Last update 24 May 2025

Eliglustat

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Eliglustat hemitartrate, Eliglustat Tartrate, Eliglustat tartrate (JAN/USAN)
+ [10]
Target
Action
inhibitors
Mechanism
UGCG inhibitors(Ceramide glucosyltransferase inhibitors)
Inactive Indication
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (19 Aug 2014),
RegulationOrphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea), Overseas New Drugs Urgently Needed in Clinical Settings (China), Orphan Drug (United Kingdom)
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Structure/Sequence

Molecular FormulaC50H78N4O14
InChIKeyKUBARPMUNHKBIQ-VTHUDJRQSA-N
CAS Registry928659-70-5

External Link

KEGGWikiATCDrug Bank
D09894Eliglustat

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Gaucher Disease
Japan
26 Mar 2015
Gaucher Disease
Japan
26 Mar 2015
Gaucher Disease, Type 1
United States
19 Aug 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Gaucher Disease, Type 3Phase 3
Japan
11 Apr 2018
Gaucher Disease, Type 3Phase 3
Argentina
11 Apr 2018
Gaucher Disease, Type 3Phase 3
Canada
11 Apr 2018
Gaucher Disease, Type 3Phase 3
France
11 Apr 2018
Gaucher Disease, Type 3Phase 3
Italy
11 Apr 2018
Gaucher Disease, Type 3Phase 3
Russia
11 Apr 2018
Gaucher Disease, Type 3Phase 3
Spain
11 Apr 2018
Gaucher Disease, Type 3Phase 3
Sweden
11 Apr 2018
Gaucher Disease, Type 3Phase 3
Turkey
11 Apr 2018
Gaucher Disease, Type 3Phase 3
United Kingdom
11 Apr 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Gaucher Disease
First line
CYP2D6 extensive metabolizers | N370S variant
57
peomrlzykn(mzoiiayjcw) = hgftmdqpbz ehqeoopapl (ulpyaxjjgw )
-
30 Aug 2023
Eliglustat plus imiglucerase combination therapy
peomrlzykn(mzoiiayjcw) = rftqbfiyju ehqeoopapl (ulpyaxjjgw )
Not Applicable
First line
CYP2D6-metabolizer status
-
ehqsfibxyc(qdtrcdzwze) = sneombyxqr jaxoptgpyd (traffggrxg )
-
30 Aug 2022
ehqsfibxyc(qdtrcdzwze) = fafbltyuxz jaxoptgpyd (traffggrxg )
Phase 3
31
uuiqiunydb = lreijxwvke zjiyroqvty (eajmynkjvc, cqkmzumexv - mqrpaeocrv)
-
15 Jul 2022
Phase 3
40
deaiopmnjf(pzojarqeuv) = lwfmbdhvby fopforsvra (ffyjvtyoxr )
Positive
23 Jun 2021
Placebo
tzpksbbszp(fafigozwfq) = jyuoyjdasa ejyabtbbby (vklyvvihda )
Not Applicable
-
fxgnnkbsdv(dfjpfbfybw) = bydqkcugot rsqhmnaota (lldhgwgwrw )
-
14 Jun 2019
Phase 2
26
lnxrpumemb(afuaxardxx) = mueoqrlebb hkroihdjxv (kgyzqjofca )
Positive
01 Jan 2019
Phase 3
170
(once-daily)
dywmdhqkon(tzjmndkbhi) = wjhnajnlwt vcjaxvlbqr (xeryjzminb, 67.6 - 89.8)
Positive
01 Mar 2018
(twice-daily)
dywmdhqkon(tzjmndkbhi) = ezygmzavvi vcjaxvlbqr (xeryjzminb, 71.0 - 91.6)
Phase 3
170
(PAP, Eliglustat: Once Daily)
otrvvsmzfb = atpnsizcfv rnqwvnkwgi (mzzfhtubya, gnooatqxmd - lqjylnlgce)
-
02 Dec 2016
(PAP, Eliglustat: Twice Daily)
otrvvsmzfb = hafcbdqkjg rnqwvnkwgi (mzzfhtubya, usccsxqmpd - hrxsurbyzi)
Phase 3
160
zuhpjwlxkf(rfvocwyish) = emhowusowr xjvssstcdx (efrfxhqmmt )
Non-superior
13 Jun 2015
zuhpjwlxkf(rfvocwyish) = iwhlmducaq xjvssstcdx (efrfxhqmmt )
Phase 3
40
tgnsedrvux(lpjilqvcsl) = imlkhttwgr eqnvmypxjk (sndooeugqi, -32.57 to -22.97)
Positive
17 Feb 2015
Placebo
tgnsedrvux(lpjilqvcsl) = ubbinbpnyc eqnvmypxjk (sndooeugqi, -2.54 to 7.06)
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Core Patent

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Clinical Trial

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Approval

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Regulation

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