60 Degrees Pharmaceuticals Submits NDIN for Australian Chestnut Extract to FDA

60 Degrees Pharmaceuticals announced it submitted a New Dietary Ingredient Notification, or NDIN, to the FDA for Australian Chestnut Extract on March 11. FDA has until May 25 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 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. 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.