This is an individually randomized, controlled, single blind four arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent preventive treatment with dihydroartemisinin-piperaquine (IPT-DP). Arm 2: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus chloroquine (CQ) (IPT-SPCQ). Arm 3: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus amodiaquine (AQ) (IPT-SPAQ).Arm 4: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, anemia, cognitive function and educational testing, as well as infection prevalence and disease incidence in young children sleeping student's households to assess the impact on transmission.

Start Date01 Oct 2024

Sponsor / Collaborator

Liverpool School of Tropical Medicine

CTRI/2024/07/070677 / Not yet recruitingPhase 2

A Phase 1b/2a Open Label Bridging Safety, Pharmacokinetics and Tolerability Studies on Chloroquine Based HREZ Combination Regimens in Adults with Pulmonary Tuberculosis - NIL

Start Date24 Jul 2024

Sponsor / Collaborator

Foundation For Neglected Disease Research

NCT04704999 / RecruitingPhase 4IIT

Optimizing the Dose of Tafenoquine for the Radical Cure of Plasmodium Vivax Malaria in Southeast Asia

Tafenoquine was recently approved by regulatory authorities in the USA and Australia. Tafenoquine is an alternative radical curative treatment to primaquine acting against the dormant liver stage of Plasmodium vivax (the hypnozoite). Tafenoquine (an 8-aminoquinoline) has the substantial advantage of single dosing as compared to a 14-day course of primaquine to achieve radical cure. The recommended tafenoquine dose is 300 mg, which was shown to be significantly worse in radical curative efficacy to a total primaquine dose of 3.5 mg/kg in Southeast Asia. The cure rate of tafenoquine 300 mg in Southeast Asian study sites was only 74%. The comparator 3.5 mg/kg total primaquine dose is the standard and most commonly used dose globally, but in Southeast Asia and the Western Pacific, higher doses of primaquine are needed for radical cure. This study aims to determine the optimal dose of tafenoquine in Southeast Asia.

Start Date22 Jul 2024

Sponsor / Collaborator

University of Oxford

100 Clinical Results associated with Chloroquine Phosphate

100 Translational Medicine associated with Chloroquine Phosphate

100 Patents (Medical) associated with Chloroquine Phosphate

646

Literatures (Medical) associated with Chloroquine Phosphate

01 Nov 2024·MOLECULAR AND CELLULAR ENDOCRINOLOGY

The glycolysis-related AMPK/ULK signaling pathway mediates the inhibitory effect of adiponectin in prostate cancer cells

Article

Author: Yang, Simin ; Sun, Ying ; Cong, Li ; Guo, Yifan ; Hu, Fang ; Zhao, Zhi

OBJECTIVE:

Reduced adiponectin (ADPN) levels have been implicated in the pathogenesis of prostate cancer (PCa). The role of glycolysis in cancer development and treatment has attracted increasing attention. The present study aimed to elucidate its impact on PCa and to explore the mechanistic involvement of glycolysis.

METHODS:

An RM-1 cell xenograft model of Adpn-knockout mice was used to corroborate the effects of glycolysis, AMP-activated protein kinase (AMPK) signaling, and autophagy on tumor xenograft progression. The effect of ADPN on PCa cells was evaluated using the Cell Counting Kit-8 (CCK-8), lactate levels, and flow cytometry. The expression of glycolysis-related genes was detected using real-time RT-PCR in LNCaP and PC-3 cells after incubation with ADPN. Autophagic flux after ADPN treatment was quantified by chloroquine intervention and confocal analysis of mRFP-GFP-LC3. Alterations in the levels of adiponectin receptor 1 (AdipoR1), AMPK, Unc-51-like kinase 1 (ULK1), autophagy-related protein 7 (ATG7), p62, and microtubule-associated protein 1 light chain 3 beta (LC3B) were assessed after incubation of LNCaP cells with ADPN.

