Last reviewed · How we verify

Epacadostat 100 mg

Merck Sharp & Dohme LLC · Phase 1 active Small molecule ✓ Verified May 2026 Quality 20/100

Epacadostat 100 mg is a Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 1 development. Also known as: INCB024360.

Epacadostat 100 mg is a small molecule inhibitor of the enzyme indoleamine 2,3-dioxygenase 1. It has been studied in clinical trials for various types of cancer, including solid tumors, hematologic malignancy, metastatic colorectal cancer, gastrointestinal stromal tumors, and melanoma.

Likelihood of approval
12.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 1 → approval rate +9.6pp
    Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Big-pharma sponsor +3.0pp
    Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2033–2036 —
EMA EU 2034–2037 +0.7 yr
MHRA GB 2034–2037 +0.7 yr
Health Canada CA 2034–2038 +0.9 yr
TGA AU 2034–2038 +1.2 yr
PMDA JP 2034–2038 +1.5 yr
NMPA CN 2035–2039 +2.3 yr
MFDS KR 2034–2038 +1.4 yr
CDSCO IN 2034–2039 +1.8 yr
ANVISA BR 2035–2039 +2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic nameEpacadostat 100 mg
Also known asINCB024360
SponsorMerck Sharp & Dohme LLC
ModalitySmall molecule
PhasePhase 1

Approved indications

No approved indications tracked.

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

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

Frequently asked questions about Epacadostat 100 mg

What is Epacadostat 100 mg?

Epacadostat 100 mg is a Small molecule drug developed by Merck Sharp & Dohme LLC.

Who makes Epacadostat 100 mg?

Epacadostat 100 mg is developed by Merck Sharp & Dohme LLC (see full Merck Sharp & Dohme LLC pipeline at /company/merck).

Is Epacadostat 100 mg also known as anything else?

Epacadostat 100 mg is also known as INCB024360.

What development phase is Epacadostat 100 mg in?

Epacadostat 100 mg is in Phase 1.

What are the side effects of Epacadostat 100 mg?

Common side effects of Epacadostat 100 mg include Rash, Anaemia, Constipation, Cystitis, Nasopharyngitis, Radiation skin injury.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing