Donafenib

Phase 3Small molecule

SSuzhou Zelgen Biopharmaceuticals Co.,Ltd

Donafenib is one of 195 small molecule programs targeting Portal Hypertension. It is currently in Phase 3.

Indications

Total Trials

Active Trials

194

Competitors

Pipeline

Status by Indication[3][1]

Indication

Portal HypertensionRecruiting

Intrahepatic CholangiocarcinomaNot yet recruiting

Liver CancerNot yet recruiting

Hepatocellular CarcinomaNot yet recruiting

Thyroid CancerTerminated

Advanced Solid TumorRecruiting

Hepatocellular Carcinoma (HCC)Not yet recruiting

Adjuvant TherapyRecruiting

Postoperative Adjuvant TherapyRecruiting

Portal HypertensionPhase 2

Recruiting

Intrahepatic CholangiocarcinomaPhase 2

Not yet recruiting

Liver CancerPhase 3

Not yet recruiting

Hepatocellular CarcinomaPhase 3

Not yet recruiting

Thyroid CancerPhase 3

Terminated

Advanced Solid TumorPhase 2

Recruiting

Hepatocellular Carcinoma (HCC)Phase 2

Not yet recruiting

Adjuvant TherapyPreclinical

Recruiting

Postoperative Adjuvant TherapyPhase 2

Recruiting

Competition

Competitive Landscape

251 competitors in Hepatocellular Carcinoma

#DrugCompanyPhaseTrials

Donafenib

SSuzhou Zelgen Biopharmaceuticals Co.,Ltd

Phase 3

12 2

Cysteine Hydrochloride

Novartis

Preclinical

1 3

Viread

Gilead

Preclinical

1 4

Sovaldi

Gilead

Preclinical

1 5

Coreg

Akero Therapeutics

Preclinical

2 6

Doptelet

AAkarx

Preclinical

1 7

Miraclid

TTechpool Bio-Pharma Co., Ltd.

Preclinical

1 8

Vermox

WWim Janssens

Preclinical

1 9

Statin

Bristol-Myers Squibb

Preclinical

1 10

Lyrica

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Not yet recruiting

Hepatocellular Carcinoma

NCT06512467

Phase 2Recruiting

Portal Hypertension

NCT06646198

Q3 2027

Post-ApprovalNot yet recruiting

Hepatocellular Carcinoma

NCT06496815

Q4 2027

Not yet recruiting

Liver Cancer

NCT07180459

Phase 2Recruiting

Postoperative Adjuvant Therapy

NCT06685289

Q4 2028

N/ARecruiting

Adjuvant Therapy

NCT06609876

Clinical

Trials by Indication[1]

Hepatocellular Carcinoma12 trials

Donafenib Combine With Sintilimab and HAIC in Neoadjuvant of Resectable Hepatocellular Carcinoma

Not yet recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT06512467·30 enrolled

Donafenib Combined With Immunotherapy and Local Therapy for Unresectable Hepatocellular Carcinoma That Has Failed in Previous Therapy

Not yet recruiting·TTongji Hospital·Phase 4·NCT06496815·32 enrolled

Combined HAIC, TKI/Anti-VEGF and ICIs as Conversion Therapy for Unresectable Hepatocellular Carcinoma

Recruiting·ZZe-yang Ding, MD··NCT05713994·300 enrolled

Show 9 more trials

Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma

Active, not recruiting·SSuzhou Zelgen Biopharmaceuticals Co.,Ltd·Phase 1·NCT04605185·18 enrolled

A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib or Bevacizumab in Patients With Advanced Hepatocellular Carcinoma

Unknown status·—·N/A·NCT06233994·30 enrolled

Combined TACE, TKI/Anti-VEGF and ICIs as Conversion Therapy for Advanced Hepatocellular Carcinoma

Recruiting·TTongji Hospital··NCT05717738·300 enrolled

Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma

Completed·SSuzhou Zelgen Biopharmaceuticals Co.,Ltd·Phase 2/3·NCT02645981·668 enrolled

Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma

Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·N/A·NCT06581315·204 enrolled

Donafenib Combined With TACE as Adjuvant Therapy of Patients With Hepatocellular Carcinoma