RESULTS:

Proteomic analysis of xenograft tumors demonstrated significant upregulation of glycolysis in Adpn^-/- mice. Lower levels of ADPN accelerated tumor xenograft growth, diminished p-AMPKα/AMPKα ratio and LC3B II/I ratio, and elevated levels of proliferating cell nuclear antigen (PCNA) within the tumor microenvironment. ADPN inhibited proliferation and glycolysis and potentiated apoptosis in both cell lines. Expression of glycolysis-related genes decreased after ADPN treatment. Autophagic flux was elevated, as evidenced by changes in autophagy-related proteins and confocal microscopy analysis of mRFP-GFP-LC3. It led to the suppression of p62 while inducing phosphorylation of AMPKα and upregulating AdipoR1, ULK1, ATG7, and LC3B II/I ratio.

CONCLUSION:

ADPN inhibited the proliferation and progression of PCa cell-derived tumor xenografts by inhibiting glycolysis. Specifically, ADPN effectively inhibits glycolysis and activates the downstream AMPK/ULK1 signaling pathway to suppress proliferation of PCa cells.

01 Oct 2024·PHYTOMEDICINE

Naringin and chloroquine combination mitigates chloroquine-resistant parasite-induced malaria pathogenesis by attenuating the inflammatory response

Article

Author: Bhatt, Divya ; Mugale, Madhav N ; Kumar, Saurabh ; Bawankule, Dnyaneshwar U ; Pal, Anirban ; Washimkar, Kaveri R

BACKGROUND:

Malaria, characterised by inflammation and multi-organ complications, needs novel chemotherapeutics due to the rise of drug-resistant malaria parasites, which is a serious health issue. Naringin (NGN), a flavanone glycoside (naringenin 7-O-neohesperidose), has a broad spectrum of pharmacological activities but its effect against malaria, alone and in combination, was not deeply investigated.

PURPOSE:

To assess the pharmacological efficacy of NGN alone and in combination with chloroquine (CQ) against a Plasmodium strain resistant to CQ and to elucidate its potential mode of action.

METHODS:

The anti-inflammatory potential of NGN was assessed in mouse microglial cells stimulated with hemozoin by analyzing inflammatory cytokines production. The anti-plasmodial potential of NGN was subsequently tested alone and in combination with CQ against the K1 strain of Plasmodium using the fixed ratio combination method. Further, we evaluated NGN's antimalarial efficacy against the CQ-resistant Plasmodium yoelii nigeriensis N67 strain (P. yoelii), both alone and in combination with CQ, by measuring parasitemia and survival rates. To comprehend the impact of NGN on malaria-induced inflammation in mice, we measured pro-inflammatory cytokines elevated by activated NF-кB signalling. These findings were supported by mRNA and immunohistochemical analyses of malaria-infected mice's liver and brain tissues.

RESULTS:

Our study demonstrated that NGN displayed anti-plasmodial activity, which was further augmented when combined with CQ. At 50 µM, NGN significantly reduced the elevation of pro-inflammatory cytokines in synthetic hemozoin-stimulated microglial cells. Compared to P. yoelii-infected mice, NGN (12.5 mg kg^-1) significantly reduced parasitemia in mice, resulting in a survival period of up to 13 days. Survival improved by up to 20 days when NGN and CQ were given in combination. NGN, as revealed by immunohistochemical examination of brain and liver tissues, interfered with the NF-кB pathway, potentially reducing the elevation of pro-inflammatory cytokines (TNF-α, IL-1β, IL-18, IFN-γ, and IL-6). This was supported by the overexpression of inflammation-regulatory genes (TGFβ, Nrf2, HO-1, and iNOS) and the downregulation of inflammation-stimulating genes (NF-κB, NLRP3, and caspase-1). Histopathological analysis demonstrated the potential of NGN to restore liver and brain tissues to normal. The substantial decrease in the expression and production of ICAM-1 protein in the brain tissue implies the beneficial effects of NGN, pointing towards its potential for mitigating brain pathology.

CONCLUSION:

The findings of this study revealed NGN as a promising drug-like candidate for the management of CQ-resistant parasite-induced malaria pathogenesis for adjunctive therapy in combination with standard antimalarial drugs through its modulation of the NF-κB-mediated inflammation.

01 Sep 2024·CLINICAL THERAPEUTICS

Prevalence of Potential Drug Interactions With Direct-Acting Antivirals for COVID-19 Among Hospitalized Patients

Article

Author: Ustianowski, Andrew ; Ahuja, Neera ; Mozaffari, Essy ; Rivera, Christina G ; Amin, Alpesh N ; Berry, Mark ; Chandak, Aastha ; Okulicz, Jason F. ; Rivera, Christina G. ; Okulicz, Jason F ; Jiang, Heng ; Amin, Alpesh N.

PURPOSE:

Clinicians consider polypharmacy, comorbidities, and other factors including the potential for drug-drug interactions (DDIs) when evaluating therapeutic options for specific clinical diagnoses. Contemporary treatment for coronavirus disease 2019 (COVID-19) includes direct-acting antivirals (DAAs). We sought to characterize patients' characteristics, comorbidities, and medications received during their hospitalization for COVID-19 and quantify potential DDIs that clinicians consider in selecting appropriate DAAs.

METHODS:

Patients hospitalized with a primary diagnosis of COVID-19 between May 2020 and December 2022 from the PINC AI Healthcare Database were identified. Medications administered during the hospitalization with the potential to cause DDIs with nirmatrelvir/ritonavir, remdesivir, or molnupiravir (per the Emergency Use Authorization factsheet or package insert) were assessed. For DDIs with nirmatrelvir/ritonavir, medications are categorized as "Contraindicated," "Avoid Concomitant Use," or "Other DDIs" (includes recommendation for dose modification or clinical and laboratory monitoring). For remdesivir, coadministration with chloroquine phosphate and hydroxychloroquine sulfate was not recommended. For molnupiravir, no drugs are listed as having potential DDIs. In a subset of patients, a multivariable logistic regression model was used to examine the association between documented patient/hospital characteristics and the likelihood of being "Contraindicated" to receive nirmatrelvir/ritonavir.

FINDINGS:

Of the 788,238 patients hospitalized for COVID-19 in 920 hospitals, 53% were ≥ 65 years old, and 31% had Charlson Comorbidity Index (CCI) ≥ 3. During the study period, about half of the patients received medications categorized as "Contraindicated" (11%) and/or "Avoid Concomitant Use" (41%) with nirmatrelvir/ritonavir. The frequency of administered drugs was higher in those aged ≥ 65 years (68%), CCI ≥ 3 (78%), with high-risk underlying conditions (55%). About 1% of patients received medications that were not recommended to be coadmistered with remdesivir. Among a subset of patients hospitalized for COVID-19 in 2022, those who were older, had higher CCI, high-risk underlying conditions, severe hepatic impairment, Medicare insurance, and hospitalized in larger hospitals were significantly more likely to be categorized as "Contraindicated" when considering nirmatrelvir/ritonavir as a therapeutic option to manage COVID-19.

IMPLICATIONS:

A significant proportion of patients hospitalized for COVID-19 receive medications for other conditions that have the potential to result in DDIs with DAAs; most predominantly with nirmatrelvir/ritonavir, a strong CYP3A enzyme inhibitor, fewer with remdesivir, and none with molnupiravir. Higher age and comorbidity burden were significantly associated with a higher likelihood of receiving medications that are "Contraindicated" with nirmatrelvir/ritonavir. In the evolving COVID-19 era, these findings provide insights into patients hospitalized for COVID-19, and the polypharmacy evaluations that clinicians may encounter when selecting among DAAs to manage COVID-19.

