60 Degrees Pharmaceuticals Secures Exclusive Option with Florida State University for Castanospermine Tick-Borne Disease Program

A regulatory strategy recalibration is underway at 60 Degrees Pharmaceuticals, after FDA discussions around a New Dietary Ingredient Notification prompted the company to deprioritize its dietary supplement pathway for castanospermine and pivot toward prescription drug development. The exclusive option agreement signed with the Florida State University Research Foundation (FSURF) formalizes that shift, covering IP related to castanospermine's use across four tick-borne disease indications: Powassan virus disease, tick-borne encephalitis, alpha-gal syndrome, and post-treatment Lyme disease.

Castanospermine is a naturally occurring iminosugar derived from Castanospermum australe (Australian Chestnut) with demonstrated broad antiviral and immunomodulatory activity in preclinical studies. Human safety data exists through clinical experience with celgosivir, a prodrug that converts substantially to castanospermine following oral administration, a profile that supports early regulatory positioning for an IND-track program rather than a dietary supplement route.

Under the agreement, 60 Degrees holds an exclusive option to negotiate a U.S. license for patented technology and associated know-how, alongside an evaluation period to develop a commercialization strategy and supporting development plan. For regulatory affairs leads, the dual-track history here is instructive: the company's NDI discussions with FDA appear to have surfaced pathway complexity that shifted the risk-benefit calculus toward the prescription drug route, where castanospermine's clinical and commercial potential is assessed as stronger.

The castanospermine program complements the company's ongoing tafenoquine development for babesiosis. ARAKODA (tafenoquine), approved by FDA in 2018 for malaria prevention, remains the company's commercial anchor, providing the vector-borne disease infrastructure and regulatory precedent that 60 Degrees is now leveraging for tick-borne indications. The FSURF relationship extends an existing academic collaboration model the company has employed across U.S. and Australian research partnerships.

Advancement of a formal development plan and the decision to exercise the license option will serve as the near-term indicators of how quickly 60 Degrees can translate this agreement into a defined regulatory submission strategy.

Source: GlobeNewswire via 60 Degrees Pharmaceuticals press release, July 8, 2026.