Drugs / Proguanil
Proguanil
also known as
Paludrine · 336-U-50 · Chlorguanide · Chlorguanide hydrochloride · Chloroguanide · Chloroguanide hydrochloride · Chloroquanil · Diguanyl · +14 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | MALARONE PEDIATRIC | — | 2000-07-14 | fda.gov ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT04866602 | Nov 2021 → Mar 2022 | — | Medicines for Malaria Venture | Completed | Mixed |
| 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 |
| Comparator or background therapy20 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 1/2 | 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 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 | Met primary |
| — | NCT04203186 Comparator | Mar 2020 → Jun 2021 | Plasmodium falciparum malaria | U.S. Army Medical Research and Development Command | Withdrawn | No outcome recorded Stop: Business |
| — | NCT03813108 Background | Apr 2019 → Feb 2021 | Plasmodium falciparum malaria | Radboud University Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| — | 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 |
| — | NCT01660854 Background | Jul 2012 → Jan 2013 | Plasmodium falciparum malaria | Radboud University Medical Center | Completed | No outcome recorded |
| — | NCT01218893 Background | Apr 2011 → Jan 2012 | Plasmodium falciparum 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.
| Field | Value | Cited 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/proguanil” NCT01660854 ↗ “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/proguanil” NCT01218893 ↗ |
| 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 ↗ |
| 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 hydrochloride” NCT02450578 ↗ |
| 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 ↗ |