Thursday, July 9, 2026

Drug profile · INN

capivasertib

capivasertib (TRUQAP) is a serine/threonine-protein kinase akt inhibitor. Associated with AstraZeneca. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L01) L01EX27
US status approved
Patents linked 1
Pipeline programs 14
News articles 4
Drug details — capivasertib

Quick answer

capivasertib (TRUQAP) is a serine/threonine-protein kinase akt inhibitor. Associated with AstraZeneca. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN capivasertib
Brand TRUQAP
Mechanism Serine/threonine-protein kinase AKT inhibitor
Target Serine/threonine-protein kinase AKT
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation TABLET
ATC code L01EX27
Originator AstraZeneca

Mechanism of action

Serine/threonine-protein kinase AKT inhibitor

Primary target: Serine/threonine-protein kinase AKT

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
NMPA clinical trials

Recent coverage

FDA Approves Capivasertib for PTEN-Deficient Prostate Cancer
High impact Newsprostate cancerJun 15, 2026

FDA Approves Capivasertib for PTEN-Deficient Prostate Cancer

FDA · prostate cancer · 6 min

FDA Approves Capivasertib for PTEN-Deficient prostate cancer, expanding TRUQAP into a new oncology setting. The approval pairs capivasertib with abiraterone and prednisone for adults with PTEN-deficient metastatic androgen pathway modulation-naive or sensitive disease.

Dr. Sarah Mitchell
FDA approves capivasertib plus abiraterone and prednisone in PTEN-deficient mHSPC
High impact Newsprostate cancerJun 14, 2026

FDA approves capivasertib plus abiraterone and prednisone in PTEN-deficient mHSPC

FDA · prostate cancer · 6 min

The FDA approved capivasertib plus abiraterone and prednisone for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive prostate cancer. The move creates a new catalyst for AstraZeneca’s Truqap and adds a biomarker-defined prostate cancer use to track.

Dr. Elena Rossi
Truqap gains US approval in PTEN-deficient metastatic prostate cancer
High impact Newsprostate cancerJun 13, 2026

Truqap gains US approval in PTEN-deficient metastatic prostate cancer

FDA · prostate cancer · 6 min

AstraZeneca’s Truqap (capivasertib) has been approved in the US with abiraterone and prednisone for PTEN-deficient metastatic prostate cancer. The move creates a first-in-class targeted option and a new catalyst to watch for BD teams, investors, and analysts.

Dr. Elena Rossi
FDA Advisory Committee Recommends AstraZeneca's TRUQAP for PTEN-Deficient Prostate Cancer
Critical impact NewsOncology - Prostate CancerMay 1, 2026

FDA Advisory Committee Recommends AstraZeneca's TRUQAP for PTEN-Deficient Prostate Cancer

FDA · Oncology - Prostate Cancer · 3 min

FDA Advisory Committee votes 7-1 to recommend AstraZeneca's TRUQAP (capivasertib) for PTEN-deficient metastatic hormone-sensitive prostate cancer patients.

James Chen, PharmD

Pipeline programs

  1. Capivasertib Phase 3 · AstraZeneca · Triple Negative Breast Neoplasms
  2. D3612L00005 Phase 3 · AstraZeneca · HR+ / HER2- advanced breast cancer
  3. D3614C00001 Phase 3 · AstraZeneca · Triple-negative Breast Cancer
  4. D3615C00001 Phase 3 · AstraZeneca · Locally advanced (inoperable) or metastatic HR+/HER2 breast
  5. D361BC00001 Phase 3 · AstraZeneca · Metastatic Hormone-sensitive Prostate Cancer Characterised b
  6. D361EC00001 Phase 3 · AstraZeneca · Metastatic Castration Resistant Prostate Cancer (mCRPC)
  7. Niraparib tosylate monohydrate + abiraterone... for Prostate Cancer Phase 3 · George Institute for · Prostate Cancer
  8. RLY-2608-102 Phase 3 · Relay Therapeutics · PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Gro

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)
  1. WO 2026109729

    COMBINAISON COMPRENANT LE CAPIVASERTIB ET L'ABIRATÉRONE POUR LE TRAITEMENT DU CANCER DE LA PROSTATE MÉTASTATIQUE SENSIBLE AUX HORMONES (MHSPC) DÉFICIENT EN PTEN

    Expires Wed May 23 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is capivasertib?

capivasertib (TRUQAP) is a serine/threonine-protein kinase akt inhibitor. Associated with AstraZeneca. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for capivasertib?

TRUQAP is a marketed brand name for capivasertib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of capivasertib?

capivasertib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.