Ensartinib hydrochloride is under clinical development by Xcovery Holding Co and currently in the Phase II and Phase III 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 Ensartinib hydrochloride’s likelihood of approval (LoA) and phase transition for Central Nervous System (CNS) Tumor took place on 05 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.

In addition, the same event on 05 Nov 2022 decreased Ensartinib hydrochloride’s LoA and PTSR for Letterer-Siwe Disease (Multifocal and multisystemic (disseminated) Langerhans-cell histiocytosis), decreased LoA and PTSR for Neuroblastoma, and decreased LoA and PTSR for Non-Hodgkin Lymphoma.

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

Ensartinib hydrochloride overview

Ensartinib hydrochloride (Bemena) is an anti-neoplastic agent. It is formulated as capsules for oral route of administration. Bemena is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with anaplastic lymphoma kinase (ALK) positive who have progressed after crizotinib treatment or are intolerant to crizotinib. Bemena is indicated for the first-line treatment of anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Ensartinib (X-396) is under development for the treatment of non-small-cell lung cancer, melanoma, recurrent or refractory pediatric solid tumors including central nervous system tumors, non-Hodgkin lymphomas, Langerhans cell histiocytosis (LCH), juvenile xanthogranuloma (JXG), histiocytic sarcoma, diffuse intrinsic pontine glioma, optic pathway gliomas, pineal tumor, leptomeningeal disease and neuroblastoma. It is administered orally. X-396 is a small molecule inhibitor of ALK tyrosine kinase receptor. It was also under development for breast cancer, head and neck cancer, colorectal cancer and small-cell lung cancer.

Xcovery Holding Co overview

Xcovery Holding Co (Xcovery Holding) is a biotechnology company. The company is headquartered in United States.

Quick View Ensartinib hydrochloride LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Ensartinib hydrochloride
Administration Pathway
  • Oral
Therapeutic Areas
  • Genetic Disorders
  • 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.