Eliglustat

Generic Name
Eliglustat
Brand Names
Cerdelga
Drug Type
Small Molecule
Chemical Formula
C23H36N2O4
CAS Number
491833-29-5
Unique Ingredient Identifier
DR40J4WA67
Background

Eliglustat is a glucosylceramide synthase inhibitor used for the long-term treatment of type 1 Gaucher disease. Gaucher disease is a rare genetic disorder characterized by the deficiency of acid β-glucosidase, an enzyme that converts glucosylceramide into glucose and ceramide. In patients with Gaucher disease, the accumulation of glucosylceramide leads to th...

Indication

Eliglustat is a glucosylceramide synthase inhibitor indicated for the long-term treatment of type 1 Gaucher disease in adult patients who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test. CYP2D6 ultra-rapid metabolizers may not achieve adequate eliglustat concentrations to...

Associated Conditions
Gaucher Disease, Type 1
Associated Therapies
-

A Study to Evaluate Pharmacokinetic Parameters and Safety of Eliglustat Absorption Through the Mouth

Phase 1
Completed
Conditions
Interventions
First Posted Date
2024-01-05
Last Posted Date
2024-01-05
Lead Sponsor
Sanofi
Target Recruit Count
6
Registration Number
NCT06193304
Locations
🇺🇸

Covance Clinical Researsh Unit, Evansville, Indiana, United States

A Study to Evaluate Pharmacokinetic Parameters of Eliglustat in Healthy Volunteers Who Are CYP2D6 Extensive or Poor Metabolizers

Phase 1
Completed
Conditions
Interventions
First Posted Date
2024-01-03
Last Posted Date
2024-01-10
Lead Sponsor
Sanofi
Target Recruit Count
18
Registration Number
NCT06188325
Locations
🇺🇸

M.D.Covance Clinical Research Unit 1341 W, Dallas, Texas, United States

GSL Synthetase Inhibitor in Combination With Immune Checkpoint Inhibitor in Previously Treated Blood and Solid Tumor

First Posted Date
2021-06-30
Last Posted Date
2023-12-19
Lead Sponsor
Chinese PLA General Hospital
Target Recruit Count
31
Registration Number
NCT04944888
Locations
🇨🇳

Department of Biotherapeutic, Chinese PLA General Hospital, Beijing, China

Eliglustat on Gaucher Disease Type IIIB

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2018-05-09
Last Posted Date
2022-09-15
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
4
Registration Number
NCT03519646
Locations
🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

A Study of the Effects of Renal Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-09-01
Last Posted Date
2017-03-08
Lead Sponsor
Sanofi
Target Recruit Count
32
Registration Number
NCT02536937
Locations
🇺🇸

Investigational Site Number 840004, Miami, Florida, United States

🇺🇸

Investigational Site Number 840001, Knoxville, Tennessee, United States

🇺🇸

Investigational Site Number 840002, St. Paul, Minnesota, United States

A Study of the Effects of Hepatic Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-09-01
Last Posted Date
2017-02-10
Lead Sponsor
Genzyme, a Sanofi Company
Target Recruit Count
24
Registration Number
NCT02536911
Locations
🇺🇸

Investigational Site Number 840002, Miami, Florida, United States

🇺🇸

Investigational Site Number 840001, Knoxville, Tennessee, United States

Taste Evaluation of Different Liquid Formulations With Eliglustat

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-04-21
Last Posted Date
2015-05-27
Lead Sponsor
Genzyme, a Sanofi Company
Target Recruit Count
8
Registration Number
NCT02422654
Locations
🇺🇸

Investigational Site Number 840001, Evansville, Indiana, United States

Study to Evaluate the Effect of Eliglustat on the Pharmacokinetics, Safety and Tolerability of Metoprolol in Healthy Adults

Phase 1
Completed
Conditions
Interventions
First Posted Date
2012-08-08
Last Posted Date
2015-03-23
Lead Sponsor
Genzyme, a Sanofi Company
Target Recruit Count
14
Registration Number
NCT01659944
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