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.

openfdaRegulatory3 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2026-06-12 (see label)	approved	Jun 12, 2026	openfda
US FDA	Malignant Breast Neoplasm	HR positive, HER2 negative locally advanced or metastatic breast cancer • in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alterations as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.	approved	Nov 16, 2023	openfda
US FDA	Malignant Prostate Neoplasm	PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer • in combination with abiraterone and prednisone for the treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test.	approved	Nov 16, 2023	openfda

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 14 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 51–55 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
NCT03182634	The UK Plasma Based Molecular Profiling of Advanced Breast Cancer to Inform Therapeutic CHoices (plasmaMATCH) Trial(plasmaMATCH)	unknown	Phase 2	1,150	Institute of Cancer Research, United KingdomOTHER	1	Jan 22, 2019	clinicaltrials
NCT02525068	A Study of Enzalutamide in Combination With AZD5363 in Patients With mCRPC

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 17 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