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glasdegib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| SMO receptor antagonists | 5304 | 1095173-27-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Glasdegib is an inhibitor of the Hedgehog pathway. Glasdegib binds to and inhibits Smoothened, a transmembrane protein involved in hedgehog signal transduction.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BA (Bioavailability) | 77.12 % |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 21, 2018 | FDA | PFIZER INC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 128.35 | 55.82 | 37 | 227 | 158312 | 90469871 |
| Death | 69.69 | 55.82 | 31 | 233 | 456520 | 90171663 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 95.08 | 47.48 | 42 | 362 | 185661 | 42435270 |
| Death | 56.09 | 47.48 | 41 | 363 | 471144 | 42149787 |
| Pneumonia | 53.02 | 47.48 | 38 | 366 | 422111 | 42198820 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 215.68 | 44.86 | 79 | 638 | 316688 | 110271894 |
| Death | 107.12 | 44.86 | 62 | 655 | 698807 | 109889775 |
| Pneumonia | 52.78 | 44.86 | 44 | 673 | 876670 | 109711912 |
| Neoplasm progression | 46.57 | 44.86 | 17 | 700 | 64578 | 110524004 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01XJ03 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Hedgehog pathway inhibitors |
| FDA MoA | N0000184148 | Smoothened Receptor Antagonists |
| FDA EPC | N0000184149 | Hedgehog Pathway Inhibitor |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:66908 | SMO receptor antagonist |
| CHEBI has role | CHEBI:140921 | Hedgehog signaling pathway inhibitor |
Related Drugs by ATC class:
L01XJ Hedgehog pathway inhibitors 2 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Acute myeloid leukemia, disease | indication | 91861009 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 12.45 | acidic |
| pKa2 | 12.88 | acidic |
| pKa3 | 13.49 | acidic |
| pKa4 | 7.85 | Basic |
| pKa5 | 6.86 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 25MG BASE | DAURISMO | PFIZER | N210656 | Nov. 21, 2018 | RX | TABLET | ORAL | 11168066 | April 13, 2036 | USE, IN COMBINATION WITH LOW-DOSE CYTARABINE, FOR THE TREATMENT OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULT PATIENTS WHO ARE >= 75 YEARS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
| EQ 25MG BASE | DAURISMO | PFIZER | N210656 | Nov. 21, 2018 | RX | TABLET | ORAL | 11891372 | April 13, 2036 | USE, IN COMBINATION WITH LOW-DOSE CYTARABINE, FOR THE TREATMENT OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULT PATIENTS WHO ARE >= 75 YEARS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Smoothened homolog | GPCR | ANTAGONIST | IC50 | 8.30 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Smoothened homolog | GPCR | IC50 | 8.30 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| K673DMO5H9 | UNII |
| 4038031 | VANDF |
| C4519273 | UMLSCUI |
| CHEBI:145428 | CHEBI |
| CHEMBL2043437 | ChEMBL_ID |
| 25166913 | PUBCHEM_CID |
| DB11978 | DRUGBANK_ID |
| CHEMBL4297534 | ChEMBL_ID |
| D10636 | KEGG_DRUG |
| 9930 | INN_ID |
| C000592580 | MESH_SUPPLEMENTAL_RECORD_UI |
| 8201 | IUPHAR_LIGAND_ID |
| 782978008 | SNOMEDCT_US |
| 783019002 | SNOMEDCT_US |
| 299196 | MMSL |
| d09075 | MMSL |
| 017851 | NDDF |
| 2105845 | RXNORM |
| K673DMO5H9 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Daurismo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0298 | TABLET, FILM COATED | 25 mg | ORAL | NDA | 30 sections |
| Daurismo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0298 | TABLET, FILM COATED | 25 mg | ORAL | NDA | 30 sections |
| Daurismo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-1531 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 30 sections |
| Daurismo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-1531 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 30 sections |