Truqap

(Capivasertib)

ApprovedSmall molecule

Truqap is a small molecule that works as a Serine/threonine-Protein Kinase AKT Inhibitor.[2] It is being used across 28 indications, with its most advanced program in Approved.[1]

Truqap is one of 466 small molecule programs targeting Breast Cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

465

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Breast CancerActive, not recruiting

Neoplasm of Mature B-CellsApproved

Lymphoid NeoplasmApproved

Triple-Negative Breast CancerApproved

Prostate AdenocarcinomaApproved

Cervical CancerApproved

Breast NeoplasmActive, not recruiting

Advanced LymphomaActive, not recruiting

Intracranial MeningiomaRecruiting

Endometrial AdenocarcinomaActive, not recruiting

Breast CancerPhase 3

Active, not recruiting

Neoplasm of Mature B-CellsApproved

Approved

Lymphoid NeoplasmApproved

Approved

Triple-Negative Breast CancerApproved

Approved

Prostate AdenocarcinomaApproved

Approved

Cervical CancerApproved

Approved

Breast NeoplasmApproved

Active, not recruiting

Advanced LymphomaPhase 2

Active, not recruiting

Intracranial MeningiomaPhase 2

Recruiting

Endometrial AdenocarcinomaPhase 2

Active, not recruiting

Showing 10 of 28 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Truqap

AstraZeneca

Approved

6 2

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

1 3

Tianeptine

Pfizer

Preclinical

1 4

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

1 5

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 6

Bisphosphonate

Amgen

Preclinical

2 7

Perflutren Lipid Microsphere

IImaRx Therapeutics

Preclinical

1 8

Ibrance

Pfizer

Preclinical

1 9

QBX258

Novartis

Preclinical

1 10

Fluorothymidine F-18

MM.D. Anderson Cancer Center

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Moderate Hepatic Impairment

NCT07343960

Phase 2Active, not recruiting

Advanced Lymphoma

NCT02465060

Q1 2027

Phase 3Active, not recruiting

Breast Cancer

NCT06635447

Phase 2Recruiting

Hormone Therapy

NCT05720260

PreclinicalActive, not recruiting

Triple Negative Breast Neoplasms

NCT03742102

Phase 3Active, not recruiting

Hormone Sensitive Prostate Cancer

NCT04493853

Clinical

Trials by Indication[1]

Breast Cancer6 trials

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

Recruiting·SStemline Therapeutics, Inc.·Phase 1/2·NCT05563220·435 enrolled

Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04305496·818 enrolled

Capivasertib Plus Fulvestrant vs. Fulvestrant in Primary High-risk Lobular Breast Cancer

Recruiting·GGBG Forschungs GmbH·Phase 2·NCT06607757·120 enrolled

Show 3 more trials

Effect of Capivasertib on ctDNA in ER Positive Breast Cancer

Withdrawn·IImperial College London·Phase 2·NCT06613516

A Phase IIIb Single Arm, 2 Cohorts Study Assessing the Efficacy and Safety of Capivasertib+ Fulvestrant as Treatment for Locally Advanced(Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With Endocrine Therapy in Chinese Patients

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06635447·293 enrolled

An Interventional, Open-label, Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment

Recruiting·WWest German Study Group·Phase 3·NCT07281833·250 enrolled

Prostate Cancer2 trials

Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05348577·1,035 enrolled

Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer

Recruiting·UUniversity of British Columbia·Phase 2·NCT04812366·315 enrolled

Absorption2 trials

A Study to Investigate the Absolute Bioavailability, Absorption, Metabolism, Distribution and Excretion of [14C]AZD5363 (Capivasertib)

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT05419401·7 enrolled

Study to Assess the Effect of Food and Acid Reducing Agents on the Absorption of Capivasertib in Healthy Participants

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04944771·48 enrolled

Locally Advanced1 trial

Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT03997123·923 enrolled

Metastatic Prostate Cancer1 trial

A Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of Capivasertib (AZD5363) in Combination With Novel Agents in Patients With Metastatic Prostate Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04087174·27 enrolled

27 more indications

Hormone Therapy1 trial

Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC

Recruiting·NNational Taiwan University Hospital·Phase 2·NCT05720260·42 enrolled

Statin1 trial

A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Rosuvastatin in Healthy Participants

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT07088913·20 enrolled

Hematological Malignancies1 trial

HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological Malignancies

Not yet recruiting·PPrincess Maxima Center for Pediatric Oncology·Phase 1/2·NCT07175415·42 enrolled

Phase 21 trial

AMTEC IIT: Phase 2 Multiarm Study in TNBC

Terminated·—·Phase 2·NCT03801369·24 enrolled

Advanced Solid Tumors1 trial

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT05039801·54 enrolled

Treatment1 trial

Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04439123·35 enrolled

ESS1 trial

A Study to Assess How Itraconazole Affects the Uptake and Elimination of Capivasertib in the Body

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04712396·11 enrolled

Advanced Solid Tumours1 trial

A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04958226·21 enrolled

Chemotherapy1 trial

CApivasertib, Venetoclax And Low-intensity chemotheRapY for Adults With ALL/LBL

Recruiting·UUniversity of Chicago·Phase 1/2·NCT07294677·104 enrolled

Lymphoma1 trial

Study of Capivasertib in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT05008055·30 enrolled

Hormone Sensitive Prostate Cancer1 trial

A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib+Abiraterone Versus Placebo+Abiraterone as Treatment for Patients With DeNovo Metastatic Hormone-Sensitive Prostate Cancer Characterised by PTEN Deficiency.

