Drug Profile
Ensartinib - Betta Pharmaceuticals/Xcovery
Alternative Names: Ensacove; Ensartinib Hydrochloride; X-396Latest Information Update: 18 Mar 2024
Price :
$50
*
At a glance
- Originator Xcovery
- Developer AstraZeneca; Betta Pharmaceuticals Co Ltd; Cancer Research Institute; Ludwig Institute for Cancer Research; Memorial Sloan-Kettering Cancer Center; National Cancer Institute (USA); Xcovery Holdings
- Class Antineoplastics; Piperazines; Pyridazines; Small molecules
- Mechanism of Action Anaplastic lymphoma kinase inhibitors; EphA2 receptor antagonists; Proto-oncogene protein c-met inhibitors; ROS1 protein inhibitors; TrkA receptor antagonists; TrkC receptor antagonists
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Marketed Non-small cell lung cancer
- Phase II CNS cancer; Malignant melanoma; Non-Hodgkin's lymphoma; Solid tumours
Most Recent Events
- 14 Mar 2024 US FDA accepts NDA for ensartinib for ALK-positive non-small cell lung cancer (NSCLC) for review
- 13 Mar 2024 FDA assigns PDUFA action date of 28/12/2024 for ensartinib for metastatic ALK-positive non-small cell lung cancer
- 12 Dec 2023 Phase-II clinical trials in Non-small cell lung cancer (Metastatic disease, Late-stage disease, Recurrent, Second-line therapy or greater) (PO) (NCT03753685)