Product Description
Binimetinib is used in combination with encorafenib to treat melanoma (skin cancer) that has spread or cannot be removed by surgery. It is only used if the melanoma cells have the BRAF V600E or V600K mutations. Binimetinib belongs to the group of medicines, called antineoplastics (cancer medicines). (Sourced from: https://www.mayoclinic.org/drugs-supplements/binimetinib-oral-route/side-effects/drg-20443876?p=1)
Mechanisms of Action: MAP2K Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Brazil | Canada | Chile | Croatia | Czech | Denmark | Ecuador | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Latvia | Lithuania | Luxembourg | Mexico | Netherlands | Norway | Peru | Poland | Portugal | Romania | Russia | Saudi Arabia | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Company: Pfizer
Company Location: Eastern America
Company Founding Year: 1849
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 32
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Pfizer presented P2 Non-Small-Cell Lung Cancer results on 2025-10-19 for Binimetinib
Highest Development Phases
Phase 3: Biliary Tract Cancer|Colorectal Cancer|Melanoma
Phase 2: Brain Cancer|Neurofibroma, Plexiform|Neurofibromatoses|Neurofibromatosis 1|Non-Small-Cell Lung Cancer|Oncology Unspecified|Thyroid Cancer|Triple Negative Breast Cancer|Uveal Melanoma
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT03231306 |
NF108-BINI | P2 |
Completed |
Neurofibromatosis 1|Neurofibroma, Plexiform|Neurofibromatoses |
2024-04-17 |
2025-01-30 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
NCT03971409 |
InCITe | P2 |
Active, not recruiting |
Triple Negative Breast Cancer |
2027-01-31 |
12% |
2026-04-23 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2021-000177-80 |
MEKi Combo trial | P2 |
Active, not recruiting |
Oncology Unspecified |
2027-01-03 |
2022-03-13 |
Treatments |
|
NCT04074096 |
BEPCOME-MB | P2 |
Active, not recruiting |
Brain Cancer|Melanoma |
2026-05-07 |
12% |
2026-06-06 |
|
NCT05615818 |
SAFIR-ABC10 | P3 |
Recruiting |
Biliary Tract Cancer |
2027-06-01 |
8% |
2024-06-26 |
Primary Endpoints|Treatments |
NCT03803553 |
NCT03803553 | P3 |
Recruiting |
Colorectal Cancer |
2026-12-01 |
2024-11-27 |
Primary Endpoints|Treatments |
|
NCT05170334 |
MCC-20955 | P2 |
Active, not recruiting |
Uveal Melanoma |
2025-12-01 |
12% |
2026-04-07 |
Primary Completion Date|Primary Endpoints |
jRCT2011230032 |
jRCT2011230032 | P2 |
Not yet recruiting |
Thyroid Cancer |
2025-05-31 |
|||
NCT05195632 |
OCEANII | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2024-05-27 |
12% |
2025-06-24 |
|
NCT04741997 |
MCC-20641 | P1 |
Recruiting |
Melanoma |
2026-07-22 |
50% |
2026-03-03 |
|
jRCT2011200018 |
jRCT2011200018 | P2 |
Active, not recruiting |
Thyroid Cancer |
2025-03-31 |
|||
NCT05340621 |
NAUTILUS | P2 |
Completed |
Melanoma |
2025-01-29 |
2025-03-08 |
Primary Endpoints |
|
2021-000743-41 |
2021-000743-41 | P3 |
Active, not recruiting |
Melanoma |
2035-01-21 |
2022-03-13 |
Treatments |
|
NCT05270044 |
COLUMBUS-AD | P3 |
Active, not recruiting |
Melanoma |
2027-03-31 |
2023-11-27 |
Primary Endpoints |
|
2024-512038-13-00 |
C4221016 | P3 |
Active, not recruiting |
Melanoma |
2026-06-30 |
20% |
2025-05-02 |
|
NCT04657991 |
C4221016 | P3 |
Active, not recruiting |
Melanoma |
2026-01-12 |
20% |
2026-03-03 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT04903119 |
MCC-20-MEL-11-PMC | P1 |
Recruiting |
Melanoma |
2028-07-01 |
50% |
2026-02-14 |
Primary Endpoints |
2021-006331-26 |
BEPCOME-MB | P2 |
Active, not recruiting |
Melanoma |
2030-01-13 |
12% |
||
2024-516585-11-00 |
2024-516585-11-00 | P2 |
Recruiting |
Melanoma |
2029-12-31 |
2025-05-02 |
Treatments |
|
NCT06887088 |
ENCEFALO | P2 |
Recruiting |
Melanoma|Brain Cancer |
2028-01-01 |
2025-08-27 |
Primary Endpoints|Start Date|Treatments |
|
NCT04598009 |
NCI-2020-07748 | P2 |
Recruiting |
Melanoma |
2027-05-31 |
12% |
2026-06-05 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2023-509471-17-00 |
C4221023 | P2 |
Active, not recruiting |
Melanoma |
2027-05-23 |
2025-05-02 |
Treatments |
|
2020-005771-12 |
NeoBRAF | P2 |
Active, not recruiting |
Colorectal Cancer |
2026-04-25 |
|||
2024-515929-28-00 |
C4221008 | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2025-12-31 |
2025-05-02 |
Treatments |
|
2017-002887-42 |
EBIN | P2 |
Completed |
Melanoma |
2025-09-28 |
2025-05-06 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/04/2025 |
News Article |
Pfizer Reports Solid Third-Quarter 2025 Results; Raises and Narrows 2025 EPS Guidance |
|
09/25/2025 |
News Article |
Pfizer Highlights Momentum in Redefining Standards of Care in Cancer at ESMO 2025 |
|
04/25/2025 |
News Article |
Cogent Biosciences Presents Four Posters at the American Association for Cancer Research Annual Meeting 2025 and Announces Two New Leaders |
|
01/09/2025 |
News Article |
FORE Biotherapeutics Highlights Recent Pipeline Achievements for its Targeted-Oncology Program and Provides Strategic Objectives for 2025 |