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: BASEL SWITZERLAND V8
Company CEO: Severin Schwan
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, 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, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States
Active Clinical Trial Count: 33
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|Hemangioma|Histiocytic Disorders, Malignant|Histiocytic Sarcoma|Histiocytosis, Langerhans-Cell|Histiocytosis, Sinus|Hodgkin Lymphoma|Intestinal Cancer|Juvenile Myelomonocytic Leukemia,|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 |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| DETERMINE | P3 |
Recruiting |
Ovarian Cancer|Thyroid Cancer|Erdheim-Chester Disease|Melanoma|Multiple Myeloma|Glioma|Anaplastic Thyroid Carcinoma|Papillary Carcinoma|Laryngeal Cancer|Ovarian Diseases|Non-Small-Cell Lung Cancer|Colorectal Cancer|Rectal Diseases |
2029-10-01 |
35% |
2025-05-22 |
Primary Endpoints|Treatments |
| DETERMINE | P3 |
Recruiting |
Lymphoproliferative Disorders |
2029-10-01 |
27% |
2025-05-31 |
Primary Endpoints|Treatments |
| WO42178 | P2 |
Active, not recruiting |
Oncology Unspecified |
2028-05-30 |
2025-05-02 |
Treatments |
|
| BOUQUET | P2 |
Active, not recruiting |
Ovarian Cancer |
2028-02-28 |
12% |
2024-09-20 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| DRUP | P2 |
Recruiting |
Multiple Myeloma|Lymphoma, Non-Hodgkin|Abnormalities, Multiple|Hodgkin Lymphoma|Vision, Low|Lymphoma, B-Cell |
2027-09-01 |
12% |
2024-01-25 |
Primary Endpoints |
| 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 |
| STUDY00019211 | P1 |
Recruiting |
Adenocarcinoma|Pancreatic Ductal Carcinoma|Pancreatic Cancer |
2026-06-01 |
23% |
2025-02-14 |
Primary Endpoints|Treatments |
| CAPTUR | P2 |
Recruiting |
Lymphoma, Non-Hodgkin|Multiple Myeloma |
2026-01-31 |
12% |
2024-06-28 |
Primary Endpoints |
| Morpheus Lung | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2025-09-30 |
12% |
2024-12-27 |
Patient Enrollment|Primary Endpoints |
| CONCERTO | P2 |
Recruiting |
Juvenile Myelomonocytic Leukemia,|Chronic Myelomonocytic Leukemia |
2025-08-15 |
12% |
2023-03-11 |
Primary Completion Date|Primary Endpoints |
| COBI-AVM Study | P2 |
Active, not recruiting |
Arteriovenous Malformations|Hemangioma |
2025-08-01 |
50% |
2025-06-07 |
|
| 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 |
| 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 |
| CRAFT | P2 |
Completed |
Oncology Solid Tumor Unspecified |
2024-12-30 |
2025-06-01 |
Treatments |
|
| NACHO-COBI | P2 |
Recruiting |
Erdheim-Chester Disease|Xanthogranuloma, Juvenile|Langerhans Cell Sarcoma|Histiocytosis, Langerhans-Cell|Histiocytic Disorders, Malignant|Histiocytic Sarcoma|Histiocytosis, Sinus |
2024-12-01 |
12% |
2023-03-16 |
Primary Endpoints|Treatments |
| ROME | P2 |
Completed |
Non-Small-Cell Lung Cancer|Breast Cancer|Intestinal Cancer |
2024-09-06 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
| My Pathway | P2 |
Completed |
Bladder Cancer |
2023-05-24 |
52% |
2024-02-23 |
Primary Completion Date|Primary Endpoints |
| RadioCoBRIM | P2 |
Active, not recruiting |
Brain Cancer|Melanoma |
2021-11-21 |
2022-03-13 |
Treatments |
|
| MCC-18597 | P1 |
Active, not recruiting |
Skin Cancer|Melanoma |
2019-10-31 |
23% |
2023-11-22 |
Primary Endpoints|Study Completion Date|Treatments |
| B-FAST | P3 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2028-08-03 |
82% |
2024-11-02 |
|
| TAPUR | P2 |
Recruiting |
Lymphoma, Non-Hodgkin|Multiple Myeloma |
2027-12-31 |
12% |
2025-04-26 |
|
| NAUTIKA1 | P2 |
Recruiting |
Non-Small-Cell Lung Cancer |
2025-12-30 |
12% |
2024-05-02 |
|
| STUDY00022141 | P1 |
Recruiting |
Pancreatic Cancer|Adenocarcinoma |
2025-12-16 |
4% |
2024-10-30 |
Primary Completion Date|Primary Endpoints |
| NCT03202940 | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2025-01-01 |
36% |
2024-04-24 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| HM-RAFI-103 | P1 |
Active, not recruiting |
Oncology Solid Tumor Unspecified |
2024-09-30 |
12% |
2023-08-02 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |