Ensartinib API is a synthetic small-molecule ALK tyrosine kinase inhibitor (TKI) developed for targeted oncology applications. It inhibits anaplastic lymphoma kinase (ALK), including ALK fusion proteins and several ALK mutation variants involved in cancer progression.
Ensartinib is also known as X-396 and belongs to the aminopyridazine-based kinase inhibitor class. It is orally bioavailable and is supplied as an oral capsule in its approved formulation.
Ensartinib is a targeted anticancer compound that inhibits ALK signaling. ALK gene rearrangements can result in oncogenic ALK fusion proteins, including EML4-ALK, which can drive tumor-cell growth. Inhibition of ALK signaling can therefore suppress proliferation of ALK-dependent cancer cells.
The free-base Ensartinib has the molecular formula C₂₆H₂₇Cl₂FN₆O₃ and molecular weight 561.44 g/mol according to the FDA substance record.
Swapnroop Drugs and Pharmaceuticals provides Ensartinib API for qualified pharmaceutical manufacturing, formulation development, oncology research and pharmaceutical sourcing requirements.
Ensartinib is a specialized oncology API relevant to ALK-targeted drug development.
Ensartinib inhibits ALK kinase activity, including ALK fusion proteins and several ALK mutation variants. It also inhibits other kinases, including ROS1, MET and EphA2. Blocking ALK-mediated signaling interferes with downstream pathways involved in tumor-cell proliferation and survival.
Ensartinib is associated with:
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 5.5 – 6.5 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |