Phase 2a Proof-of-Concept, Multicenter, Randomized, Open Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of a Single Dose of the Combination M5717-pyronaridine as Chemoprevention in Asymptomatic Adults and Adolescents With Plasmodium Falciparum Malaria Infection (CAPTURE-2)

This study will evaluate the efficacy and safety of a single dose of M5717 plus pyronaridine tetraphosphate in clearing current Plasmodium falciparum infection and protecting against recurrent infections in asymptomatic adults and adolescents. The study will also assess the duration of protection provided by different doses of M5717 plus pyronaridine and the additional contribution of M5717 to the duration of protection using external study data.

Start Date28 Nov 2023

Sponsor / Collaborator

Merck Healthcare KGaA

NCT05689047 / Active, not recruitingPhase 2

Phase IIa Proof of Concept, Multicenter, Randomized, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Combination M5717 Plus Pyronaridine Administered Once Daily for 1 or 2 Days to Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetic of the combination M5717 plus pyronaridine in participants with acute uncomplicated Plasmodium falciparum malaria. Pyramax (Artesunate/Pyronaridine) will act as an internal control providing reference safety data and a benchmark for the efficacy evaluation.

Start Date29 Mar 2023

Sponsor / Collaborator

Merck Healthcare KGaA

PACTR202301678338690 / RecruitingPhase 2

A Phase 2a, Multi-centre, Randomised, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Pyronaridine as an Add-on Therapy in Adults With Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia

Start Date26 Jan 2023

Sponsor / Collaborator

Armaceutica, Inc.

100 Clinical Results associated with Pyronaridine Phosphate

100 Translational Medicine associated with Pyronaridine Phosphate

100 Patents (Medical) associated with Pyronaridine Phosphate

313

Literatures (Medical) associated with Pyronaridine Phosphate

04 Sep 2024·Antimicrobial Agents and Chemotherapy

Therapeutic efficacy of pyronaridine-artesunate (Pyramax) in treating Plasmodium vivax malaria in the central highlands of Vietnam

Article

Author: Phong, Nguen Chinh ; Van, Nguyen Thi Thanh ; San, Nguyen Ngoc ; Quang, Huynh Hong ; Birrell, Geoffrey W. ; Edgel, Kimberly A. ; Manh, Nguyen Duc ; Edstein, Michael D. ; Martin, Nicholas J. ; Thanh, Nguyen Van ; Chavchich, Marina

ABSTRACT The emergence and spread of chloroquine-resistant Plasmodium vivax have necessitated the assessment of alternative blood schizonticidal drugs. In Vietnam, chloroquine-resistant P. vivax malaria has been reported. In an open-label, single-arm trial, the safety, tolerability, and efficacy of pyronaridine-artesunate (Pyramax, PA) was evaluated in Dak Nong province, Vietnam. A 3-day course of PA was administered to adults and children (≥20 kg) infected with P. vivax . Patients also received primaquine (0.25 mg/kg daily for 14 days). PA was well tolerated with transient asymptomatic increases in liver transaminases. The per-protocol proportion of patients with day 42 PCR-unadjusted adequate clinical and parasitological response was 96.0% (95% CI, 84.9%–99.0%, n = 48/50). The median parasite clearance time was 12 h (range, 12–36 h), with a median fever clearance time of 24 h (range, 12–60 h). Single nucleotide polymorphisms (SNPs) as potential genetic markers of reduced drug susceptibility were analyzed in three putative drug resistance markers, Pvcrt-o , Pvmdr1 , and PvK12 . Insertion at position K10 of the Pvcrt-o gene was found in 74.6% (44/59) of isolates. Pvmdr1 SNPs at Y976F and F1076L were present in 61% (36/59) and 78% (46/59), respectively. Amplification of Pvmdr1 gene (two copies) was found in 5.1% (3/59) of parasite samples. Only 5.1% (3/59) of isolates had mutation 552I of the PvK12 gene. Overall, PA rapidly cleared P. vivax blood asexual stages and was highly efficacious in treating vivax malaria, with no evidence of artemisinin resistance found. PA provides an alternative to chloroquine treatment for vivax malaria in Vietnam. CLINICAL TRIALS This study is registered with the Australian New Zealand Clinical Trials Registry as ACTRN12618001429246 .

