Product Description
Cobimetinib is an orally bioavailable small-molecule inhibitor of mitogen-activated protein kinase kinase 1 (MAP2K1 or MEK1), with potential antineoplastic activity. Cobimetinib specifically binds to and inhibits the catalytic activity of MEK1, resulting in inhibition of extracellular signal-related kinase 2 (ERK2) phosphorylation and activation and decreased tumor cell proliferation. (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Cobimetinib)
Mechanisms of Action: MAP2K Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Latvia | Lithuania | Luxembourg | Malaysia | Netherlands | New Zealand | Norway | Peru | Poland | Portugal | Romania | Russia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay
Approved Indications: None
Known Adverse Events: None
Company: Hoffmann-La Roche
Company Location:
Company Founding Year: 1896
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Latvia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 34
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Anaplastic Thyroid Carcinoma|Colorectal Cancer|Erdheim-Chester Disease|Glioma|Laryngeal Cancer|Lymphoproliferative Disorders|Melanoma|Multiple Myeloma|Non-Small-Cell Lung Cancer|Ovarian Cancer|Ovarian Diseases|Papillary Carcinoma|Rectal Diseases|Thyroid Cancer
Phase 2: Abnormalities, Multiple|Adenocarcinoma|Arteriovenous Malformations|Bladder Cancer|Brain Cancer|Breast Cancer|Chronic Myelomonocytic Leukemia|Histiocytic Disorders, Malignant|Histiocytic Sarcoma|Histiocytosis, Langerhans-Cell|Histiocytosis, Sinus|Hodgkin Lymphoma|Intestinal Cancer|Langerhans Cell Sarcoma|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Oncology Solid Tumor Unspecified|Oncology Unspecified|Pancreatic Cancer|Vision, Low|Xanthogranuloma, Juvenile
Phase 1: Pancreatic Ductal Carcinoma|Skin Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04005690 |
STUDY00019211 | P1 |
Recruiting |
Adenocarcinoma|Pancreatic Cancer|Pancreatic Ductal Carcinoma |
2026-06-01 |
50% |
2025-02-14 |
Primary Endpoints|Treatments |
NCT02721459 |
MCC-18597 | P1 |
Active, not recruiting |
Melanoma|Skin Cancer |
2019-10-31 |
50% |
2023-11-22 |
Primary Endpoints|Study Completion Date|Treatments |
NCT03337698 |
Morpheus Lung | P2 |
Completed |
Non-Small-Cell Lung Cancer |
2025-10-14 |
12% |
2025-12-13 |
Primary Endpoints |
NCT05125471 |
COBI-AVM Study | P2 |
Completed |
Arteriovenous Malformations |
2025-09-03 |
12% |
2025-09-11 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT04409639 |
CONCERTO | P2 |
Active, not recruiting |
Chronic Myelomonocytic Leukemia |
2025-04-02 |
12% |
2026-02-13 |
Primary Completion Date|Primary Endpoints|Treatments |
2018-002190-21 |
ROME | P2 |
Completed |
Breast Cancer|Non-Small-Cell Lung Cancer|Intestinal Cancer |
2024-09-06 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
NCT02091141 |
My Pathway | P2 |
Completed |
Bladder Cancer |
2023-05-24 |
52% |
2024-02-23 |
Primary Completion Date|Primary Endpoints |
2017-000768-13 |
RadioCoBRIM | P2 |
Active, not recruiting |
Melanoma|Brain Cancer |
2021-11-21 |
2022-03-13 |
Treatments |
|
NCT05768178 |
DETERMINE | P3 |
Recruiting |
Multiple Myeloma|Colorectal Cancer|Non-Small-Cell Lung Cancer|Ovarian Diseases|Laryngeal Cancer|Rectal Diseases|Papillary Carcinoma|Erdheim-Chester Disease|Ovarian Cancer|Glioma|Melanoma|Thyroid Cancer|Anaplastic Thyroid Carcinoma |
2029-10-01 |
35% |
2025-05-22 |
Primary Endpoints|Treatments |
NCT05722886 |
DETERMINE | P3 |
Recruiting |
Lymphoproliferative Disorders |
2029-10-01 |
27% |
2025-05-31 |
Primary Endpoints|Treatments |
NCT04341181 |
ProTarget | P2 |
Recruiting |
Oncology Solid Tumor Unspecified |
2029-04-30 |
12% |
2025-07-26 |
Primary Endpoints |
2023-508194-89-00 |
WO42178 | P2 |
Active, not recruiting |
Oncology Unspecified |
2028-05-30 |
2025-05-02 |
Treatments |
|
NCT04931342 |
BOUQUET | P2 |
Active, not recruiting |
Ovarian Cancer |
2028-02-28 |
12% |
2024-09-20 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT02925234 |
DRUP | P2 |
Recruiting |
Lymphoma, Non-Hodgkin|Multiple Myeloma|Hodgkin Lymphoma|Vision, Low|Abnormalities, Multiple|Lymphoma, B-Cell |
2027-09-01 |
12% |
2024-01-25 |
Primary Endpoints |
NCT03297606 |
CAPTUR | P2 |
Recruiting |
Lymphoma, Non-Hodgkin|Multiple Myeloma |
2026-12-31 |
12% |
2026-03-05 |
Primary Completion Date|Primary Endpoints |
NCT05756556 |
MVR-T3011-IT-2004 | P2 |
Suspended |
Melanoma |
2026-12-31 |
13% |
2024-02-02 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
NCT04079179 |
NACHO-COBI | P2 |
Recruiting |
Histiocytosis, Sinus|Histiocytosis, Langerhans-Cell|Histiocytic Sarcoma|Histiocytic Disorders, Malignant|Langerhans Cell Sarcoma|Xanthogranuloma, Juvenile|Erdheim-Chester Disease |
2025-12-01 |
12% |
2025-06-21 |
Primary Endpoints |
NCT05034627 |
STUDY00022141 | P1 |
Active, not recruiting |
Adenocarcinoma|Pancreatic Cancer |
2025-12-16 |
50% |
2025-10-28 |
Primary Endpoints|Treatments|Trial Status |
NCT03202940 |
NCT03202940 | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2029-01-01 |
2% |
2025-09-26 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT02693535 |
TAPUR | P2 |
Recruiting |
Lymphoma, Non-Hodgkin|Multiple Myeloma |
2027-12-31 |
12% |
2026-02-14 |
|
NCT04302025 |
NAUTIKA1 | P2 |
Recruiting |
Non-Small-Cell Lung Cancer |
2026-11-30 |
12% |
2025-10-23 |
|
NCT03193190 |
Morpheus-Pancreatic Cancer | P2 |
Completed |
Adenocarcinoma|Pancreatic Cancer |
2025-02-27 |
12% |
2025-04-19 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date |
NCT03732703 |
MyDRUG | P2 |
Completed |
Multiple Myeloma |
2024-12-31 |
52% |
2025-02-15 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT03178552 |
B-FAST | P3 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2026-10-31 |
78% |
2025-09-11 |
|
NCT07449754 |
HM-RAFI-201 | P2 |
Recruiting |
Melanoma |
2029-09-01 |
12% |
2026-03-05 |
Primary Endpoints|Treatments |