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
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:
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]
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Product listing data last checked October 13, 2026.
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.
This comparison covers identity and listing information only. It does not establish regulatory approval, pharmaceutical equivalence, bioequivalence, quality, safety or clinical effectiveness.
| Attribute | Other listed enzalutamide products | Originator (Xtandi) |
|---|---|---|
| Active substance | Enzalutamide, as listed. Formulation details are not stated in several product listings.[4] | Enzalutamide[1] |
| Brand name | Each manufacturer's own brand name (7 products listed, for example Zaluta, Prozenza, Enzamide)[4] | Xtandi (US and EU)[1][3] |
| Company | Beacon, Ziska and Everest where named; the manufacturer is not stated for four listings; manufacturing country listed: Bangladesh where stated[4] | Astellas[1][3] |
| Dosage form | Tablet for the named Bangladesh brands; not stated for the other listings[4] | Capsules and tablets (US label)[1] |
| Strength | 40 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] |
| Pack | Not stated in most listings (Enzalunix: 120 tablets per pot)[4] | Not listed by Medicine for World[4] |
| Regulatory approval | Varies 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] |
| Classification | Product 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 same | Same active ingredient, strength, dosage form and route of administration as the originator, where the product is approved as a generic[5] | Reference product[1] |
| Bioequivalence | Must 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 data | Does 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 appearance | May differ (for example colour or excipients); minor differences are generally allowed and rarely matter clinically[6] | Its own formulation and appearance[1] |
| Manufacturing standards | Made under the same strict good-manufacturing-practice standards as the originator; plants are inspected[5] | Same standards[5] |
| Price | Tends to cost less, because the maker does not repeat the original studies[5]. No prices are shown on this page. | Usually higher[5] |
| Market entry | Generally 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] |
The information below summarises the US prescribing information. It is not complete; read the full label and talk to your doctor.[1]
| Side effect | Share of patients |
|---|---|
| Asthenic conditions (weakness, fatigue) | 47% (placebo 33%) |
| Back pain | 29% (placebo 22%) |
| Constipation | 23% (placebo 17%) |
| Hot flush | 18% (placebo 8%) |
| Hypertension | 14% (placebo 4.1%) |
| Fall | 13% (placebo 5%) |
| Non-pathological fracture | 9% (placebo 3%) |
Enzalutamide is taken by mouth once a day with or without food, swallowed whole. Your doctor decides the dose and the treatment duration.[1]
| Use | Daily dose | Notes |
|---|---|---|
| All indications | 160 mg once daily | Four 40 mg capsules/tablets or two 80 mg tablets; until progression or unacceptable toxicity |
| Castration-resistant or metastatic castration-sensitive cancer | 160 mg once daily | Together with a GnRH analog, or after bilateral orchiectomy |
| Non-metastatic castration-sensitive cancer, high-risk biochemical recurrence | 160 mg once daily | With 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 reaction | Withhold for one week or until grade 2 or lower | Then resume at the same dose or at 120 mg or 80 mg |
| With a strong CYP2C8 inhibitor | Avoid; if unavoidable, 80 mg once daily | Return to the previous dose after the inhibitor is stopped |
| With a strong CYP3A4 inducer | Avoid; if unavoidable, 240 mg once daily | Return to the previous dose after the inducer is stopped |
| Liver or kidney impairment | No dose change for any liver impairment or for mild to moderate kidney impairment | Severe 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]
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Enzalutamide is a prescription-only, once-daily oral androgen receptor inhibitor for prostate cancer. The originator brand is Xtandi, made by Astellas.
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.
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.).
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.
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.
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.
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.
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.
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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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.