Epacadostat is under clinical development by Incyte and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Epacadostat’s likelihood of approval (LoA) and phase transition for Non-Small Cell Lung Cancer took place on 31 Oct 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Epacadostat Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Epacadostat overview

Epacadostat (INCB-24360) is under development for the treatment of non-small cell lung cancer, urothelial carcinoma, rectal cancer and recurrent glioblastoma multiforme, epstein-barr virus positive (EBV+) nasopharyngeal carcinoma and salivary gland cancer. It is a small molecule administered orally as a tablet and targets indoleamine-2, 3-dioxygenase-1 (IDO1).

It was under development for epithelial ovarian cancer, ocular melanoma, metastatic melanoma, primary peritoneal carcinoma, fallopian tube cancer, thymic carcinoma, metastatic renal cell carcinoma, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, metastatic urothelial cancer, recurrent head and neck cancer squamous cell carcinoma, ocular melanoma, colorectal cancer, ovarian cancer, diffuse large B-cell lymphoma, breast cancer, adenocarcinoma of endometrial cancer, B-cell Hodgkin, non-hodgkin lymphoma, pancreatic cancer, endometrial cancer, renal cell carcinoma, hepatocellular carcinoma and gastric cancer, myelodysplastic syndrome.

Incyte overview

Incyte is a biopharmaceutical company, which discovers, develops and commercializes proprietary cancer therapeutics. The company’s lead product, Jakafi (ruxolitinib) is marketed in the US for the treatment of patients with high-risk myelofibrosis; and polycythemia vera who are intolerant to hydroxyurea. The company distributes Jakafi through a network of specialty pharmacy providers and wholesalers. In collaboration with Incyte, Novartis International Pharmaceutical Ltd (Novartis) develops and commercializes ruxolitinib outside the US for hematologic and cancer indications under the name Jakavi. The company’s pipeline portfolio encompasses drugs for the treatment of lung cancer, graft versus host disease, non-small cell lung cancer, b-cell malignancies, solid tumors, glioblastoma, liver cancer, and advanced malignancies. Incyte is headquartered in Wilmington, Delaware, the US.

Quick View Epacadostat LOA Data

Report Segments
  • Innovator
Drug Name
  • Epacadostat
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Phase II

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.