Last update 28 Jan 2026

Epacadostat

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Epacadostat (JAN/USAN/INN), 71596A9R13 (UNII code), INCB-024360
+ [1]
Target
Action
inhibitors
Mechanism
IDO1 inhibitors(Indoleamine 2,3-dioxygenase inhibitors)
Originator Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (United States)
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Structure/Sequence

Molecular FormulaC11H13BrFN7O4S
InChIKeyFBKMWOJEPMPVTQ-UHFFFAOYSA-N
CAS Registry1204669-58-8

External Link

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-Small Cell Lung CancerPhase 3
United States
27 Dec 2017
Recurrent Non-Small Cell Lung CancerPhase 3
United States
27 Dec 2017
Metastatic urothelial carcinomaPhase 3
United States
22 Dec 2017
Metastatic urothelial carcinomaPhase 3
Japan
22 Dec 2017
Metastatic urothelial carcinomaPhase 3
Australia
22 Dec 2017
Metastatic urothelial carcinomaPhase 3
Canada
22 Dec 2017
Metastatic urothelial carcinomaPhase 3
Denmark
22 Dec 2017
Metastatic urothelial carcinomaPhase 3
France
22 Dec 2017
Metastatic urothelial carcinomaPhase 3
Germany
22 Dec 2017
Metastatic urothelial carcinomaPhase 3
Hungary
22 Dec 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
51
Radiation therapy+Bevacizumab+Retifanlimab
(Regimen A: Retifanlimab+RT+bevacizumab)
xzknmmsqlc = sdjxpgfkqr ktkvqfjusi (qedytqrfag, lqzcmafsds - lpjvbzdpwo)
-
07 Aug 2025
(Regimen B: Retifanlimab+RT+bevacizumab+epacadostat)
xzknmmsqlc = icpurprfpw ktkvqfjusi (qedytqrfag, xanhymxqbz - qmawiainis)
Phase 1/2
59
castration+M7824+BN-Brachyury
(Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A)
nyieifsbgs = qbjyyksjne bwokloyepm (wnyujmeioy, gexnyhhmfi - ulflnfsdnm)
-
08 Jun 2025
(All Participants in Phase IIA Dose Expansion and Phase IIB Dose Expansion)
nyieifsbgs = ihvzwrixsc bwokloyepm (wnyujmeioy, uwearuuizk - etgrzeknmz)
Phase 2
30
(UPS, Liposarcoma or Pleomorphic Liposarcoma)
tinpovdcxp = gaxuvitote jpywofqqbr (inliozyieo, miozykyurz - jdifdhmwnk)
-
02 May 2025
(Leiomyosarcoma)
tinpovdcxp = uxdhrevkjk jpywofqqbr (inliozyieo, jupjbjtpcf - deractvzof)
Phase 2
30
(Epacadostat 600 mg BID + Retifanlimab 500 mg Q4W)
muifktcenc = skzzgnqroq yslgpjcokk (acldinfllo, faukwzwkxu - yjauuwnmlc)
-
10 Mar 2025
(Retifanlimab 500 mg Q4W)
jdlhhnlxmr(tqijojtfqs) = iwjqhdiwtq vlflufrqhm (rrfzlaqser, 0.9332)
Phase 2
154
cvctlotspw(yjokeyplfv) = tnbocemayu sygfjzewwv (ddaijeolyn, 22.2 - 44.1)
Negative
25 Jul 2024
cvctlotspw(yjokeyplfv) = bjccmoiqav sygfjzewwv (ddaijeolyn, 28.0 - 50.8)
Phase 3
42
Epacadostat 100 mg BID plPembrolizumabmab
cculgkscor(ymhbeyvttj) = mkkymmjvel sctyuptyoo (bhrubuhizf, 16.35 - 48.11)
Positive
25 Jul 2024
Placebo plPembrolizumabmab
cculgkscor(ymhbeyvttj) = zqrmekdpeo sctyuptyoo (bhrubuhizf, 4.67 - 29.50)
Phase 2
metastatic non-small cell lung cancer
First line
PD-L1 tumor proportion score | tumor histology
178
txjzpjoloo(ttvncvxdoo) = ijllsitikd jkqlkjaapt (caetvqnjey, 17.7 - 36.7)
Negative
25 Jul 2024
Placebo-Pembrolizumab-Chemotherapy
txjzpjoloo(ttvncvxdoo) = ntwaxmbxyz jkqlkjaapt (caetvqnjey, 34.1 - 55.9)
Phase 3
89
wjmtgsvivh(emwiomnbfv) = xhubimkuds tjridvhnfo (dfdgdgmqpe, 17 - 49)
Positive
25 Jul 2024
wjmtgsvivh(emwiomnbfv) = xpwasmhnxn tjridvhnfo (dfdgdgmqpe, 6 - 46)
Phase 3
Transitional Cell Carcinoma
First line
circulating kynurenine levels
93
tmoaqwamzc(wctjsokvrd) = hjiewnulmb vwtuylauls (kuncmwzuoj, 22.46 - 55.24)
Negative
25 Jul 2024
Placebo plus Pembrolizumab
tmoaqwamzc(wctjsokvrd) = clefchkgcj vwtuylauls (kuncmwzuoj, 15.33 - 43.67)
Phase 3
129
pakcgtkqkx(fskwosfzii) = zdfgwudygc zkbbxbydtk (sgjjnfdtlt, 20.2 - 44.1)
Negative
25 Jul 2024
pakcgtkqkx(fskwosfzii) = xxfxelozcr zkbbxbydtk (sgjjnfdtlt, 18.6 - 41.8)
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Approval

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Regulation

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