03 Sep 2024·ACS Omega

Oral Pyronaridine Tetraphosphate Reduces Tissue Presence of Parasites in a Mouse Model of Chagas Disease

Article

Author: Ekins, Sean ; Lane, Thomas R. ; Barbosa da Silva, Elany ; Giardini, Miriam A. ; Siqueira-Neto, Jair Lage ; Bernatchez, Jean A. ; Calvet Alvarez, Claudia Magalhaes

The eukaryotic parasite Trypanosoma cruzi (T. cruzi) is responsible for Chagas disease, which results in heart failure in patients. The disease is more common in Latin America, and is an emerging infection with The Centers for Disease Control estimating that greater than 300,000 people are currently infected in the United States. This disease has also spread from South and Central America, where it is endemic to many other countries, including Australia, Japan, and Spain. Current therapy for Chagas disease is inadequate due to limited efficacy in the indeterminate and chronic phases of the disease, in addition to the adverse effects from nifurtimox and benznidazole, which are nitro-containing drugs used for therapy. There is a clear need for new therapies for the Chagas disease. Using a computational machine learning approach, we have previously shown that the antimalarial pyronaridine tetraphosphate is active against T. cruzi Brazil-luc in vitro against parasites infecting a myoblast cell line and is also active in vivo in an acute mouse model of Chagas disease when dosed i.p. We now further evaluated oral pyronaridine as a monotherapy to determine the minimum effective dose to treat acute and chronic models of Chagas disease. Our results for T. cruzi Brazil-luc demonstrated daily oral dosing with pyronaridine from 150 to 600 mg/kg resulted in statistically significant inhibition in the 7 day acute mouse model. Combination therapy with daily dosing of benznidazole and pyronaridine in the acute infection model demonstrated that 300 mg/kg pyronaridine could return statistically significant antiparasitic activity to a subtherapetic 10 mg/kg benznidazole. In contrast, pyronaridine as monotherapy or combined with benznidazole lacked efficacy in the chronic mouse model, whereas 100 mg/kg benznidazole alone demonstrated undetectable parasites in the heart of mice. Pyronaridine requires further assessment in other chronic models to identify if it can be used beyond the acute stage of T. cruzi infection.

01 Sep 2024·Biomolecules & Therapeutics

Pyronaridine Inhibited MUC5AC Mucin Gene Expression by Regulation of Nuclear Factor Kappa B Signaling Pathway in Human Pulmonary Mucoepidermoid Cells

Article

Author: Lee, Hyun Jae ; Hossain, Rajib ; Lee, Choong Jae

In this study, the potential effects of pyronaridine, an antimalarial agent, on airway MUC5AC mucin gene expression were investigated. The human pulmonary epithelial NCI-H292 cells were pretreated with pyronaridine for 30 min and then stimulated with phorbol 12-myristate 13-acetate (PMA) for 24 h. The effect of pyronaridine on the PMA-induced nuclear factor kappa B (NF-κB) signaling pathway was also examined. Pyronaridine inhibited glycoprotein production and mRNA expression of MUC5AC mucins induced by PMA through the inhibition of degradation of inhibitory kappa Bα and NF-κB p65 nuclear translocation. These results suggest that pyronaridine suppresses gene expression of mucin through regulation of the NF-κB signaling pathway in human pulmonary epithelial cells.

