A trial designed to determine whether there is a clinically significant drug-drug interaction of tafenoquine with DHA-piperaquine using a control arm with radical cure given at the end of follow up (delayed radical cure).

Start Date01 Nov 2025

Sponsor / Collaborator

Menzies School of Health Research

NCT07060404

/ Not yet recruitingPhase 2/3IIT

Pharmacokinetics of Primaquine and Tafenoquine in Lactating Women - Towards Equitable Radical Cure of Vivax Malaria

In Papua New Guinea, administration of primaquine (PQ) or tafenoquine (TQ) to breastfeeding mothers is contraindicated during the first six months postpartum, when infants are recommended to be exclusively breastfed, because of a lack of comprehensive pharmacokinetic data on PQ/TQ neonatal and infant exposure via breast milk. The therapeutic restriction of PQ/TQ use in lactating women during the first six months postpartum effectively translates into
10% of females being excluded from radical cure in endemic areas at any time. This is because many at risk women live in remote areas, are frequently lost to follow-up, or may have conceived again before they reattend. As a result, radical cure is rarely achieved and women are exposed to recurrent infections and cumulative risk of anaemia. Relapses may occur for years, placing subsequent pregnancies at risk and perpetuating intergenerational failure of fetal growth. They also contribute to malaria transmission, thus household and community exposure to vivax malaria.
The goal of the present study is to determine how much PQ/TQ is transferred to a suckling baby, if a mother receives a treatment course of PQ/TQ at time of delivery. We also want to confirm that this treatment is safe and has no major side effects for babies in Papua New Guinea.
The study Interventions areas follows: Group 1 - Participants receive PNG standard of care; PQ given 6-months postpartum; Group 2 - Participants receive a 14-day treatment regimen of PQ, at the standard dose prescribed in PNG for vivax radical cure (0.5 mg/kg/day for 14 days); Group 3 - Participants receive an accelerated high-dose 7-day treatment regimen of PQ, as per current WHO recommendations (1.0 mg/kg/day for 7 days); Group 4 - Participants receive a single dose of 300mg tafenoquine.
All participants will be monitored for a total duration of 6 months, with the safety, tolerability, pharmacokinetics and preliminary relapse efficacy of PQ/TQ evaluated at standardised time points over this period (Day 0, 1, 3, 6, 8, 15, 20, 28, and Month 2, 3, 4, 5 and 6). At each of these time points, participants will be asked to describe any symptoms they may be experiencing, participate in a medical examination, and provide a blood and breast milk sample for drug analysis and safety (biochemistry and haematology testing). The investigators will also collect a small blood sample (heel prick) from the infant to measure drug concentrations and safety testing.

Start Date01 Aug 2025

Sponsor / Collaborator

Curtin University

[+2]

NCT07052162

/ Not yet recruitingPhase 4IIT

Safety, Pharmacokinetics, and Preliminary Efficacy of Tafenoquine for the Treatment of Vivax Malaria in Papua New Guinean Children

Plasmodium vivax is the most geographically widespread malaria species and the second largest contributor to symptomatic malaria worldwide. It accounts for half of all malaria cases outside Africa, with an estimated 14.3 million clinical vivax malaria cases reported annually, contributing to an annual cost of US$359 million. Children are most vulnerable to infection, with P. vivax prevalence peaking between 2 to 6 years of age. In Papua New Guinea (PNG), there are >1.5 million suspected P. vivax cases annually, and while P. falciparum infections are the most prevalent, P. vivax transmission is the most intense in the world. P. vivax in PNG provides a unique epidemiological setting in which to assess innovative treatments in children.
The complex biology of P. vivax represents a challenge for malaria control and chemotherapy, especially dormant liver-stage parasites (hypnozoites) which can reactivate (relapse) and cause disease at a time remote from the primary infection. Hypnozoite relapse is the primary cause of vivax malaria in endemic regions and is resistant to most antimalarial drugs. Identifying effective treatments for radical cure, the complete elimination of parasites (both blood- and liver-stage), is therefore a priority. The World Health Organization (WHO) recommends a 14-day radical cure regimen for uncomplicated vivax malaria; comprised of blood stage treatment (chloroquine or artemisinin combination therapy (ACT)) and 14 days of the 8-aminoquinoline drug primaquine (PQ; 0.25-0.5 mg/kg/day) for liver-stage cure. More recently, the 8-aminoquinoline tafenoquine has garnered interest as an alternative radical cure agent to primaquine. However, there is limited data on the pharmacokinetics, tolerability and radical cure efficacy of tafenoquine in children.
The overall aim of the study is to characterise the pharmacokinetic profile of tafenoquine (and primary metabolite) in Papua New Guinean children.

