Synthetic study demonstrates a 17-step synthesis of radiolabelled homoharringtonine, enabling required human mass balance trials for leukemia therapy.
A total synthesis of enantiomerically pure [14C]‐labelled (–)‐homoharringtonine in 17 steps is reported. This synthetic process enabled the production of Good Manufacturing Practice (GMP) compliant (–)‐[14C]homoharringtonine that was used in a human mass balance study that was a post‐approval commitment to the U.S. Food and Drug Administration. (–)‐Homoharringtonine, also called omacetaxine mepesuccinate, is approved to treat adult patients with chronic myeloid leukemia (CML), a blood and bone marrow disease. In November 2012, the product was commercialised as Synribo® in the U.S., marketed by Teva Pharmaceuticals.
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Marguerit et al. (2015) studied this question.
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