Last reviewed 2026-05-14 · How we verify

Epacadostat 100 mg

At a glance

Approved indications

No approved indications tracked.

Common side effects

• Rash
• Anaemia
• Constipation
• Cystitis
• Nasopharyngitis
• Radiation skin injury
• Alanine aminotransferase increased
• Blood thyroid stimulating hormone increased
• Electrocardiogram QT prolonged
• Hypoalbuminaemia
• Seborrhoeic keratosis
• Insomnia

Key clinical trials

• Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma (PHASE3)
• Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307) (PHASE3)
• Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05) (PHASE2)
• Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302) (PHASE3)
• Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer (PHASE2)
• Epacadostat and Pembrolizumab in Patients With GIST (PHASE2)
• Study of Epacadostat (INCB024360) Alone and In Combination With Pembrolizumab (MK-3475) With Chemotherapy and Pembrolizumab Without Chemotherapy in Participants With Advanced Solid Tumors (MK-3475-434) (PHASE1)
• A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Participants With Advanced or Metastatic Malignancies (ECHO-208) (PHASE1, PHASE2)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Epacadostat 100 mg CI brief — competitive landscape report
• Epacadostat 100 mg updates RSS · CI watch RSS
• Merck Sharp & Dohme LLC portfolio CI