PD-001

PD-001 is a patented, enteric-coated oral formulation of cepharanthine developed to improve the drug’s oral bioavailability and therapeutic potential in oncology and infectious diseases. Cepharanthine is a natural product that has been used for over 70 years in Japan for various acute and chronic conditions. However, its clinical use outside Japan has been limited by poor oral absorption. PD-001 addresses this limitation with an improved formulation that enables effective oral administration, eliminating the need for frequent intravenous dosing. Preclinical studies have shown that PD-001 achieves markedly superior bioavailability compared to generic cepharanthine tablets. Mechanistically, cepharanthine exhibits anti-cancer, anti-inflammatory, immunomodulatory, antiviral, antioxidant, and antiparasitic properties. In cancer models (notably esophageal and prostate cancer), it demonstrates synergistic effects when combined with standard-of-care chemotherapy agents such as cabazitaxel[2][4][5][7]. The lead indications under development are esophageal cancer (with orphan drug designation from FDA), prostate cancer (especially castration-resistant metastatic disease), and COVID-19.

Other names

enteric-coated oral cepharanthinereformulated cepharanthine