An Open-label Randomised Trial to Assess the Therapeutic Efficacy and Tolerability of Arterolane-piperaquine Plus Single Low Dose Primaquine Versus Arterolane-piperaquine Plus Mefloquine and Single Low Dose Primaquine Versus Artemether-lumefantrine Plus Single Low Dose Primaquine in the Treatment of Uncomplicated Falciparum Malaria in Children in Kenya

This open-label randomised controlled clinical trial will compare the safety, tolerability, therapeutic efficacy and pharmacokinetics and pharmacodynamics of arterolane-piperaquine, arterolane-piperaquine plus mefloquine versus artemether-lumefantrine.in children with uncomplicated falciparum malaria in Kilifi, Kenya. This study will also provide an up to date insight on the current presence of antimalarial resistance in this site.
In addition, all children will be treated with a single low dose of primaquine, dosing is age based.
The investigators will recruit 219 patients aged 2 years to 12 years with acute uncomplicated falciparum malaria in Kilifi County Hospital.

Start Date07 Mar 2018

Sponsor / Collaborator

University of Oxford

CTRI/2015/07/006050 / CompletedPhase 4

A Phase IV, Non comparative, Open label, Multicentric Trial to Evaluate the Safety and Efficacy of SYNRIAMÃ?Â® in the Treatment of Acute Uncomplicated Plasmodium vivax

Start Date03 Aug 2015

Sponsor / Collaborator

Sun Pharmaceutical Industries Ltd.

NCT02461186 / WithdrawnPhase 2/3IIT

An Open-label Randomized Trial to Assess the Therapeutic Efficacy of Arterolane-piperaquine Versus Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Falciparum Malaria in Eastern Myanmar, an Area of Emerging Artemisinin-resistant Falciparum Malaria

Emerging resistance to artemisinins and their partner drugs severely threatens the treatment of falciparum malaria in Myanmar with artemisinin combination therapies. To inform drug policy, it is crucial to evaluate alternative antimalarial treatments.
The investigators here propose a randomized clinical trial comparing parasite clearance parameters and efficacy of 3 days arterolane-piperaquine with standard treatment with 3 days dihydroartemisinin (DHA)-piperaquine in adult patients with uncomplicated falciparum malaria in Myanmar stratified for the presence of "K13" mutation in the infecting parasite strains.

Start Date01 Jun 2015

Sponsor / Collaborator

University of Oxford

100 Clinical Results associated with Arterolane maleate/Piperaquine Phosphate

100 Translational Medicine associated with Arterolane maleate/Piperaquine Phosphate

100 Patents (Medical) associated with Arterolane maleate/Piperaquine Phosphate

Literatures (Medical) associated with Arterolane maleate/Piperaquine Phosphate

01 Mar 2015·Acta TropicaQ3 · MEDICINE

Efficacy of Synriam™, a new antimalarial combination of OZ277 and piperaquine, against different developmental stages of Schistosoma mansoni

Q3 · MEDICINE

Article

Author: Mossallam, Shereen F ; Amer, Eglal I ; El-Faham, Marwa H

Control of schistosomiasis relies on a single drug, praziquantel (PZQ). Given the rising concerns about the potential emergence of PZQ-resistant strains, it has now become necessary to search for novel therapeutics. However, the current pace for anti-schistosomal drug discovery is slow; hence, repositioning of existing approved drugs can offer a safe, rapid and cost-effective solution. The anti-malarial synthetic artemisinin-derivatives trioxolanes demonstrated anti-schistosomal efficacies against the three major species infecting humans and, unlike PZQ, showed activities against both juvenile and adult worm stages. The 1,2,4-trioxolane/OZ277 (arterolane maleate) in combination with a partner drug: piperaquine phosphate was recently developed as an anti-malarial drug and manufactured by Ranbaxy (India) as Synriam™ (SYN). Herein, the in vivo activities of SYN were investigated in a mouse model of Schistosoma mansoni (S. mansoni), compared to PZQ. We show that a single fixed dose of 240mg/kg SYN (40mg/kg arterolane and 200mg/kg piperaqine) induced significant protective effects in mice, in terms of reduction in worm and tissue egg burdens, which were evident against all schistosome developmental stages. Extensive alterations in the tegument and subtegumental tissues of SYN-exposed worms were revealed by both scanning and transmission electron microscopes. Progressive decrease in worm activity and occurrence of death were noticed in vitro upon exposure to the drug - more pronounced in the presence of haemin. This report provides the first evidence of the efficacy of a combination of 1,2,4-trioxolane and piperaquine against S. mansoni in mice. Being effective against young stages, SYN could be used to prevent early Schistosoma infection.