News (Medical) associated with Chloroquine Phosphate

12 Aug 2024

·www.globenewswire.com

60 Degrees Pharma Provides University of Kentucky with Right of Reference to ARAKODA® NDA in Support of SJ733 Phase IIb Study

University of Kentucky will commence a Phase IIb clinical study of drug development candidate SJ733 for treatment of vivax malaria.SJ733 will be combined with a single dose of tafenoquine in the study.The right of reference allows FDA to review 60 Degrees Pharma’s regulatory file when the agency evaluates new study protocols for the SJ733-tafenoquine Phase IIb program. WASHINGTON, Aug. 12, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the “Company” or “60 Degrees Pharma”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today that it has granted the University of Kentucky a right of reference to the Company’s new drug application (“NDA”) for ARAKODA® (tafenoquine). ARAKODA is the Company’s anti-malarial approved by the U.S. Food and Drug Administration (“FDA”) in 2018, indicated for the prophylaxis of malaria in patients aged 18 years of age and older. The right of reference will allow FDA to review clinical efficacy and safety data, non-clinical data, and chemistry, manufacturing and control information on ARAKODA as the agency reviews protocols and new Investigational New Drug (“IND”) application submissions related to the University of Kentucky’s investigational SJ733 Phase IIb program. SJ733 is an oral ATP4 inhibitor of Plasmodium, which has been shown to have a favorable safety profile and rapid anti-parasitic effect. The Phase IIb study being conducted by the University of Kentucky and Eisai Co. Ltd. (“Eisai”) will combine SJ733 with tafenoquine – the active ingredient in ARAKODA – to evaluate the safety, tolerability, and pharmacokinetics of a single-dose combination of the two drugs. The trial is funded by the Global Health Innovative Technology Fund. The current state-of-the-art treatment for vivax malaria is a combination of tafenoquine and chloroquine administered over three days; however, resistance of P. vivax to chloroquine is widespread in some parts of the world. “Innovations in treating P. vivax malaria, which infects an estimated 14 million people a year, have been limited in recent decades,” said Dr. R. Kip Guy, principal investigator on the Phase IIb study, and Professor and Dean of the University of Kentucky College of Pharmacy. “The upcoming study of SJ733 combined with tafenoquine has the potential to pave the way for very meaningful improvement in malaria treatment around the world.” 60 Degrees Pharma will supply tafenoquine and placebos as study drugs in the University of Kentucky Phase IIb trial. Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA®. The safety of the approved regimen of tafenoquine for malaria prophylaxis has been assessed in five separate randomized, double-blind, active comparator or placebo-controlled trials for durations of up to six months. About the SJ733 Phase IIb Clinical Trial at University of Kentucky The overall objective of the Phase IIb study is to examine the clinical safety and efficacy of the combination of SJ733 and TQ for radical cure of P. uncomplicated P. vivax malaria in adults with a 1, 2, or 3-day schedule of the SJ733-tafenoquine combination. The purpose is to develop an SJ733-TQ combination drug suitable for treatment of all patients with uncomplicated P. vivax malaria. The targeted results for this study are data that support 1 to 3 doses of an SJ733-TQ fixed-dose combination for radical cure of P. vivax mono-infected patients. This will set the stage for subsequent pivotal Phase 3 studies. SJ733 is a PfATP4 inhibitor that meets criteria for treatment of uncomplicated malaria. Three clinical trials of SJ733 have been completed. Phase I examined safety and pharmacokinetics of SJ733. Phase I tested pharmacodynamics in the human challenge model. Phase II (NCT04709692) determined the parasite reduction ratio, parasite reduction half-life and minimum inhibitory concentration of SJ733 in adults with uncomplicated malaria and assessed the exposure-response relationship (PK/PD). Current Phase Ia, Ib, and IIa human data show an excellent safety profile and tolerability, good oral availability, and moderate drug clearance. Eisai and the University of Kentucky have collaboratively designed the Phase IIb study and supportive non-clinical safety and pharmacokinetics studies, which will be contracted to rigorously qualified CROs and overseen by Eisai’s subject matter experts. Eisai will manage the manufacture of a new batch of SJ733 clinical trial material, as well as oversee conduct of the supportive non-clinical safety and pharmacokinetics studies. The University of Kentucky will oversee the regulatory filings to amend the current US-FDA IND (held by Professor Guy) for development of SJ733 and the Phase IIb clinical trial work, including the local ethics and regulatory submissions. 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, may offer potential advantages in less-frequent dosing for prophylaxis for 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 of age 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; 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, 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 three 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 for 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 for 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 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 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 Contact:Sheila A. BurkeSheilaBurke-consultant@60degreespharma.com(484) 667-6330 Investor Contact:Patrick Gaynespatrickgaynes@60degreespharma.com(310) 989-5666 This press release was published by a CLEAR® Verified individual.