Start Date01 Jul 2025

Sponsor / Collaborator

Curtin University

[+2]

100 Clinical Results associated with Tafenoquine Succinate

100 Translational Medicine associated with Tafenoquine Succinate

100 Patents (Medical) associated with Tafenoquine Succinate

446

Literatures (Medical) associated with Tafenoquine Succinate

01 Jun 2025·LANCET INFECTIOUS DISEASES

Quantifying Plasmodium vivax radical cure efficacy: a modelling study integrating clinical trial data and transmission dynamics

Article

Author: Drakeley, Chris ; White, Michael ; Mueller, Ivo ; Ciavarella, Constanze ; Price, Ric N

BACKGROUND:

Plasmodium vivax forms dormant liver stages (hypnozoites) that can reactivate weeks to months after primary infection. Radical cure requires a combination of antimalarial drugs to kill both the blood-stage and liver-stage parasites. Hypnozoiticidal efficacy of the liver-stage drugs primaquine and tafenoquine cannot be estimated directly because hypnozoites are undetectable. We aimed to estimate hypnozoiticidal efficacy from clinical trial data, and quantify the community-level impact of implementing case management with radical cure.

METHODS:

We calibrated a novel P vivax Recurrence Model to publicly available data from prospective clinical trials to estimate the hypnozoiticidal efficacy of different supervised primaquine (3·5 mg/kg or 7 mg/kg over 7 or 14 days) and tafenoquine (5 mg/kg or 7·5 mg/kg single dose) regimens in patients with normal glucose-6-phosphate dehydrogenase (G6PD) activity. We used an existing P vivax Individual-Based Model to quantify the 5-year impact of case management with unsupervised primaquine or tafenoquine regimens across various transmission settings.

FINDINGS:

We estimated median hypnozoiticidal efficacies of 99·1% (95% credible interval 96·0-100) for primaquine 7 mg/kg over 14 days; 96·3% (90·8-99·7) for primaquine 7 mg/kg over 7 days; 72·3% (68·1-76·3) for primaquine 3·5 mg/kg over 7 or 14 days; 62·4% (49·1-76·3) for tafenoquine 5 mg/kg single dose; and 87·5% (62·1-99·3) for tafenoquine 7·5 mg/kg single dose. 5 years of community-level tafenoquine case management was estimated to reduce P vivax transmission by 74-79% where pre-intervention prevalence as measured by PCR was low (<2%) and by 17-20% where prevalence as measured by PCR was high (around 35%). Similar 5-year reductions were estimated with primaquine case management only when adherence to the primaquine regimen was above 50%.

INTERPRETATION:

Substantial reductions in prevalence as measured by PCR were predicted with primaquine and tafenoquine regimens if these could be implemented with high coverage and adherence. The benefits of preventing P vivax relapses need to be balanced against the risks of inducing severe haemolysis in patients with G6PD deficiency.

FUNDING:

Bill & Melinda Gates Foundation and Horizon Europe.