PLOS Neglected Tropical DiseasesQ2 · MEDICINE

Efficacy and Safety of Moxidectin, Synriam, Synriam-Praziquantel versus Praziquantel against Schistosoma haematobium and S. mansoni Infections: A Randomized, Exploratory Phase 2 Trial

Q2 · MEDICINE

ArticleOA

Author: Coulibaly, Jean T ; Barda, Beatrice ; Keiser, Jennifer ; Hattendorf, Jan ; Puchkov, Maxim ; Huwyler, Jörg

BACKGROUNDSchistosomiasis affects millions of people, yet treatment options are limited. The antimalarial Synriam (piperaquine 150 mg/arterolane 750 mg) and the anthelminthic moxidectin revealed promising antischistosomal properties in preclinical or clinical studies.METHODOLOGYWe conducted two single-blind, randomized exploratory Phase 2 trials in Schistosoma mansoni and S. haematobium-infected adolescents in northern and central Côte d'Ivoire. Our primary endpoints were cure rates (CRs) and egg reduction rates (ERRs) based on geometric mean and safety. Each subject was asked to provide two stool samples (S. mansoni trial) for Kato-Katz analysis or three urine samples (S. haematobium trial) for urine filtration and one finger prick for malaria screening at baseline and follow-up. Participants were randomly assigned to either moxidectin, Synriam, Synriam plus praziquantel or praziquantel.PRINCIPAL FINDINGS128 adolescents (age: 12-17 years) were included in each study. Against S. haematobium moxidectin and Synriam revealed low efficacy. On the other hand, Synriam plus praziquantel and praziquantel yielded CRs of 60.0% and 38.5% and ERRs of 96.0% and 93.5%, respectively. CRs observed in the treatment of S. mansoni were 13.0%, 6.7%, 27.0%, and 27.6% for moxidectin, Synriam, Synriam plus praziquantel and praziquantel, respectively. ERRs ranged from 64.9% (Synriam) to 87.5% (praziquantel).CONCLUSION/SIGNIFICANCESynriam and moxidectin show low efficacy against S. haematobium, hence an ancillary benefit is not expected when these drugs are used for treating onchocerciasis and malaria in co-endemic settings. Further studies are needed to corroborate our findings that moxidectin and Synriam show moderate ERRs against S. mansoni.

100 Deals associated with Arterolane maleate/Piperaquine Phosphate

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Approved

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Indication	Country/Location	Organization	Date
Malaria, Vivax	IN	Sun Pharmaceutical Industries Ltd.	10 Nov 2013
Malaria, Falciparum	IN	Sun Pharmaceutical Industries Ltd.	17 Apr 2012
Malaria	IN	Ranbaxy Laboratories Ltd.	01 Jan 2012

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Malaria, Falciparum	Phase 2	MW	Sun Pharmaceutical Industries Ltd.	15 Apr 2009

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03452475 (Pubmed \| Lancet Infect Dis)	Phase 3	Malaria, Falciparum	219	Arterolane-piperaquine-mefloquine	dvdrjwuefb(otkuaxhbbc) = edasypisvl nnjgcvrowi (akjibxmlue, 95 - 100) View more	-	07 Jun 2021
				Arterolane-piperaquine	(pqrpctifaa) = wgqrkztuhn henfvalyly (uiabmuuokp, 2 - 9)

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