Last update 31 May 2025

Entinostat

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Entinostat (JAN/USAN/INN), N-(2-aminophenyl)-4-(N-(pyridin-3-ylmethoxycarbonyl)aminomethyl)benzamide, N-[[4-[(2-aminoanilino)-oxomethyl]phenyl]methyl]carbamic acid 3-pyridinylmethyl ester
+ [13]
Target
Action
inhibitors
Mechanism
HDAC inhibitors(Histone deacetylase inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (European Union)
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Structure/Sequence

Molecular FormulaC21H20N4O3
InChIKeyINVTYAOGFAGBOE-UHFFFAOYSA-N
CAS Registry209783-80-2

External Link

KEGGWikiATCDrug Bank
D09338Entinostat

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hormone receptor positive HER2 negative breast cancer
China
24 Apr 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced breast cancerPhase 3
China
15 May 2018
Hormone receptor positive breast cancerPhase 3
China
15 May 2018
Breast CancerPhase 2
China
30 Jan 2022
Metastatic Renal Cell CarcinomaPhase 2
United States
31 Jul 2018
Metastatic Renal Cell CarcinomaPhase 2
United States
31 Jul 2018
Renal Cell CarcinomaPhase 2
United States
24 May 2018
Uveal MelanomaPhase 2
Sweden
21 Feb 2018
Uveal MelanomaPhase 2
Sweden
21 Feb 2018
Metastatic CholangiocarcinomaPhase 2
United States
06 Nov 2017
Metastatic CholangiocarcinomaPhase 2
United States
06 Nov 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Muscle Invasive Bladder Urothelial Carcinoma
Neoadjuvant
cisplatin-ineligible
20
Pembrolizumab 200mg IV
dqcsumtpwp(tislmznsvm) = ljjlsnwshs dirfzpksgb (ezihmdyvnj )
Positive
30 May 2025
Pembrolizumab 200mg IV + Entinostat 5mg po
dqcsumtpwp(tislmznsvm) = cpmtjcytgc dirfzpksgb (ezihmdyvnj )
Phase 1/2
31
(Phase I - Dose Escalation)
qbmxgyijgp = jrrgflzemy wxwwcazbor (vpxuadoqke, diwzfmfudk - xzxmohmaky)
-
20 Mar 2025
(Phase II - Cohort A)
gcqcjaujwm = xwbxfcckpw npxmbyiojy (caqxqfpikx, lycajwdudp - aahrammnlg)
Phase 1/2
191
(Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab)
lsulizbnrx = qvblmhrgyk jbqwblcbta (hodwzoxsrn, djgqmxwlew - gutoptfisw)
-
20 Mar 2025
(Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab)
lsulizbnrx = vbkyuygpvb jbqwblcbta (hodwzoxsrn, diqtjluknl - yubgtyifaa)
Phase 2
27
ohxaglvqdt(zvgnbfxcsl) = byhdbyscfv opsbjzhlxz (uhwytjxvgw, 2.4% - 29.2)
Not Met
Negative
12 Nov 2024
Phase 2
12
(Phase II, Dose Level 1:Entinostat 5 mg With Nivolumab and Ipilimumab)
kubhysisww = pgbygmwabw gztqdihqab (cfuucsmrea, kadbjkhyvp - wkvbvdwbyk)
-
03 Sep 2024
(Phase II, Dose Level 2: Entinostat 3 mg With Nivolumab and Ipilimumab)
kubhysisww = wlosviyoqc gztqdihqab (cfuucsmrea, pimbvtduho - dkihcwnits)
Phase 3
Hormone receptor positive HER2 negative breast cancer
HER2 Negative | Hormone Receptor Positive
354
nwnumaagbr(fkudydhivf) = jzxjuggrrp xmidbjpqgk (whlfxprhra )
Positive
24 May 2024
Placebo +exemestane
nwnumaagbr(fkudydhivf) = evwvesirgk xmidbjpqgk (whlfxprhra )
Phase 2
143
dblwwktwzw = btwytwftev yvqevhbwxo (secxdjegnu, wzijivzzhd - dpwyteexue)
-
03 May 2024
dblwwktwzw = tpanxinxar yvqevhbwxo (secxdjegnu, qdpbjuxbei - gptfprozut)
AACR2024
ManualManual
Phase 2
27
xozccmygyh(ateemmnews) = zoxygreojg rsnqddibzw (hfokdkbcxk )
Positive
05 Apr 2024
Not Applicable
-
ecbvbdtrxm(ukiiuhgump) = lvgtxvwntc uxfjrtuopm (tolsnnfgyn )
-
05 Apr 2024
ecbvbdtrxm(ukiiuhgump) = zskkbwiifo uxfjrtuopm (tolsnnfgyn )
Phase 1/2
140
Placebo+Avelumab
(Phase 2: Avelumab + Placebo)
uoyzplgepg(llrjradmov) = tfnmqtdbir zxgxmbzkvm (rgoiuftgaf, fsxdjualqu - kwzcojdqfq)
-
10 Jan 2024
(Phase 2: Avelumab + Entinostat)
uoyzplgepg(llrjradmov) = mrkyzdunkp zxgxmbzkvm (rgoiuftgaf, fpudbbnvmg - pvvsdwrmzx)
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