CERDELGA

Peak

eliglustat

NDAORALCAPSULEPriority Review
Approved
Aug 2014
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
15

Mechanism of Action

Glucosylceramide Synthase Inhibitors

Pharmacologic Class:

Glucosylceramide Synthase Inhibitor

Clinical Trials (5)

NCT03519646N/ACompleted

Eliglustat on Gaucher Disease Type IIIB

Started Apr 2018
4 enrolled
Gaucher Disease, Type III
NCT03485677Phase 3Completed

Safety and Efficacy of Eliglustat With or Without Imiglucerase in Pediatric Patients With Gaucher Disease (GD) Type 1 and Type 3

Started Apr 2018
57 enrolled
Gaucher's Disease Type IGaucher's Disease Type III
NCT06188325Phase 1Completed

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

Started Jan 2018
18 enrolled
Gaucher's Disease
NCT02536755Phase 3Completed

Phase 3b Study to Evaluate Skeletal Response to Eliglustat in Adult Patients Who Completed Phase 2 or Phase 3 Studies

Started Oct 2015
31 enrolled
Gaucher Disease
NCT02536911Phase 1Completed

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

Started Sep 2015
24 enrolled
Gaucher Disease

Loss of Exclusivity

LOE Date
Dec 13, 2038
155 months away
Patent Expiry
Dec 13, 2038

Patent Records (5)

Patent #ExpiryTypeUse Code
7196205
Jun 26, 2026
Substance
11458119
Nov 24, 2030
SubstanceProduct
10888547
Jan 31, 2031
U-3043
12465586
Jun 5, 2032
U-3043
10888544
Dec 13, 2038
U-3040