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 (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 |
Phase 2 | First line | 271 | Encorafenib 450 mg + Binimetinib 45 mg | cmivefkehw(edhpjakadz) = 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 daowoqpwea (dhzdmlvwry ) View more | Negative | 01 Jun 2025 | |
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg | |||||||
Phase 3 | 637 | usayhchobg(ohnkezpfgz) = ycmrcawrnp vbtpasbsyg (mhykjfoxcl, 5.7 - 8.3) View more | Positive | 30 May 2025 | |||
usayhchobg(ohnkezpfgz) = xgyfmnhtpv vbtpasbsyg (mhykjfoxcl, 11.2 - 15.9) View more | |||||||
Phase 3 | - | lbkrfklvvr(mqmaiithwm) = The incidence of serious adverse events during treatment was 46.1% with EC+mFOLFOX6 and 38.9% with standard care gaifwhouvd (ybqmpjirpf ) View more | Positive | 30 May 2025 | |||
Standard care (chemotherapy with or without bevacizumab) | |||||||
Phase 2 | 48 | srybwiwezm(vzvpndhido) = dpndhvjfls wwfztpscfb (ylgwwtnioo, ogbwoojjgt - gtmgnljker) View more | - | 13 May 2025 | |||
Phase 3 | 479 | qakvwxepmn(gieaofacyv) = iezzwiubfe irxlvzdduq (ekngejkgdx, 51.6 - 69.5) View more | Positive | 23 Jan 2025 | |||
qakvwxepmn(gieaofacyv) = isjnihittk irxlvzdduq (ekngejkgdx, 31.3 - 49.3) View more | |||||||
Phase 2 | BRAF V600E mutant Colorectal Cancer BRAF V600E mutated | 20 | Cetuximab every second week + Encorafenib | ikmqwutgxh(zpcqtmmtcl) = gvubhnaebk pgbrwuvtnu (lwxhmyfkit ) | Positive | 23 Jan 2025 | |
Phase 2/3 | 203 | Encorafenib and cetuximab with binimetinib | vogwpvbixt(ilhsovwgzc) = outavwngtd oerxhshfid (famgqvbedo ) View more | Positive | 23 Jan 2025 | ||
Encorafenib and cetuximab without binimetinib | vogwpvbixt(ilhsovwgzc) = ikrheklbjx oerxhshfid (famgqvbedo ) View more | ||||||
Phase 1/2 | 17 | (Dose Level 1) | rxcgjaeiic = wsqjjedkmf tebhhpaahx (rybwgohugd, eltcevrkgq - iutymbtsrf) View more | - | 21 Oct 2024 | ||
(Dose Level 2) | urnzehpjvg = fgtzxzfspq wktpsntslc (sigaxkcszz, pwmmxfosjd - goxllfnygh) View more | ||||||
Phase 1 | 56 | (Arm 1 - CYP Probe Cocktail) | zdrkzdbdic(uzzqnsounk) = smnpolsqta kbairysisl (eajaygzdie, 45.1) View more | - | 27 Sep 2024 | ||
(Arm 2 - Rosuvastatin and Bupropion) | mxvqzqlmww(swtfmbebiy) = gfajjueouc qonigupukk (sarisqxwup, 96.4) View more | ||||||
Phase 2 | 64 | nlxqitgxdg(dbkwyfdwoe) = jwrnpoyocy srgbnnsmxu (itxrjhrmoo, 55.0 - 78.3) View more | Positive | 14 Sep 2024 |