Drugs / Epacadostat
last change May 2026 re-read 2 minutes ago

Epacadostat

also known as INCB024360 · previously INCB24360

Small molecule targets IDO1 via inhibition

Developed for
cancer · lung cancer · urothelial carcinoma · head and neck cancer · head and neck squamous cell carcinoma · melanoma · primary peritoneal carcinoma · colorectal cancer
+40 more · fallopian tube cancer · fallopian tube carcinoma · glioblastoma · non-small cell lung carcinoma · ovarian cancer · ovarian carcinoma · acute myeloid leukemia · endometrial cancer · gastroesophageal junction adenocarcinoma · lymphoma · peritoneum cancer · renal cell carcinoma · B-cell neoplasm · carcinoma of esophagus · castration-resistant prostate carcinoma · cutaneous melanoma · endometrial carcinoma · esophageal adenocarcinoma · esophageal squamous cell carcinoma · gastric adenocarcinoma · gastric cancer · gastrointestinal stromal tumor · hematopoietic and lymphoid cell neoplasm · hepatocellular carcinoma · malignant epithelial tumor of ovary · metastatic malignant neoplasm · mucosal melanoma · myelodysplastic syndrome · nasopharyngeal carcinoma · ovarian clear cell cancer · pancreatic adenocarcinoma · pancreatic ductal adenocarcinoma · rectal cancer · sarcoma · small cell lung carcinoma · thymic carcinoma · triple-negative breast carcinoma · urinary bladder cancer · urinary bladder carcinoma · uveal melanoma
Investigated by
Incyte Corporation · Merck Sharp & Dohme LLC · National Cancer Institute (NCI) · Bristol-Myers Squibb · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · University of Chicago
+32 more · AstraZeneca · City of Hope Medical Center · Insel Gruppe AG, University Hospital Bern · M.D. Anderson Cancer Center · Roswell Park Cancer Institute · Washington University School of Medicine · Addario Lung Cancer Medical Institute · Aduro Biotech, Inc. · Alain Algazi · Celldex Therapeutics · Chao Huang · Chase Heaton, MD · Columbia University · European Network of Gynaecological Oncological Trial Groups (ENGOT) · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Fox Chase Cancer Center · Fred Hutchinson Cancer Center · GOG Foundation · Genentech, Inc. · George Albert Fisher · Georgetown University · H. Lee Moffitt Cancer Center and Research Institute · Hoffmann-La Roche · ImmunoVaccine Technologies, Inc. (IMV Inc.) · James J Lee · Masonic Cancer Center, University of Minnesota · Memorial Sloan Kettering Cancer Center · NRG Oncology · OncoSec Medical Incorporated · University of California, Davis · University of Kansas Medical Center · University of Virginia