01 Jun 2025·HEARING RESEARCH

Drug-induced hearing loss: a real-world pharmacovigilance study using the FDA adverse event reporting system database

Article

Author: Zhu, Bin ; Du, Qian ; Dong, Jie ; Zhao, Zhigang ; Shi, Yanfeng ; Li, Dongxuan ; Wu, Tingxi ; Wang, Peng

Drug-induced hearing loss (DIHL) is highly prevalent, but a comprehensive picture of ototoxicity associated with drugs are still lacking. In order to comprehensively summarize the hearing safety information of current drugs, we used the real-world data from 2004 to 2023 in the FDA Adverse Event Reporting System (FAERS) database to integrate the reported ototoxicity information of drugs and applied disproportionality analysis to evaluate the hearing impairment risk induced by drugs. A total of 108,435 adverse event (AE) reports of hearing impairment were extracted from the FAERS database, involving 1300 reported culprit-drugs. On the whole, acetylsalicylic acid was the most frequently reported potential ototoxic drug, followed by levothyroxine sodium, adalimumab, omeprazole, and ergocalciferol. Immunosuppressants was the most frequently reported drug class, followed by analgesics, psychoanaleptics, agents acting on the renin-angiotensin system, and antineoplastic agents. In risk signal detection, 432 of 1300 drugs exhibited potential ototoxic risk, in which tafenoquine showed the strongest statistical correlation with hearing impairment, followed by teprotumumab, amyl nitrite, potassium iodide, and paromomycin. Among main drug classes, antibacterials for systemic use was the drug class contained the maximum number of drugs with positive ototoxic risk signals, followed by psychoanaleptics, agents acting on the renin-angiotensin system, antineoplastic agents, and analgesics. In conclusion, our study summarized a comprehensive drug list containing 1300 reported potential ototoxic drugs in the FAERS database and profiled their ototoxicity risk characteristic from the aspect of reporting frequency and risk signal strength, which can provide reference for clinical medical staff to strengthen monitoring and management of DIHL.

24 May 2025·Journal of biomolecular structure & dynamics

Repurposing FDA-approved drugs as NLRP3 inhibitors against inflammatory diseases: machine learning and molecular simulation approaches

Article

Author: Agarwal, Vipul ; Raj, Vinit ; Haldhar, Rajesh ; Lee, Sangkil ; Ahmed, Bilal ; Hirad, Abdurahman Hajinur ; Gupta, Anugya ; Han, Sang Beom

Activation of NLRP3 (NOD-like receptor family, pyrin domain-containing protein 3) has been associated with multiple chronic pathologies, including diabetes, atherosclerosis, and rheumatoid arthritis. Moreover, histone deacetylases (HDACs), specifically HDAC6 is required for the NLRP3 inflammasome to assemble and activate. Thus, NLRP3 serves as an attractive target for the development of novel therapeutic approaches. Several companies are now attempting to develop specific modulators of the NLRP3 inflammasome, but only a handful of small molecules of NLRP3 inflammasome inhibitors, such as MCC950 and Tranilast, are currently available for clinical use. However, their use is limited due to severe side effects and short half-lives. Thus, the repurposing of FDA-approved drugs with NLRP3 inhibitory activity is needed. The present study was aimed at repurposing preexisting drugs that might act as safe and effective NLRP3 inhibitors. A library of 2,697 FDA-approved drugs was screened for binding with NLRP3 (PDB: 7ALV) using Glide (Schrödinger). The top seven FDA-approved drugs with potential binding affinities were selected based on docking scores and subjected to ADMET profiling using pkCSM and SwissADME. The binding of the ADMET-favorable FDA-approved drugs to NLRP3 was validated using MMGBSA (Prime) and Molecular Dynamics (Desmond) in the Schrödinger suite. ADMET profiling revealed that of the seven best docking drugs, empagliflozin and citicoline had good drug-likeness properties. Moreover, MMGBSA analysis and molecular dynamics demonstrated that empagliflozin and citicoline exhibited stable ligand-NLRP3 interactions in the presence of solvents. This study sheds light on the ability of various FDA-approved drugs to act as NLRP3 inhibitors.

