Drug Type Small molecule drug |
Synonyms Encorafenib (JAN/USAN/INN), 康奈非尼, 恩可非尼 + [9] |
Target |
Action inhibitors |
Mechanism BRAF V600E inhibitors |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (27 Jun 2018), |
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (Australia) |
Molecular FormulaC22H27ClFN7O4S |
InChIKeyCMJCXYNUCSMDBY-ZDUSSCGKSA-N |
CAS Registry1269440-17-6 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11053 | Encorafenib |
Indication | Country/Location | Organization | Date |
---|---|---|---|
BRAF mutated anaplastic thyroid cancer | Japan | 17 May 2024 | |
Thyroid Cancer with BRAF mutation | Japan | 17 May 2024 | |
BRAF V600E mutant Non-small Cell Lung Cancer | United States | 11 Oct 2023 | |
BRAF mutation positive Melanoma | Japan | 27 Nov 2020 | |
BRAF Mutation colorectal cancers | Japan | 08 Jan 2019 | |
BRAF V600 mutation-positive Melanoma | European Union | 19 Sep 2018 | |
BRAF V600 mutation-positive Melanoma | Iceland | 19 Sep 2018 | |
BRAF V600 mutation-positive Melanoma | Liechtenstein | 19 Sep 2018 | |
BRAF V600 mutation-positive Melanoma | Norway | 19 Sep 2018 | |
BRAF V600E mutant Colorectal Cancer | European Union | 19 Sep 2018 | |
BRAF V600E mutant Colorectal Cancer | Iceland | 19 Sep 2018 | |
BRAF V600E mutant Colorectal Cancer | Liechtenstein | 19 Sep 2018 | |
BRAF V600E mutant Colorectal Cancer | Norway | 19 Sep 2018 | |
BRAF V600E Mutation-Positive Melanoma | United States | 27 Jun 2018 | |
BRAF V600K Mutation-Positive Melanoma | United States | 27 Jun 2018 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Melanoma | Phase 3 | Argentina | 02 May 2022 | |
Melanoma | Phase 3 | Australia | 02 May 2022 | |
Melanoma | Phase 3 | Austria | 02 May 2022 | |
Melanoma | Phase 3 | Belgium | 02 May 2022 | |
Melanoma | Phase 3 | Brazil | 02 May 2022 | |
Melanoma | Phase 3 | Canada | 02 May 2022 | |
Melanoma | Phase 3 | Czechia | 02 May 2022 | |
Melanoma | Phase 3 | France | 02 May 2022 | |
Melanoma | Phase 3 | Germany | 02 May 2022 | |
Melanoma | Phase 3 | Greece | 02 May 2022 |
Not Applicable | 709 | rcvbityluy(smbbylipdh) = 2.9% eangrupsta (lwipmvgttw ) View more | - | 03 Jul 2025 | |||
Not Applicable | 43 | tfnfhsyeag(xllrzybimp) = 7% bvqnenobof (fbvdjqqhqh ) View more | Positive | 03 Jul 2025 | |||
Not Applicable | 20 | gkfzgnqusd(uopgtxuyhh) = 5% cdhhgmxqtw (tjudalmotq ) View more | Positive | 03 Jul 2025 | |||
Phase 1 | Toxicity BRAFV600E-mutated | KRAS-WT | RNF43 mutation | 2 | pmgbmdehic(noqcfdfywn) = The two patients described developed severe bone toxicities including rib fractures, a toe fracture, osteoporotic thoracic collapses, hypercalcemia, and alternated bone biomarkers vienlclsax (vdlfrapvhi ) | Negative | 01 Jul 2025 | ||
Phase 3 | - | ouptnfsjfi(smpbpefpyk) = The incidence of serious adverse events during treatment was 46.1% with EC+mFOLFOX6 and 38.9% with standard care dsnqwexgsn (cmymbczhvu ) View more | Positive | 26 Jun 2025 | |||
Standard care (chemotherapy with or without bevacizumab) | |||||||
Phase 2 | Melanoma First line | 271 | Encorafenib 450 mg + Binimetinib 45 mg | koumxxqphk(gtzzzdycky) = Grade 3-5 treatment-related adverse events occurred in 57 (42%) of 136 patients who started treatment in the Encorafenib 450 mg + Binimetinib 45 mg group and in 42 (32%) of 131 patients who started treatment in the Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg group pdmysetlbg (pimagngzdc ) View more | Negative | 01 Jun 2025 | |
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg | |||||||
Phase 3 | 637 | doxuigvnzy(xeeeidxfmd) = udomdtszeb mundavkdqy (ttnkouwhrw, 5.7 - 8.3) View more | Positive | 30 May 2025 | |||
doxuigvnzy(xeeeidxfmd) = mhhijomnsw mundavkdqy (ttnkouwhrw, 11.2 - 15.9) View more | |||||||
Phase 2 | 48 | nzsccjxcvo(uuajcpgfxj) = fpciltlyvg wrmacexsom (lnwtdusiml, pgvxacxivc - fydmqqsywj) View more | - | 13 May 2025 | |||
Phase 3 | 479 | umwanxvyxb(xguhnkdtxd) = czghwxnqed jjorxnzgmf (pguxwarseb, 51.6 - 69.5) View more | Positive | 23 Jan 2025 | |||
umwanxvyxb(xguhnkdtxd) = zqgjttblis jjorxnzgmf (pguxwarseb, 31.3 - 49.3) View more | |||||||
Phase 2 | BRAF V600E mutant Colorectal Cancer BRAF V600E mutated | 20 | Cetuximab every second week + Encorafenib | gxzcsdwdia(yocgicvsra) = jsliwmyjjx wpxczneheg (gsefvdcykj ) | Positive | 23 Jan 2025 |