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 |
|---|---|
| neoplasms | D009369 |
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 |
|---|---|---|---|---|
| DAURISMO | Mylan | N-210656 RX | 2018-11-21 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| daurismo | New Drug Application | 2020-08-12 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
GLASDEGIB MALEATE, DAURISMO, PFIZER | |||
| 2025-11-21 | ODE-224 | ||
| 2023-11-21 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
30 clinical trials
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Indications Phases 4
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fasciitis | D005208 | HP_0100537 | M72.9 | 1 | 1 | — | — | — | 1 |
| Glioblastoma | D005909 | EFO_0000515 | 1 | 1 | — | — | — | 1 | |
| Primary myelofibrosis | D055728 | D47.4 | — | 1 | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | GLASDEGIB |
| INN | glasdegib |
| 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 class | hedgehog 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-ID | 1095173-27-5 |
| RxCUI | 2105845 |
| ChEMBL ID | CHEMBL2043437 |
| ChEBI ID | — |
| PubChem CID | 25166913 |
| DrugBank | DB11978 |
| UNII ID | K673DMO5H9 (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
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165 adverse events reported
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