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]

Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. is initiating the regulatory process to gain access to the U.S. market for Australian Chestnut Extract as a botanical product for non-prescription uses [1][5]. Group 1: Company Developments - The company has exercised its option with Florida State University to negotiate an exclusive license for large-scale purification techniques to extract castanospermine from Australian Chestnut seeds [1]. - Since signing the option agreement in April 2025, the company has conducted safety testing on Australian Chestnut Extract and developed various prototype capsule formulations for oral delivery [5]. - 60 Degrees Pharmaceuticals specializes in developing new medicines for vector-borne diseases and received FDA approval for its lead product, ARAKODA, in 2018 [6]. Group 2: Product Information - Castanospermum australe, the source of castanospermine, is primarily found in Queensland and New South Wales, Australia, as well as in Florida, Hawaii, and California [2]. - Castanospermine has been shown to modulate carbohydrate metabolism and impact disease outcomes in animal models through immunomodulation [3]. - It is also a metabolite of celgosivir, which has been evaluated in clinical trials against HIV and Hepatitis C, suggesting castanospermine's safety and activity against similar pharmacological targets [4].