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iCo-009 is an oral formulation of amphotericin B developed to treat systemic fungal infections and visceral leishmaniasis. Amphotericin B is a well-established antifungal and antiprotozoal agent traditionally administered intravenously due to poor oral bioavailability and significant nephrotoxicity. iCo-009 utilizes a novel lipid-based delivery technology that enables effective oral absorption, achieving therapeutic blood levels with reduced kidney toxicity in preclinical models. The drug was invented by Drs. Kishor & Ellen Wasan at the University of British Columbia and licensed exclusively worldwide to iCo Therapeutics. It has been granted Orphan Drug status by the US FDA for visceral leishmaniasis, a life-threatening parasitic disease[1][6]. Preclinical studies have demonstrated efficacy against Aspergillus and Candida species as well as Leishmania parasites, with minimal observed renal toxicity[2][5][6]. As of the latest updates, clinical development has included phase 1b trials in mycoses (systemic fungal infections), but no recent reports indicate advancement beyond early-phase studies[3].
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