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Drug intelligence / Profile preview
Sapu-003 (also known as SAPU 003) is an investigational intravenous nanoparticle formulation of everolimus, a validated mTOR inhibitor. Developed by Sapu Nano (a subsidiary of Oncotelic Therapeutics) using its proprietary Deciparticle™ platform, Sapu-003 encapsulates everolimus into ultra-small nanoparticles (<20 nm) to enable intravenous administration. This formulation is designed to overcome the limitations of oral everolimus, such as low bioavailability, variable systemic exposure, and gastrointestinal toxicities, while achieving dual mTORC1 and mTORC2 inhibition. Sapu-003 is currently in Phase 1b clinical development for the treatment of advanced mTOR-sensitive solid tumors, including HR-positive/HER2-negative breast cancer, renal cell carcinoma, neuroendocrine tumors, and hepatocellular carcinoma.
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