News (Medical) associated with Tafenoquine Succinate

04 Jun 2025

·www.globenewswire.com

60 Degrees Pharmaceuticals Expands Options for Malaria Prevention with Introduction of ARAKODA® (tafenoquine) 8-Count Bottle Format

New 8-count bottles now available through major retail pharmaciesARAKODA® is the only weekly prophylactic therapy to provide protection against the blood and liver stages of malaria WASHINGTON, June 04, 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 the introduction of a new 8-count bottle format for ARAKODA® (tafenoquine). The 8-count bottle format may be suitable for use with patients who are making shorter trips to areas of the world where malaria is endemic. The new format expands the packaging options available to healthcare professionals who prescribe ARAKODA for the prevention of malaria and travelers taking trips of one week or less. The 8-count bottles are now available through major retail pharmacies, including Amazon Pharmacy. For individuals traveling to endemic areas, ARAKODA tablets are indicated for the prophylaxis of malaria in patients 18 years of age and older. ARAKODA is the only weekly prophylactic therapy to provide protection against all stages of malaria. 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. 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 ifG6PD status is unknown;Patients with a history of psychotic disorders or current psychotic symptoms; orKnown 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. Cautionary Note Regarding Forward-Looking StatementsThis press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for tafenoquine (ARAKODA® or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials or patient recruitment in our trials might be slow or negligible; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the information contained in our Annual Report on Form 10-K filed with the SEC on April 1, 2024, and our subsequent SEC filings. Investors and security holders are urged to read these documents free of charge on the SEC’s website at www.sec.gov. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Media Contacts:Sheila A. BurkeSheilaBurke-consultant@60degreespharma.com (484) 667-6330 Investor Contact:Patrick Gaynespatrickgaynes@60degreespharma

Drug Approval

03 Jun 2025

·www.globenewswire.com

Babesiosis Incidence in U.S. 10x Higher Than CDC Estimates, According to Insurance Claims Study Commissioned by 60 Degrees Pharmaceuticals

25,000 U.S. adults per year claim reimbursement for medical costs associated with babesiosis v. CDC estimates of 2,000A full 45 percent of persistent babesiosis cases include chronic fatigueHealthcare providers treating patients who present with unexplained chronic fatigue may wish to consider babesiosis as a differential diagnosisCompany plans to submit a new drug application (NDA) to FDA in 2026, has two babesiosis clinical trials underway with another anticipated to commence enrollment later this year WASHINGTON, June 03, 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 results of an insurance claims analysis related to babesiosis and chronic fatigue, as conducted by Komodo Health, a healthcare technology company that delivers the evidentiary standard for real-world data and analytics, contracted by the Company. Results showed approximately 25,000 Americans seek reimbursement for babesiosis-related medical costs each year, according to 60 Degrees Pharmaceuticals. In contrast, current estimates published by the Centers for Disease Control and Prevention (CDC) show only 2,000 cases in 2020. Babesia infections last at least 12 months in 14 percent of patients and may relapse up to 27 months later, as documented in the scientific literature. Many physicians treating tick-borne infections speculate the true duration of infection may be much longer. The claims data indicated approximately 31 percent of babesiosis cases persist longer than 30 days, and that nearly half of those are associated with chronic fatigue lasting longer than six months. Fatigue is the last symptom of babesiosis to resolve in acute disease. Chronic fatigue during babesiosis has not been systematically described in the literature. Further, the claims data, which captured approximately 40 percent of U.S. diagnostic data, showed that over three years, more than 12 million U.S. adults experienced chronic fatigue greater than six months in duration. Current Infectious Diseases Society of America advice and other professional guidelines do not mandate babesiosis as a differential diagnosis if a patient self-reports experiencing such fatigue. The Company is testing, through its clinical development program, the medical hypothesis that the true burden of babesiosis is much larger than claims data suggest and is a function of the incidence of chronic fatigue lasting six months or longer, multiplied by the proportion of such individuals with confirmable infections. A molecular incidence study in patients with chronic fatigue commissioned by the Company was recently completed. Once published, the data will allow establishment of a ceiling on the incidence of persistent babesiosis. Clinical Babesiosis Studies Sponsored by 60 Degrees PharmaceuticalsThree 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. 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 ifG6PD status is unknown;Patients with a history of psychotic disorders or current psychotic symptoms; orKnown 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. Cautionary Note Regarding Forward-Looking StatementsThis press release may contain “forward-looking statements” within the meaning of the safeharbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for tafenoquine (ARAKODA® or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials or patient recruitment in our trials might be slow or negligible; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the information contained in our Annual Report on Form 10-K filed with the SEC on April 1, 2024, and our subsequent SEC filings. Investors and security holders are urged to read these documents free of charge on the SEC’s website at www.sec.gov. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Media Contacts:Sheila A. BurkeSheilaBurke-consultant@60degreespharma.com(484) 667-6330 Investor Contact:Patrick Gaynespatrickgaynes@60degreespharma.com

