Capivasertib

Overview

Capivasertib has been investigated for the treatment of Metastatic Breast Cancer.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Rosuvastatin in Healthy Participants	2025/07/28	NCT07088913	Not Applicable	Not yet recruiting	AstraZeneca
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer	2025/05/21	NCT06982521	Phase 3	Recruiting	Relay Therapeutics, Inc.
A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain	2025/01/08	NCT06764186	Phase 3	Recruiting	AstraZeneca
Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients	2024/10/10	NCT06635447	Phase 3	Recruiting	AstraZeneca
Effect of Capivasertib on ctDNA in ER Positive Breast Cancer	2024/09/26	NCT06613516	Phase 2	Not yet recruiting	Imperial College London
Capivasertib Plus Fulvestrant vs. Fulvestrant in Primary High-risk Lobular Breast Cancer	2024/09/23	NCT06607757	Phase 2	Recruiting	GBG Forschungs GmbH
Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC	2023/02/09	NCT05720260	Phase 2	Recruiting	National Taiwan University Hospital
A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss	2022/10/25	NCT05593497	Phase 2	Recruiting	VA Office of Research and Development
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer	2022/10/03	NCT05563220	Phase 1	Recruiting	Stemline Therapeutics, Inc.
A Study to Investigate the Absolute Bioavailability, Absorption, Metabolism, Distribution and Excretion of [14C]AZD5363 (Capivasertib)	2022/06/15	NCT05419401	Phase 1	Completed	AstraZeneca

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
TRUQAP	AstraZeneca Pharmaceuticals LP	0310-9500	ORAL	160 mg in 1 1	11/16/2023
TRUQAP	AstraZeneca Pharmaceuticals LP	0310-9501	ORAL	200 mg in 1 1	11/16/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Truqap	AstraZeneca AB,151 85 Sodertalje,Sweden	Authorised	6/17/2024
Truqap	AstraZeneca AB,151 85 Sodertalje,Sweden	Authorised	6/17/2024

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
TRUQAP FILM-COATED TABLETS 200MG	AstraZeneca AB	SIN17111P	TABLET, FILM COATED	200mg	10/14/2024
TRUQAP FILM-COATED TABLETS 160MG	AstraZeneca AB	SIN17112P	TABLET, FILM COATED	160mg	10/14/2024

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
TRUQAP TABLETS 160MG	N/A	ASTRAZENECA HONG KONG LIMITED	N/A	N/A	12/16/2024
TRUQAP TABLETS 200MG	N/A	ASTRAZENECA HONG KONG LIMITED	N/A	N/A	12/16/2024

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
TRUQAP capivasertib 160 mg film coated tablet blister pack	407961	AstraZeneca Pty Ltd	Medicine	A	5/9/2024
TRUQAP capivasertib 200 mg film coated tablet blister pack	407960	AstraZeneca Pty Ltd	Medicine	A	5/9/2024

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
TRUQAP	astrazeneca canada inc	02544741	Tablet - Oral	200 MG	4/1/2024
TRUQAP	astrazeneca canada inc	02544733	Tablet - Oral	160 MG	4/16/2024

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
TRUQAP 160 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Astrazeneca Ab	1241820001	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Not Commercialized
TRUQAP 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Astrazeneca Ab	1241820002	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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3 months ago

RLY-2608, a mutant-selective PI3Kα inhibitor, combined with fulvestrant achieved a 38.7% overall response rate and 10.3-month median progression-free survival in patients with PIK3CA-mutant HR+/HER2- advanced breast cancer.

NICE Approves Capivasertib-Fulvestrant Combination for Advanced Breast Cancer Treatment

4 months ago

NICE has issued guidance approving capivasertib in combination with fulvestrant for treating hormone receptor-positive HER2-negative advanced breast cancer after endocrine treatment.

AstraZeneca Discontinues Phase 3 Trial of Truqap for Metastatic Prostate Cancer