Is Capivasertib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Capivasertib, including Truqap (200 mg, Film-coated tablet, SAR 28902.65); Truqap (160 mg, Film-coated tablet, SAR 28902.65).

Is Capivasertib approved by the US FDA?

Drugs@FDA lists 1 application product line for Capivasertib, including TRUQAP (Prescription).

Is Capivasertib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Capivasertib: Truqap.

Are there safety signals or safety updates for Capivasertib?

US FDA: 1 entry (latest 2026-06-12).

Active substance

Capivasertib

SFDA 2
US FDA 1
EMA 1
Health Canada 2
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
Truqap	200 mg	Film-coated tablet · Oral use	64 Blister	SAR 28902.65	NCE · Prescription	AstraZeneca UK Limited	Valid
Truqap	160 mg	Film-coated tablet · Oral use	64 Blister	SAR 28902.65	NCE · Prescription	AstraZeneca UK Limited	Valid

Indications — CHI Daman Drug Formulary

BREAST CANCER MET.HORMONAL

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

Product	Strength	Form · route	Applicant	Status	First approved
TRUQAP	160MG; 200MG	tablet · oral	ASTRAZENECA	Prescription	16 Nov 2023

EMA European Union — centrally authorised medicines

Truqap AstraZeneca AB · Authorised · authorised 17 Jun 2024 · ATC L01EX27

Therapeutic indication (EMA)

Truqap is indicated in combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. In pre- or perimenopausal women, Truqap plus fulvestrant should be combined with a luteinising hormone releasing hormone (LHRH) agonist. For men, administration of LHRH agonist according to current clinical practice standards should be considered.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TRUQAP	02544733	160 MG	TABLET · ORAL	ASTRAZENECA CANADA INC
TRUQAP	02544741	200 MG	TABLET · ORAL	ASTRAZENECA CANADA INC

Safety signals and safety-related labeling changes

US FDA 12 Jun 2026 TRUQAP — 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 capivasertib →

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.