Product Description
An orally available hydroxyamidine and inhibitor of indoleamine 2,3-dioxygenase (IDO1), with potential immunomodulating and antineoplastic activities. epacadostat targets and binds to IDO1, an enzyme responsible for the oxidation of tryptophan into kynurenine. By inhibiting IDO1 and decreasing kynurenine in tumor cells, epacadostat increases and restores the proliferation and activation of various immune cells, including dendritic cells (DCs), NK cells, and T-lymphocytes, as well as interferon (IFN) production, and a reduction in tumor-associated regulatory T cells (Tregs). Activation of the immune system, which is suppressed in many cancers, may inhibit the growth of IDO1-expressing tumor cells. IDO1 is overexpressed by a variety of tumor cell types and DCs. (Sourced from: https://www.cancer.gov/publications/dictionaries/cancer-drug/def/epacadostat)
Mechanisms of Action: IDO1 Inhibitor
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Incyte
Company Location: WILMINGTON DE 19803
Company CEO: Hervé Hoppenot
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Japan, Portugal, Spain, United States
Active Clinical Trial Count: 9
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Head and Neck Cancer|Squamous Cell Carcinoma|Transitional Cell Carcinoma
Phase 2: Adenocarcinoma|Bladder Cancer|Colorectal Cancer|Glioblastoma|Glioma|Pancreatic Cancer|Sarcoma
Phase 1: Non-Small-Cell Lung Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
JapicCTI-183887 |
JapicCTI-183887 | P1 |
Active |
Non-Small-Cell Lung Cancer |
2022-12-01 |
|||
NCT03006302 |
J16173 | P2 |
Completed |
Adenocarcinoma|Pancreatic Cancer |
2023-08-22 |
35% |
2024-10-09 |
Primary Endpoints|Study Completion Date |
2024-512015-47-00 |
MK-3475-669 | P3 |
Active, not recruiting |
Head and Neck Cancer|Squamous Cell Carcinoma |
2024-12-27 |
2025-05-02 |
Treatments |
|
NCT03516708 |
1R01CA278197 | P2 |
Recruiting |
Colorectal Cancer |
2027-07-15 |
12% |
2024-11-14 |
Patient Enrollment|Primary Endpoints|Start Date|Treatments |
NCT03414229 |
NCT03414229 | P2 |
Active, not recruiting |
Sarcoma |
2024-09-09 |
12% |
2025-05-03 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT03532295 |
NCT03532295 | P2 |
Completed |
Glioblastoma|Glioma |
2024-07-26 |
12% |
2025-11-22 |
Primary Endpoints|Study Completion Date|Trial Status |
2020-002244-23 |
Optimus | P2 |
Completed |
Bladder Cancer|Transitional Cell Carcinoma |
2024-01-29 |
2025-05-06 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
JapicCTI-163423 |
JapicCTI-163423 | P1 |
Active |
Non-Small-Cell Lung Cancer |
2020-06-01 |
|||
JapicCTI-183978 |
JapicCTI-183978 | P3 |
Active |
Transitional Cell Carcinoma |
2021-04-01 |