Phase 2Drug ApprovalPhase 1NDAClinical Result

22 Jul 2024

·healthcare-digital.com

Research Breakthrough Promises New Lupus Treatments

The purple ribbon denotes World Lupus Day, May 10. As study of patients with lupus uncovers a root cause of the condition we take a deeper look at the autoimmune disease and how it is currently treated A study of patients with lupus has uncovered a root cause of the disease that may eventually lead to new treatments, researchers reported in a study published in Nature. The immune disorder affects more than 1.5 million people in the US alone, and damages skin, joints, the kidneys, the brain and other organs. Comparing blood samples from 19 patients suffering from lupus with healthy people, researchers found that the patients had an imbalance in immune-system cells called ‘T cells’. There was reduced production of T cells that aid in healing, and increased production of T cells that produce autoantibodies to attack healthy cells. In the wake of the study, we take a look at lupus – at its effects and the available treatments. What is lupus? Lupus is an autoimmune disease that causes the body's immune system to attack its own tissues and organs. This condition can affect various parts of the body, including skin, joints, kidneys, brain, heart and lungs. Diagnosis can be complex, as symptoms often mimic those of other ailments. Treatment options for lupus depend on the severity of symptoms and which organs are affected. The cause of lupus remains unknown, but researchers believe it involves a combination of genetic and environmental factors. Women are more likely to develop lupus than men, and it is more prevalent in certain ethnic groups. Patients with lupus are advised to protect themselves from sun exposure, as ultraviolet light can trigger flares in some individuals. How is lupus treated? Medications include anti-inflammatory drugs, antimalarial drugs and immunosuppressants. Research has shown antimalarial drugs such as hydroxychloroquine and chloroquine can decrease the frequency and severity of lupus flare-ups. They work by modulating the immune system, which is overactive in lupus patients. This helps reduce inflammation and pain, particularly in the skin and joints. These medications also help protect the heart, and are thought to lower the risk of blood clots in lupus patients. This is significant as individuals with lupus have an increased risk of cardiovascular complications. Antimalarials are used in combination with immunosuppressants for more severe cases. Immunosuppressants are used to treat lupus because the condition results in the body's immune system mistakenly attacking healthy tissue, causing inflammation and damage to organs including the kidneys, heart and lungs. Common immunosuppressants used in lupus treatment include methotrexate, azathioprine, mycophenolate mofetil, and cyclophosphamide. These can be administered orally or intravenously, depending on the specific drug and the patient's condition. The use of immunosuppressants carries risks, as a suppressed immune system makes the patient more susceptible to infections. Companies that specialise in lupus medicines Medications used to treat lupus include anti-inflammatory drugs, antimalarial drugs and immunosuppressants. The following are among the companies that produce treatments in these three categories. Immunosuppressants GlaxoSmithKline : Benlysta (based on belimumab) AstraZeneca : Saphnelo (anifrolumab-fnia) Aurinia Pharmaceuticals: Lupkynis (voclosporin) Roche : Rituxan (rituximab) Bristol Myers Squibb : Orencia (abatacept) Eli Lilly : Olumiant (baricitinib) Pfizer : Xeljanz (tofacitinib) Antimalarials Sanofi : Plaquenil (hydroxychloroquine) Anti-inflammatories Novartis : Ilaris (canakinumab) Janssen Pharmaceuticals: Remicade (infliximab) UCB: Cimzia (certolizumab pegol)

