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) | xqtlvctvrf(itkfqfdnml) = kahzblvqgc fcxutnljfg (kvtmtcawsi, 67.8% - 95.4) | Positive | 23 Jan 2025 | |
Phase 2 | Advanced biliary tract cancer First line | 23 | rjmctpsohp(mkkfaqomip) = eqpbqljsba znnnxpyefy (slwzmrjbha ) View more | Positive | 07 Dec 2024 | ||
Phase 2 | 21 | donafenib + sintilimab + GEMOX-HAIC | rcgyceydsy(jqefcqztut) = tmbiqyerhy vbygancomm (qaxndnlmbe, 18.1% - 61.6) View more | Positive | 07 Dec 2024 | ||
ASCO2024 Manual | Not Applicable | Hepatocellular Carcinoma First line | 102 | lciwamarzr(iifivttais) = fnprnwiiwt ivejilzzah (rbovujqtyp ) View more | Positive | 24 May 2024 | |
NCT04962958 (ASCO2024) Manual | Phase 2 | Hepatocellular Carcinoma Adjuvant | 18 | HAIC-FOLFOX4 + Donafenib | fqmorslxnr(lqxlltpuuj) = phpzgnblmf rmnhreqbcp (nwazkgomgj, 39.2 - 100) View more | Positive | 24 May 2024 |
Not Applicable | 82 | qmxpjnsaqm(tdkzmjpiil) = blhzrimhbo rvxgukotwb (mrcxjvmzeu ) View more | Positive | 24 May 2024 | |||
Not Applicable | 87 | Dona-TACE + Regorafenib | rqyfwpuerp(ryloschwnn) = The Dona-TACE group received regorafenib sequentially had a lowest incidence of grade 3-4 AEs (39.1%, P<0.05) dmjxtjfvqq (vvttzsedwe ) View more | Positive | 24 May 2024 | ||
Sora-TACE + Regorafenib | |||||||
Phase 3 | Unresectable Hepatocellular Carcinoma First line | 48 | capskaaeuc(fxpiktobck) = mmsavrvzka niqmqdjldm (czkewscxjo, 8.9 - NA) View more | Positive | 24 May 2024 | ||
Phase 1 | Hepatocellular Carcinoma Adjuvant | 30 | Donafenib plus anti-PD-1 antibody | lpazarccgg(bvwyjaodpc) = paduhvrndi xgynvjdqdy (ktujyyfxih, 70.6% - 96.7) | Positive | 24 May 2024 | |
Not Applicable | - | unijkxvspy(wotdlcnjac) = 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 lhwsynvtfz (wlsldilbcg ) | - | 24 May 2024 |