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT05161143·30 enrolled

Safety and Efficacy of Donafenib in Patients With Advanced Hepatocellular Carcinoma

Completed·SSuzhou Zelgen Biopharmaceuticals Co.,Ltd·Phase 1/2·NCT02229071·106 enrolled

Donafenib Combine With Sintilimab and HAIC (Hepatic Artery Infusion Chemotherapy，HAIC）in the First-line Treatment of Unresectable Hepatocellular Carcinoma

Unknown status·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT05166772·30 enrolled

Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma

Unknown status·SSuzhou Zelgen Biopharmaceuticals Co.,Ltd·Phase 1/2·NCT04503902·46 enrolled

Thyroid Cancer3 trials

Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer

Recruiting·WWest China Hospital·Phase 2·NCT06482086·75 enrolled

A Phase 3 Study of Donafenib in Patients With Radioiodine-refractory Differentiated Thyroid Cancer

Terminated·SSuzhou Zelgen Biopharmaceuticals Co.,Ltd·Phase 3·NCT03602495·204 enrolled

Phase 2 Trial of Donafenib in 131I-Refractory Differentiated Thyroid Cancer

Completed·SSuzhou Zelgen Biopharmaceuticals Co.,Ltd·Phase 2·NCT02870569·48 enrolled

Liver Cancer2 trials

The Treatment of Unresectable Liver Cancer With E-TACE Combined With Donafenib：A Prospective, Single-arm, Multicenter, Observational Study

Not yet recruiting·XXuhua Duan··NCT07180459·118 enrolled

A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Targeted Therapy and a PD-1 Inhibitor in Patients With Postoperative Hepatocellular Carcinoma and Microvascular Invasion

Not yet recruiting·ZZhai Wenlong·Approved·NCT07790419·40 enrolled

Pancreatic Cancer1 trial

A Study of Donafenib Plus S-1 in Treating Patients With Metastatic Pancreatic Cancer After Chemotherapy With Nab-paclitaxel Plus Gemcitabine Regimen

Unknown status·FFudan University·Phase 2·NCT05138159·10 enrolled

Randomized Controlled Trial1 trial

Neoadjuvant HAIC of TACE Plus Donafenib in BCLC B Stage HCC: a Multi-center Randomized Controlled Trial.

Terminated·PPeking University·Phase 2/3·NCT05171166·18 enrolled

20 more indications

Gastrointestinal Tumors1 trial

A Phase 1/2 Study of Donafenib in Combination With KN046 in Advanced Gastrointestinal Tumors

Unknown status·SSuzhou Zelgen Biopharmaceuticals Co.,Ltd·Phase 1/2·NCT04612712·42 enrolled

Gastric Cancer1 trial

Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer

Terminated·SSuzhou Zelgen Biopharmaceuticals Co.,Ltd·Phase 1/2·NCT02489214·13 enrolled

Advanced Solid Tumor1 trial

A Study of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor

Recruiting·SSuzhou Zelgen Biopharmaceuticals Co.,Ltd·Phase 1/2·NCT06239298·130 enrolled

Metastatic Colorectal Cancer1 trial

Donafenib for Previously Treated Metastatic Colorectal Cancer

Completed·SSuzhou Zelgen Biopharmaceuticals Co.,Ltd·Phase 3·NCT02870582·536 enrolled

Postoperative Adjuvant Therapy1 trial

Donafenib Combined With Capecitabine for Postoperative Adjuvant Therapy of Biliary Malignant Tumors With High-risk Recurrence Risk

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT06685289·70 enrolled

Toripalimab1 trial

HAIC Combined With Toripalimab and Donafenib for Advanced BTC

Unknown status·LLu Wang, MD, PhD·Phase 2·NCT05350943·70 enrolled

Portal Hypertension1 trial

TIPS Plus Half-dose Donafenib in AHCC with PVTT-associated Portal Hypertension

Recruiting·FFei Gao·Phase 2·NCT06646198·40 enrolled

Unresectable1 trial

HAIC Combined With Donafenib Tosilate and Toripalimab for Unresectable HCC

Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT05493332·93 enrolled

Neoadjuvant Treatment1 trial

Clinical Study of Radiotherapy Combined With Donafenib for Neoadjuvant Treatment of Patients With HCC With Portal Vein Carcinoma Thrombosis

