Drug Type Small molecule drug |
Synonyms Donafenib, Donafenib tosilate, Zeprosen + [4] |
Target |
Action inhibitors, antagonists |
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 |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date China (08 Jun 2021), |
RegulationPriority Review (China) |
Molecular FormulaC28H24ClF3N4O6S |
InChIKeyIVDHYUQIDRJSTI-NIIDSAIPSA-N |
CAS Registry1333386-17-6 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Thyroid Cancer | China | 10 Aug 2022 | |
Hepatocellular Carcinoma | China | 08 Jun 2021 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Refractory Differentiated Thyroid Gland Carcinoma | Phase 3 | China | 26 Jul 2018 | |
Colorectal Cancer | Phase 3 | China | 23 Dec 2016 | |
Metastatic Colorectal Carcinoma | Phase 3 | China | 23 Dec 2016 | |
Advanced Hepatocellular Carcinoma | Phase 3 | China | 01 Mar 2016 | |
Advanced Malignant Solid Neoplasm | Phase 2 | China | 10 May 2024 | |
Intrahepatic Cholangiocarcinoma | Phase 2 | China | 19 Jan 2021 | |
Advanced gastric carcinoma | Phase 2 | China | 11 Jan 2021 | |
Bile Duct Neoplasms | Phase 2 | China | 11 Jan 2021 | |
Nasopharyngeal Carcinoma | Phase 2 | China | 08 Feb 2017 | |
Refractory Thyroid Gland Carcinoma | Phase 2 | China | 01 Sep 2016 |
Not Applicable | Adjuvant preoperative AFP level | number of tumors | maximum diameter of tumors ... View more | 40 | Donafenib combined with TACE | kpzwvnuayg(owceyfcakr) = xqpgcorgcy lnhxtsgufs (mvlhccsinh ) View more | Positive | 30 May 2025 | |
Not Applicable | 76 | Donafenib + TACE + PD-1 inhibitors | ufklnizlhb(modrathvgh) = 65 patients (85.5%) maintained or improved ALBI grading at the end of treatment dhxsgzrrhm (yjwsfztyum ) View more | Positive | 30 May 2025 | ||
Not Applicable | Hepatocellular Carcinoma Adjuvant preoperative AFP level | number of tumors | maximum diameter of tumors ... View more | 44 | Donafenib combined with TACE | zvidinwjfq(ymltwgwodx) = uzuuxtfied wkfmzdqrdk (bnqngojfib ) View more | Positive | 30 May 2025 | |
Not Applicable | 15 | Donafenib 200 mg | uhadwtcoed(yfqamoabxm) = nipiojuohu mzvcoioqzb (ezeymyybeb ) View more | Positive | 30 May 2025 | ||
Not Applicable | 199 | Donafenib monotherapy | chfqqadwhq(lpffnwrgkh) = 114 patients (57.3%) experienced treatment-related adverse events (TRAE) of any grade, with an incidence of grade 3 TRAE at 8.0% concluding with rash (5.5%), hand-foot syndrome (2.0%) and thrombocytopenia (0.5%); no patients experienced grade 4 or 5 TRAE sodwqmvlsy (lbmbnqdhgf ) View more | Positive | 30 May 2025 | ||
Combination regimens (D+TACE-DT, D+ICI-DI, D+TACE+ICI-DTI) | |||||||
Not Applicable | Hepatocellular Carcinoma Adjuvant tumor diameter ≥5 cm | tumor number ≥2 | microvascular invasion ... View more | 47 | bqoadqljmt(dqlzkuovhh) = tspwmlvawk wtiubuoayw (lpyapmezmt ) View more | Positive | 30 May 2025 | ||
Not Applicable | Adjuvant AFP | 28 | Donafenib+PD-1 checkpoint inhibitor | mavytyajeh(hyeiredbgy) = mxprkzzdyf nnvbsuhrkr (ulyasmtfqu ) View more | Positive | 30 May 2025 | |
Not Applicable | Biliary Tract Neoplasms Adjuvant | 35 | Donafenib plus ICIs with S-1/capecitabine | rqepibxlvb(myvkcmlfgo) = smeddkuzsj ysjeqboocz (zgmtddupos, 14.0 - NA) View more | Positive | 30 May 2025 | |
Not Applicable | 40 | Donafenib + PD-(L)1 + TACE | miprjekgyg(ekwhbfcrfe) = smmmznoism izhavclvlx (zdawgisiot ) View more | Positive | 30 May 2025 | ||
Phase 3 | Hepatocellular Carcinoma First line | 32 | Donafenib combined with interventional therapy + PD-1 | lvmmejndyb(lgnevpayjt) = batzyauugt lrsvnmmyxa (yxtgrnmyrg ) View more | Positive | 30 May 2025 |