Donafenib tosylate is under clinical development by Suzhou Zelgen Biopharmaceutical and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Donafenib tosylate’s likelihood of approval (LoA) and phase transition for Esophageal Cancer took place on 05 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Donafenib tosylate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Donafenib tosylate overview

Donafenib tosylate (Zepsun) is a deuterated sorafenib derivative. It is formulated as tablets for oral route of administration. Zepsun is indicated to treat patients with unresectable advanced hepatocellular carcinoma who have not received systemic treatment in the past.

Donafenib is under development for the treatment of solid tumors, endometrial cancer, advanced metastatic or recurrent head and neck squamous cell carcinoma (HNSCC), hepatocellular carcinoma, metastatic nasopharyngeal carcinoma, esophageal cancer, colorectal cancer, pancreatic cancer and cholangiocarcinoma. It is administered orally in the form of tablet. The drug candidate acts by targeting platelet-derived growth factor receptor (PDGFR) and vascular endothelial growth factor receptor (VEGFR), Raf kinase and receptor tyrosine kinases. Raf kinase and receptor tyrosine kinases regulates many pathways of cellular functions such as cell proliferation, differentiation, migration, or apoptosis. It was also under development for refractory differentiated thyroid cancer includes papillary thyroid cancer, follicular, hurthle cell thyroid cancers, metastatic gastric cancer, esophageal cancer, acute myelocytic leukemia.

It was also under development for the treatment of relapsed acute myeloid leukemia.

As of 2021, Donafenib as monotherapy discontinued development for metastatic colorectal cancer.

Suzhou Zelgen Biopharmaceutical overview

Suzhou Zelgen Biopharmaceutical (Zelgen) is a pharmaceutical company that carries out research and development, and production of innovative medicines. The company’s pipeline product includes donafenib tosylate tablets, topical recombinant human thrombin, jacktinib hydrochloride tablets, recombinant human thyroid-stimulating hormone for injection, jacktinib hydrochloride cream, ocaltinib capsules, magnesium obeticholate tablets and ZG19018. Its products are used in the treatment of nasopharyngeal carcinomas, myelofibrosis, thyroid cancer, liver cancer, non-small cell lung cancer, colorectal cancer, hemorrhage, and hepatobiliary diseases, among others. The company operates research and development activities in Kunshan, China; and California, the US. Zelgen is headquartered in Kunshan, Jiangsu, China.

Quick View Donafenib tosylate LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Donafenib tosylate
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.