ImmunotherapyDrug Approval

08 Jul 2024

·www.pharmaceutical-technology.com

GSK and MVV launch malaria medicine in Brazil and Thailand

The new single-dose medicine prevents the relapse of Plasmodium vivax malaria. Credit: sun ok / Shutterstock. GSK and Medicines for Malaria Venture (MMV) have announced the launch of a new single-dose medicine, tafenoquine, to prevent the relapse of Plasmodium vivax (P. vivax) malaria in malaria-endemic countries Brazil and Thailand. Tafenoquine is co-administered with chloroquine, for radical cure. An antimalarial drug, tafenoquine is an 8-aminoquinoline that targets the liver stage of P. vivax malaria. When used with chloroquine, which addresses the blood-stage infection, tafenoquine can effectively treat both stages of the disease. But tafenoquine can cause acute haemolytic anaemia in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency. See Also: Ascentage Pharma’s olverembatinib approved in Macau for leukaemia NN-6561 by Novo Nordisk for Metabolic Dysfunction-Associated Steatohepatitis (MASH): Likelihood of Approval As a result, a G6PD test is essential before the drug can be prescribed. The Ministries of Health in Thailand and Brazil have conducted feasibility studies on the routine use of tafenoquine after point-of-care G6PD testing. These studies, supported by MMV, have been instrumental in their decisions to adopt this new anti-malarial strategy. In Brazil, the urgency of the public health emergency in the Yanomami Special Indigenous Health District, where P. vivax malaria is particularly prevalent, led to the accelerated approval of tafenoquine in March 2024. Tafenoquine has now received approvals in Australia, Brazil, Colombia, Ethiopia, Guyana, Peru, the Philippines and the US. GSK chief global health officer Thomas Breuer stated: “The news underscores GSK’s long-standing commitment to malaria and we are proud that tafenoquine, co-administered with chloroquine, the first radical cure medicine for P. vivax malaria, is now launched in both Brazil and Thailand, taking us another step closer to our shared goal of eliminating malaria. “Working together with MMV and PATH [the Program for Appropriate Techonology in Health] through the Partnership for Vivax Elimination to optimise this new treatment option has been fundamental to countries being able to introduce this new tool.” In June 2024 GSK received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Omjjara (momelotinib) to treat patients with myelofibrosis.

Drug ApprovalClinical Study

100 Deals associated with Chloroquine Phosphate

External Link

KEGG	Wiki	ATC	Drug Bank
D02125	Chloroquine Phosphate	P01BA01	DB00608

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Fever	CN	Tianjin Huajin Pharmaceutical Co. Ltd.	01 Jan 1982
Inflammation	CN	Tianjin Huajin Pharmaceutical Co. Ltd.	01 Jan 1982
Pain	CN	Tianjin Huajin Pharmaceutical Co. Ltd.	01 Jan 1982
Amebiasis	US	Sanofi-Aventis U.S. LLC	31 Oct 1949
Malaria	US	Sanofi-Aventis U.S. LLC	31 Oct 1949

