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60 Degrees Pharmaceuticals Files New Dietary Ingredient Notification (NDIN) with FDA for Australian Chestnut Extract
FDA has until May 25, 2026 to object to the notification, after which the Company will be free to market its proposed dietary supplement containing Australian
About this update from 60 Degrees Pharmaceuticals, Inc.
[{"type":"text","content":"FDA has until May 25, 2026 to object to the notification, after which the Company will be free to market its proposed dietary supplement containing Australian Chestnut ExtractCompany has signed an option agreement with Florida State University (FSU) to license a capsule formulation, expanding on its recent exercise of a license option for large-scale production WASHINGTON, March 18, 2026 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees Pharma” or the “Company”), a pharmaceutical company focused on developing new medicines for vector-borne disease, today announced it submitted a New Dietary Ingredient Notification (NDIN) to the U.S. Food and Drug Administration (FDA) for Australian Chestnut Extract on March 11, 2026. FDA has until May 25, 2026, to object to the notification, after which the Company will be free to market its planned dietary supplement containing Australian Chestnut Extract. The Company has also signed an option agreement to license Florida State University’s (FSU) ownership rights related to new capsule formulation methods for Australian Chestnut Extract, which FSU jointly owns with the Company. This expands on the Company’s January 2026 exercise of a license option with FSU for exclusive rights to large-scale purification of Castanospermine for non-prescription uses. Australian Chestnut Extract is derived from the seeds of Castanospermum australe (commonly known as the Australian Chestnut, the Moreton Bay Chestnut, and the Black Bean Tree). The dominant molecular constituent of Australian Chestnut Extract is castanospermine.According to recent scientific literature, at low doses, castanospermine modulates carbohydrate metabolism, altering glycogen, glucose levels, and other clinical markers. In animal models, high doses have been shown to impact disease outcomes in several therapeutic areas through immunomodulation. Castanospermine is also a metabolite of celgosivir, a product evaluated in clinical trials in more than 500 patients against HIV and Hepatitis C, but which is no longer in commercial development for those indications. That safety record suggests castanospermine is safe at achievable doses in humans and is active against the same pharmacological targets as in animal studies. About 60 Degrees Pharmaceuticals, Inc.60 Degrees Pharmaceuticals, Inc., founded in 2010, ...