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Amphotericin B liposomal (0.4% liposomal gel) is an investigational topical formulation of the polyene antifungal antibiotic amphotericin B, specifically developed by Soroka University Medical Center for the treatment of cutaneous leishmaniasis. The drug is encapsulated in nano-liposomes (approximately 100 nm in diameter) to enhance skin penetration and localize the active agent at the site of infection, thereby minimizing the systemic absorption and nephrotoxicity typically associated with intravenous amphotericin B. Its mechanism of action involves binding to ergosterol in the cell membrane of Leishmania parasites (such as Leishmania major and Leishmania tropica), creating aqueous pores that lead to the leakage of essential intracellular components and subsequent pathogen death. This formulation has been evaluated in Phase 2 clinical trials to assess its efficacy and safety compared to placebo in patients with PCR-confirmed cutaneous leishmaniasis.
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