Unknown status·—·Phase 4·NCT05022628·30 enrolled

Non-Small Cell Lung Cancer1 trial

Treatment of Non-small Cell Lung Cancer With PD-1 Monoclonal Antibody Combined With Donafenib Toluene Sulfonate

Unknown status·FFirst Affiliated Hospital of Zhejiang University·Phase 1·NCT04059874·20 enrolled

Adult1 trial

The Mass Balance and Biotransformation of [14C]Donafenib in Healthy Adult Man

Completed·SSuzhou Zelgen Biopharmaceuticals Co.,Ltd·Phase 1·NCT04816123·6 enrolled

Intrahepatic Cholangiocarcinoma1 trial

FOLFOX-HAIC Combined With Donafenib and Pucotenlimab as First-Line Treatment for Unresectable Intrahepatic Cholangiocarcinoma

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT07353827·36 enrolled

Relapsed AML1 trial

Combination of Donafenib and Cytarabine/Daunorubicin in Relapsed AML

Terminated·SSuzhou Zelgen Biopharmaceuticals Co.,Ltd·Phase 1·NCT04402723·8 enrolled

Nasopharyngeal Carcinoma1 trial

Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma

Terminated·SSuzhou Zelgen Biopharmaceuticals Co.,Ltd·Phase 1/2·NCT02698111·20 enrolled

Esophageal Cancer1 trial

A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer

Terminated·SSuzhou Zelgen Biopharmaceuticals Co.,Ltd·Phase 1/2·NCT02489201·19 enrolled

Advanced Solid Tumors1 trial

A Study of CS1001 in Combination With Donafenib in Subjects With Advanced Solid Tumors

Unknown status·SSuzhou Zelgen Biopharmaceuticals Co.,Ltd·Phase 1·NCT04472858·30 enrolled

Liver Transplant1 trial

Donafenib Combined With Hepatic Artery Chemoembolization for Perioperative Treatment of Liver Transplantation

Unknown status·—·Phase 2·NCT05576909·20 enrolled

Adjuvant Therapy1 trial

Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC

Recruiting·SSun Yat-sen University·N/A·NCT06609876·108 enrolled

Hepatocellular Carcinoma (HCC)1 trial

A Single-Center, Phase II, Randomized Controlled Clinical Study to Evaluate Dapagliflozin as an Addition to First-Line Treatment for Unresectable Hepatocellular Carcinoma With Metabolic Syndrome

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT07729592·44 enrolled

Carcinoma, Hepatocellular1 trial

Prospective, Single-arm, Multicenter Clinical Study of Hepatic Artery Infusion Chemotherapy With Donafenib for Adjuvant Treatment of HCC Patients With High Risk of Recurrence After Hepatectomy.

Completed·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT04962958·30 enrolled

Sources

References

[1]
ClinicalTrials.gov — 39 trial records for Donafenib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Donafenib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Donafenib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Suzhou Zelgen Biopharmaceuticals Co.,Ltd company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: SSuzhou Zelgen Biopharmaceuticals Co.,Ltd

Donafenib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q4 2027

Q4 2028

Trials by Indication[1]

Hepatocellular Carcinoma12 trials

Thyroid Cancer3 trials

Liver Cancer2 trials

Pancreatic Cancer1 trial

Randomized Controlled Trial1 trial

Gastrointestinal Tumors1 trial

Gastric Cancer1 trial

Advanced Solid Tumor1 trial

Metastatic Colorectal Cancer1 trial

Postoperative Adjuvant Therapy1 trial

Toripalimab1 trial

Portal Hypertension1 trial

Unresectable1 trial

Neoadjuvant Treatment1 trial

Non-Small Cell Lung Cancer1 trial

Adult1 trial

Intrahepatic Cholangiocarcinoma1 trial

Relapsed AML1 trial

Nasopharyngeal Carcinoma1 trial

Esophageal Cancer1 trial

Advanced Solid Tumors1 trial

Liver Transplant1 trial

Adjuvant Therapy1 trial

Hepatocellular Carcinoma (HCC)1 trial

Carcinoma, Hepatocellular1 trial

References

Drug Info

Quick Facts

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