Last update 06 Jun 2025

Enasidenib Mesylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Enasidenib, IDHIFA, 恩西地平
+ [5]
Target
Action
inhibitors
Mechanism
IDH2 inhibitors(Isocitrate dehydrogenase [NADP], mitochondrial inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (01 Aug 2017),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China)
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Structure/Sequence

Molecular FormulaC20H21F6N7O4S
InChIKeyORZHZQZYWXEDDL-UHFFFAOYSA-N
CAS Registry1650550-25-6

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Acute Myeloid Leukemia
United States
01 Aug 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
IDH2 mutation Acute Myeloblastic LeukemiaPhase 3
United States
30 Dec 2015
IDH2 mutation Acute Myeloblastic LeukemiaPhase 3
China
30 Dec 2015
IDH2 mutation Acute Myeloblastic LeukemiaPhase 3
Australia
30 Dec 2015
IDH2 mutation Acute Myeloblastic LeukemiaPhase 3
Austria
30 Dec 2015
IDH2 mutation Acute Myeloblastic LeukemiaPhase 3
Belgium
30 Dec 2015
IDH2 mutation Acute Myeloblastic LeukemiaPhase 3
Brazil
30 Dec 2015
IDH2 mutation Acute Myeloblastic LeukemiaPhase 3
Canada
30 Dec 2015
IDH2 mutation Acute Myeloblastic LeukemiaPhase 3
Czechia
30 Dec 2015
IDH2 mutation Acute Myeloblastic LeukemiaPhase 3
Denmark
30 Dec 2015
IDH2 mutation Acute Myeloblastic LeukemiaPhase 3
France
30 Dec 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
6
brtcxbhoie = abybktvgip fvxosjjyup (sjvbmvcmog, xjpzafvkpp - thdbovvurm)
-
18 Dec 2024
Phase 1
Acute Myeloid Leukemia
complex cytogenetics | antecedent MDS/MPN | therapy-related AML ...
31
srfupoeyqd(pgegthwlfs) = oebghcgnwy sfxknpsxll (qxmfghcnao )
Positive
09 Dec 2024
srfupoeyqd(pgegthwlfs) = wvvgipxufo sfxknpsxll (qxmfghcnao )
Not Applicable
-
Enasidenib 100 mg PO QD
wexjvhyzia(nzzbdfrdkr) = None of the 87 severe AE (SAE) were related to ENA in these two cohorts. Differentiation syndromes were manageable and reported in 5/58 (8.6%) patients. lmhgtstcrl (arfoqcbkfs )
-
07 Dec 2024
Azacitidine (AZA, 75 mg/m2/d x 7 days, SC)
Not Applicable
643
enasidenib ± azacitidine or chemotherapy
icledzoyyx(kjiwihrlvz) = aujjuwdwvi lhfblhnsud (hcplcqtlpm )
Positive
20 Mar 2024
icledzoyyx(kjiwihrlvz) = rxjtdawrau lhfblhnsud (hcplcqtlpm )
Phase 1
15
Enasidenib 100 mg/day
idyijlsqoj(qstisinmds) = qinuaqhdsy ljwfntiwyk (sbkstxlqan )
Positive
01 Feb 2024
Phase 1/2
Acute Myeloid Leukemia
First line
IDH2 Mutation
60
Enasidenib monotherapy
azpmpydygn(aidwgglnaa) = ungyajgegt zovawzfnqr (pxhedgdhqk )
Positive
23 Jan 2024
Enasidenib + azacitidine combination therapy
azpmpydygn(aidwgglnaa) = jfoxwjufnf zovawzfnqr (pxhedgdhqk )
Phase 1
23
lvosdgghrj(dbrkvdhkjs) = czsgqcgnvy egbprrmcia (wowbhxpxcp )
-
10 Dec 2023
lvosdgghrj(dbrkvdhkjs) = ttahznmvzg egbprrmcia (wowbhxpxcp )
Phase 1/2
27
ednlfomxbd(xxtddtpylr) = nayfkylote uyqhungphi (xbfscwuwaw, 8.2 - NR)
-
09 Dec 2023
Not Applicable
Adjuvant
1
tbulfgypja(iuqfvumtoe) = ogmpnjmmrp tbwpibicdp (cnpnfysrby )
Positive
10 Nov 2023
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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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