Drug ApprovalNDA

15 May 2025

·www.einpresswire.com

60 Degrees Pharmaceuticals Announces First Quarter 2025 Results

Q1 2024 net product revenues increased 55% year-over-year to $163.6 thousand. Gross profit increased 124% to $90.3 thousand. WASHINGTON, May 15, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP ; SXTPW) (the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, reported today their financial results for the first fiscal quarter of the 2025 year, ended March 31, 2025. Financial Highlights for the Quarter Ended March 31, 2025: Net product revenues increased approximately 55% from $105.7 thousand for the first quarter of 2024 to approximately $163.6 thousand for the first quarter of 2025; the Company credits growth from domestic sales of ARAKODA ® . The Company achieved a gross profit of approximately $90.3 thousand in the first quarter of 2025, compared with an approximate gross profit of $40.2 thousand in the first quarter of 2024. Operating expenses were approximately $2.09 million in the first quarter of 2025, compared with approximately $1.41 million in the first quarter of 2024. Increased expenditures in sales and investor-related services along with stock-based compensation accounted for $535.4 thousand of the increase. Net loss attributable to common shareholders in the first quarter of 2025 was approximately $2.01 million, or ($1.56) per share, compared with a net income of approximately $308.7 thousand, or $1.83 per share in the first quarter of 2024. The change in fair value of derivative liabilities accounted for $1.74 million of this difference in income attributable. 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 . Cautionary Note Regarding Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for tafenoquine (ARAKODA ® or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the information contained in our Annual Report on Form 10-K filed with the SEC on March 27, 2025, and our subsequent SEC filings. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at www.sec.gov. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Media Contact: Sheila A. Burke SheilaBurke-consultant@60degreespharma.com (484) 667-6330 Investor Contact: Patrick Gaynes patrickgaynes@60degreespharma.com (310) 989-5666 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug ApprovalFinancial Statement

100 Deals associated with Tafenoquine Succinate

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KEGG	Wiki	ATC	Drug Bank
D10670	Tafenoquine Succinate	P01BA07	DB06608

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Malaria	United States	60 Degrees Pharmaceuticals, Inc.	08 Aug 2018
Malaria, Vivax	United States	GlaxoSmithKline Intellectual Property Development Ltd.	20 Jul 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hemolysis	Phase 3	Brazil	GSK Plc	30 Apr 2015
Hemolysis	Phase 3	Colombia	GSK Plc	30 Apr 2015
Hemolysis	Phase 3	Ethiopia	GSK Plc	30 Apr 2015
Hemolysis	Phase 3	Peru	GSK Plc	30 Apr 2015
Hemolysis	Phase 3	Thailand	GSK Plc	30 Apr 2015
Hemolysis	Phase 3	Vietnam	GSK Plc	30 Apr 2015
Fatigue	Phase 2	-	60 Pharmaceuticals LLC	01 Feb 2025
Babesiosis	Phase 2	United States	60 Pharmaceuticals LLC	17 Jun 2024
COVID-19	Phase 2	United States	60 Pharmaceuticals LLC	19 Feb 2021
Malaria, Falciparum	Phase 2	-	Smithkline Beecham	01 May 2000