Trials 58 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT02042430 Aug 2014 → Nov 2016 fallopian tube cancer, primary peritoneal carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 111 trials
Phase 1 NCT03471286 Jun 2019 → Jul 2021 cancer Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Terminated No outcome recorded
Phase 1 NCT03707457 Mar → Nov 2019 glioblastoma Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Terminated No outcome recorded
Phase 1 NCT03491579 Dec 2018 → Sep 2019 acute myeloid leukemia Insel Gruppe AG, University Hospital Bern Withdrawn No outcome recorded
Phase 1 NCT03444649 Sep 2018 → Aug 2019 acute myeloid leukemia Insel Gruppe AG, University Hospital Bern Withdrawn No outcome recorded
Phase 1 NCT03589651 Aug 2018 → Nov 2022 Incyte Corporation Completed No outcome recorded
Phase 1 NCT03217669 Feb 2018 → Apr 2024 non-small cell lung carcinoma Chao Huang Unknown No outcome recorded
Phase 1 NCT02862457 Aug 2016 → Nov 2020 non-small cell lung carcinoma Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT02559492 Nov 2015 → Sep 2018 cancer Incyte Corporation Terminated No outcome recorded
Phase 1 NCT02298153 Jan 2015 → Nov 2017 non-small cell lung carcinoma, urothelial carcinoma Incyte Corporation Terminated No outcome recorded
Phase 1 NCT02118285 Jul 2014 → Nov 2015 fallopian tube carcinoma, ovarian cancer, primary peritoneal carcinoma Masonic Cancer Center, University of Minnesota Completed No outcome recorded
Phase 1/216 trials
Phase 1/2 NCT03516708 Jan 2020 → Jul 2027 expected rectal cancer Washington University School of Medicine Recruiting No outcome recorded
Phase 1/2 NCT03182894 Sep 2018 → Jul 2019 colorectal cancer James J Lee Withdrawn No outcome recorded
Phase 1/2 NCT03493945 May 2018 → Oct 2024 castration-resistant prostate carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 1/2 NCT03347123 Mar 2018 → Jan 2021 cancer Incyte Corporation Terminated No outcome recorded
Phase 1/2 NCT03361228 Mar 2018 → Mar 2019 cancer Incyte Corporation Terminated No outcome recorded
Phase 1/2 NCT03322384 Jan 2018 → Feb 2020 cancer, lymphoma University of California, Davis Completed No outcome recorded
Phase 1/2 NCT03085914 May 2017 → Jan 2019 cancer Incyte Corporation Completed No outcome recorded
Phase 1/2 NCT02959437 Feb 2017 → Feb 2019 metastatic malignant neoplasm Incyte Corporation Terminated No outcome recorded
Phase 1/2 NCT02785250 Apr 2016 → Oct 2020 fallopian tube cancer, malignant epithelial tumor of ovary, peritoneum cancer ImmunoVaccine Technologies, Inc. (IMV Inc.) Unknown No outcome recorded
Phase 1/2 NCT02575807 Mar 2016 → Apr 2018 fallopian tube cancer, peritoneum cancer Aduro Biotech, Inc. Terminated No outcome recorded
Phase 223 trials
Phase 2 NCT04586244 Jan 2022 → Jan 2024 urothelial carcinoma Incyte Corporation Terminated No outcome recorded
Phase 2 NCT04463771 Jan 2021 → May 2026 endometrial cancer Incyte Corporation Completed No outcome recorded
Phase 2 NCT04231864 Dec 2020 → Apr 2022 nasopharyngeal carcinoma Alain Algazi Withdrawn No outcome recorded
Phase 2 NCT03532295 Apr 2020 → Jul 2024 glioblastoma Washington University School of Medicine Completed No outcome recorded
Phase 2 NCT03432676 Jul 2019 → Apr 2020 ATM-related cancer predisposition, BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, pancreatic ductal adenocarcinoma M.D. Anderson Cancer Center Withdrawn No outcome recorded
Phase 2 NCT03832673 May 2019 urinary bladder carcinoma Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Withdrawn No outcome recorded
Phase 2 NCT03823131 May 2019 → Jul 2022 head and neck squamous cell carcinoma Chase Heaton, MD Terminated No outcome recorded
Phase 2 NCT03602586 Dec 2018 → Feb 2021 ovarian carcinoma, ovarian clear cell cancer National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT03402880 Oct 2018 small cell lung carcinoma City of Hope Medical Center Withdrawn No outcome recorded
Phase 2 NCT03238638 Sep 2018 → Dec 2020 head and neck cancer University of Chicago Withdrawn No outcome recorded
Phase 37 trials
Phase 3 NCT03348904 Dec 2017 → May 2018 lung cancer Incyte Corporation Terminated No outcome recorded
Phase 3 NCT03374488 Dec 2017 → Jul 2018 urothelial carcinoma Incyte Corporation Completed No outcome recorded
Phase 3 NCT03342352 Dec 2017 → Apr 2018 head and neck cancer Incyte Corporation Withdrawn No outcome recorded
Phase 3 NCT03260894 Dec 2017 → Aug 2018 renal cell carcinoma Incyte Corporation Completed No outcome recorded
Phase 3 NCT03361865 Dec 2017 → Aug 2018 urothelial carcinoma Incyte Corporation Completed No outcome recorded
Phase 3 NCT03358472 Dec 2017 → Jul 2018 head and neck squamous cell carcinoma Incyte Corporation Completed No outcome recorded
Phase 3 NCT02752074 Jun 2016 → Jan 2018 melanoma Incyte Corporation Completed No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT03277352 Background Nov 2017 → Jul 2020 metastatic malignant neoplasm Incyte Corporation Terminated No outcome recorded
Phase 21 trial
Phase 2 NCT01685255 Comparator Aug 2012 → Oct 2014 ovarian carcinoma Incyte Corporation Terminated No outcome recorded

