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HND033 is a small molecule tyrosine kinase inhibitor (TKI) being developed by Handa Pharma for the treatment of Chronic Myeloid Leukemia (CML). Developed under the ONCORE™ 505(b)(2) regulatory pathway, HND033 is a reformulation of an existing TKI intended to optimize clinical outcomes by improving bioavailability, reducing pharmacokinetic variability, and removing restrictions related to food intake or the use of proton pump inhibitors (PPIs). The specific tyrosine kinase target has not been publicly disclosed. As of the current pipeline status, the drug is in the preclinical development stage, having progressed through pilot bioavailability studies.
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