60 Degrees Pharmaceuticals Files New Dietary Ingredient Notification (NDIN) with FDA for Australian Chestnut Extract

Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. has submitted a New Dietary Ingredient Notification for Australian Chestnut Extract to the FDA, with a marketing opportunity expected post-May 25, 2026, if no objections arise [1][9] Group 1: Company Developments - The company has signed an option agreement with Florida State University (FSU) to license rights related to new capsule formulation methods for Australian Chestnut Extract, building on a previous license for large-scale purification of Castanospermine [2][9] - 60 Degrees Pharmaceuticals specializes in developing medicines for vector-borne diseases and received FDA approval for its lead product, ARAKODA® (tafenoquine), in 2018, which is available in the U.S. and Australia [6] Group 2: Product Information - Australian Chestnut Extract is derived from the seeds of Castanospermum australe, with castanospermine as its dominant molecular constituent [3] - Scientific literature indicates that castanospermine can modulate carbohydrate metabolism at low doses and has shown potential in impacting disease outcomes through immunomodulation in animal models [4] - Castanospermine is a metabolite of celgosivir, previously evaluated in clinical trials for HIV and Hepatitis C, suggesting its safety and efficacy at achievable doses in humans [5]