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Samuraciclib is an orally available, selective small molecule inhibitor of cyclin-dependent kinase 7 (CDK7), developed as a targeted antineoplastic therapy. By inhibiting CDK7, samuraciclib disrupts transcriptional regulation and cell cycle progression in cancer cells—mechanisms that are often dysregulated in malignancies. It is being investigated primarily for hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer, especially in patients previously treated with CDK4/6 inhibitors and aromatase therapy. Clinical studies have also explored its use in triple-negative breast cancer (TNBC) and other solid tumors such as prostate, pancreatic, ovarian, colorectal cancers and small cell lung cancer. Samuraciclib has demonstrated a favorable safety profile with mostly mild gastrointestinal side effects and shows encouraging efficacy signals both as monotherapy and in combination with endocrine therapies like fulvestrant or oral SERDs[2][4][5][6][10].
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