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eliglustat 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| enzyme inhibitors | 4834 | 491833-29-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Eliglustat tartrate is a small molecule inhibitor of glucosylceramide synthase that resembles the ceramide substrate for the enzyme. Gaucher disease is caused by a deficiency of the lysosomal enzyme acid beta-glucosidase. Acid beta-glucosidase catalyzes the conversion of the sphingolipid glucocerebroside into glucose and ceramide. The enzymatic deficiency causes an accumulation of glucosylceramide (GL-1) primarily in the lysosomal compartment of macrophages, giving rise to foam cells or "Gaucher cells".
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.17 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| CL (Clearance) | 20.95 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.21 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 7.70 hours | Lombardo F, Berellini G, Obach RS |
| BA (Bioavailability) | 83 % |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 2.720 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 8.110 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 13.677 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 14.028 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 6.530 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 20.560 | % | High | 1 |
| herg | hERG pIC50 | 5.366 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 18.621 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 116.413 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 6.960 | % | High | 1 |
| kinase-safety-class | ACVR2B,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAPK10,MAPK7,MET,NTRK2,PDK2,PDK4,PIK3CA,PIK3CB,PRKDC,TEK,TGFBR1 | 25 | |||
| kinase-selectivity-class | AXL,PDK4 | 2 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 8.204 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 96.605 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 10.170 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 33.806 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 20.340 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 175.388 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 35.730 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 8.960 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 796.159 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 19, 2014 | FDA | GENZYME CORP | |
| Nov. 20, 2014 | EMA | Genzyme Europe BV |
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 |
|---|---|---|---|---|---|---|
| Product dose omission in error | 245.51 | 38.39 | 55 | 1007 | 20448 | 90606937 |
| Weight increased | 120.42 | 38.39 | 69 | 993 | 417858 | 90209527 |
| Weight decreased | 99.35 | 38.39 | 59 | 1003 | 379851 | 90247534 |
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 |
|---|---|---|---|---|---|---|
| Product dose omission in error | 282.13 | 43.49 | 55 | 585 | 8299 | 42612396 |
| Weight increased | 202.87 | 43.49 | 71 | 569 | 107912 | 42512783 |
| Weight decreased | 105.13 | 43.49 | 54 | 586 | 207894 | 42412801 |
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 |
|---|---|---|---|---|---|---|
| Product dose omission in error | 408.04 | 37.10 | 87 | 1344 | 23425 | 110564443 |
| Weight increased | 227.22 | 37.10 | 109 | 1322 | 419535 | 110168333 |
| Weight decreased | 164.23 | 37.10 | 91 | 1340 | 467966 | 110119902 |
| Product dose omission issue | 52.84 | 37.10 | 39 | 1392 | 321743 | 110266125 |
| Intentional dose omission | 50.27 | 37.10 | 16 | 1415 | 20064 | 110567804 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | A16AX10 | ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Various alimentary tract and metabolism products |
| FDA MoA | N0000020019 | Glucosylceramide Synthase Inhibitors |
| MeSH PA | D004791 | Enzyme Inhibitors |
| FDA EPC | N0000175783 | Glucosylceramide Synthase Inhibitor |
| FDA MoA | N0000182137 | Cytochrome P450 2D6 Inhibitors |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:50382 | EC 2.4.1.80 (ceramide glucosyltransferase) inhibitor |
Related Drugs by ATC class:
A16AX Various alimentary tract and metabolism products 23 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Glucosylceramide beta-glucosidase deficiency | indication | 190794006 | DOID:1926 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 13.37 | acidic |
| pKa2 | 8.14 | 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 84MG BASE | CERDELGA | GENZYME CORP | N205494 | Aug. 19, 2014 | RX | CAPSULE | ORAL | 10888547 | Jan. 31, 2031 | LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE OR INTERMEDIATE METABOLIZERS WITH 84 MG TWICE PER DAY OF ELIGLUSTAT (EQUIVALENT TO 100 MG OF ELIGLUSTAT TARTRATE TWICE PER DAY) |
| EQ 84MG BASE | CERDELGA | GENZYME CORP | N205494 | Aug. 19, 2014 | RX | CAPSULE | ORAL | 10888547 | Jan. 31, 2031 | LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 POOR METABOLIZERS WITH 84 MG ONCE DAILY OF ELIGLUSTAT (EQUIVALENT TO 100 MG OF ELIGLUSTAT TARTRATE) |
| EQ 84MG BASE | CERDELGA | GENZYME CORP | N205494 | Aug. 19, 2014 | RX | CAPSULE | ORAL | 12465586 | June 5, 2032 | LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE OR INTERMEDIATE METABOLIZERS WITH 84 MG TWICE PER DAY OF ELIGLUSTAT (EQUIVALENT TO 100 MG OF ELIGLUSTAT TARTRATE TWICE PER DAY) |
| EQ 84MG BASE | CERDELGA | GENZYME CORP | N205494 | Aug. 19, 2014 | RX | CAPSULE | ORAL | 12465586 | June 5, 2032 | LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 POOR METABOLIZERS WITH 84 MG ONCE DAILY OF ELIGLUSTAT (EQUIVALENT TO 100 MG OF ELIGLUSTAT TARTRATE) |
| EQ 84MG BASE | CERDELGA | GENZYME CORP | N205494 | Aug. 19, 2014 | RX | CAPSULE | ORAL | 10888544 | Dec. 13, 2038 | LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE METABOLIZERS WITH MILD HEPATIC IMPAIRMENT AND ARE CONCURRENTLY TAKING A STRONG OR MODERATE CYP3A INHIBITOR |
| EQ 84MG BASE | CERDELGA | GENZYME CORP | N205494 | Aug. 19, 2014 | RX | CAPSULE | ORAL | 10888544 | Dec. 13, 2038 | LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE METABOLIZERS WITH MODERATE TO SEVERE RENAL IMPAIRMENT |
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 |
|---|---|---|---|---|---|---|---|---|---|
| Ceramide glucosyltransferase | Enzyme | INHIBITOR | IC50 | 6.83 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE |
External reference:
| ID | Source |
|---|---|
| DR40J4WA67 | UNII |
| D09893 | KEGG_DRUG |
| 928659-70-5 | SECONDARY_CAS_RN |
| 4033647 | VANDF |
| C3272698 | UMLSCUI |
| CHEBI:82752 | CHEBI |
| CHEMBL2110588 | ChEMBL_ID |
| 23652731 | PUBCHEM_CID |
| DB09039 | DRUGBANK_ID |
| CHEMBL5723563 | ChEMBL_ID |
| 9325 | INN_ID |
| C522917 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7536 | IUPHAR_LIGAND_ID |
| 1547219 | RXNORM |
| 228048 | MMSL |
| 30495 | MMSL |
| 33941 | MMSL |
| d08283 | MMSL |
| 015653 | NDDF |
| 015654 | NDDF |
| 714006001 | SNOMEDCT_US |
| 714011004 | SNOMEDCT_US |
| 863995003 | SNOMEDCT_US |
| DR40J4WA67 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Cerdelga | HUMAN PRESCRIPTION DRUG LABEL | 1 | 58468-0220 | CAPSULE | 84 mg | ORAL | NDA | 30 sections |