60 Degrees Pharmaceuticals Defines Potential Human Babesiosis Market Size for ARAKODA® (tafenoquine): Annual Max TAM, Sales of $245 Million; Cumulative through Patent Expiration, $1.1 Billion

Core Insights - 60 Degrees Pharmaceuticals has identified a total addressable market (TAM) for ARAKODA (tafenoquine) in treating human babesiosis, estimating it at 380,000 patients and $245 million in annual sales, with a cumulative TAM of 1.17 million patients and $1.1 billion through patent expiration in 2035 [1][2][8] - The company is advancing clinical research for tafenoquine to address the unmet medical need for babesiosis, a serious tick-borne illness, with no FDA-approved treatments currently available [1][3] Market Research - The TAM calculations were based on a nationwide survey of 6,000 patients and a quantitative research survey of 300 healthcare professionals conducted by Format Analytics [2][8] Clinical Trials - Three clinical trials sponsored by 60 Degrees Pharmaceuticals are underway to evaluate the safety and efficacy of tafenoquine for treating babesiosis, with data expected in the first half of 2026 [4][8] - A New Drug Application (NDA) submission to the U.S. FDA for babesiosis is anticipated in 2026, contingent on positive trial results [4][8] Product Information - ARAKODA (tafenoquine) was approved for malaria prophylaxis in the U.S. in 2018 and launched commercially in 2019, with a long terminal half-life of approximately 16 days allowing for less frequent dosing [5][6] - Tafenoquine is not currently approved for the treatment or prevention of babesiosis [6] Company Overview - 60 Degrees Pharmaceuticals, founded in 2010, focuses on developing new medicines for infectious diseases and has received FDA approval for ARAKODA for malaria prevention [17]