Drugs / Proguanil

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) MALARONE PEDIATRIC 2000-07-14 fda.gov

Trials 12 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT04866602 Nov 2021 → Mar 2022 Medicines for Malaria Venture Completed No outcome recorded
Phase 1 NCT04568772 Nov 2020 → Jul 2021 gastroesophageal reflux disease Seoul National University Hospital Completed No outcome recorded
Phase 1 NCT04002687 Apr → Oct 2019 malaria Medicines for Malaria Venture Completed No outcome recorded
Phase 1 NCT02054299 Apr 2013 → Feb 2016 University Medical Center Goettingen Completed No outcome recorded
Phase 1 NCT01858831 Apr → May 2012 malaria GlaxoSmithKline Completed No outcome recorded
Phase 22 trials
Phase 2 NCT05974267 Nov 2023 → Dec 2024 Plasmodium falciparum malaria Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Completed No outcome recorded
Phase 2 NCT00984256 Sep 2009 → Apr 2010 malaria U.S. Army Medical Research and Development Command Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT00084227 Jul 2004 → Jul 2005 Plasmodium falciparum malaria Pfizer Completed No outcome recorded
Phase 44 trials
Phase 4 NCT03726593 Oct 2018 → Aug 2022 Plasmodium falciparum malaria Armed Forces Research Institute of Medical Sciences, Thailand Unknown No outcome recorded
Phase 4 NCT02564471 Nov 2016 → Aug 2018 rabies State University of New York - Upstate Medical University Completed No outcome recorded
Phase 4 NCT00421473 Mar 2007 → Dec 2008 HIV infectious disease, malaria Radboud University Medical Center Completed No outcome recorded
Phase 4 NCT00451139 malaria Jimma University Completed No outcome recorded
Also used as a comparator or background therapy in 20 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT06294912 Background Apr 2024 → Jan 2025 malaria Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT02858817 Background Nov 2016 → Nov 2017 malaria University Hospital Tuebingen Completed No outcome recorded
Phase 1 NCT02450578 Comparator Oct 2015 → Apr 2016 Plasmodium falciparum malaria Medicines for Malaria Venture Completed No outcome recorded
Phase 1 NCT01456546 Comparator Oct 2011 → Jul 2013 University of Southern Denmark Completed No outcome recorded
Phase 1/25 trials
Phase 1/2 NCT02836002 Background Jun 2016 → Jun 2017 malaria Radboud University Medical Center Completed No outcome recorded
Phase 1/2 NCT01704794 Comparator Apr 2013 → Apr 2014 sickle cell disease Lagos State University Unknown No outcome recorded
Phase 1/2 NCT01703104 Comparator Jan → Mar 2012 sickle cell disease Lagos State University Completed No outcome recorded
Phase 1/2 NCT01442168 Comparator Sep 2011 → Sep 2013 Plasmodium falciparum malaria Modus Therapeutics AB Terminated No outcome recorded
Phase 1/2 NCT01319448 Comparator Sep 2011 → Apr 2013 malaria, sickle cell disease London School of Hygiene and Tropical Medicine Completed No outcome recorded
Phase 44 trials
Phase 4 NCT03178643 Comparator Jan 2018 → Dec 2020 Plasmodium falciparum malaria Duke University Completed No outcome recorded
Phase 4 NCT02297477 Comparator Dec 2014 → Dec 2015 Plasmodium falciparum malaria Armed Forces Research Institute of Medical Sciences, Thailand Unknown No outcome recorded
Phase 4 NCT01150344 Comparator Jul 2010 → Apr 2014 malaria Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
Phase 4 NCT00444106 Comparator May 2007 → Nov 2008 Plasmodium falciparum malaria Novartis Completed No outcome recorded
Phase not applicable7 trials
NCT04203186 Comparator Mar 2020 → Jun 2021 Plasmodium falciparum malaria U.S. Army Medical Research and Development Command Withdrawn No outcome recorded
NCT03813108 Background Apr 2019 → Feb 2021 Plasmodium falciparum malaria Radboud University Medical Center Terminated No outcome recorded
NCT03454048 Background May → Nov 2018 Plasmodium falciparum malaria Radboud University Medical Center Completed No outcome recorded
NCT03293641 Background May 2016 → Jan 2017 disorder of zinc metabolism, infectious disease, sickle cell disease Lucas Otieno Tina, MD MSc Completed No outcome recorded
NCT02080026 Background Jun 2014 → Jul 2015 malaria Radboud University Medical Center Completed No outcome recorded

Evidence & citations 25 cited values

Every value below carries the sentence it was read from. 33 sources stand behind the page.

