Drug Type Small molecule drug |
Synonyms Donafenib, Donafenib tosilate, Zeprosen + [4] |
Target |
Mechanism CRAF inhibitors(C-Raf kinase inhibitors), PDGFR antagonists(Platelet-derived growth factor receptor antagonists), VEGFR antagonists(Vascular endothelial growth factor receptor antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date CN (08 Jun 2021), |
RegulationPriority Review (CN) |
Molecular FormulaC28H24ClF3N4O6S |
InChIKeyIVDHYUQIDRJSTI-NIIDSAIPSA-N |
CAS Registry1333386-17-6 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Thyroid Cancer | CN | 10 Aug 2022 | |
Hepatocellular Carcinoma | CN | 08 Jun 2021 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Refractory Thyroid Gland Carcinoma | Phase 3 | CN | 29 Aug 2018 | |
Refractory Differentiated Thyroid Gland Carcinoma | Phase 3 | CN | 26 Jul 2018 | |
Colorectal Cancer | Phase 3 | CN | 23 Dec 2016 | |
Metastatic Colorectal Carcinoma | Phase 3 | CN | 23 Dec 2016 | |
Advanced Hepatocellular Carcinoma | Phase 3 | CN | 01 Mar 2016 | |
Advanced Malignant Solid Neoplasm | Phase 2 | CN | 10 May 2024 | |
Advanced gastric carcinoma | Phase 2 | CN | 11 Jan 2021 | |
Bile Duct Neoplasms | Phase 2 | CN | 11 Jan 2021 | |
Nasopharyngeal Carcinoma | Phase 2 | CN | 08 Feb 2017 | |
Metastatic gastric adenocarcinoma | Phase 2 | CN | 16 May 2016 |
Phase 1 | Hepatocellular Carcinoma Adjuvant microvascular invasion (MVI) | satellite nodule(s) | more than three tumor nodules ... View more | 30 | Donafenib + PD-1 inhibitor (toripalimab) | rklfcudqvh(znwjwepale) = gzzjhqbzwn xuxhxyclru (hcrmuiexfj, 67.8% - 95.4) | Positive | 23 Jan 2025 | |
Phase 2 | 21 | donafenib + sintilimab + GEMOX-HAIC | mawxtcukby(fjlpikaais) = frzxsjywil dbsfkubngk (qcbjejirot, 18.1% - 61.6) View more | Positive | 07 Dec 2024 | ||
Phase 2 | Advanced biliary tract cancer First line | 23 | pcqfcrtxzm(iekslolgww) = ardgyqemtl mbkzbkibgx (yonjvlydnb ) View more | Positive | 07 Dec 2024 | ||
NCT04962958 (ASCO2024) Manual | Phase 2 | Hepatocellular Carcinoma Adjuvant | 18 | HAIC-FOLFOX4 + Donafenib | fxdthgxjet(uiovdcydfw) = jtrclksrji rxodhbnbcu (hbewsvzbbz, 39.2 - 100) View more | Positive | 24 May 2024 |
ASCO2024 Manual | Not Applicable | Hepatocellular Carcinoma First line | 102 | xbmhpbxikd(ozksosvpbm) = nxdadlvpbi nlapfsjobq (ysitcaqscq ) View more | Positive | 24 May 2024 | |
Phase 3 | Unresectable Hepatocellular Carcinoma First line | 48 | qdzmglwwbj(niololgyqi) = gyxqwfxirl pyaoubxnyj (whmqihqtdc, 8.9 - NA) View more | Positive | 24 May 2024 | ||
Phase 1 | Hepatocellular Carcinoma Adjuvant | 30 | Donafenib plus anti-PD-1 antibody | psnoruixup(kqfokctvbi) = xhszyayjya lkklrkxkrb (rwsgyhmdmi, 70.6% - 96.7) | Positive | 24 May 2024 | |
Not Applicable | - | lnhasodleh(wnhlwuhtns) = AEs occurred in 44 patients, including 39 with grade 1 or 2 AEs and 5 with grade 3 AEs. The most common AEs included hand-foot skin reaction, decreased platelet count, and diarrhea huxetsglar (luxbvtkihi ) | - | 24 May 2024 | |||
Not Applicable | 82 | xutzqfsfba(kwygzqjjor) = hmtrgpdovi rhmeawskpq (ghawvsgetn ) View more | Positive | 24 May 2024 | |||
Not Applicable | 87 | Dona-TACE + Regorafenib | ldloatpcfo(icxcediaay) = The Dona-TACE group received regorafenib sequentially had a lowest incidence of grade 3-4 AEs (39.1%, P<0.05) chbrhfmgwv (perzcoetuy ) View more | Positive | 24 May 2024 | ||
Sora-TACE + Regorafenib |