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: None *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Merck
Company Location: KENILWORTH NJ 07033
Company CEO: Robert M. Davis
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Highest Development Phases
Phase 2: Glioblastoma|Acute Myeloid Leukemia
Phase 1: Myelodysplastic Syndrome|Acute Myeloid Leukemia|Diffuse Large B-Cell Lymphoma|Non-Small-Cell Lung Cancer|Prostate Cancer|Triple Negative Breast Cancer|NUT Carcinoma|Pancreatic Cancer|Pancreatic Ductal Carcinoma|Acute Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Multiple Myeloma|Ductal Breast Carcinoma|Adenocarcinoma|B-Cell Leukemia|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| MK-8628-005 | P1 |
Terminated |
Diffuse Large B-Cell Lymphoma|Myelodysplastic Syndrome|Acute Myeloid Leukemia |
2018-01-18 |
|
| MK-8628-006 | P1 |
Terminated |
Prostate Cancer|NUT Carcinoma|Non-Small-Cell Lung Cancer|Triple Negative Breast Cancer |
2017-04-26 |
|
| MK-8628 Solid Tumor Trial | P1 |
Completed |
NUT Carcinoma|Triple Negative Breast Cancer|Prostate Cancer|Non-Small-Cell Lung Cancer |
2017-04-26 |
|
| MK-8628-003 | P1 |
Completed |
Triple Negative Breast Cancer|Prostate Cancer|Ductal Breast Carcinoma|NUT Carcinoma|Non-Small-Cell Lung Cancer|Pancreatic Cancer|Pancreatic Ductal Carcinoma|Adenocarcinoma |
2017-03-03 |