Press releases naming this drug 21 releases

DateIssuerRelease
2018-04-06 Incyte Corporation Incyte and Merck Provide Update on Phase 3 Study of Epacadostat in Combination with KEYTRUDA® (pembrolizumab) in Patients with Unresectable or Metastatic Melanoma incyte.com
2017-09-09 Incyte Corporation Progression-Free Survival Data from ECHO-202 Trial of Incyte’s Epacadostat in Combination with KEYTRUDA® (pembrolizumab) Underscore Durability of Response in Patients with Advanced Melanoma incyte.com
2017-09-09 Incyte Corporation Progression-Free Survival Data from ECHO-202 Trial of Incyte’s Epacadostat in Combination with Merck’s KEYTRUDA® (pembrolizumab) Underscore Durability of Response in Patients with Advanced Melanoma incyte.com
2017-08-30 Incyte Corporation New Data for Epacadostat in Combination with KEYTRUDA® (pembrolizumab) Demonstrate Durable Responses in Patients with Advanced Melanoma incyte.com
2017-06-05 Incyte Corporation Updated Data from ECHO-202 Trial of Incyte’s Epacadostat in Combination with Merck’s KEYTRUDA® (Pembrolizumab) Demonstrate Clinical Activity across Multiple Tumor Types incyte.com
2017-06-05 Incyte Corporation Clinical Trial Data for Combination of Epacadostat and Opdivo® (nivolumab) Demonstrate Durable Clinical Responses in Patients with Melanoma and Head and Neck Cancer incyte.com
2017-06-03 Incyte Corporation Combination of Incyte’s Epacadostat plus Merck’s KEYTRUDA® (pembrolizumab) Demonstrates Activity in Clinical Trial of Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) incyte.com
2017-06-03 Incyte Corporation Combination of Epacadostat plus Keytruda® (pembrolizumab) Demonstrates Activity in Clinical Trial of Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) incyte.com
2017-05-17 Incyte Corporation New Data for Presentation at ASCO 2017 Reinforce Clinical Profile of Epacadostat in Combination with Keytruda® (pembrolizumab) incyte.com
2017-05-17 Incyte Corporation First Data from Combination of Epacadostat with Opdivo® (nivolumab) Will Be Highlighted at ASCO 2017 incyte.com
2017-04-02 Incyte Corporation Bristol-Myers Squibb and Incyte to Advance the Combination of Opdivo (nivolumab) and Epacadostat into First-line Registrational Trials incyte.com
2017-03-31 Incyte Corporation Incyte and Merck Provide Additional Details on Previously Announced Collaboration Investigating Epacadostat and KEYTRUDA® (pembrolizumab) incyte.com

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 63 sources stand behind the page.

FieldValueCited text
Known as Epacadostat “The open-label, phase 1/2 ECHO-203 study evaluated the safety, tolerability, and efficacy of the IDO1 inhibitor epacadostat in combination with durvalumab, a human anti-PD-L1...” PMID 36309837 Oct 2022
53

“Patients will receive epacadostat in combination with pembrolizumab.” NCT03325465

NCT03322566

NCT03358472

NCT03361228

NCT03402880

NCT03291054

NCT03432676

NCT02559492

NCT03589651

NCT03491579

NCT02752074

NCT03217669

NCT02862457

NCT03602586

NCT02785250

NCT03374488

NCT03493945

NCT04231864

NCT03085914

NCT03277352

NCT03006302

NCT03361865

NCT01685255

NCT03463161

NCT03444649

NCT03532295

NCT02166905

NCT03310567

NCT03322540

NCT02364076

NCT03322384

NCT02327078

NCT03196232

NCT04463771

NCT03414229

NCT03832673

NCT04586244

NCT02042430

NCT03348904

NCT03182894

NCT03516708

NCT03592407

NCT01961115

NCT03342352

NCT03471286

NCT03260894

NCT03823131

NCT01604889

NCT03238638

NCT02298153

NCT02959437

NCT02575807

NCT03347123

Known as INCB024360 “Epacadostat (INCB024360) is an inhibitor of the enzyme indoleamine 2,3-dioxygenase 1 (IDO1) that has shown promise in the treatment of solid tumors and lymphomas in ongoing...” NCT03322384
13

INCB024360 (Epacadostat) is an IDO1 inhibitor under investigation in combination with different immunotherapies in treatment of various malignancies.” NCT03493945

“A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)” NCT02318277

“Phase II Study of Epacadostat (INCB024360) in Combination With Pembrolizumab in Patients With Locally Advanced/Metastatic Sarcoma” NCT03414229

“Oral Epacadostat (INCB024360) (50, 100, or 300 mg twice per day,on days 1-21 of each cycle, every 21 days)” NCT03182894

“Epacadostat (INCB024360) is an Inhibitor of Indoleamine 2,3- dioxygenase 1 (IDO1).” NCT03491579

“Epacadostat (INCB024360) is an Inhibitor of Indoleamine 2,3- dioxygenase 1 (IDO1).” NCT03444649

“Drug: Epacadostat (INCB024360)” NCT02785250

NCT03707457

NCT01195311

NCT02118285

NCT01982487

NCT01822691

NCT02178722

Known as previously INCB24360 previously INCB24360NCT03832673
Action Inhibit “Epacadostat is a potent inhibitor of the immunosuppressive indoleamine 2,3-dioxygenase 1 (IDO1) enzyme.” PMID 30894212 Mar 2019
Modality Small molecule CHEMBL3545369
Route Oral “Patients received oral epacadostat (25, 50, 100, or 300 mg twice daily [BID]; 75 mg daily [50 mg AM, 25 mg PM]; or 50 mg BID intermittent [2 weeks on/1 week off])” PMID 30894212 Mar 2019
Target IDO1 “Epacadostat is a potent inhibitor of the immunosuppressive indoleamine 2,3-dioxygenase 1 (IDO1) enzyme.” PMID 30894212 Mar 2019