Is Brexpiprazole registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 17 valid registrations of Brexpiprazole, including Debrex (2 mg, Film-coated tablet, SAR 320.05); Debrex (0.5 mg, Film-coated tablet, SAR 47.15); Debrex (1 mg, Film-coated tablet, SAR 320.05); Debrex (4 mg, Film-coated tablet, SAR 320.05); Debrex (3 mg, Film-coated tablet, SAR 320.05).

Is Brexpiprazole approved by the US FDA?

Drugs@FDA lists 13 application product lines for Brexpiprazole, including REXULTI (Prescription); BREXPIPRAZOLE (Prescription); BREXPIPRAZOLE (Discontinued); BREXPIPRAZOLE (Discontinued); BREXPIPRAZOLE (Discontinued).

Is Brexpiprazole authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Brexpiprazole: Rxulti.

Are there safety signals or safety updates for Brexpiprazole?

US FDA: 1 entry (latest 2026-04-30).

Active substance

Brexpiprazole

SFDA 17
US FDA 13
EMA 1
Health Canada 6
US price lines 6
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Debrex	2 mg	Film-coated tablet · Oral use	30 Blister	SAR 320.05	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Debrex	0.5 mg	Film-coated tablet · Oral use	10 Blister	SAR 47.15	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Debrex	1 mg	Film-coated tablet · Oral use	30 Blister	SAR 320.05	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Debrex	4 mg	Film-coated tablet · Oral use	30 Blister	SAR 320.05	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Debrex	3 mg	Film-coated tablet · Oral use	30 Blister	SAR 320.05	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
REXULTI 0.25 mg Tablet	0.25 mg	Tablet · Oral use	28 Blister	SAR 86.20	NCE · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
REXULTI 0.5 mg Tablet	0.5 mg	Tablet · Oral use	28 Blister	SAR 141.40	NCE · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
REXULTI 1 mg Tablet	1 mg	Tablet · Oral use	28 Blister	SAR 405.35	NCE · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
REXULTI 2 mg Tablet	2 mg	Tablet · Oral use	28 Blister	SAR 405.35	NCE · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
REXULTI 3 mg Tablet	3 mg	Tablet · Oral use	28 Blister	SAR 405.35	NCE · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
REXULTI 4 mg Tablet	4 mg	Tablet · Oral use	28 Blister	SAR 405.35	NCE · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
Zolabri	3 mg	Film-coated tablet · Oral use	30 Blister	SAR 308.60	Generic · Prescription	Saudi Amarox	Valid
Zolabri	2 mg	Film-coated tablet · Oral use	30 Blister	SAR 308.60	Generic · Prescription	Saudi Amarox	Valid
Zolabri	1 mg	Film-coated tablet · Oral use	30 Blister	SAR 308.60	Generic · Prescription	Saudi Amarox	Valid
Zolabri	0.5 mg	Film-coated tablet · Oral use	30 Blister	SAR 136.35	Generic · Prescription	Saudi Amarox	Valid
Zolabri	0.25 mg	Film-coated tablet · Oral use	30 Blister	SAR 83.10	Generic · Prescription	Saudi Amarox	Valid
Zolabri	4 mg	Film-coated tablet · Oral use	30 Blister	SAR 83.10	Generic · Prescription	Saudi Amarox	Valid

Indications — CHI Daman Drug Formulary

ALZHEIMER / DEMENTIA; DEPRESSION; SCHIZOPHRENIA

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

Product	Strength	Form · route	Applicant	Status	First approved
REXULTI	0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG	tablet · oral	OTSUKA	Prescription	10 Jul 2015
BREXPIPRAZOLE	0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG	tablet · oral	ALEMBIC	Prescription	13 Jan 2025
BREXPIPRAZOLE	0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG	tablet · oral	TEVA PHARMS USA INC	Discontinued	11 Aug 2022
BREXPIPRAZOLE	0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG	tablet · oral	SANDOZ	Discontinued	26 Sep 2022
BREXPIPRAZOLE	0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG	tablet · oral	ZYDUS PHARMS	Discontinued	10 Jan 2023
BREXPIPRAZOLE	0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG	tablet · oral	AMNEAL	Discontinued	31 Jan 2023
BREXPIPRAZOLE	0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG	tablet · oral	AJANTA PHARMA LTD	Discontinued	3 Feb 2023
BREXPIPRAZOLE	0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG	tablet · oral	LUPIN	Discontinued	18 Mar 2023
BREXPIPRAZOLE	0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG	tablet · oral	CHARTWELL RX	Discontinued	25 Oct 2023
BREXPIPRAZOLE	0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG	tablet · oral	AUROBINDO PHARMA LTD	Discontinued	2 Nov 2023
BREXPIPRAZOLE	0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG	tablet · oral	HETERO LABS LTD V	Discontinued	20 Nov 2023
BREXPIPRAZOLE	0.25MG; 0.5MG; 1MG; 2MG; 3MG; 4MG	tablet · oral	ALKEM LABS LTD	Discontinued	28 Nov 2023
BREXPIPRAZOLE	0.25MG; 0.5MG; 1MG; 2MG; 3MG	tablet · oral	APOTEX	Discontinued	24 Feb 2025

EMA European Union — centrally authorised medicines

Rxulti Otsuka Pharmaceutical Netherlands B.V. · Authorised · authorised 26 Jul 2018 · ATC N05AX16

Therapeutic indication (EMA)

Rxulti is indicated for the treatment of schizophrenia in adult and adolescents aged 13 years and older.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
REXULTI	02461749	0.25 MG	TABLET · ORAL	OTSUKA PHARMACEUTICAL CO LTD
REXULTI	02461757	0.5 MG	TABLET · ORAL	OTSUKA PHARMACEUTICAL CO LTD
REXULTI	02461765	1 MG	TABLET · ORAL	OTSUKA PHARMACEUTICAL CO LTD
REXULTI	02461773	2 MG	TABLET · ORAL	OTSUKA PHARMACEUTICAL CO LTD
REXULTI	02461781	3 MG	TABLET · ORAL	OTSUKA PHARMACEUTICAL CO LTD
REXULTI	02461803	4 MG	TABLET · ORAL	OTSUKA PHARMACEUTICAL CO LTD

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	REXULTI 0.25 MG TABLET	$49.49708	per EA	23 Sep 2026
US NADAC	REXULTI 0.5 MG TABLET	$49.48616	per EA	23 Sep 2026
US NADAC	REXULTI 1 MG TABLET	$49.55969	per EA	23 Sep 2026
US NADAC	REXULTI 2 MG TABLET	$49.52525	per EA	23 Sep 2026
US NADAC	REXULTI 3 MG TABLET	$49.50907	per EA	23 Sep 2026
US NADAC	REXULTI 4 MG TABLET	$49.46742	per EA	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 30 Apr 2026 REXULTI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for brexpiprazole →

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.