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: None *
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: Noma | Melanoma
Known Adverse Events: Lymphopenia | Hyponatremia | Hypophosphatemia | Diarrhea
Company: Hoffmann-La Roche
Company Location: BASEL SWITZERLAND V8
Company CEO: Severin Schwan
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Italy, Japan, Korea, Spain, United Kingdom, United States
Active Clinical Trial Count: 21
Highest Development Phases
Phase 3: Anaplastic Thyroid Carcinoma|Colorectal Cancer|Erdheim-Chester Disease|Glioma|Laryngeal Cancer|Melanoma|Multiple Myeloma|Non-Small-Cell Lung Cancer|Ovarian Cancer|Ovarian Diseases|Papillary Carcinoma|Rectal Diseases|Thyroid Cancer
Phase 2: Arteriovenous Malformations|Bladder Cancer|Brain Cancer|Bronchial Cancer|Bronchogenic Carcinoma|Cervical Cancer|Chronic Myelomonocytic Leukemia|Esophageal Cancer|Esophageal Diseases|Gastrointestinal Cancer|Hairy Cell Leukemia|Hemangioma|Histiocytic Disorders, Malignant|Histiocytic Sarcoma|Histiocytosis, Langerhans-Cell|Histiocytosis, Sinus|Intestinal Diseases|Juvenile Myelomonocytic Leukemia,|Langerhans Cell Sarcoma|Pancreatic Cancer|Respiratory Tract Cancer|Skin Cancer|Small Cell Lung Cancer|Squamous Cell Carcinoma|Thoracic Cancer|Tic Disorders|Xanthogranuloma, Juvenile
Phase 1: Adenocarcinoma|Oncology Solid Tumor Unspecified
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| DETERMINE | P3 |
Recruiting |
Non-Small-Cell Lung Cancer|Glioma|Anaplastic Thyroid Carcinoma|Colorectal Cancer|Erdheim-Chester Disease|Thyroid Cancer|Ovarian Cancer|Rectal Diseases|Multiple Myeloma|Papillary Carcinoma|Ovarian Diseases|Laryngeal Cancer|Melanoma |
2029-10-01 |
|
| HCL-PG04 | P2 |
Active, not recruiting |
Hairy Cell Leukemia |
2028-05-18 |
|
| NEO-TIM | P2 |
Active, not recruiting |
Melanoma |
2027-05-27 |
|
| MVR-T3011-IT-2004 | P2 |
Suspended |
Melanoma |
2026-12-31 |
57% |
| MVR-T3011-IT-2004 | P2 |
Suspended |
Melanoma |
2026-12-31 |
57% |