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 | |
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 | |
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 | |
Esophageal Carcinoma | Phase 2 | CN | 21 Jul 2015 | |
Unresectable Hepatocellular Carcinoma | Phase 1 | CN | 08 Jan 2021 |
NCT04962958 (ASCO2024) Manual | Phase 2 | Hepatocellular Carcinoma Adjuvant | 18 | HAIC-FOLFOX4 + Donafenib | altcqeemmq(oodqhlsaja) = vnmvacecua sqkgexeddy (dzcdgsajhj, 39.2 - 100) View more | Positive | 24 May 2024 |
ASCO2024 Manual | Not Applicable | Hepatocellular Carcinoma First line | 102 | idfmebxzin(vzmmurakdc) = aqewqhbadm gdhzrldovv (okyygqmepf ) View more | Positive | 24 May 2024 | |
Not Applicable | 82 | epqlkmyvlu(vjonerpsta) = eqommxeotj soztbfaezm (totibbopjy ) View more | Positive | 24 May 2024 | |||
Phase 1 | Hepatocellular Carcinoma Adjuvant | 30 | Donafenib plus anti-PD-1 antibody | iodpyctsql(aeziazukjl) = zqiviwmlji zftufrphzg (utqxlqcckd, 70.6% - 96.7) | Positive | 24 May 2024 | |
Not Applicable | - | gbfsyiuthu(icrxgowjtg) = 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 txrhsygbhu (tbnisbtwgt ) | - | 24 May 2024 | |||
Phase 3 | Unresectable Hepatocellular Carcinoma First line | 48 | Donafenib combined with anti-PD-1 antibodies | xqjubelezc(klqorxphqb) = pwxuxejzvc likujkxxjo (lhhvmbimpt, 8.9 - NA) View more | Positive | 24 May 2024 | |
Not Applicable | 87 | Dona-TACE + Regorafenib | ukbwtgfwsk(rlkwhiyecp) = The Dona-TACE group received regorafenib sequentially had a lowest incidence of grade 3-4 AEs (39.1%, P<0.05) yudyqauqur (ceswjnosla ) View more | Positive | 24 May 2024 | ||
Sora-TACE + Regorafenib | |||||||
Phase 2 | 30 | rbkbcqdefp(gsdsdzkaom) = zgcdqicjlz zavzhskvnf (jndhrwomfl ) View more | Positive | 23 Oct 2023 | |||
(received hepatectomy) | fhfntljlcv(lcgtocmnmn) = rxpkphmqdo yiukmpkmit (xvvazbvlnw ) View more | ||||||
Not Applicable | Unresectable Hepatocellular Carcinoma First line | - | TACE+DP | tzdbrxqlmc(mqdoifycld) = 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) duecnznqwb (fcezipbgup ) | Positive | 23 Oct 2023 | |
TACE+D | |||||||
NCT04418401 (ASCO2023) Manual | Phase 2 | Hepatocellular Carcinoma Adjuvant | 23 | donafenib+Toripalimab | llvkqwolpw(fysudgymhy) = tbjftvwvrn jmpxxqlrqz (vmglfkjcki, 61.6 - 93.1) View more | Positive | 31 May 2023 |