60 Degrees Pharmaceuticals Targets Human and Canine Babesiosis Markets With Tafenoquine

July 15, 2025

DENVER, Colo., Jul 15, 2025 (247marketnews.com)- 60 Degrees Pharmaceuticals (NASDAQ:SXTP) continues to advance its tafenoquine franchise on two parallel fronts, canine and human babesiosis, by preparing regulatory submissions and laying the groundwork for what could be a $1.1 billion cumulative market opportunity by 2035.

FDA MUMS Designation for Canine Babesiosis in Sight

In a press release issued after the market close on Monday, 60 Degrees announced plans to submit a Minor Use/Minor Species (MUMS) designation request to the FDA for tafenoquine as a treatment for acute canine babesiosis, a serious tick-borne disease affecting hundreds to thousands of dogs annually in the U.S.

Geoff Dow, EO of 60 Degrees Pharmaceuticals, commented, “Data from the canine babesiosis studies are impactful when viewed in the larger context of the ground-breaking human babesiosis research we are now sponsoring. The positive findings of the canine babesiosis study are in line with our earlier findings that tafenoquine could be effective against babesiosis in humans.”

The submission, expected in 2025, will be based on results from three clinical efficacy studies, including one company-sponsored trial at North Carolina State University, as well as existing canine safety and chemistry manufacturing and controls (CMC) data developed during tafenoquine’s use in ARAKODA for malaria.

In all studies, ARAKODA (tafenoquine) was well tolerated and appeared to support recovery in dogs with both experimental and naturally acquired Babesia infections. With no FDA-approved oral treatment currently available and existing therapies posing toxicity or resistance risks, the potential for tafenoquine to fill a critical therapeutic gap in veterinary medicine is substantial.

Human Babesiosis Market Pegged at $245 Million Annually

In a follow-up announcement Tuesday morning, the company unveiled detailed market research findings that define the total addressable market (TAM) for ARAKODA (tafenoquine) in human babesiosis at 380,000 annual patients, equating to $245 million in annual sales potential and $1.1 billion cumulatively through 2035, when the patent is expected to expire.

Dow added, “The full extent to which 60 Degrees Pharmaceuticals may be in a position to improve the lives of large numbers of people who suffer with babesiosis is now coming into view.”

The findings stem from a nationwide survey of 6,000 patients and a quantitative study involving 300 healthcare professionals, conducted by Format Analytics. The data reveal a clear unmet need, particularly in patients co-infected with Lyme Disease. Currently, human babesiosis is managed with off-label therapies that often lack efficacy or promote drug resistance when used repeatedly.

A New Drug Application (NDA) for tafenoquine in human babesiosis is planned for 2026, contingent on positive data from three ongoing or planned U.S. clinical trials.

One Drug, Two Markets — Human and Animal Health Synergy

By pursuing FDA approval under both human and veterinary pathways, 60 Degrees Pharmaceuticals is leveraging the full potential of tafenoquine. The MUMS designation could provide regulatory and market exclusivity benefits in the animal health sector, while the human program targets a fast-growing, underserved population segment vulnerable to emerging tick-borne illnesses.

As tick-borne diseases like Lyme and babesiosis continue to rise, 60 Degrees’ tafenoquine strategy positions the company as a dual-sector innovator in infectious disease therapeutics.

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