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Gedatolisib
Gedatolisib is a small molecule pharmaceutical. It is currently being investigated in clinical studies. The pharmaceutical is active against serine/threonine-protein kinase mTOR and phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
No data
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
19 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_0003869C50521—18
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD01517912———2
Non-small-cell lung carcinomaD00228921———2
Endometrial neoplasmsD016889EFO_000423011———2
Triple negative breast neoplasmsD06472621———2
Myelodysplastic syndromesD009190D46—1———1
Myeloid leukemia acuteD015470C92.0—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C804————4
Head and neck neoplasmsD0062582————2
Pancreatic neoplasmsD010190EFO_0003860C251————1
Squamous cell neoplasmsD0183071————1
Ovarian neoplasmsD010051EFO_0003893C561————1
Small cell lung carcinomaD0557521————1
Healthy volunteers/patients—1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGEDATOLISIB
INNgedatolisib
Description
Gedatolisib (PF-05212384) is an experimental drug for treatment of cancer in development by Celcuity, Inc. The mechanism of action is accomplished by binding the different p110 catalytic subunit isoforms of  PI3K and the kinase site of mTOR.
Classification
Small molecule
Drug classphosphatidylinositol 3-kinase (PI3K) inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CN(C)C1CCN(C(=O)c2ccc(NC(=O)Nc3ccc(-c4nc(N5CCOCC5)nc(N5CCOCC5)n4)cc3)cc2)CC1
Identifiers
PDB—
CAS-ID1197160-78-3
RxCUI—
ChEMBL IDCHEMBL592445
ChEBI ID—
PubChem CID44516953
DrugBankDB11896
UNII ID96265TNH2R (ChemIDplus, GSRS)
Target
Agency Approved
MTOR
MTOR
PIK3CA
PIK3CA
Organism
Homo sapiens
Gene name
MTOR
Gene synonyms
FRAP, FRAP1, FRAP2, RAFT1, RAPT1
NCBI Gene ID
2475
Protein name
serine/threonine-protein kinase mTOR
Protein synonyms
FK506 binding protein 12-rapamycin associated protein 2, FK506-binding protein 12-rapamycin complex-associated protein 1, FKBP-rapamycin associated protein, FKBP12-rapamycin complex-associated protein, FKBP12-rapamycin complex-associated protein 1, Mammalian target of rapamycin, Mechanistic target of rapamycin, mechanistic target of rapamycin (serine/threonine kinase), mTOR, Rapamycin and FKBP12 target 1, rapamycin associated protein FRAP2, Rapamycin target protein 1
Uniprot ID
Q9Y4I3
Mouse ortholog
Mtor (56717)
serine/threonine-protein kinase mTOR (Q9JLN9)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 340 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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5 adverse events reported
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