Product Description
Encorafenib is used along with binimetinib (Mektovi) to treat certain types of melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be removed by surgery. It is also used with cetuximab (Erbitux) to treat a certain type of colon cancer in adults that has spread to other parts of the body after other treatment(s). Encorafenib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. (Sourced from: https://medlineplus.gov/druginfo/meds/a618040.html)
Mechanisms of Action: BRAF 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 | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Mexico | Netherlands | Norway | Peru | Poland | Portugal | Romania | Russia | Saudi Arabia | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Pfizer
Company Location: NEW YORK NY 10017
Company CEO: Albert Bourla
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, India, Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 44
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Pfizer presented P2 Non-Small-Cell Lung Cancer results on 2025-10-19 for Encorafenib
- Clinical Outcomes Reported - Pfizer presented P3 Colorectal Cancer results on 2025-05-30 for Encorafenib
- Clinical Outcomes Reported - Pfizer presented P3 Biliary Tract Cancer results on 2025-06-01 for Encorafenib
Highest Development Phases
Phase 3: Biliary Tract Cancer|Colorectal Cancer|Melanoma
Phase 2: Adenocarcinoma|Brain Cancer|Multiple Myeloma|Non-Small-Cell Lung Cancer|Oncology Solid Tumor Unspecified|Thyroid Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05615818 |
SAFIR-ABC10 | P3 |
Recruiting |
Biliary Tract Cancer |
2027-06-01 |
17% |
2024-06-26 |
Primary Endpoints|Treatments |
NCT04657991 |
C4221016 | P3 |
Active, not recruiting |
Melanoma |
2025-12-14 |
34% |
2025-08-15 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT04607421 |
C4221015 | P3 |
Active, not recruiting |
Colorectal Cancer |
2025-12-08 |
38% |
2025-08-15 |
|
NCT06640166 |
ECLYPse | P2 |
Recruiting |
Adenocarcinoma|Colorectal Cancer |
2025-12-31 |
12% |
2024-10-16 |
|
2024-515929-28-00 |
C4221008 | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2025-12-31 |
40% |
2025-05-02 |
Treatments |
jRCT2011230032 |
jRCT2011230032 | P2 |
Not yet recruiting |
Thyroid Cancer |
2025-05-31 |
|||
NCT03843775 |
NCT03843775 | P2 |
Completed |
Oncology Solid Tumor Unspecified |
2023-09-02 |
12% |
2023-09-07 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT02834364 |
GMMG-BIRMA | P2 |
Completed |
Multiple Myeloma |
2023-03-29 |
18% |
2023-11-27 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT06887088 |
ENCEFALO | P2 |
Recruiting |
Brain Cancer|Melanoma |
2028-01-01 |
12% |
2025-08-27 |
Primary Endpoints|Start Date|Treatments |
NCT06578559 |
BRICKET | P2 |
Recruiting |
Colorectal Cancer |
2026-08-01 |
12% |
2024-08-30 |
|
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 |
43% |
2023-11-27 |
Primary Endpoints |
NCT03803553 |
NCT03803553 | P3 |
Recruiting |
Colorectal Cancer |
2026-12-01 |
2024-11-27 |
Primary Endpoints|Treatments |
|
2023-509405-77-00 |
C4221015 | P3 |
Active, not recruiting |
Colorectal Cancer |
2026-11-15 |
38% |
2025-05-02 |
|
jRCT2031200393 |
jRCT2031200393 | P3 |
Recruiting |
Colorectal Cancer |
2026-11-15 |
|||
NCT05985954 |
NCI-2023-06254 | P1 |
Recruiting |
Colorectal Cancer |
2028-03-28 |
2% |
2024-08-27 |
Primary Completion Date|Primary Endpoints |
2024-512038-13-00 |
C4221016 | P3 |
Active, not recruiting |
Melanoma |
2026-06-30 |
34% |
2025-05-02 |
|
NCT04903119 |
MCC-20-MEL-11-PMC | P1 |
Recruiting |
Melanoma |
2027-07-01 |
12% |
2025-03-08 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT04741997 |
MCC-20641 | P1 |
Recruiting |
Melanoma |
2026-07-01 |
2% |
2025-09-11 |
Primary Endpoints |
2024-516585-11-00 |
2024-516585-11-00 | P2 |
Recruiting |
Melanoma |
2029-12-31 |
2025-05-02 |
Treatments |
|
NCT06194929 |
DETERMINE | P2 |
Recruiting |
Melanoma|Brain Cancer |
2028-01-15 |
12% |
2025-12-04 |
|
2023-509471-17-00 |
C4221023 | P2 |
Active, not recruiting |
Melanoma |
2027-05-23 |
12% |
2025-05-02 |
Treatments |
2024-512119-34-00 |
C4221022 | P2 |
Active, not recruiting |
Colorectal Cancer |
2027-03-28 |
12% |
2025-05-02 |
Treatments |
NCT05706779 |
NEORAF | P2 |
Recruiting |
Colorectal Cancer |
2026-12-30 |
29% |
2025-09-03 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2021-000828-35 |
NEORAF | P2 |
Active, not recruiting |
Colorectal Cancer|Adenocarcinoma |
2026-11-17 |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/04/2025 |
News Article |
Pfizer Reports Solid Third-Quarter 2025 Results; Raises and Narrows 2025 EPS Guidance |
|
10/24/2025 |
News Article |
Human Combinatorial Antibody Libraries Market to Surge USD 189.57 Million by 2034, Reports Towards Healthcare |
|
09/25/2025 |
News Article |
Pfizer Highlights Momentum in Redefining Standards of Care in Cancer at ESMO 2025 |
|
08/05/2025 |
News Article |
Pfizer Reports Strong Second-Quarter 2025 Results And Raises 2025 EPS Guidance |