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RL001 is a novel self-emulsifying soft-capsule formulation of abiraterone acetate, developed by Hunan Huize Biopharmaceutical Technology and Jiangsu Wango Pharmaceutical. It utilizes a self-emulsifying drug delivery system (SEDDS) to enhance the oral bioavailability and mitigate the significant food effect associated with the conventional tablet form of abiraterone acetate (Zytiga). By improving solubility and absorption, RL001 aims to achieve therapeutic efficacy at a lower dose compared to the standard 1000 mg tablet. Abiraterone acetate is a prodrug that is converted in vivo to abiraterone, a potent inhibitor of the enzyme 17α-hydroxylase/C17,20-lyase (CYP17), which is essential for androgen biosynthesis in the testes, adrenal glands, and prostate tumor tissue. RL001 is currently in Phase I clinical development for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC).
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