News (Medical) associated with Pyronaridine Phosphate

30 Jan 2023

·www.prnewswire.com

Acute Myeloid Leukemia Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 200+ Companies Working in the Domain

The incidence of AML has gradually increased around the globe. Males and older people had a higher possibility to develop AML. Developed countries tended to have higher age-standardized incidence rates and death rates than developing regions. Novel therapies for AML, including refinements of conventional cytotoxic chemotherapies, genetic and epigenetic targeted drugs, as well as immunotherapies, have significantly improved patient outcomes in recent years. LAS VEGAS, Jan. 30, 2023 /PRNewswire/ -- DelveInsight's ' Acute Myeloid Leukemia Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline acute myeloid leukemia therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the acute myeloid leukemia pipeline domain. Key Takeaways from the Acute Myeloid Leukemia Pipeline Report DelveInsight's acute myeloid leukemia pipeline report depicts a robust space with 200+ active players working to develop 260+ pipeline therapies for acute myeloid leukemia treatment. Key acute myeloid leukemia companies such as GlycoMimetics, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Takeda Oncology, Orca Bio, Gilead Sciences, Actinium Pharmaceuticals, Kronos Bio, Bristol-Myers Squibb, ImmunityBio, Bellicum Pharmaceuticals, Syros Pharmaceuticals, Armaceutica, Teva Pharmaceutical Industries, New Epsilon Innovation Limited, MediGene, TC Biopharm, PersonGen BioTherapeutics, Oncoceutics, Janssen Research & Development, LLC, Immune-Onc Therapeutics, Novartis, Jasper Therapeutics, Agastiya Biotech, Poseida Therapeutics, Molecular Partners, Allogene Therapeutics, and others are evaluating new acute myeloid leukemia drugs to improve the treatment landscape. Promising acute myeloid leukemia pipeline therapies in various stages of development include Uproleselan, SKLB1028, Pevonedistat, Orca T, Magrolimab, Iomab-B, Entospletinib, Nivolumab, ALT 803, BPX-501, TCB008, Tamibarotene, Pyronaridine, Trisenox (Arsenic Trioxide), NEI-01, MDG1011, OmnImmune, anti-FLT3 CAR-T, JNJ 63709178, IO 202, IDH 305, JSP 191, AB001, P-ckit-ALLO1, MP-0533, ALLO-316, ALL0-819, and others. In January 2023, Innate Pharma SA announced the publication in Nature Biotechnology of preclinical data showing the control of acute myeloid leukemia (AML) cells by a trifunctional NKp46-CD16a-NK cell engager (NKCE) targeting CD123. In January 2023, the FDA granted JBI-802 orphan drug designation for patients diagnosed with small cell lung cancer (SCLC) and acute myeloid leukemia (AML), according to a press release from Jubilant Therapeutics. In January 2022, Astex Pharmaceuticals, Inc. announced that the European Commission (EC) had granted orphan-drug designation (ODD) to the oral fixed-dose combination of decitabine and cedazuridine (ASTX727) for the treatment of Acute Myeloid Leukemia (AML). Request a sample and discover the recent advances in acute myeloid leukemia drug treatment @ Acute Myeloid Leukemia Pipeline Report The acute myeloid leukemia pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage acute myeloid leukemia drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the acute myeloid leukemia clinical trial landscape. Acute Myeloid Leukemia Overview Acute myeloid leukemia (AML) is the most common type of leukemia in adults, accounting for roughly 80% of all cases. Clonal expansion of immature "blast cells" in the peripheral blood and bone marrow results in ineffective erythropoiesis and bone marrow failure. There are various types of AML. Each affects a different type of blood cell. The acute myeloid leukemia symptoms you experience are determined by the type of blood cell that is affected. The common acute myeloid leukemia symptoms include tiredness, weakness, pale skin, irregular heartbeat, dizziness, and others. Many tests are used for acute myeloid leukemia diagnosis. Doctors will also perform tests to determine the subtype of AML. Chemotherapy is the primary treatment for most AML types, sometimes in conjunction with a targeted therapy drug. A stem cell transplant could follow this. Other drugs (aside from standard chemotherapy drugs) may be used