Is Enzalutamide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Enzalutamide, including Enzastik (40 mg, Capsule, soft, SAR 8979.30); Enzular (40 mg, Capsule, SAR 8933.45); XTANDI 40 mg capsule (40 mg, Capsule, soft, SAR 9620.65).

Is Enzalutamide approved by the US FDA?

Drugs@FDA lists 6 application product lines for Enzalutamide, including XTANDI (Prescription); XTANDI (Prescription); ENZALUTAMIDE (Prescription); ENZALUTAMIDE (Discontinued); ENZALUTAMIDE (Discontinued).

Is Enzalutamide authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Enzalutamide: Enzalutamide Accordpharma, Xtandi, Enzalutamide Viatris.

Is Enzalutamide on the WHO Model List of Essential Medicines?

Yes — 8.2.4. Hormones and antihormones (complementary list): Therapeutic equivalent to abiraterone for Malignant neoplasms of prostate.

Are there safety signals or safety updates for Enzalutamide?

EMA PRAC: 9 entries; US FDA: 2 entries (latest 2026-07-24).

Active substance

Enzalutamide

SFDA 3
US FDA 6
EMA 3
Health Canada 5
WHO EML 1
Safety 11

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Enzastik	40 mg	Capsule, soft · Oral use	112 Blister	SAR 8979.30	Generic · Prescription	Aurobindo Pharma Limited	Valid
Enzular	40 mg	Capsule · Oral use	120 Bottle	SAR 8933.45	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
XTANDI 40 mg capsule	40 mg	Capsule, soft · Oral use	112 Blister	SAR 9620.65	NCE · Prescription	ASTELLAS PHARMA	Valid

Indications — CHI Daman Drug Formulary

PROSTATE CANCER

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
XTANDI	40MG	capsule · oral	ASTELLAS	Prescription	31 Aug 2012
XTANDI	40MG; 80MG	tablet · oral	ASTELLAS	Prescription	4 Aug 2020
ENZALUTAMIDE	40MG; 80MG	tablet · oral	SANDOZ	Prescription	20 Apr 2026
ENZALUTAMIDE	40MG	capsule · oral	ACTAVIS LABS FL INC	Discontinued	14 May 2021
ENZALUTAMIDE	40MG	capsule · oral	APOTEX	Discontinued	22 Apr 2022
ENZALUTAMIDE	40MG	capsule · oral	ZYDUS PHARMS	Discontinued	26 Sep 2024

EMA European Union — centrally authorised medicines

Enzalutamide Accordpharma Accord Healthcare · Authorised · ATC L02BB04

Therapeutic indication (EMA)

Treatment of prostate cancer.

Xtandi Astellas Pharma Europe B.V. · Authorised · authorised 21 Jun 2013 · ATC L02BB04

Therapeutic indication (EMA)

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.

Enzalutamide Viatris Viatris Limited · Authorised · authorised 22 Aug 2024 · ATC L02BB04

Therapeutic indication (EMA)

Enzalutamide Viatris is indicated:• 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);• in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1); • for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1);• for 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);• for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-ENZALUTAMIDE	02562677	40 MG	CAPSULE · ORAL	APOTEX INC
AURO-ENZALUTAMIDE	02494736	40 MG	CAPSULE · ORAL	AURO PHARMA INC
JAMP ENZALUTAMIDE	02515229	40 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
REDDY-ENZALUTAMIDE	02558424	40 MG	CAPSULE · ORAL	DR REDDY'S LABORATORIES LTD
XTANDI	02407329	40 MG	CAPSULE · ORAL	ASTELLAS PHARMA CANADA INC

WHO WHO Model List of Essential Medicines (2025)

8.2.4. Hormones and antihormones · complementary
Therapeutic equivalent to abiraterone for Malignant neoplasms of prostate

Safety signals and safety-related labeling changes

US FDA 24 Jul 2026 XTANDI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 24 Jul 2026 XTANDI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 5 Jun 2025 PRAC signal: Laboratory test interference leading to falsely elevated digoxin plasma levels with enzalutamide
Action for MAH: update of the product information: Yes
EMA PRAC 16 Jan 2025 PRAC signal: Laboratory test interference leading to falsely elevated digoxin plasma levels with enzalutamide
Action for MAH: update of the product information: No
EMA PRAC 10 Feb 2022 PRAC signal: Erythema multiforme
Action for MAH: update of the product information: Yes
EMA PRAC 30 Sep 2021 PRAC signal: Erythema multiforme
Action for MAH: update of the product information: No
EMA PRAC 6 Jul 2017 PRAC signal: Hepatotoxicity
Action for MAH: update of the product information: No
EMA PRAC 9 Mar 2017 PRAC signal: Hepatotoxicity
Action for MAH: update of the product information: No
EMA PRAC 27 Oct 2016 PRAC signal: Hepatotoxicity
Action for MAH: update of the product information: No
EMA PRAC 13 Jun 2014 PRAC signal: Myalgia
Action for MAH: update of the product information: Yes
EMA PRAC 6 Feb 2014 PRAC signal: Myalgia
Action for MAH: update of the product information: No

All safety entries for enzalutamide →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.