Shin Poong Pharma Trials

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

stroquinan (SP-8203) / Shin Poong Pharma

SP-8203-3001, NCT06660719: Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of Care

Recruiting

852

RoW

SP-8203, Otaplimastat (SP-8203), Placebo

Shin Poong Pharmaceutical Co. Ltd.

Ischemic Stroke

03/27

Pyramax (artesunate/pyronaridine) / Medicines for Malaria Venture, Shin Poong Pharma

ACTRN12622001407785: Efficacy and safety of pyronaridine-artesunate for the treatment of uncomplicated Plasmodium falciparum malaria in Gia Lai province, Viet Nam in 2022.

Not yet recruiting

World Health Organization, World Health Organization, National Malaria control program

Patients infected with plasmodium falciparum.

ACTRN12618001348246: Evaluation of the efficacy and safety of the drugs Pyronaridine-Artesunate (Pyramax™) and Primaquine to treat uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in Salavanh province, Lao PDR

Not yet recruiting

120

Ministry of Health, World Health Oranization , Ministry of Health

Malaria

ACTRN12621001743853: Efficacy and safety of pyronaridine-artesunate for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for the treatment of uncomplicated Plasmodium vivax malaria in Binh Phuoc, Gia Lai and Phu Yen provinces, Viet Nam in 2021.

Recruiting

World Health Organization, World Health Organization, National Malaria control program

Patients infected Plasmodium falciparum , Patients infected Plasmodium vivax

CHIMIO2, NCT04778813: Evaluation of Three Artemisinin-based Combinations for the Treatment of Uncomplicated Malaria in Childreen in Burkina Faso

Not yet recruiting

1050

RoW

Artemether-lumefantrine, Dihydroartemisinin pyperaquin, Artesunate Pyronaridine

Centre national de recherche et de formation sur le paludisme, Programme national de lutte contre le paludisme (PNLP), Burkina Faso, Unité de recherche clinique de Nanoro (URCN), USAID/IMPACT Malaria

Malaria, Burkina Faso

12/21

06/22

APACT, NCT03726593: Drug Combinations of Atovaquone-Proguanil (AP) With ACT

Recruiting

252

RoW

Artesunate and Pyronaridine, Atovaquone Proguanil and Artesunate Pyronaridine, Atovaquone Proguanil and Artesunate Mefloquine

Armed Forces Research Institute of Medical Sciences, Thailand, National Center for Parasitology, Entomology, and Malaria Control (CNM), Naval Medical Research Unit-2 (NAMRU-2)

Plasmodium Falciparum Malaria (Drug Resistant)

08/22

12/22

MALCOV, NCT04695197: Malaria as a Risk Factor for COVID-19 in Western Kenya and Burkina Faso

Completed

143

RoW

Artemether-lumefantrine (AL), Coartem, Pyronaridine-artesunate (PA), Pyramax

Liverpool School of Tropical Medicine, London School of Hygiene and Tropical Medicine, Kenya Medical Research Institute, Groupe de Recherche Action en Sante, Centres for Disease Control and Prevention, Kenya., Bill and Melinda Gates Foundation, Centers for Disease Control and Prevention

Covid-19, Malaria

11/22

02/24

NCT05084911: The Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients (Phase3)

Completed

1807

Europe, RoW

Pyramax, Placebo

Shin Poong Pharmaceutical Co. Ltd.

COVID-19

03/23

SAFIRE, NCT06962319: Safety of Antimalarials in the FIRst trimEster

Not yet recruiting

1510

RoW

dihydroartemisinin-piperaquine (DP), Pyronaridine-artesunate (PA), Artemether-lumefantrine

Liverpool School of Tropical Medicine, Malaria Research and Training Center, Mali International Center of Excellence in Research, University of Sciences, Techniques, and Technologies of Bamako, Mali, KEMRI Centre for Global Health Research (CGHR), Kisumu, Kenya, Clinical Research Unit of Nanoro (CRUN), Institut de Recherche en Sciences de la Santé, Medicines for Malaria Venture (co-sponsor), US Centers for Disease Control and Prevention (CDC), Division of Parasitic Diseases & Malaria

Malaria, Pregnancy, Malaria, Antepartum, Malaria (Uncomplicated)

08/28

08/29

ACTRN12622000638730: Monitoring and evaluation of the efficacy and safety of Artesunate-Mefloquine (ASMQ) and Artesunate-Pyronaridine (ASP) for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in Cambodia

Terminated

2/3

120

Ministry of Health, World Health Organization

Patients with Plasmodium falciparum infection, Patients with Plasmodium vivax infection

PROVIDENCE, NCT04701606: The Safety and Efficacy of Pyronaridine-artesunate (PyramaxÂ® or ArtecomÂ®)in COVID-19 Patients

Recruiting

2/3

402

RoW

ArtecomÂ® (pyronaridine-artesunate), PyramaxÂ® (pyronaridine-artesunate), Placebo

Shin Poong Pharmaceutical Co. Ltd.

