Drugs / Donafenib
Donafenib
Trials 55
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT04605185 | Jan 2021 → Dec 2024 | hepatocellular carcinoma | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT04472858 | Oct 2020 → Dec 2023 | neoplasm | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT04418401 | Jun 2020 → Nov 2025 | hepatocellular carcinoma | Zhejiang University | Completed | No outcome recorded |
| Phase 1 | NCT04059874 | Jul 2019 → Jul 2020 | non-small cell lung carcinoma | First Affiliated Hospital of Zhejiang University | Unknown | No outcome recorded |
| Phase 1 | NCT04402723 | Nov 2018 → Feb 2022 | acute myeloid leukemia | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Terminated | No outcome recorded |
| Phase 1 | NCT04816123 | Oct → Dec 2018 | — | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Completed | No outcome recorded |
| Phase 1/29 trials | ||||||
| Phase 1/2 | NCT06239298 | May 2024 → Mar 2026 | neoplasm | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Unknown | No outcome recorded |
| Phase 1/2 | NCT04612712 | Jan 2021 → Jun 2022 | — | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04979663 | Dec 2020 → Jun 2022 | biliary tract cancer | Fudan University | Unknown | No outcome recorded |
| Phase 1/2 | NCT04503902 | Oct 2020 → Dec 2023 | hepatocellular carcinoma | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Unknown | No outcome recorded |
| Phase 1/2 | NCT02698111 | Feb 2017 → Oct 2021 | nasopharyngeal carcinoma | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Terminated | No outcome recorded |
| Phase 1/2 | NCT02489214 | May 2016 → Jun 2019 | gastric cancer | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Terminated | No outcome recorded |
| Phase 1/2 | NCT02489201 | Jul 2015 → Oct 2020 | esophageal cancer | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Terminated | No outcome recorded |
| Phase 1/2 | NCT02229071 | Apr 2014 → Dec 2015 | hepatocellular carcinoma | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Completed | No outcome recorded |
| Phase 1/2 | NCT02489916 | Mar 2014 → Oct 2015 | colorectal cancer | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Completed | No outcome recorded |
| Phase 230 trials · 2 met primary | ||||||
| Phase 2 | NCT07584018 | May 2026 → Jun 2027 expected | hepatocellular carcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07463248 | Apr 2026 → Jan 2028 expected | hepatocellular carcinoma | Wang Xin | Recruiting | No outcome recorded |
| Phase 2 | NCT07353827 | Feb 2026 → Aug 2027 expected | intrahepatic cholangiocarcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07363356 | Jan → Oct 2026 expected | hepatocellular carcinoma | Eastern Hepatobiliary Surgery Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07230314 | Nov 2025 → Nov 2026 expected | hepatocellular carcinoma | Jinling Hospital, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07157306 | Sep 2025 → Jan 2027 expected | hepatocellular carcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06812039 | Jan 2025 → Dec 2026 expected | hepatocellular carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06685289 | Nov 2024 → Nov 2026 expected | biliary tract cancer | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT06646198 | Oct 2024 → May 2026 overdue | hepatocellular carcinoma | Fei Gao | Recruiting | No outcome recorded |
| Phase 2 | NCT06512467 | Jul 2024 → Jul 2026 overdue | hepatocellular carcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06787911 | Jul 2024 → May 2025 overdue | thyroid cancer | Yu Wang | Recruiting | No outcome recorded |
| Phase 2 | NCT06498622 | Jul 2024 → May 2027 expected | hepatocellular carcinoma | Anhui Provincial Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06244225 | Jan 2024 → Jan 2026 overdue | hepatocellular carcinoma | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | No outcome recorded |
| Phase 2 | NCT06041490 | Sep 2023 → Jun 2026 overdue | hepatocellular carcinoma, osteosarcoma | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05576909 | Mar 2023 → Oct 2024 | hepatocellular carcinoma | Beijing Tsinghua Chang Gung Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05545124 | Nov 2022 → Nov 2023 | hepatocellular carcinoma | Henan Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05668884 | Oct 2022 → Dec 2026 expected | biliary tract cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT05493332 | Sep 2022 → Sep 2023 | hepatocellular carcinoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 2 | NCT05507632 | Aug 2022 → Mar 2026 overdue | hepatocellular carcinoma | Nanfang Hospital, Southern Medical University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05348811 | Jun 2022 → Oct 2025 | cholangiocarcinoma | Zhongda Hospital | Completed | No outcome recorded |
| Phase 2 | NCT05310331 | Mar 2022 → Dec 2023 | cervical carcinoma | Lei Li | Unknown | No outcome recorded |
| Phase 2 | NCT05350943 | Mar → Nov 2022 | adenocarcinoma of gallbladder and extrahepatic biliary tract | Lu Wang, MD, PhD | Unknown | No outcome recorded |
| Phase 2 | NCT04962958 | Dec 2021 → Sep 2025 | hepatocellular carcinoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Completed | No outcome recorded |
