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: KENILWORTH NJ 07033
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: Diffuse Large B-Cell Lymphoma|Acute Myeloid Leukemia|Triple Negative Breast Cancer|Prostate Cancer|NUT Carcinoma|Myelodysplastic Syndrome|Non-Small-Cell Lung Cancer|B-Cell Leukemia|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Pancreatic Ductal Carcinoma|Pancreatic Cancer|Multiple Myeloma|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia|Adenocarcinoma|Ductal Breast Carcinoma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| MK-8628-005 | P1 |
Terminated |
Acute Myeloid Leukemia|Myelodysplastic Syndrome|Diffuse Large B-Cell Lymphoma |
2018-01-18 |
41% |
2022-05-04 |
Primary Endpoints|Treatments |
| MK-8628-006 | P1 |
Terminated |
Triple Negative Breast Cancer|Prostate Cancer|Non-Small-Cell Lung Cancer|NUT Carcinoma |
2017-04-26 |
2022-05-04 |
Primary Endpoints |
|
| MK-8628 Solid Tumor Trial | P1 |
Completed |
Non-Small-Cell Lung Cancer|NUT Carcinoma|Triple Negative Breast Cancer|Prostate Cancer |
2017-04-26 |
2025-06-13 |
Treatments |
|
| MK-8628-003 | P1 |
Completed |
Pancreatic Ductal Carcinoma|Pancreatic Cancer|Triple Negative Breast Cancer|Adenocarcinoma|Non-Small-Cell Lung Cancer|Ductal Breast Carcinoma|Prostate Cancer|NUT Carcinoma |
2017-03-03 |
2023-12-08 |
Primary Endpoints|Treatments |
|
| MK-8628-001 | P1 |
Completed |
Acute Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|B-Cell Leukemia|Acute Myeloid Leukemia|Multiple Myeloma|Diffuse Large B-Cell Lymphoma|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma |
2017-01-20 |
2023-12-08 |
||
| SIIT | P2 |
Withdrawn |
Acute Myeloid Leukemia |
2016-03-01 |
2023-12-08 |
Primary Endpoints|Treatments |
|
| MK-8628-002 | P2 |
Terminated |
Glioblastoma |
2015-10-20 |
2023-12-08 |