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.
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
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Start date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
Trade Name
FDA
EMA
Daurismo
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| daurismo | New Drug Application | 2023-11-02 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| myeloid leukemia acute | — | D015470 | C92.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
GLASDEGIB MALEATE, DAURISMO, PFIZER | |||
| 2025-11-21 | ODE-224 | ||
HCPCS
No data
Clinical
Clinical Trials
30 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | — | C92.0 | 4 | 6 | 4 | — | 1 | 14 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | 1 | 1 | — | — | 3 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 1 | 1 | 1 | — | — | 3 |
| Sarcoma | D012509 | — | — | — | — | 1 | — | — | 1 |
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 Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 6 | — | — | — | — | 6 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | 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 | — |
| 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
Protein synonyms
frizzled family member 11, Protein Gx, seven transmembrane helix receptor, smoothened homolog, smoothened, frizzled family receptor, smoothened, seven transmembrane spanning receptor
Uniprot ID
Mouse ortholog
Smo (319757)
protein smoothened (P56726)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 674 documents
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Safety
Black-box Warning
Black-box warning for: Daurismo
Adverse Events
Top Adverse Reactions
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431 adverse events reported
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