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    DRUG:

    Zepsun (donafenib)

    i
    Other names: CM4307, CM-4307, CM 4307
    Company:
    Suzhou Zelgen
    Drug class:
    Multi-tyrosine kinase inhibitor, cRAF inhibitor
    Related drugs:
    17d
    PATH: Study on the Safety and Efficacy of Donafinib Combined With Anti-PD-1 Antibody as Adjuvant Therapy for HCC Patients (clinicaltrials.gov)
    P1, N=30, Completed, Zhejiang University | Recruiting --> Completed | Trial completion date: Jun 2024 --> Nov 2025 | Trial primary completion date: Dec 2023 --> Nov 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    Zepsun (donafenib)
    19d
    Synergistic antitumor effect of oroxylin A and donafenib in hepatocellular carcinoma through tumor protein p53 signaling pathway activation. (PubMed, World J Gastroenterol)
    Oroxylin A and donafenib exert a synergistic anti-tumor effect in HCC by co-activating the TP53 signaling pathway through distinct but complementary molecular axes. This combination strategy presents a promising and viable therapeutic approach to overcome the limitations of donafenib monotherapy in the treatment of HCC.
    Journal
    |
    MDM4 (The mouse double minute 4) • CDK9 (Cyclin Dependent Kinase 9)
    |
    Zepsun (donafenib)
    21d
    Effects of Cytochrome P450 enzymes and drug-drug interaction on donafenib metabolism: in vivo, in vitro and in silico. (PubMed, Bioorg Chem)
    This study systematically elucidated the metabolic characteristics of the hepatocellular carcinoma (HCC) therapeutic drug donafenib and its drug-drug interaction (DDI) with the antiviral agent arbidol. Moreover, Tmax was prolonged by 68.42%, while CLz/F was decreased by 53.85%. These results provided critical references for clinical dosage adjustment, facilitating personalized treatment and reducing the risk of adverse reactions.
    Preclinical • Journal
    |
    CYP3A4 (Cytochrome P450, family 3, subfamily A, polypeptide 4)
    |
    Zepsun (donafenib)
    25d
    Effect of Huaier Granule on Nephrotoxicity Associated With Targeted Therapy for Advanced Hepatobiliary Malignancies. (clinicaltrials.gov)
    P2, N=76, Completed, Fudan University | Recruiting --> Completed | Phase classification: P4 --> P2 | N=53 --> 76 | Trial completion date: Apr 2025 --> Dec 2025 | Trial primary completion date: Feb 2025 --> Sep 2025
    Trial completion • Phase classification • Enrollment change • Trial completion date • Trial primary completion date • Adverse events
    |
    sorafenib • Lenvima (lenvatinib) • AiTan (rivoceranib) • Stivarga (regorafenib) • Zepsun (donafenib)
    1m
    Prospective Cohort Study on the Efficacy and Safety of Sequential TIPS-TACE/HAIC Combined or Not Combined with Donafenib and Tislelizumab in the Treatment of BCLC Stage C Hepatocellular Carcinoma Patients with Concomitant Portal Hypertension (ChiCTR2600116845)
    P=N/A, N=96, Not yet recruiting, Beijing Youan Hospital, Capital Medical University; Beijing Youan Hospital, Capital Medical University
    New trial
    |
    Tevimbra (tislelizumab-jsgr) • Zepsun (donafenib)
    1m
    Pharmacokinetics and Individualized Dose Optimization of Donafenib in Hepatocellular Carcinoma Patients after Transjugular Intrahepatic Portosystemic Shunt (TIPS) (ChiCTR2500115846)
    P=N/A, N=20, Not yet recruiting, Beijing Youan Hospital, Capital Medical University; Beijing Youan Hospital, Capital Medical University
    New trial
    |
    Zepsun (donafenib)
    1m
    Donafenib monotherapy or combined with PD-1/L1 inhibitors or transcatheter arterial chemoembolization as adjuvant therapy in hepatocellular carcinoma patients with high-risk recurrence after radical resection, a multi-cohort clinical study. (ChiCTR2500112389)
    P=N/A, N=90, Recruiting, The First Affiliated Hospital of Harbin Medical University; The First Affiliated Hospital of Harbin Medical University
    New trial
    |
    AFP (Alpha-fetoprotein)
    |
    Zepsun (donafenib)
    1m
    Exploratory Clinical Study of TACE Combined with Iparomlimab and Tuvonralimab and Donafenib in Conversion Therapy for Unresectable Locally Advanced and Advanced Hepatocellular Carcinoma (ChiCTR2500112149)
    P=N/A, N=42, Not yet recruiting, The First Affiliated Hospital of University of science and technology of China; The First Affiliated Hospital of University of science and technology
    New trial
    |
    Qibeian (iparomlimab/tuvonralimab) • Zepsun (donafenib) • iparomlimab (QL1604)
    1m
    A phase Ⅱ, single-arm, exploratory study of GEMOX regimen combined with tislelizumab and donafenib in the perioperative treatment of potentially resectable intrahepatic cholangiocarcinoma with high risk of recurrence (ChiCTR2500112067)
    P2, N=20, Not yet recruiting, Hunan Provincial People's Hospital; Hunan Provincial People's Hospital
    New P2 trial
    |
    Tevimbra (tislelizumab-jsgr) • Zepsun (donafenib)
    1m
    Drug Sensitivity Testing-Based Tumor Organoids to Guide Adjuvant Therapy After Hepatectomy for Primary Liver Cancer (clinicaltrials.gov)
    P2, N=56, Not yet recruiting, Eastern Hepatobiliary Surgery Hospital
    New P2 trial
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • 5-fluorouracil • Tyvyt (sintilimab) • AiTan (rivoceranib) • Zepsun (donafenib)
    2ms
    A Phase II Trial of Organoid Drug Sensitivity Testing to Guide Therapy in Unresectable Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=94, Not yet recruiting, Eastern Hepatobiliary Surgery Hospital
    New P2 trial
    |
    Tecentriq (atezolizumab) • sorafenib • Tyvyt (sintilimab) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr) • AiTan (rivoceranib) • Zepsun (donafenib)
    2ms
    FOLFOX-HAIC Combined With Donafenib and Pucotenlimab as First-Line Treatment for Unresectable Intrahepatic Cholangiocarcinoma (clinicaltrials.gov)
    P2, N=36, Not yet recruiting, Sun Yat-sen University
    New P2 trial
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Puyouheng (pucotenlimab) • Zepsun (donafenib)