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

Business Upturn

15-07-2025

New Drug Application intended for 2026, subject to generation of positive data from three U.S. clinical trials planned or in progress
Total addressable market (TAM) for ARAKODA for Human Babesiosis is informed by results of a 6,000 nationwide patient survey and a quantitative research study involving 300 healthcare professionals
WASHINGTON, July 15, 2025 (GLOBE NEWSWIRE) — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) ('60 Degrees' or the 'Company'), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced it has determined the maximum size of the commercial market for ARAKODA® (tafenoquine) for treatment of human babesiosis to be 380,000 patients/$245,000,000 in sales annually, with a cumulative TAM of 1.17 million patients/$1.1 billion through patent expiration in 2035. Human babesiosis is a serious and debilitating emerging tick-borne illness often found as a co-infection in patients with Lyme Disease. There is a substantial unmet medical need due to the lack of FDA-approved treatments and the frequent generation of resistance associated with repeated use of generic drugs to manage persistent disease.
TAM calculations were based on a nation-wide 6,000 patient survey and a quantitative research survey of 300 healthcare professionals conducted by Format Analytics, an independent market research firm.
'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,' said Chief Executive Office of 60 Degrees Pharmaceuticals, Geoff Dow, PhD. 'Yet, no approved treatment exists for this disabling and sometimes deadly disease. As the leader in this space, our goal is to continue advancing our robust clinical research program evaluating tafenoquine for babesiosis, and to secure approval of a supplemental indication for ARAKODA as expeditiously as possible.'
Clinical Babesiosis Studies Sponsored by 60 Degrees Pharmaceuticals
Three 60 Degrees Pharmaceuticals-sponsored clinical trials ( NCT06478641 , NCT06207370 , NCT06656351 ) are underway or planned to evaluate tafenoquine's safety and efficacy in treating humans diagnosed with babesiosis. Data are expected from one or more of these studies in the first half of 2026 and will be used as part of a planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration for babesiosis, anticipated in 2026.
About ARAKODA® (tafenoquine)
Tafenoquine was discovered by Walter Reed Army Institute of Research. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA® and in Australia as KODATEF®. Both were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in each respective country. They are available at retail pharmacies as a prescription-only malaria prevention drug. According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, offers the advantage of less frequent dosing for the prophylaxis of malaria. ARAKODA® is not suitable for everyone, and patients and prescribers should review the Important Safety Information below. Individuals at risk of contracting malaria are prescribed ARAKODA® 2 x 100 mg tablets once per day for three days (the loading phase) prior to travel to an area of the world where malaria is endemic, 2 x 100 mg tablets weekly for up to six months during travel, then 2 x 100 mg in the week following travel.
Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the U.S. Food and Drug Administration for such an indication.
ARAKODA® (tafenoquine) Important Safety Information
ARAKODA® is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older.
Contraindications
ARAKODA® should not be administered to: Glucose-6-phosphate dehydrogenase ('G6PD') deficiency or unknown G6PD status;
Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if G6PD status is unknown;
Patients with a history of psychotic disorders or current psychotic symptoms; or
Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA®.
Warnings and Precautions
Hemolytic Anemia: G6PD testing must be performed before prescribing ARAKODA® due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis.
G6PD Deficiency in Pregnancy or Lactation: ARAKODA® may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA® is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA® through breast milk. Check infant's G6PD status before breastfeeding begins.
Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur.
Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions, or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA® therapy and evaluation by a mental health professional as soon as possible.
Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA®. If hypersensitivity reactions occur, institute appropriate therapy.
Delayed Adverse Reactions: Due to the long half-life of ARAKODA® (approximately 16 days), psychiatric effects, hemolytic anemia, methemoglobinemia, and hypersensitivity reactions may be delayed in onset and/or duration.
Adverse Reactions: The most common adverse reactions (incidence greater than or equal to 1 percent) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase (ALT), motion sickness, insomnia, depression, abnormal dreams, and anxiety.
Drug Interactions
Avoid co-administration with drugs that are substrates of organic cation transporter-2 or multidrug and toxin extrusion transporters.
Use in Specific Populations
Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of ARAKODA®.
To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals, Inc. at 1- 888-834-0225 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . The full prescribing information of ARAKODA® is located here .
About 60 Degrees Pharmaceuticals, Inc.
60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and marketing new medicines for the treatment and prevention of infectious diseases that affect the lives of millions of people. 60 Degrees Pharmaceuticals, Inc. achieved FDA approval of its lead product, ARAKODA® (tafenoquine), for malaria prevention, in 2018. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research organizations in the U.S., Australia, and Singapore. The 60 Degrees Pharmaceuticals, Inc. mission has been supported through in-kind funding from the U.S. Department of Defense and private institutional investors including Knight Therapeutics Inc., a Canadian-based Pan-American specialty pharmaceutical company. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at www.60degreespharma.com . The statements contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management's current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements.
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Media Contacts:Sheila A. Burke
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