Drug · Small Molecule

Capivasertib

CI-DRUG-00000137Explore in graph →NCIt C102564 CHEMBL2325741 CIViC Approved

Regulatory

Approvals (6)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory6 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as TRUQAP (DIN 02544733) under ATC L01EX27 CAPIVASERTIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 16, 2024	health-canada-dpd
CA Health Canada	—	Marketed in Canada as TRUQAP (DIN 02544741) under ATC L01EX27 CAPIVASERTIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 1, 2024	health-canada-dpd
EU EMA	Malignant Breast Neoplasm	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.

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 18 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	31	13	9	55	6	CA, EU, US	Nov 16, 2023	Dec 1, 2010
Malignant Breast Neoplasm	Approved	Phase 3	11	3	4	17	2	EU, US	Nov 16, 2023	2014-01
Malignant Prostate Neoplasm	Approved	Phase 3	3	1	1	7	1	US	Nov 16, 2023	Jan 29, 2014
Malignant Uterine Corpus Neoplasm	Phase2	Phase 2	4	1	0	5

Curated evidence

Clinical evidence (42)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–42 of 42 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
PIK3CA H1047R3
Capivasertib + Lapatinib

Clinical trials

Trials with this intervention (55)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 55 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT04493853	Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency(CAPItello-281)	active not recruiting	Phase 3	1,012	AstraZenecaINDUSTRY	32	Sep 10, 2026	clinicaltrials
NCT07343960	A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment

Molecule

Record

Kind: Small Molecule
Mechanism: Serine/threonine-protein kinase AKT inhibitor
Targets: 3 genes
UNII: WFR23M21IE
Aliases: AZC5363, AZD 5363, AZD-5363, AZD5363, Capivasertib, CAPIVASERTIB (AZD5363), Truqap, TRUQAP

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (6)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EX27	CAPIVASERTIB
DIN (Health Canada)	02544733	TRUQAP
DIN (Health Canada)	02544741

PIK3CA Mutation4
Capivasertib	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Sensitivity Response	2	accepted	EID1504 HER2 overexpressing breast cancer cell lines with PIK3CA mutation BT474c (K111N) and HCC-1954 (H1047R) were used to establish mouse tumor xenografts. In BT474c xenografts, three dosing schedules of AZ… (full text at CIViC) PMID 22294718 · Davies et al., 2012 · Open in CIViC	civic
〃	Malignant Gastric Neoplasm	Predictive	D	Supports Sensitivity Response	3	accepted	EID1501 In a panel of 22 gastric cancer cell lines, 4 of 6 cell lines having the highest sensitivity to AZD5363 contained a PIK3CA mutation (E542K, E453K, E545K). A patient derived gastric cancer xenograft mo… (full text at CIViC) PMID 24088382 · Li et al., 2013 · Open in CIViC	civic
〃	Malignant NeoplasmALIAS	Predictive	B	Supports Sensitivity Response	4	accepted	EID3040 In a study of 37 patients with AKT1 (E13K) mutations, 5 patients harbored a concurrent PI3K/mTOR pathway alteration. The PFS of patients with a concurrent PI3K/mTOR pathway alteration was significantl… (full text at CIViC) PMID 28489509 · Hyman et al., 2017 · Open in CIViC	civic
〃	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	3	accepted	EID1503 Sensitivity to pan-Akt inhibitor AZD5363 was assessed in a panel of 182 cell lines (160 with PTEN evaluated) derived from solid and hematological tumors. PTEN loss of function due to loss or mutation … (full text at CIViC) PMID 22294718 · Davies et al., 2012 · Open in CIViC	civic

AKT1 E17K4
Capivasertib	Malignant Breast Neoplasm	Predictive	C	Supports Sensitivity Response	3	accepted	EID709 In a phase-I study of AZD5363, partial response was observed in 2 patients with breast and ovarian carcinoma, respectively, and AKT1 E17K mutations. While full study results have not yet been publishe… (full text at CIViC) PMID 26351323 · Davies et al., 2015 · Open in CIViC	civic
〃	Malignant NeoplasmALIAS	Predictive	B	Supports Sensitivity Response	4	accepted	EID3039 AKT1 E17K mutations are oncogenic and occur in many cancers at a low prevalence. We performed a multihistology basket study of AZD5363. 58 patients with advanced solid tumors were treated. In patients… (full text at CIViC) PMID 28489509 · Hyman et al., 2017 · Open in CIViC	civic
〃	Malignant NeoplasmALIAS	Predictive	B	Supports Sensitivity Response	4	submitted	EID9007 In a subprotocol of the NCI-MATCH Trial (EAY131-Y Nonrandomized Trial), 35 patients with AKT E17K Mutant Tumors progressive after Standard therapy received Treatment with capivasertib. Among the patie… (full text at CIViC) PMID 33377972 · Kalinsky et al., 2021 · Open in CIViC	civic
Capivasertib + FulvestrantCombination	HER2 Negative Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	3	submitted	EID12181 In a phase 3 trial (NCT04305496) of 708 patients with advanced HR+ HER2- breast cancer, the combination of the AKT inhibitor capivasertib and the estrogen receptor degrader fulvestrant resulted in sig… (full text at CIViC) PMID 37256976 · Turner et al., 2023 · Open in CIViC	civic

PTEN Loss2
Capivasertib + DocetaxelCombination	Malignant Gastric Neoplasm	Predictive	D	Supports Sensitivity Response	1	accepted	EID1500 A patient derived mouse xenograft model was established with gastric cancer cells having PTEN loss. The xenograft was resistant to monotherapy with both the pan-Akt inhibitor AZD5363, and also to the … (full text at CIViC) PMID 24088382 · Li et al., 2013 · Open in CIViC	civic
Capivasertib	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	3	accepted	EID1502 In a panel of 182 cell lines (162 with PIK3CA mutation status known) from solid and hematological tumors, significant correlation was found between AZD5363 (pan-Akt inhibitor) sensitivity and PIK3CA m… (full text at CIViC) PMID 22294718 · Davies et al., 2012 · Open in CIViC	civic

MTOR H1968Y2
Capivasertib	Melanoma	Predictive	D	Supports Sensitivity Response	3	rejected	EID721 In a cell line with expression of H1968Y or P2213S mTOR mutations, LY294002 and AZD5363 were more effective than temsirolimus or BYL719 in suppressing cell growth. PMID 26490311 · Kong et al., 2016 · Open in CIViC	civic
Capivasertib + PI3K/BET Inhibitor LY294002Substitutes	Melanoma	Predictive	D	Supports Sensitivity Response	3	accepted	EID713 In a cell line (HEK293T) with expression of H1968Y or P2213S mTOR mutations, LY294002 and AZD5363 were more effective than temsirolimus or BYL719 in suppressing cell growth. PMID 26490311 · Kong et al., 2016 · Open in CIViC	civic