FieldValueCited text
Known as Proguanil “The purpose of this study is to determine the tolerability and pharmacokinetics of Sevuparin/DF02 when administered as an i.v. infusion in combination with Malanil®...” NCT01442168
28

“Drug: Malarone treatment When thick smear positive, of at day 21 after challenge, all volunteers will be treated with malarone. Other Name: atovaquone/proguanilNCT01660854

“Atovaquone (ATV),Proguanil (PG) 1000-400 mg + Amodiaquine (AQ) 612 mg on days 1,2, 3.” NCT04002687

“Folic Acid, Proguanil, Penicillin V, Hydroxyurea over 6 months” NCT03293641

“Atovaquone 500 mg + Proguanil 348 mg” NCT04866602

“atovaquon/proguanilNCT01218893

NCT03178643

NCT02564471

NCT03813108

NCT04568772

NCT00984256

NCT03726593

NCT00084227

NCT02297477

NCT01858831

NCT04203186

NCT00451139

NCT00444106

NCT01319448

NCT00421473

NCT02054299

NCT01456546

NCT02836002

NCT02080026

NCT02858817

NCT05974267

NCT03454048

NCT01150344

NCT06294912

Known as 336-U-50 ChEMBL registry synonym — accepted as the source's own label CHEMBL1377
Known as Chlorguanide ChEMBL registry synonym — accepted as the source's own label CHEMBL1377
Known as Chlorguanide hydrochloride ChEMBL registry synonym — accepted as the source's own label CHEMBL1377
Known as Chloroguanide ChEMBL registry synonym — accepted as the source's own label CHEMBL1377
Known as Chloroguanide hydrochloride ChEMBL registry synonym — accepted as the source's own label CHEMBL1377
Known as Chloroquanil ChEMBL registry synonym — accepted as the source's own label CHEMBL1377
Known as Diguanyl ChEMBL registry synonym — accepted as the source's own label CHEMBL1377
Known as Drinupal ChEMBL registry synonym — accepted as the source's own label CHEMBL1377
Known as Guanatol ChEMBL registry synonym — accepted as the source's own label CHEMBL1377
Known as GW AH7673A ChEMBL registry synonym — accepted as the source's own label CHEMBL1377
Known as M-4888 ChEMBL registry synonym — accepted as the source's own label CHEMBL1377
Known as NSC-12977 ChEMBL registry synonym — accepted as the source's own label CHEMBL1377
Known as NSC-26614 ChEMBL registry synonym — accepted as the source's own label CHEMBL1377
Known as Paludrine ClinicalTrials.gov intervention name — accepted as the source's own label NCT01703104
1

NCT01704794

Known as Palusil ChEMBL registry synonym — accepted as the source's own label CHEMBL1377
Known as Proguanil hcl ChEMBL registry synonym — accepted as the source's own label CHEMBL1377
Known as proguanil hydrochloride “250 mg atovaquone, 100 mg proguanil hydrochlorideNCT02450578
Known as Proguanil hydrochloride component of malarone ChEMBL registry synonym — accepted as the source's own label CHEMBL1377
Known as Proguanil hydrochloride component of malarone pediatric ChEMBL registry synonym — accepted as the source's own label CHEMBL1377
Known as Proguanili hydrochloridum ChEMBL registry synonym — accepted as the source's own label CHEMBL1377
Known as RP-3359 ChEMBL registry synonym — accepted as the source's own label CHEMBL1377
Known as SN-12837 ChEMBL registry synonym — accepted as the source's own label CHEMBL1377
Modality Small molecule CHEMBL1377
Route Oral “Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days, dosage dependent on body weight.” NCT00444106