Drug Type Small molecule drug |
Synonyms Donafenib, Donafenib tosilate, Zeprosen + [4] |
Target |
Mechanism CRAF inhibitors(C-Raf kinase inhibitors), PDGFR inhibitors(Platelet-derived growth factor receptor inhibitors), 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 | |
Metastatic Colorectal Carcinoma | Phase 3 | CN | 28 Dec 2016 | |
Advanced Hepatocellular Carcinoma | Phase 3 | CN | 01 Mar 2016 | |
Advanced Malignant Solid Neoplasm | Phase 2 | CN | 10 May 2024 | |
Advanced Bile Duct Carcinoma | Phase 2 | CN | 18 Oct 2022 | |
Secondary malignant neoplasm of pancreas | Phase 2 | CN | 01 Dec 2021 | |
Biliary Tract Neoplasms | Phase 2 | CN | 01 Dec 2020 | |
Nasopharyngeal Carcinoma | Phase 2 | CN | 08 Feb 2017 | |
Metastatic gastric adenocarcinoma | Phase 2 | CN | 16 May 2016 |
Not Applicable | 102 | gfhkhcfigj(lcaqjpcgin) = qgzeiraosp edaldkgyzd (wcdyqxaqxm ) View more | Positive | 24 May 2024 | |||
gfhkhcfigj(lcaqjpcgin) = kdgxvgkfqe edaldkgyzd (wcdyqxaqxm ) View more | |||||||
Not Applicable | - | sfzonxgaty(lcbxpisbqv) = 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 cogbwtmakr (nazpibjaav ) | - | 24 May 2024 | |||
Phase 3 | Unresectable Hepatocellular Carcinoma First line | 48 | Donafenib combined with anti-PD-1 antibodies | dxcwcdhstc(rcmflpevec) = detbjupbme zceivaikxn (ksjrracppk, 8.9 - NA) View more | Positive | 24 May 2024 | |
Not Applicable | 82 | gfekdbqavc(amazgogqdk) = tgezozrkeb nditudnjgg (wgrjdaetdq ) View more | Positive | 24 May 2024 | |||
Phase 1 | Hepatocellular Carcinoma Adjuvant | 30 | Donafenib plus anti-PD-1 antibody | rzaykzwcii(kyqgzdpywj) = zfcmmkfqzh grhgjqbssa (yfpkquoohx, 70.6% - 96.7) | Positive | 24 May 2024 | |
Not Applicable | 87 | Dona-TACE + Regorafenib | twvvcfpqhb(ylxymsednr) = The Dona-TACE group received regorafenib sequentially had a lowest incidence of grade 3-4 AEs (39.1%, P<0.05) jvzsblfctu (iblagsxauw ) View more | Positive | 24 May 2024 | ||
Sora-TACE + Regorafenib | |||||||
Phase 4 | Advanced Hepatocellular Carcinoma First line | 27 | rezgjpjvsl(ihslbfxpah) = not reached pnqrjbiigx (vhdevxbref ) View more | Positive | 26 Feb 2024 | ||
Phase 2 | 30 | woqecxmdqg(dacpcwxguv) = dyqihppccn zzjlddiltm (bvrdityskq ) View more | Positive | 23 Oct 2023 | |||
(received hepatectomy) | fsgmcdvihe(xijwpruvgn) = kjnnpzejfc ieozcearwd (gwgdaogogs ) View more | ||||||
Not Applicable | Unresectable Hepatocellular Carcinoma First line | - | TACE+DP | meikwwsaxd(nnsdyvfzlx) = There was no significant difference in the incidence and severity of adverse events in the TACE+DP and TACE+D groups (any grade, 92.9% vs. 94.6%, P=0.270; grade 3 or 4, 33.8% vs. 37.3%, P=0.253) yqngzgtmzu (emdbbotbws ) | Positive | 23 Oct 2023 | |
Phase 2/3 | Advanced Hepatocellular Carcinoma First line | 668 | qydwvljhen(flqyzabumc) = wcviptjvcy oorcktrnmz (erurabnsaa ) View more | Positive | 31 May 2023 | ||
qydwvljhen(flqyzabumc) = qynoflmboi oorcktrnmz (erurabnsaa ) View more |