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Condylomata Acuminata	Phase 2	CN	Guangzhou Hybribio Biotech Ltd.	31 Dec 2020
COVID-19	Phase 2	GR	Uni-Pharma Kleon Tsetis SA	06 Apr 2020
Human Papillomavirus Infection	IND Approval	CN	Guangzhou Hybribio Biotech Ltd.	20 Sep 2024
Acute Myeloid Leukemia	Preclinical	-	University of Sao Paulo	14 May 2024
Diabetes Mellitus	Preclinical	KR	CHA University	19 Oct 2020
Diabetic Nephropathies	Preclinical	US	American University of Beirut	05 Nov 2019
Diabetic Nephropathies	Preclinical	-	AuB, Inc.Startup	05 Nov 2019
Autoimmune Diseases	Preclinical	CN	The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine	12 Jun 2019
Early Stage Breast Carcinoma	Preclinical	US	George Mason University	15 Jul 2016
Refractory Lung Carcinoma	Preclinical	US	LSU Health Sciences Center	15 Jul 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03952650 (CTgov)	Phase 1/2	Malaria	252	PYR+PfSPZ (1a - Pilot/Safety: Dosing Interval on Days: 1)	gjsqhhkkir(dzvxywdlzr) = drofiqvbsn mvmtvpjdhx (hxbykalxpn, evbmeanqfg - knmjkdbzeb) View more	-	12 Jul 2022
				PYR+PfSPZ (2a - Pilot/Safety: Dosing Interval on Days: 1)	gjsqhhkkir(dzvxywdlzr) = fflyjbqtpt mvmtvpjdhx (hxbykalxpn, tqxrprkvga - tggwgfhqjm) View more
NCT03337152 (CTgov)	Phase 4	Glucosephosphate Dehydrogenase Deficiency \| Malaria, Vivax	54	primaquine (1A: Primaquine)	rlztzcoeyr(kxjeiphlay) = blwodrfntd lkqflkjidh (ymteibhuzq, cyzzlrqadt - dcuglvuvrx) View more	-	12 Nov 2021
				chloroquine+primaquine (1B: Chloroquine + Primaquine)	rlztzcoeyr(kxjeiphlay) = npkdskvgtk lkqflkjidh (ymteibhuzq, zwvaflvjem - harxfeqjpz) View more
NCT01023477 (CTgov)	Phase 1/2	Noninfiltrating Intraductal Carcinoma	12	Breast Biopsy+Chloroquine Standard Dose (500mg/week) (Chloroquine Standard Dose (500mg/Week))	auvvqckzjr(rhodmbfmnd) = tlqmeityax yhxrvevjri (frsqzbbpgi, nofhsplcwz - csruiesvdg) View more	-	29 Jun 2021
				Breast Biopsy+Chloroquine Low Dose (250mg/week) (Chloroquine Low Dose (250mg/Week))	auvvqckzjr(rhodmbfmnd) = gvvrjldlrs yhxrvevjri (frsqzbbpgi, aydzpgjzis - woegmcmbwc) View more
NCT02610686 (Pubmed \| Antimicrob Agents Chemother)	Phase 4	Malaria, Vivax First line	-	Chloroquine	sqroqjefub(bqsffcneod) = qzfszuqmdl ufvqzklhii (kjjzqamuwq ) View more	-	24 May 2021
NCT02564471 (MALRAB, CTgov)	Phase 4	Rabies	103	Chloroquine+Rabies Vaccine (Chloroquine)	pkgqybgeqm(tapqkhkero) = xpbaeuiyke ktjlmvjhcj (smsqvjhbrz, qfxpyxqwqt - vpvsplugmu) View more	-	13 Apr 2021
				Atovaquone+Rabies Vaccine+Proguanil (Atovaquone and Proguanil (Malarone))	pkgqybgeqm(tapqkhkero) = datpnkcqct ktjlmvjhcj (smsqvjhbrz, ehkswwrznm - rgawdsgkvn) View more
NCT01946880 (ALE06, CTgov)	Phase 2	Systemic Lupus Erythematosus	102	MMF (MMF Maintenance)	duxyzoryfl(mrpkkthods) = insoanpwqb ydndllyjua (zhouozcvmk, iraftrvixn - wfyzstjngq) View more	-	17 Aug 2020
				MMF (MMF Withdrawal)	duxyzoryfl(mrpkkthods) = ovjhhfxrcv ydndllyjua (zhouozcvmk, ppdiauudnt - htexvjfcpk) View more
NCT03449758 (SariPRO, CTgov)	Phase 4	Neoplasms \| Rheumatoid Arthritis	84	SARILUMAB+Chloroquine+Hydroxychloroquine+Azathioprine+Sulfasalazine+Methotrexate+Leflunomide	rknkeucsls(toqkzmiadc) = mfucsbeuwx mwkiholimr (pzkchsrbin, auagbpxbdd - jrrirwatjf) View more	-	10 Aug 2020
CRD42016053312 (Pubmed)	Phase 4	Malaria, Vivax	3,421	Chloroquine alone	hlkszginee(mxeyfnmuii) = kbtkrbbsiz cztqkpgrbp (olxnqlzbts ) View more	-	01 Aug 2019
				Chloroquine plus primaquine	hlkszginee(syibftbhhw) = ohemdqkroq jauudchzgm (nxrotiysqb )
EULAR2018	Not Applicable	Rheumatoid Arthritis	26	chloroquine	mdvpeobunm(vwzumcgfuo) = voemvapiwq vnuhtdwrog (lxjsjcxhpp ) View more	Negative	13 Jun 2018

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