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Drug ReportsEliglustat
Cerdelga(eliglustat)
Cerdelga, Eliglustat (eliglustat) is a small molecule pharmaceutical. Eliglustat was first approved as Cerdelga on 2014-08-19. It is used to treat gaucher disease in the USA. It has been approved in Europe to treat gaucher disease.
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Variants
Financial
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Events Timeline
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YTD
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Cerdelga, Eliglustat (discontinued: Eliglustat)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Eliglustat tartrate
Tradename
Company
Number
Date
Products
CERDELGASanofiN-205494 RX2014-08-19
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
cerdelgaNew Drug Application2024-03-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
gaucher diseaseOrphanet_355D005776E75.22
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Eliglustat Tartrate, Cerdelga, Genzyme Corp
108885442038-12-13U-3040, U-3041
108885472031-01-31U-3042, U-3043
114581192030-11-24DS, DP
71962052026-06-26DP
ATC Codes
A: Alimentary tract and metabolism drugs
— A16: Other alimentary tract and metabolism products in atc
— A16A: Other alimentary tract and metabolism products in atc
— A16AX: Various alimentary tract and metabolism products
— A16AX10: Eliglustat
HCPCS
No data
Clinical
Clinical Trials
19 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
Gaucher diseaseD005776Orphanet_355E75.22625—114
DiseaseD004194EFO_0000408R69——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LipidosesD008064—E75.6—1———1
Deficiency diseasesD003677EFO_1001067E63—1———1
Colorectal neoplasmsD015179———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———3————3
Hematologic neoplasmsD019337——1————1
NeoplasmsD009369—C801————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEliglustat
INNeliglustat
Description
Eliglustat is a carboxamide obtained by formal condensation of the carboxy group of octanoic acid with the primary amino group of (1R,2R)-2-amino-1-(2,3-dihydro-1,4-benzodioxin-6-yl)-3-(pyrrolidin-1-yl)propan-1-ol. A ceramide glucosyltransferase inhibitor used (as its tartrate salt) for treatment of Gaucher's disease. It has a role as an EC 2.4.1.80 (ceramide glucosyltransferase) inhibitor. It is a benzodioxine, a N-alkylpyrrolidine, a secondary alcohol and a carboxamide. It is a conjugate base of an eliglustat(1+).
Classification
Small molecule
Drug classenzyme inhibitors: glucosyltransferase inhibitors
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Structure (InChI/SMILES or Protein Sequence)
CCCCCCCC(=O)N[C@H](CN1CCCC1)[C@H](O)c1ccc2c(c1)OCCO2
Identifiers
PDB—
CAS-ID491833-29-5
RxCUI—
ChEMBL IDCHEMBL2110588
ChEBI ID82752
PubChem CID23652731
DrugBankDB09039
UNII IDDR40J4WA67 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 630 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,080 adverse events reported
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