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Daurismo(glasdegib)
Daurismo (glasdegib) is a small molecule pharmaceutical. Glasdegib was first approved as Daurismo on 2018-11-21. It is used to treat myeloid leukemia acute in the USA. It has been approved in Europe to treat myeloid leukemia acute. The pharmaceutical is active against protein smoothened; smoothened homolog.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
Trade Name
FDA
EMA
Daurismo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Glasdegib maleate
Tradename
Company
Number
Date
Products
DAURISMOMylanN-210656 RX2018-11-21
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
daurismoNew Drug Application2020-08-12
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myeloid leukemia acute—D015470C92.0
Agency Specific
FDA
EMA
Expiration
Code
GLASDEGIB MALEATE, DAURISMO, PFIZER
2025-11-21ODE-224
2023-11-21NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Glasdegib Maleate, Daurismo, Pfizer
104147482036-04-13DS, DP
111680662036-04-13U-3254
81484012031-01-30DS, DP
84315972028-06-29DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XJ: Hedgehog pathway inhibitors
— L01XJ03: Glasdegib
HCPCS
No data
Clinical
Clinical Trials
30 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
Myeloid leukemia acuteD015470C92.0464—114
Myelodysplastic syndromesD009190D46111——3
Myelomonocytic leukemia chronicD015477C93.1111——3
SarcomaD012509——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FasciitisD005208HP_0100537M72.911———1
GlioblastomaD005909EFO_000051511———1
Primary myelofibrosisD055728D47.4—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—6————6
Hepatic insufficiencyD0485501————1
Renal insufficiencyD051437HP_0000083N191————1
NeoplasmsD009369C801————1
Hematologic neoplasmsD0193371————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGLASDEGIB
INNglasdegib
Description
Glasdegib is a member of the class of benzimidazoles that is 1H-benzimidazole which is substituted by a (2R,4S)-4-{[(4-cyanophenyl)carbamoyl]amino}-1-methylpiperidin-2-yl group at position 2. It is a hedgehog signalling pathway inhibitor that acts by binding to Smoothened (SMO) receptors and blocking signal transduction (IC50 = 5 nM). It is used in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients (aged >= 75 years), or who have medical conditions that prevent the use of standard chemotherapy. It has a role as a SMO receptor antagonist, a Hedgehog signaling pathway inhibitor and an antineoplastic agent. It is a member of benzimidazoles, a member of piperidines, a member of phenylureas and a nitrile.
Classification
Small molecule
Drug classhedgehog signaling inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CN1CC[C@@H](NC(=O)Nc2ccc(C#N)cc2)C[C@@H]1c1nc2ccccc2[nH]1
Identifiers
PDB—
CAS-ID1095173-27-5
RxCUI2105845
ChEMBL IDCHEMBL2043437
ChEBI ID—
PubChem CID25166913
DrugBankDB11978
UNII IDK673DMO5H9 (ChemIDplus, GSRS)
Target
Agency Approved
SMO
SMO
Organism
Homo sapiens
Gene name
SMO
Gene synonyms
SMOH
NCBI Gene ID
Protein name
protein smoothened; smoothened homolog
Protein synonyms
frizzled family member 11, Protein Gx, seven transmembrane helix receptor, smoothened, frizzled family receptor, smoothened, seven transmembrane spanning receptor
Uniprot ID
Mouse ortholog
Smo (319757)
protein smoothened; smoothened homolog (P56726)
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 573 documents
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Safety
Black-box Warning
Black-box warning for: Daurismo
Adverse Events
Top Adverse Reactions
Mock data
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165 adverse events reported
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