| Phase 2 | NCT05162352 | Dec 2021 → Oct 2022 | hepatocellular carcinoma | Second Affiliated Hospital of Guangzhou Medical University | Completed | Met primary |
| Phase 2 | NCT05262959 | Dec 2021 → Apr 2024 | — | Shanghai Zhongshan Hospital | Completed | No outcome recorded |
| Phase 2 | NCT05138159 | Dec 2021 → May 2023 | malignant pancreatic neoplasm | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT05166772 | Dec 2021 → Dec 2023 | hepatocellular carcinoma | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05161143 | Dec 2021 → Dec 2023 | hepatocellular carcinoma | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT06482086 | Jun 2021 → Dec 2024 overdue | thyroid gland carcinoma | West China Hospital | Recruiting | Met primary |
| Phase 2 | NCT02870569 | Sep 2016 → Jul 2018 | differentiated thyroid carcinoma | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05171166 | Dec 2021 → Oct 2025 | hepatocellular carcinoma | Peking University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT02645981 | Mar 2016 → Nov 2019 | hepatocellular carcinoma | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT03602495 | Aug 2018 → Feb 2021 | differentiated thyroid carcinoma | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Terminated | No outcome recorded |
| Phase 3 | NCT02870582 | Dec 2016 → Apr 2020 | colorectal cancer | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06496815 | Aug 2024 → Aug 2026 overdue | hepatocellular carcinoma | Tongji Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05022628 | Sep 2021 → Aug 2023 | hepatocellular carcinoma | Anhui Provincial Hospital | Unknown | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT06609876 | Oct 2024 → Oct 2026 expected | hepatocellular carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| — | NCT06581315 | Aug 2024 → Aug 2027 expected | hepatocellular carcinoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| — | NCT06233994 | Jan 2024 → Jan 2026 | hepatocellular carcinoma | Changsha Taihe Hospital | Unknown | No outcome recorded |
| — | NCT05247996 | Mar → Dec 2022 | intrahepatic cholangiocarcinoma | The Central Hospital of Lishui City | Unknown | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT06363006 Background | Mar 2024 → Jan 2026 overdue | hepatocellular carcinoma | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07557914 Background | Oct 2026 → Feb 2029 expected | diabetes mellitus, hepatocellular carcinoma | Haibo Shao | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05673824 Background | Jan 2023 → Sep 2025 | poisoning | Fudan University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2023-10-24 | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Results 2023 ESMO I 多纳非尼最新数据荣登ESMO国际舞台 zelgen.com ↗
根据 mRECIST标准 评估 ，ORR达80.6%（95% CI，64.0%-91.8%），其中 4例（11.1%）患者 达到 完全 缓解 （CR），25例（69.4%）达部 分缓 解（PR）. |
| 2022-08-15 | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Results APPLE 2022 I 泽璟制药多纳非尼阶段性数据闪耀亮相 zelgen.com ↗
研究 结果 显示 多纳 非尼 联合 TACE及抗 PD-1抗体 治疗 uHCC具有 良好 的疗 效和 安全 性. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-10-24 | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | 2023 ESMO I 多纳非尼最新数据荣登ESMO国际舞台 zelgen.com ↗ |
| 2022-08-15 | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | APPLE 2022 I 泽璟制药多纳非尼阶段性数据闪耀亮相 zelgen.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 58 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Donafenib | “Drug sensitivity testing will be performed on a panel of approved targeted and immunotherapeutic agents (including Apatinib, Atezolizumab + Bevacizumab, Donafenib +...” NCT07363356 ↗56“The first-line targeted-immunotherapy regimens consisted of tislelizumab combined with one of the first-line evidence-based tyrosine kinase inhibitors (TKIs), including...” NCT07463248 ↗ “TKI (Sorafenib 400mg, bid, po or Lenvatinib 8mg, qd, po if bodyweight less than 60 kg,12mg, qd, po if bodyweight more than 60kg or Donafenib：200mg, bid, po) +...” NCT06041490 ↗ “Treatment period: Therapeutic agents were selected according to clinical routine, including but not limited to Sorafenib, Lenvatinib, Donafenib, Regorafenib, Apatinib and Cabozantinib.” NCT05673824 ↗ “Multi-target drugs (lenvatinib or donafenib) are selected at the patient's preference.” NCT05247996 ↗ “oral administration of Donafenib (0.2g, bid) was consistently administered” NCT07230314 ↗ “neoadjuvant therapy with Donafenib and PD-1 antibody Sintilimab” NCT06787911 ↗ “Donafenib 200mg, PO, BID” NCT06363006 ↗ |
| Known as | CM4307 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02489916 ↗ |
| Known as | donafenib tosilate | “This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the tyrosine kinase inhibitor donafenib tosilate tablets” NCT02489214 ↗ |
| Known as | donafenib tosilate tablets | “Drug: Donafenib Tosilate Tablets” NCT04605185 ↗1“donafenib tosilate tablets” NCT02489201 ↗ |
| Known as | donafenib tosylate | “tyrosine kinase inhibitor donafenib tosylate tablets(400 mg/d,200mg bid)” NCT02489201 ↗ |
| Action | Inhibit | “an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases” NCT02229071 ↗ |
| Modality | Small molecule | “an oral multikinase inhibitor” NCT02229071 ↗ |
| Route | Oral | “Donafenib 200 mg orally twice daily” NCT02229071 ↗ |