Covid19

04/22

NCT05689047: Phase IIa Proof of Concept Study of M5717-Pyronaridine in Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)

Completed

RoW

M5717 330 mg, M5717 500 mg, M5717 660 mg, Pyronaridine 360 mg, Pyronaridine 540 mg, Pyronaridine 720 mg, Pyronaridine-artesunate (Pyramax) 360 mg/120 mg, Pyronaridine- artesunate (Pyramax) 540 mg/180 mg, Pyronaridine-artesunate (Pyramax) 720 mg/240 mg

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Acute Malaria

05/24

NCT05441410: Comparing Safety and Protective Efficacy of Vaccine Candidate PfSPZ-CVac and MVA ME-TRAP/ ChAd63 ME-TRAP in Adults

Not yet recruiting

1/2

Pyronaridine Tetraphosphate, Artesunate Drug Combination, Pyramax, PfSPZ Challenge (NF54), MVA ME-TRAP, ChAd63 ME-TRAP, Sodium chloride (NaCl) 0.9%, Placebo: Saline

University Hospital Tuebingen, Sanaria Inc., University of Oxford

Malaria

06/26

NCT05929157: A Crossover Bioavailability Clinical Trial of Parenteral Pyronaridine and Artesunate

Not yet recruiting

1/2

RoW

artesunate-pyronaridine

Centre de Recherche Médicale de Lambaréné, Institute of Tropical Medicine, University of Tuebingen

Severe Malarial Treatment

12/24

06/25

ACTRN12618001621202: Therapeutic efficacy of pyronaridine-artesunate for Plasmodium vivax in Myanmar

Not yet recruiting

N/A

140

Ministry of Health and Sports, WHO/GMS (World Health Organization/Greater Mekong Subregion)

malaria

ACTRN12618001620213: Therapeutic efficacy studies of pyronaridine-artesunate combination for the treatment of uncomplicated Plasmodium falciparum malaria in Myanmar

Recruiting

N/A

140

Ministry of Health and Sports, WHO/GMS (World Health Organization/Greater Mekong Subregion)

malaria, Fever

ACTRN12618001999224: Monitoring and evaluation of the efficacy and safety of Artesunate-Mefloquine (ASMQ) and Artesunate-Pyronaridine (ASP) for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in Cambodia

Recruiting

N/A

600

National Center for Parasitology, Entomology, and Malaria Control, World Health Organization, U.S. Agency for International Development

Patients with P. falciparum , Patients with P. vivax

ACTRN12615000171516: Pyronaridine-artesunate efficacy for the treatment of uncomplicated falciparum malaria in Cambodia

Active, not recruiting

N/A

145

World Health Organization, National Centre for Parasitology, Entomology and Malaria Control

Patients with plasmodium falciparum infection

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

stroquinan (SP-8203) / Shin Poong Pharma

SP-8203-3001, NCT06660719: Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of Care

Recruiting

852

RoW

SP-8203, Otaplimastat (SP-8203), Placebo

Shin Poong Pharmaceutical Co. Ltd.

Ischemic Stroke

03/27

Pyramax (artesunate/pyronaridine) / Medicines for Malaria Venture, Shin Poong Pharma

ACTRN12622001407785: Efficacy and safety of pyronaridine-artesunate for the treatment of uncomplicated Plasmodium falciparum malaria in Gia Lai province, Viet Nam in 2022.

Not yet recruiting

World Health Organization, World Health Organization, National Malaria control program

Patients infected with plasmodium falciparum.