to treat people with acute promyelocytic leukemia (APL). Find out more about drugs for acute myeloid leukemia @ New Acute Myeloid Leukemia Drugs A snapshot of the Acute Myeloid Leukemia Pipeline Drugs mentioned in the report: Learn more about the emerging acute myeloid leukemia pipeline therapies @ Acute Myeloid Leukemia Clinical Trials Acute Myeloid Leukemia Therapeutics Assessment The acute myeloid leukemia pipeline report proffers an integral view of acute myeloid leukemia emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Acute Myeloid Leukemia Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous Therapeutics Assessment By Molecule Type: Small molecule, Cell therapy, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Cell replacements, E-selectin inhibitors, Interleukin-15 receptor agonists, Immunologic cytotoxicity, T lymphocyte replacements, Bcr-abl tyrosine kinase inhibitors, Epidermal growth factor receptor antagonists, Fms-like tyrosine kinase 3 inhibitors, Lyn protein-tyrosine kinase inhibitors, NEDD 8 activating enzyme inhibitors Key Acute Myeloid Leukemia Companies: GlycoMimetics, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Takeda Oncology, Orca Bio, Gilead Sciences, Actinium Pharmaceuticals, Kronos Bio, Bristol-Myers Squibb, ImmunityBio, Bellicum Pharmaceuticals, Syros Pharmaceuticals, Armaceutica, Teva Pharmaceutical Industries, New Epsilon Innovation Limited, MediGene, TC Biopharm, PersonGen BioTherapeutics, Oncoceutics, Janssen Research & Development, LLC, Immune-Onc Therapeutics, Novartis, Jasper Therapeutics, Agastiya Biotech, Poseida Therapeutics, Molecular Partners, Allogene Therapeutics, and others. Key Acute Myeloid Leukemia Pipeline Therapies: Uproleselan, SKLB1028, Pevonedistat, Orca T, Magrolimab, Iomab-B, Entospletinib, Nivolumab, ALT 803, BPX-501, TCB008, Tamibarotene, Pyronaridine, Trisenox (Arsenic Trioxide), NEI-01, MDG1011, OmnImmune, anti-FLT3 CAR-T, JNJ 63709178, IO 202, IDH 305, JSP 191, AB001, P-ckit-ALLO1, MP-0533, ALLO-316, ALL0-819, and others. Dive deep into rich insights for new drugs for acute myeloid leukemia treatment; visit @ Acute Myeloid Leukemia Medications Table of Contents For further information on the acute myeloid leukemia pipeline therapeutics, reach out @ Acute Myeloid Leukemia Drug Treatment Related Reports Acute Myeloid Leukemia Market Acute Myeloid Leukemia Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key acute myeloid leukemia companies, including Takeda Oncology, Immunity Bio, Teva Pharmaceuticals, among others. Relapsed/Refractory Acute Myeloid Leukemia Epidemiology Relapsed/Refractory Acute Myeloid Leukemia Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted relapsed/refractory acute myeloid leukemia epidemiology in the 7MM. Acute Lymphocytic Leukemia Pipeline Acute Lymphocytic Leukemia Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key acute lymphocytic leukemia companies, including AbbVie, Novartis, Jazz Pharmaceutical, among others. Chronic Lymphocytic Leukemia Pipeline Chronic Lymphocytic Leukemia Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key chronic lymphocytic leukemia companies, including Celgene, Loxo Oncology, Octapharma, among others. Chronic Myeloid Leukemia Pipeline Chronic Myeloid Leukemia Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key chronic myeloid leukemia companies, including Kartos Therapeutics, Novartis, Incyte Corporation, among others. 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It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

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100 Deals associated with Pyronaridine Phosphate

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KEGG	Wiki	ATC	Drug Bank
-	Pyronaridine Phosphate	P01B	DB12975

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Malaria	-	-	-

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Lymphoblastic Leukemia	Phase 2	KE	Armaceutica, Inc.	30 Jan 2022
Acute Myeloid Leukemia	Phase 2	KE	Armaceutica, Inc.	30 Jan 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01383109 (CTgov)	Phase 1	Malaria	6	14C-labeled Pyronaridine	pnvzqlhepv(gxjfbvtzjb) = hytrxfmhbb xtevbwqjtj (xcsfmracik, cvooieqcda - gzgswgvajj) View more	-	26 Jan 2022

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