Product Description
Birabresib (MK-8628/OTX015) is a first-in-class bromodomain inhibitor with activity in select hematologic tumors. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/29733771/)
Mechanisms of Action: BET 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: Merck
Company Location: Eastern America
Company CEO: Robert M. Davis
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 2: Acute Myeloid Leukemia|Glioblastoma
Phase 1: Non-Small-Cell Lung Cancer|NUT Carcinoma|Acute Myeloid Leukemia|Myelodysplastic Syndrome|Diffuse Large B-Cell Lymphoma|Prostate Cancer|Triple Negative Breast Cancer|Pancreatic Ductal Carcinoma|Ductal Breast Carcinoma|Pancreatic Cancer|Adenocarcinoma|Acute Lymphoid Leukemia|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Multiple Myeloma|B-Cell Leukemia
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT02698189 |
MK-8628-005 | P1 |
Terminated |
Acute Myeloid Leukemia|Diffuse Large B-Cell Lymphoma|Myelodysplastic Syndrome |
2018-01-18 |
41% |
2022-05-04 |
Primary Endpoints|Treatments |
NCT02698176 |
MK-8628-006 | P1 |
Terminated |
Non-Small-Cell Lung Cancer|Triple Negative Breast Cancer|NUT Carcinoma|Prostate Cancer |
2017-04-26 |
2022-05-04 |
Primary Endpoints |
|
2015-005488-18 |
MK-8628 Solid Tumor Trial | P1 |
Completed |
Non-Small-Cell Lung Cancer|NUT Carcinoma|Triple Negative Breast Cancer|Prostate Cancer |
2017-04-26 |
2025-07-02 |
Treatments |
|
NCT02259114 |
MK-8628-003 | P1 |
Completed |
Pancreatic Cancer|Non-Small-Cell Lung Cancer|Prostate Cancer|Pancreatic Ductal Carcinoma|Ductal Breast Carcinoma|Triple Negative Breast Cancer|NUT Carcinoma|Adenocarcinoma |
2017-03-03 |
2023-12-08 |
Primary Endpoints|Treatments |
|
NCT01713582 |
MK-8628-001 | P1 |
Completed |
B-Cell Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia|Diffuse Large B-Cell Lymphoma|Acute Myeloid Leukemia|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Multiple Myeloma |
2017-01-20 |
2023-12-08 |
||
NCT02303782 |
SIIT | P2 |
Withdrawn |
Acute Myeloid Leukemia |
2016-03-01 |
2023-12-08 |
Primary Endpoints|Treatments |
|
NCT02296476 |
MK-8628-002 | P2 |
Terminated |
Glioblastoma |
2015-10-20 |
2023-12-08 |