeal edema after marketing; stop permanently for serious reactions
  • Ischemic heart disease occurred in 3.5% versus 2% with placebo (fatal in 0.4% versus 0.1%); falls in 12% versus 6% and fractures in 13% versus 6%
  • Dysphagia or choking can occur because of product size and can be severe; a smaller tablet may be considered
  • Embryo-fetal toxicity: Xtandi can cause fetal harm and loss of pregnancy; safety and efficacy in females have not been established
  • The EU product information also warns about second primary malignancies (mainly bladder cancer), severe skin reactions and QT prolongation with androgen deprivation therapy

Interactions, pregnancy and fertility

  • Strong CYP2C8 inhibitors (for example gemfibrozil) raised exposure about 2.2-fold: avoid, or reduce to 80 mg once daily.
  • Strong CYP3A4 inducers (for example rifampin) lowered exposure by 37%: avoid, or increase to 240 mg once daily.
  • Enzalutamide itself induces CYP3A4, CYP2C9 and CYP2C19: midazolam exposure fell 86%, omeprazole 72% and S-warfarin 56%; avoid sensitive substrates where possible.
  • Digoxin exposure rose 33% (P-gp substrate); enzalutamide can also interfere with some digoxin immunoassays, so tell the laboratory.
  • Contraception: men with partners who could become pregnant should use effective contraception during treatment and for 3 months after the last dose; use a condom with a pregnant partner.
  • Fertility: enzalutamide may impair male fertility.
Dosing

How enzalutamide is taken (US label)

Enzalutamide is taken by mouth once a day with or without food, swallowed whole. Your doctor decides the dose and the treatment duration.[1]

UseDaily doseNotes
All indications160 mg once dailyFour 40 mg capsules/tablets or two 80 mg tablets; until progression or unacceptable toxicity
Castration-resistant or metastatic castration-sensitive cancer160 mg once dailyTogether with a GnRH analog, or after bilateral orchiectomy
Non-metastatic castration-sensitive cancer, high-risk biochemical recurrence160 mg once dailyWith or without a GnRH analog; may be suspended if PSA is undetectable (below 0.2 ng/mL) after 36 weeks and restarted at the PSA thresholds in the label
Grade 3 or higher, or intolerable, adverse reactionWithhold for one week or until grade 2 or lowerThen resume at the same dose or at 120 mg or 80 mg
With a strong CYP2C8 inhibitorAvoid; if unavoidable, 80 mg once dailyReturn to the previous dose after the inhibitor is stopped
With a strong CYP3A4 inducerAvoid; if unavoidable, 240 mg once dailyReturn to the previous dose after the inducer is stopped
Liver or kidney impairmentNo dose change for any liver impairment or for mild to moderate kidney impairmentSevere kidney impairment (CLcr below 30 mL/min) and end-stage kidney disease have not been studied

The doses in the table are US label information, not a personal recommendation. Capsules are 40 mg; tablets are 40 mg and 80 mg.[1]

How it works

Enzalutamide is an androgen receptor inhibitor. It blocks the receptor through which male hormones stimulate prostate cancer cells.[1]

Depending on the stage, it is used together with a GnRH analog or after orchiectomy (testosterone-lowering treatment), as set out in the label.[1]

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FAQ

Frequently asked questions about enzalutamide

What is enzalutamide?

Enzalutamide is a prescription-only, once-daily oral androgen receptor inhibitor for prostate cancer. The originator brand is Xtandi, made by Astellas.

What is enzalutamide used for?

In the US label, Xtandi is used for castration-resistant prostate cancer, metastatic castration-sensitive prostate cancer and non-metastatic castration-sensitive prostate cancer with high-risk biochemical recurrence. The EU lists five uses in adult men. Approved uses differ by country.

Who makes the originator medicine?

Astellas. Xtandi was first approved in the United States on 31 August 2012 and authorised in the European Union on 21 June 2013 (Astellas Pharma Europe B.V.).

How is enzalutamide taken?

The US label says 160 mg once daily, with or without food, swallowed whole, until disease progression or unacceptable toxicity. Doses change with some interacting medicines and after certain adverse reactions.

What are the most common side effects?

In the PREVAIL trial in the US label, asthenic conditions (47%), back pain (29%), constipation (23%), hot flush (18%) and hypertension (14%) were among the most frequent.

Is there a boxed warning?

No. The US label has no boxed warning, but it warns about seizure, PRES, hypersensitivity, ischemic heart disease, falls and fractures, embryo-fetal toxicity and swallowing problems.

Which medicines interact with enzalutamide?

Strong CYP2C8 inhibitors (such as gemfibrozil) raise enzalutamide levels and strong CYP3A4 inducers (such as rifampin) lower them. Enzalutamide itself lowers the levels of many medicines, including warfarin. Ask your doctor or pharmacist about everything you take.

What does this directory include?

7 products represented by their manufacturers or suppliers as containing enzalutamide (for example Zaluta, Prozenza, Enzamide, Enzalunix, Glenza, BDENZA, Indenza). It is not a complete global list, and inclusion does not mean that a product is authorised in any specific country.

Are the listed products equivalent to Xtandi?

Equivalence is established by the regulator product by product, through bioequivalence data compared with the originator, so it cannot be assumed from a listing alone. The listed products are represented by their manufacturers as containing enzalutamide. Their regulatory status and equivalence to Xtandi should be confirmed with your national medicines authority and your doctor.

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Use the non-binding enquiry form on this page. Medicine for World reviews destination-country rules and may ask for a prescription before offering any option.

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Transparency

Editorial and medical review

Current editorial and medical-review status is shown below. No independent medical review is claimed until it has been completed.

Written by
Enzalutamide Editorial Team
Medically reviewed by
Independent medical review pending
Medical review date
Not yet independently reviewed
Product data last checked
October 13, 2026 (listing details as supplied; regulatory status not verified)
Independent review status
Pending; recheck immediately when official sources change and before adding any new medical claim
Sources

Sources

Medical and regulatory facts come from official product information. Product listing details come from a supplied dataset. Numbers in square brackets on this page refer to the sources below.

  1. [1]
    XTANDI (enzalutamide) US prescribing information – FDA label (revised 7/2026)Indications, strengths, dosing, contraindications, warnings, adverse reactions, interactions, pregnancy, trial results. Check the current label for later revisions · Accessed: October 13, 2026
    Official source
  2. [2]
    U.S. FDA – Drugs@FDA: NDA 203415, XTANDIOriginal approval date (31 August 2012) · Accessed: October 13, 2026
    Official source
  3. [3]
    European Medicines Agency – Xtandi: EPAREU authorisation (21 June 2013), authorisation holder and EU indications and warnings · Accessed: October 13, 2026
    Official source
  4. [4]
    Product listing dataset supplied by Medicine for WorldBrand name, manufacturer, strength and dosage form compiled from Bangladesh drug listings (MedEx), the manufacturer's product page (Enzalunix) and the Medicine for World enzalutamide page. These listing details do not by themselves establish regulatory approval or therapeutic equivalence. · Accessed: October 13, 2026
    Supplied data – not independently verified
  5. [5]
    U.S. FDA – Generic Drug FactsSame active ingredient, strength, form and route; bioequivalence; manufacturing standards; cost; approval pathway · Accessed: October 13, 2026
    Official source
  6. [6]
    U.S. FDA – Generic Drugs: Questions & AnswersBioequivalence meaning, no repeat clinical trials, appearance and inactive ingredients, safety monitoring · Accessed: October 13, 2026
    Official source