Drug Profile

Epacadostat - Incyte Corporation

Alternative Names: INCB-024360; INCB-24360

Latest Information Update: 15 Dec 2025

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At a glance

Originator Incyte Corporation
Developer Aduro BioTech; Bristol-Myers Squibb; Columbia University; IMV; Incyte Corporation; MedImmune; Merck AG; Merck Sharp & Dohme; National Cancer Institute (USA); Sidney Kimmel Cancer Center; Stanford University; Washington University School of Medicine
Class Antineoplastics; Halogenated hydrocarbons; Nitroso compounds; Oxadiazoles; Small molecules; Sulfonamides
Mechanism of Action Indoleamine-pyrrole 2,3-dioxygenase inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Malignant melanoma
New Molecular Entity Yes

Phase III Head and neck cancer; Malignant melanoma; Non-small cell lung cancer; Renal cell carcinoma; Urogenital cancer
Phase II Endometrial cancer; Fallopian tube cancer; Gastric cancer; Gastrointestinal stromal tumours; Glioblastoma; Oesophageal cancer; Ovarian cancer; Pancreatic cancer; Peritoneal cancer; Sarcoma; Solid tumours
Phase I/II Cancer; Colorectal cancer; Prostate cancer; Rectal cancer

31 Oct 2025 Washington University School of Medicine completes a Phase-II clinical trials in Glioblastoma (Combination therapy, Recurrent, Late-stage disease) in USA (PO) (NCT03532295)
30 Oct 2025 Incyte Corporation and Merck Sharp & Dohme completes the phase III trial for Head and neck cancer (Combination therapy, First-line therapy, Metastatic disease, Recurrent) US, Taiwan, Australia, Austria, Canada, France, Germany, Hungary, Italy, Japan, South Korea, Poland, Portugal, Spain, Turkey and the UK (NCT03358472)
04 Jun 2025 Incyte Corporation completes phase III clinical trials in Renal cell carcinoma (Combination therapy, Metastatic disease, First-line therapy, Late-stage disease) in USA, Norway, United Kingdom, Ukraine, Turkey, Taiwan, Spain, Russia, New Zealand, South Korea, Japan, Italy, Ireland, Hungary, Germany, France, Chile, Canada, Brazil, Australia (PO) (NCT03260894)

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