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04493853·1,012 enrolled

Moderate Hepatic Impairment1 trial

A Phase I, Single-dose, Non-randomized, Open-label, Parallel Group Study to Assess the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment

Recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT07343960·20 enrolled

Melanoma (Skin Cancer)1 trial

A Phase 1b/2 Trial Investigating the Safety and Efficacy of Oral AMXT 1501 and Oral DFMO in Combination With Standard of Care in Patients With Advanced Solid Tumors Who Progressed After Prior Therapies

Recruiting·AAminex Therapeutics, Inc.·Preclinical·NCT07287917·92 enrolled

BRCA1 Mutation Carrier1 trial

A Phase Ib Study of the Oral PARP Inhibitor Olaparib With the Oral mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial, Triple Negative Breast, and Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT02208375·159 enrolled

PIK3CA Mutation1 trial

A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment With a CDK4/6 Inhibitor

Recruiting· Relay Therapeutics logo

Relay Therapeutics·Phase 3·NCT06982521·540 enrolled

Intracranial Meningioma1 trial

Phase II Trial of SMO/ AKT/ NF2/CDK Inhibitors in Progressive Meningiomas With SMO/ AKT/ NF2/CDK Pathway Mutations

Recruiting·AAlliance for Clinical Trials in Oncology·Phase 2·NCT02523014·124 enrolled

Endometrial Adenocarcinoma1 trial

A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combinations of Cediranib/Olaparib, Olaparib/Durvalumab (MEDI4736), Cediranib/Durvalumab (MEDI4736), Olaparib/AZD5363 (Capivasertib) in Women With Recurrent, Persistent or Metastatic Endometrial Cancer. A Multi-Arm Trial for Women With Recurrent or Persistent Endometrial Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03660826·288 enrolled

Advanced Lymphoma1 trial

Molecular Analysis for Therapy Choice (MATCH)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02465060·6,452 enrolled

Advanced Urothelial Carcinoma1 trial

A Phase Ib/Phase II Trial With Capivasertib Plus Immunotherapy in Bladder Cancer

Not yet recruiting·VVA Office of Research and Development·Preclinical·NCT07793578·32 enrolled

High-risk Prostate Cancer1 trial

Precision Neoadjuvant Therapy for High Risk Localized Prostate Cancer With PTEN Loss

Recruiting·VVA Office of Research and Development·Phase 2·NCT05593497·30 enrolled

Locally Advanced (Inoperable) or Metastatic Breast Cancer1 trial

A Phase Ib/III, Open-label, Randomised Study of Capivasertib Plus CDK4/6 Inhibitors and Fulvestrant Versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04862663·893 enrolled

Triple Negative Breast Neoplasms1 trial

A Phase IB/II, 2-stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) + Paclitaxel and Durvalumab (MEDI4736) in Combination With Novel Oncology Therapies With or Without Paclitaxel for First-line Metastatic Triple Negative Breast Cancer

Active, not recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT03742102·243 enrolled

Metastatic Breast Cancer1 trial

A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With Metastatic HER2-low Breast Cancer (DESTINY-Breast08)

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 1·NCT04556773·138 enrolled

Metastatic HR+/HER2- Breast Cancer1 trial

A Phase II Trial to Improve Safety of Capivasertib for HR+/HER2- Metastatic Breast Cancer

Recruiting·MMaryam Lustberg·Phase 2·NCT07426822·108 enrolled

Pediatric Cancer1 trial

European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

Recruiting·GGustave Roussy, Cancer Campus, Grand Paris·Preclinical·NCT02813135·472 enrolled

Locally Advanced or Metastatic Breast Cancer1 trial

A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With HR+ / HER2- Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06764186·101 enrolled

Unspecified2 trials

Capivasertib China PK Study

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04742036·16 enrolled

An Open-label, Fixed-sequence Study to Assess the Effect of Capivasertib on the Pharmacokinetics of Oral Dextromethorphan (CYP2D6 Substrate) in Healthy Participants.

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT07241065·42 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 16, 2023

TRUQAP

NDA NDA218197

Sources

References

[1]
ClinicalTrials.gov — 40 trial records for Capivasertib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Capivasertib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Capivasertib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA218197). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Truqap. U.S. Food & Drug Administration.
[6]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serine/threonine-Protein Kinase AKT Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AstraZeneca

Patent Landscape[5]

Patent Cliff

Oct 9, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9492453Oct 9, 2028

11236095Oct 9, 2028

11760760Oct 10, 2028

10059714Oct 10, 2028

12252495Oct 10, 2028

4 more patents

10654855Oct 10, 2028

8101623Mar 10, 2030

9487525Apr 16, 2033

10039766Apr 16, 2033

Truqap

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Breast Cancer6 trials

Prostate Cancer2 trials

Absorption2 trials

Locally Advanced1 trial

Metastatic Prostate Cancer1 trial

Hormone Therapy1 trial

Statin1 trial

Hematological Malignancies1 trial

Phase 21 trial

Advanced Solid Tumors1 trial

Treatment1 trial

ESS1 trial

Advanced Solid Tumours1 trial

Chemotherapy1 trial

Lymphoma1 trial

Hormone Sensitive Prostate Cancer1 trial

Moderate Hepatic Impairment1 trial

Melanoma (Skin Cancer)1 trial

BRCA1 Mutation Carrier1 trial

PIK3CA Mutation1 trial

Intracranial Meningioma1 trial

Endometrial Adenocarcinoma1 trial

Advanced Lymphoma1 trial

Advanced Urothelial Carcinoma1 trial

High-risk Prostate Cancer1 trial

Locally Advanced (Inoperable) or Metastatic Breast Cancer1 trial

Triple Negative Breast Neoplasms1 trial

Metastatic Breast Cancer1 trial

Metastatic HR+/HER2- Breast Cancer1 trial

Pediatric Cancer1 trial

Locally Advanced or Metastatic Breast Cancer1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Related News