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04533347 (CTgov)	Phase 2	COVID-19	86	Tafenoquine Oral Tablet (Tafenoquine)	gtsemvkdad: P-Value = 0.1879	-	07 Jan 2025
				Placebo (Placebo)
NCT05096702 (Pubmed \| Lancet Infect Dis)	Not Applicable	Malaria, Vivax glucose-6-phosphate dehydrogenase (G6PD)	5,554	Tafenoquine 300 mg	fixuwtimsx(chkvamvoxj) = shgtnemcil gabuhxybcg (vckimqjrrb, 76 - 120)	Positive	01 Jun 2024
				7-day Primaquine 0.5 mg/kg per day	fixuwtimsx(chkvamvoxj) = pcagrobagb gabuhxybcg (vckimqjrrb, 52 - 94)
ACTRN12620000995976 (Australian and New Zealand Clinical Trials Registry, Pubmed \| Clin Infect Dis)	Phase 1	Malaria \| Infectious Diseases glucose 6-phosphate dehydrogenase (G6PD)	12	Tafenoquine 200 mg	nhlwhehdpx(izzvsffytw) = nudlljyfrm ryhjjafhlq (oirzwladbn )	Positive	08 Jun 2023
				Tafenoquine 300 mg	nhlwhehdpx(izzvsffytw) = xnaohjczvo ryhjjafhlq (oirzwladbn )
NCT02802501 (200894, Pubmed \| Lancet Infect Dis)	Phase 3	Malaria, Vivax	150	Dihydroartemisinin-piperaquine alone	eipgicempy(rflxaeglho) = ravtuutung zviwrntpcq (girjjbqzdu, 4 - 22)	Negative	23 May 2023
				Dihydroartemisinin-piperaquine plus tafenoquine	eipgicempy(rflxaeglho) = drpirwaeth zviwrntpcq (girjjbqzdu, 11 - 34)
NCT05788094 (Pubmed)	Phase 4	Malaria, Vivax	-	Tafenoquine 5 mg/kg	vfmukprfwj(cpxwwlvwlm) = omrniidbrd fqpufhazbw (bvkchojwjj )	-	06 Dec 2022
				Tafenoquine 7.5 mg/kg	vfmukprfwj(cpxwwlvwlm) = mzjamdsvkq fqpufhazbw (bvkchojwjj )
NCT02563496 (TEACH \| TAF113577, Corporate Publications) Manual	Phase 2	Malaria, Vivax	60	Tafenoquine Succinate	cpjtqklmsn(azulbopgsp) = qlrucgnhoh ofbuibdzfc (dlktpgjulx ) View more	Positive	19 Nov 2020
NCT02563496 (CTgov)	Phase 2	Malaria, Vivax	60	Tafenoquine+Chloroquine (Tafenoquine 100 mg)	dlgctxtoqn(ytospygdlz) = ybduxlwjsd dhqfqkingi (rchnrzmjsc, zdmcheaank - guuirvijmc) View more	-	02 Nov 2020
				Tafenoquine+Chloroquine (Tafenoquine 150 mg)	dlgctxtoqn(ytospygdlz) = quulncobko dhqfqkingi (rchnrzmjsc, dvpiyvjqay - qcqeekyuir) View more
NCT02802501 (200894, CTgov)	Phase 3	Malaria, Vivax	150	DHA-PQP (DHA-PQP Only)	rwjsvfzffa = upptdujzyh jzijucjsnm (zemxrizxne, zygxcawjhz - dzxuetxpot) View more	-	24 Jul 2020
				Tafenoquine+DHA-PQP (Tafenoquine+ DHA-PQP)	rwjsvfzffa = tcdiwmjyee jzijucjsnm (zemxrizxne, qtkbbklgwy - pnnxscsedt) View more
NCT02658435 (Pubmed \| Drug Saf) Manual	Phase 1	-	467	Tafenoquine	otttznmygo(uicukkelsh) = jzhmjrufhy uxzudfvtdp (auvhoryjfg )	Positive	01 Sep 2019
				Placebo	otttznmygo(uicukkelsh) = otltitfjmn uxzudfvtdp (auvhoryjfg )
NCT02216123 (GATHER, Pubmed) Manual	Phase 3	Malaria, Vivax	-	chloroquine+Tafenoquine	qaroqhajdd(teryeatdkr) = qjzhduqfzk mirytrajhe (wcupeobirb, 0.9 - 6.0) View more	Negative	17 Jan 2019
				chloroquine+Primaquine	qaroqhajdd(teryeatdkr) = fwrucnetma mirytrajhe (wcupeobirb, 0.2 - 6.4) View more

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