Drug intelligence / Profile preview

Sapu-003

Development stage
Unknown
Lead developer
Oncotelic Therapeutics
Modality
Small Molecules, Nanoparticles → Drug Delivery Systems
Administration
Intravenous
01

Overview

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.

Other names
everolimus Deciparticleintravenous everolimus DeciparticleIV everolimus Deciparticle
02

Targets

AKT (RAC-alpha serine/threonine-protein kinase)FKBP1ARPS6KB1 (Ribosomal protein S6 kinase beta-1)SGK1mTOR (Mammalian target of rapamycin kinase)

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