Lerociclib is an orally active, selective cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor developed as a targeted anticancer compound. It acts on the CDK4/6 pathway, which plays an important role in regulating cell-cycle progression from the G1 phase to the S phase.
By inhibiting CDK4 and CDK6 activity, Lerociclib reduces phosphorylation of the retinoblastoma (RB) protein and interferes with cell-cycle progression. This mechanism makes Lerociclib an investigational oncology compound of interest, particularly in hormone receptor-positive breast cancer.
Lerociclib is a synthetic small-molecule pharmaceutical compound with the molecular formula C26H35N7O2 and a molecular weight of approximately 477.61 g/mol. Its CAS Number is 1227631-02-6.
Lerociclib is a selective CDK4/6 inhibitor developed for oral administration and pharmaceutical formulation research.
Lerociclib selectively inhibits CDK4 and CDK6, enzymes that regulate progression through the G1 phase of the cell cycle.
CDK4/6 inhibition prevents phosphorylation of the retinoblastoma protein (RB), resulting in suppression of E2F-dependent transcription and inhibition of G1-to-S phase transition. This can reduce proliferation of tumor cells that depend on CDK4/6 signaling.
Lerociclib has been investigated as a targeted anticancer therapy, particularly for hormone receptor-positive, HER2-negative breast cancer. It has also been studied in combination with endocrine therapies and other anticancer treatments.
As Lerociclib remains an investigational compound rather than a broadly established marketed API, its development status and potential applications should be described according to the applicable regulatory and clinical-development context.
Lerociclib API can be evaluated using validated analytical procedures for identification, assay, related substances, water content, residual solvents, elemental impurities and other applicable quality attributes.
HPLC and appropriate spectroscopic and chromatographic techniques may be used for identity, assay and purity determination. Control of related substances and degradation products is important for pharmaceutical-grade material.
Acceptance criteria should be based on the applicable manufacturer's drug-substance specification, Certificate of Analysis and relevant regulatory requirements.
Lerociclib should be stored in a tightly closed pharmaceutical-grade container under controlled storage conditions. The material should be protected from excessive heat, moisture, direct light and contamination. Specific storage requirements should follow the applicable manufacturer's approved specification.
Lerociclib API may be supplied for qualified pharmaceutical development, formulation research, analytical work and other legitimate research and manufacturing applications, subject to applicable regulatory requirements.
Lerociclib API is available for qualified pharmaceutical and research requirements subject to applicable quality and regulatory requirements. Customers can request product specifications, Certificate of Analysis, analytical documentation, packaging information and commercial details according to their requirements.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 2.0% |