Donafenib has been evaluated across numerous clinical trials ranging from Phase 1 through Phase 4, assessing its application in hepatocellular carcinoma, advanced gastrointestinal tumors, differentiated thyroid cancer, cholangiocarcinoma, metastatic colorectal cancer, and healthy adult male pharmacokinetics. Sponsored by commercial developers such as Suzhou Zelgen Biopharmaceuticals as well as academic medical centers including Peking Union Medical College Hospital and Fudan University, these studies encompass recruiting, active not recruiting, and completed recruitment statuses.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07729592 | NOT_YET_RECRUITING | Hepatocellular Carcinoma (HCC) |
Sun Yat-sen University |
2026-07 | PHASE2 |
| NCT07557914 | NOT_YET_RECRUITING | HCC - Hepatocellular Carcinoma; Diabetes |
Haibo Shao |
2026-06 | PHASE2 |
| NCT07790419 | NOT_YET_RECRUITING | Liver Cancer |
Zhai Wenlong |
2026-08-30 | PHASE4 |
| NCT07353827 | NOT_YET_RECRUITING | Intrahepatic Cholangiocarcinoma (Icc); Hepatic Arterial Infusion Chemotherapy |
Sun Yat-sen University |
2026-02-01 | PHASE2 |
| NCT06581315 | RECRUITING | Hepatocellular Carcinoma; Adjuvant Therapy |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
2024-08-28 | |
| NCT07584018 | NOT_YET_RECRUITING | HCC - Hepatocellular Carcinoma |
Tianjin Medical University Cancer Institute and Hospital |
2026-05-20 | PHASE2 |
| NCT06498622 | RECRUITING | Hepatocellular Carcinoma |
Anhui Provincial Hospital |
2024-07-20 | PHASE2 |
| NCT07157306 | NOT_YET_RECRUITING | Hepatocellular Carcinoma |
Tianjin Medical University Cancer Institute and Hospital |
2025-09-10 | PHASE2 |
| NCT06812039 | RECRUITING | Hepato Cellular Carcinoma (HCC) |
Fudan University |
2025-01-01 | PHASE2 |
| NCT05668884 | RECRUITING | Biliary Tract Carcinoma |
Fudan University |
2022-10-18 | PHASE2 |
| NCT07230314 | NOT_YET_RECRUITING | Unresectable Hepatocellular Carcinoma |
Jinling Hospital, China |
2025-11-30 | PHASE2 |
| NCT06685289 | RECRUITING | Biliary Malignant Tumors |
The First Affiliated Hospital with Nanjing Medical University |
2024-11-15 | PHASE2 |
| NCT06609876 | RECRUITING | Hepatocellular Carcinoma; Microwave Ablation; Donafenib; Recurrent Tumor |
Sun Yat-sen University |
2024-10-01 | |
| NCT06496815 | NOT_YET_RECRUITING | Unresectable Hepatocellular Carcinoma |
Tongji Hospital |
2024-08-01 | PHASE4 |
| NCT06512467 | NOT_YET_RECRUITING | Hepatocellular Carcinoma |
Tianjin Medical University Cancer Institute and Hospital |
2024-07-30 | PHASE2 |
| NCT06646198 | RECRUITING | Hepatocellular Carcinoma with PVTT |
Fei Gao |
2024-10-08 | PHASE2 |
| NCT05507632 | ACTIVE_NOT_RECRUITING | Unresectable Hepatocellular Carcinoma |
Nanfang Hospital, Southern Medical University |
2022-08-18 | PHASE2 |
| NCT06239298 | UNKNOWN | Solid Tumor |
Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
2024-05-10 | PHASE1; PHASE2 |
| NCT06244225 | RECRUITING | Hepatocellular Carcinoma |
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
2024-01-01 | PHASE2 |
| NCT06233994 | UNKNOWN | Advanced Hepatocellular Carcinoma |
Changsha Taihe Hospital |
2024-01 | |
| NCT04418401 | COMPLETED | Hepatocellular Carcinoma |
Zhejiang University |
2020-06-11 | PHASE1 |
| NCT05171166 | TERMINATED | Hepatocellular Carcinoma |
Peking University |
2021-12-24 | PHASE2; PHASE3 |
| NCT05348811 | COMPLETED | Cholangiocarcinoma |
Zhongda Hospital |
2022-06-13 | PHASE2 |
| NCT04962958 | COMPLETED | Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms; Digestive System Neoplasms; Antineoplastic Agents; Donafenib; Fluorouracil; Oxaliplatin; Antimetabolites |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
2021-12-27 | PHASE2 |
| NCT06787911 | RECRUITING | Thyroid Cancer |
Yu Wang |
2024-07-24 | PHASE2 |
| NCT06482086 | RECRUITING | Locally Advanced Thyroid Gland Carcinoma |
West China Hospital |
2021-06-01 | PHASE2 |
| NCT04605185 | UNKNOWN | Unresectable Hepatocellular Carcinoma |
Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
2021-01-08 | PHASE1 |
| NCT05576909 | UNKNOWN | Hepatocellular Carcinoma |
Beijing Tsinghua Chang Gung Hospital |
2023-03-30 | PHASE2 |
| NCT05262959 | COMPLETED | Donafenib |
Shanghai Zhongshan Hospital |
2021-12-01 | PHASE2 |
| NCT05310331 | UNKNOWN | Targeted Therapy; Chemotherapy; Recurrent Cervical Carcinoma; Metastatic Cervical Carcinoma; Persistent Advanced Cervical Carcinoma; Survival Outcomes; Adverse Effect |
Lei Li |
2022-03-27 | PHASE2 |
| NCT04472858 | UNKNOWN | Advanced Solid Tumor |
Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
2020-10-15 | PHASE1 |
| NCT04503902 | UNKNOWN | Advanced Hepatocellular Carcinoma |
Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
2020-10-15 | PHASE1; PHASE2 |
| NCT05161143 | UNKNOWN | Hepatocellular Carcinoma |
Peking Union Medical College Hospital |
2021-12 | PHASE2 |
| NCT05166772 | UNKNOWN | Hepatocellular Carcinoma |
Tianjin Medical University Cancer Institute and Hospital |
2021-12 | PHASE2 |
| NCT05545124 | UNKNOWN | Hepatocellular Carcinoma |
Henan Cancer Hospital |
2022-11 | PHASE2 |
| NCT05493332 | UNKNOWN | Hepatocellular Carcinoma |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
2022-09 | PHASE2 |
| NCT05022628 | UNKNOWN | HCC; Chemotherapy Effect |
Anhui Provincial Hospital |
2021-09-30 | PHASE4 |
| NCT05138159 | UNKNOWN | Metastatic Pancreatic Cancer |
Fudan University |
2021-12-01 | PHASE2 |
| NCT05350943 | UNKNOWN | Biliary Tract Adenocarcinoma |
Lu Wang, MD, PhD |
2022-03-01 | PHASE2 |
| NCT05162352 | COMPLETED | Hepatocellular Carcinoma |
Second Affiliated Hospital of Guangzhou Medical University |
2021-12-04 | PHASE2 |
| NCT04612712 | TERMINATED | Advanced Gastrointestinal Tumors |
Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
2021-01-19 | PHASE1; PHASE2 |
| NCT04979663 | UNKNOWN | Biliary Tract Carcinoma |
Fudan University |
2020-12-01 | PHASE1; PHASE2 |
| NCT04402723 | TERMINATED | Acute Myeloid Leukemia (AML) |
Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
2018-11-06 | PHASE1 |
| NCT02698111 | TERMINATED | Nasopharyngeal Carcinoma |
Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
2017-02-08 | PHASE1; PHASE2 |
| NCT03602495 | TERMINATED | Differentiated Thyroid Cancer |
Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
2018-08-29 | PHASE3 |
| NCT04612712 | Recruiting | Advanced Gastrointestinal Tumors |
Suzhou Zelgen Biopharmaceuticals Co.Ltd|Jiangsu Alphamab Biopharmaceuticals Co. Ltd |
2021-01-19 | Phase 1|Phase 2 |
| NCT02489201 | TERMINATED | Oesophageal Cancer |
Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
2015-07-21 | PHASE1; PHASE2 |
| NCT04059874 | UNKNOWN | Non-small Cell Lung Cancer |
First Affiliated Hospital of Zhejiang University |
2019-07-31 | PHASE1 |
| NCT02870582 | COMPLETED | Metastatic Colorectal Cancer |
Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
2016-12-28 | PHASE3 |
| NCT02645981 | COMPLETED | HCC |
Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
2016-03 | PHASE2; PHASE3 |
| NCT02489214 | TERMINATED | Gastric Cancer |
Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
2016-05-16 | PHASE1; PHASE2 |
| NCT04816123 | COMPLETED | Healthy Male Adult |
Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
2018-10-09 | PHASE1 |
| NCT04816123 | Completed | Healthy Male Adult |
Suzhou Zelgen Biopharmaceuticals Co.Ltd |
2018-10-09 | Phase 1 |
| NCT02870569 | COMPLETED | Differentiated Thyroid Cancer |
Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
2016-09 | PHASE2 |
| NCT02229071 | COMPLETED | HCC |
Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
2014-04 | PHASE1; PHASE2 |
| NCT02489916 | COMPLETED | Metastatic Colorectal Cancer |
Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
2014-03 | PHASE1; PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-07-27)
Check the
Donafenib (Sorafenib D3)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Donafenib (Sorafenib D3) Solubility in DMSO
- Donafenib (Sorafenib D3) Stock Solution
- Donafenib (Sorafenib D3) Storage
- Donafenib (Sorafenib D3) Stability
- Donafenib (Sorafenib D3) Molecular Weight
- Donafenib (Sorafenib D3) SMILES
- Donafenib (Sorafenib D3) CAS Number
- Donafenib (Sorafenib D3) Chemical Structure (2D and 3D)
- Donafenib (Sorafenib D3) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.