Not yet recruiting

120

Ministry of Health, World Health Oranization , Ministry of Health

Malaria

Recruiting

World Health Organization, World Health Organization, National Malaria control program

Patients infected Plasmodium falciparum , Patients infected Plasmodium vivax

CHIMIO2, NCT04778813: Evaluation of Three Artemisinin-based Combinations for the Treatment of Uncomplicated Malaria in Childreen in Burkina Faso

Not yet recruiting

1050

RoW

Artemether-lumefantrine, Dihydroartemisinin pyperaquin, Artesunate Pyronaridine

Malaria, Burkina Faso

12/21

06/22

APACT, NCT03726593: Drug Combinations of Atovaquone-Proguanil (AP) With ACT

Recruiting

252

RoW

Artesunate and Pyronaridine, Atovaquone Proguanil and Artesunate Pyronaridine, Atovaquone Proguanil and Artesunate Mefloquine

Armed Forces Research Institute of Medical Sciences, Thailand, National Center for Parasitology, Entomology, and Malaria Control (CNM), Naval Medical Research Unit-2 (NAMRU-2)

Plasmodium Falciparum Malaria (Drug Resistant)

08/22

12/22

MALCOV, NCT04695197: Malaria as a Risk Factor for COVID-19 in Western Kenya and Burkina Faso

Completed

143

RoW

Artemether-lumefantrine (AL), Coartem, Pyronaridine-artesunate (PA), Pyramax

Covid-19, Malaria

11/22

02/24

NCT05084911: The Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients (Phase3)

Completed

1807

Europe, RoW

Pyramax, Placebo

Shin Poong Pharmaceutical Co. Ltd.

COVID-19

03/23

SAFIRE, NCT06962319: Safety of Antimalarials in the FIRst trimEster

Not yet recruiting

1510

RoW

dihydroartemisinin-piperaquine (DP), Pyronaridine-artesunate (PA), Artemether-lumefantrine

Malaria, Pregnancy, Malaria, Antepartum, Malaria (Uncomplicated)

08/28

08/29

Terminated

2/3

120

Ministry of Health, World Health Organization

Patients with Plasmodium falciparum infection, Patients with Plasmodium vivax infection

PROVIDENCE, NCT04701606: The Safety and Efficacy of Pyronaridine-artesunate (PyramaxÂ® or ArtecomÂ®)in COVID-19 Patients

Recruiting

2/3

402

RoW

ArtecomÂ® (pyronaridine-artesunate), PyramaxÂ® (pyronaridine-artesunate), Placebo

Shin Poong Pharmaceutical Co. Ltd.

Covid19

04/22

NCT05689047: Phase IIa Proof of Concept Study of M5717-Pyronaridine in Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)

Completed

RoW

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Acute Malaria

05/24

NCT05441410: Comparing Safety and Protective Efficacy of Vaccine Candidate PfSPZ-CVac and MVA ME-TRAP/ ChAd63 ME-TRAP in Adults

Not yet recruiting

1/2

Pyronaridine Tetraphosphate, Artesunate Drug Combination, Pyramax, PfSPZ Challenge (NF54), MVA ME-TRAP, ChAd63 ME-TRAP, Sodium chloride (NaCl) 0.9%, Placebo: Saline

University Hospital Tuebingen, Sanaria Inc., University of Oxford

Malaria

06/26

NCT05929157: A Crossover Bioavailability Clinical Trial of Parenteral Pyronaridine and Artesunate

Not yet recruiting

1/2

RoW

artesunate-pyronaridine

Centre de Recherche Médicale de Lambaréné, Institute of Tropical Medicine, University of Tuebingen

Severe Malarial Treatment

12/24

06/25

ACTRN12618001621202: Therapeutic efficacy of pyronaridine-artesunate for Plasmodium vivax in Myanmar

Not yet recruiting

N/A

140

Ministry of Health and Sports, WHO/GMS (World Health Organization/Greater Mekong Subregion)

malaria

ACTRN12618001620213: Therapeutic efficacy studies of pyronaridine-artesunate combination for the treatment of uncomplicated Plasmodium falciparum malaria in Myanmar

Recruiting

N/A

140

Ministry of Health and Sports, WHO/GMS (World Health Organization/Greater Mekong Subregion)

malaria, Fever

Recruiting

N/A

600

National Center for Parasitology, Entomology, and Malaria Control, World Health Organization, U.S. Agency for International Development

Patients with P. falciparum , Patients with P. vivax

ACTRN12615000171516: Pyronaridine-artesunate efficacy for the treatment of uncomplicated falciparum malaria in Cambodia

Active, not recruiting

N/A

145

World Health Organization, National Centre for Parasitology, Entomology and Malaria Control

Patients with plasmodium falciparum infection



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