BRAFTOVI

PeakSM

encorafenib

NDAORALCAPSULE
Approved
Jun 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

V600E, as well as wild-type BRAF and CRAF in in vitro cell-free assays with IC 50 values of 0.35, 0.47, and 0.3 nM, respectively. Mutations in the BRAF gene, such as BRAF V600E, can result in constitutively activated BRAF kinases that may stimulate tumor cell growth. Encorafenib was also able to…

Clinical Trials (5)

NCT07092410Phase 4Not Yet Recruiting

Surgical or Radiotherapeutic Intervention Concerning Large Singular Stable to Progressive Metastases in Patients With BRAFV600-mutated Melanoma Receiving Treatment With Encorafenib + Binimetinib

Started Aug 2025
101 enrolled
Melanoma BRAF V600E/K Mutated
NCT07022457N/ARecruiting

UK ENcorafenib and BInimetinib Real-world Study in Melanoma

Started Jul 2025
50 enrolled
Metastatic Melanoma, BRAF V600 Mutation Positive
NCT06887088Phase 2Recruiting

Encorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases

Started May 2025
33 enrolled
Melanoma BRAF V600E/K MutatedMelanoma and Brain Metastases
NCT06578559Phase 2Active Not Recruiting

Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients BRAF V600E Mutated mCRC

Started Jul 2024
16 enrolled
Colorectal Cancer
NCT06640166Phase 2Recruiting

Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab.

Started Jun 2024
25 enrolled
Colorectal CarcinomaColorectal NeoplasmsColorectal Tumor+7 more

Loss of Exclusivity

LOE Date
Aug 5, 2033
90 months away
Patent Expiry
Aug 5, 2033
Exclusivity Expiry
Oct 11, 2030

Patent Records (5)

Patent #ExpiryTypeUse Code
8946250
Jul 23, 2029
SubstanceProduct
8541575
Feb 26, 2030
SubstanceProduct
U-4051
RE49556
Feb 27, 2030
SubstanceProduct
10005761
Aug 27, 2030
U-4051
9593099
Aug 27, 2030
Substance