Tesevatinib tosylate is under clinical development by Kadmon Holdings and currently in the 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 Tesevatinib tosylate’s likelihood of approval (LoA) and phase transition for Polycystic Kidney Disease took place on 21 Nov 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

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

Tesevatinib tosylate overview

Tesevatinib tosylate (KD-019, XL647) is under development for the treatment of autosomal dominant polycystic kidney disease, autosomal recessive polycystic kidney disease, non-small cell lung cancer with brain metastasis (or) leptomeningeal metastasis, recurrent glioblastoma multiforme. It is a small molecule administered orally. It acts by inhibiting the epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 2 (HER2), vascular endothelial growth factor receptor VEGFR 2 and 3 and ephrin B4 (EphB4) RTKs. It was under development for the treatment of non-small cell lung cancer, metastatic breast cancer, prostate cancer, metastatic or unresectable adenocarcinoma of esophagus, gastroesophageal junction and stomach cancer.

Kadmon Holdings overview

Kadmon Holdings (Kadmon) is an integrated biopharmaceutical company that discovers, develops and markets small molecules and biologics for autoimmune and fibrotic diseases, various types of cancer, and genetic diseases. The company’s pipeline encompasses investigational candidates for the treatment of moderate to severe psoriasis, idiopathic pulmonary fibrosis, and polycystic kidney disease among others. Its pipeline candidates are based on its small molecule and biologics platforms. It also develops in-licensed product candidates and technologies. The company works in partnership with various pharmaceutical and biopharmaceutical companies to advance its pipeline candidates. Kadmon is headquartered in New York, the US.

Quick View Tesevatinib tosylate LOA Data

Report Segments
  • Innovator
Drug Name
  • Tesevatinib tosylate
Administration Pathway
  • Oral
Therapeutic Areas
  • Genetic Disorders
  • Oncology
Key Developers
Highest Development Stage
  • Phase II


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.