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Drug ReportsCapivasertib
Capivasertib
Truqap (capivasertib) is a small molecule pharmaceutical. Capivasertib was first approved as Truqap on 2023-11-16. The pharmaceutical is active against RAC-beta serine/threonine-protein kinase, RAC-gamma serine/threonine-protein kinase, and RAC-alpha serine/threonine-protein kinase.
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FDA approval date
EMA approval date
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Study first post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Truqap
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Capivasertib
Tradename
Company
Number
Date
Products
TRUQAPAstraZenecaN-218197 RX2023-11-16
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
truqapNew Drug Application2023-11-16
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
CAPIVASERTIB, TRUQAP, ASTRAZENECA
2028-11-16NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Capivasertib, Truqap, Astrazeneca
94875252033-04-16DS, DP
100397662033-04-16U-3762
81016232030-03-10DS, DPU-3762
100597142028-10-10DS, DP
106548552028-10-10U-3762
117607602028-10-10U-3762
88093362025-10-25U-3762
90064302025-10-25DP
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
46 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C508112——17
Prostatic neoplasmsD011471—C61341——7
Triple negative breast neoplasmsD064726——231——4
Castration-resistant prostatic neoplasmsD064129————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C8041———5
Ovarian neoplasmsD010051EFO_0003893C5632———4
Endometrial neoplasmsD016889EFO_0004230—21———3
Non-small-cell lung carcinomaD002289———2———2
AdenocarcinomaD000230———2———2
Stomach neoplasmsD013274EFO_0003897C16—2———2
Multiple myelomaD009101—C90.0—2———2
LymphomaD008223—C85.9—2———2
MelanomaD008545——11———2
Uterine cervical neoplasmsD002583HP_0030159—11———2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———5————5
PharmacokineticsD010599——2————2
Hematologic neoplasmsD019337——1————1
Squamous cell carcinoma of head and neckD000077195——1————1
ChondrosarcomaD002813——1————1
Acinar cell carcinomaD018267——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCapivasertib
INNcapivasertib
Description
Capivasertib is an aminopiperidine that is piperidine substituted by 7H-pyrrolo[2,3-d]pyrimidin-4-yl, amino, and [(1S)-1-(4-chlorophenyl)-3-hydroxypropyl]aminocarbonyl groups at positions 1, 4, and 4, respectively. It is a pan-AKT kinase inhibitor used 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. It has a role as an antineoplastic agent and an EC 2.7.11.1 (non-specific serine/threonine protein kinase) inhibitor. It is a pyrrolopyrimidine, an aminopiperidine, a piperidinecarboxamide, a member of monochlorobenzenes, a primary alcohol and a secondary carboxamide.
Classification
Small molecule
Drug classserine/threonine kinase inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
NC1(C(=O)N[C@@H](CCO)c2ccc(Cl)cc2)CCN(c2nc[nH]c3nccc2-3)CC1
Identifiers
PDB—
CAS-ID1143532-39-1
RxCUI—
ChEMBL IDCHEMBL2325741
ChEBI ID—
PubChem CID25227436
DrugBankDB12218
UNII IDWFR23M21IE (ChemIDplus, GSRS)
Target
Agency Approved
AKT2
AKT2
AKT3
AKT3
AKT1
AKT1
Organism
Homo sapiens
Gene name
AKT2
Gene synonyms
NCBI Gene ID
Protein name
RAC-beta serine/threonine-protein kinase
Protein synonyms
murine thymoma viral (v-akt) homolog-2, PKB beta, Protein kinase Akt-2, Protein kinase B beta, putative v-akt murine thymoma viral oncoprotein 2, rac protein kinase beta, RAC-PK-beta, v-akt murine thymoma viral oncogene homolog 2
Uniprot ID
Mouse ortholog
Akt2 (11652)
RAC-beta serine/threonine-protein kinase (Q60823)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Truqap – AstraZeneca
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,736 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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26 adverse events reported
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