sulfadoxine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | FANSIDAR | — | 1981-10-28 | fda.gov ↗ |
Trials 49 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 31 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT03599596 Comparator | Sep → Dec 2018 | malaria | University College Hospital, Ibadan | Unknown | No outcome recorded |
| Phase 1 | NCT02527005 Comparator | Sep 2015 → Aug 2016 | HIV infectious disease, malaria | University of Ibadan | Completed | No outcome recorded |
| Phase 1 | NCT02524444 Comparator | Sep 2015 → Aug 2016 | — | ORIYOMI OMOTOYOSI AKINYOTU | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT02909712 Comparator | Sep 2016 → Jan 2020 | malaria, parasitemia, poisoning | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
| Phase 2 | NCT01132248 Comparator | May 2010 → Dec 2012 | urinary schistosomiasis | Albert Schweitzer Hospital | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00941785 Comparator | Jul → Dec 2009 | malaria | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
| Phase 313 trials | ||||||
| Phase 3 | NCT06173206 Comparator | Jun → Dec 2024 | malaria | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
| Phase 3 | NCT04319380 Comparator | Apr 2020 → Mar 2022 | Plasmodium falciparum malaria | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
| Phase 3 | NCT04189744 Comparator | Dec 2019 → Oct 2022 | Trichomonas vaginitis urogenital infection, bacterial vaginosis, malaria | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
| Phase 3 | NCT03143218 Comparator | Apr 2017 → Mar 2020 | Plasmodium falciparum malaria | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
| Phase 3 | NCT02793622 Comparator | Sep 2016 → Dec 2018 | malaria | University of California, San Francisco | Completed | No outcome recorded |
| Phase 3 | NCT01746199 Comparator | Dec 2013 → Oct 2015 | HIV infectious disease, malaria | Institut Pasteur | Completed | No outcome recorded |
| Phase 3 | NCT01443130 Comparator | Feb 2012 → Oct 2014 | malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT01103063 Comparator | Oct 2010 → Oct 2013 | — | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00944840 Comparator | Sep 2008 → Jul 2009 | malaria | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
| Phase 3 | NCT00852371 Comparator | Feb → Jun 2008 | malaria | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
| Phase 3 | NCT00682578 Comparator | Jul 2007 → Feb 2010 | Plasmodium falciparum malaria, Plasmodium vivax malaria | University of Oxford | Completed | No outcome recorded |
| Phase 3 | NCT00361114 Comparator | Jul 2006 → Aug 2007 | malaria | London School of Hygiene and Tropical Medicine | Terminated | No outcome recorded |
| Phase 3 | NCT00646126 Comparator | Aug 2005 → ? | Plasmodium falciparum malaria, parasitemia | Tropical Medicine Research Institute | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT03178643 Comparator | Jan 2018 → Dec 2020 | Plasmodium falciparum malaria | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT02592408 Comparator | Nov 2015 → May 2016 | malaria | Menzies School of Health Research | Completed | No outcome recorded |
| Phase 4 | NCT02575755 Comparator | Oct 2012 → Jul 2016 | Plasmodium falciparum malaria, pregnancy disorder | Papua New Guinea Institute of Medical Research | Unknown | No outcome recorded |
| Phase 4 | NCT01669941 Comparator | Aug 2012 → Oct 2014 | malaria, pregnancy disorder | Kenya Medical Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT00964691 Comparator | Aug 2009 → Aug 2010 | malaria | Ministry of Health and Medical Services, Solomon Islands | Terminated | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT06869850 Background | Sep 2025 → Dec 2027 expected | cognitive impairment with or without cerebellar ataxia, kwashiorkor | Washington University School of Medicine | Recruiting | No outcome recorded |
| — | NCT06002438 Background | Oct 2023 → Dec 2024 | protein-energy malnutrition | Washington University School of Medicine | Completed | No outcome recorded |
| — | NCT04238845 Background | Jul 2020 → Jul 2021 | malaria, protein-energy malnutrition | Institut de Recherche en Sciences de la Sante, Burkina Faso | Unknown | No outcome recorded |
| — | NCT00811421 Comparator | Sep 2009 → Dec 2012 | HIV infectious disease, malaria, pregnancy disorder | Hospital Clinic of Barcelona | Completed | No outcome recorded |
| — | NCT00509015 Comparator | Feb → Aug 2008 | Plasmodium falciparum malaria | Radboud University Medical Center | Completed | No outcome recorded |
| — | NCT00460369 Comparator | Apr → Nov 2007 | malaria | Research Institute for Development | Completed | No outcome recorded |
| — | NCT00132535 Background | Aug 2003 → Jun 2007 | HIV infectious disease, malaria | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 82 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sulfadoxine | “BACKGROUND: Sulfadoxine-pyrimethamine was a common first line drug therapy to treat uncomplicated falciparum malaria, but increasing therapeutic failures associated with the...” PMID 19707564 ↗ Aug 200960“2 courses of 3 tablets of 500 mg N1-(5,6-dimethoxy-4-pyrimidinyl) sulfanilamide (sulfadoxine) and 25 mg 2,4-diamino-5-(p-chlorophenyl)-6-ethylpyrimidine...” NCT01636895 ↗ “3 tablets of SP (500 mg sulfadoxine and 25 mg pyrimethamine per tablet) by mouth under supervision at enrolment, and 3 tablets of SP under supervision 4 to 12 weeks later in...” NCT00964691 ↗ “Treatment with a single dose of sulfadoxine /pyrimethamine plus three doses of amodiaquine or placebo was given to all study subjects at monthly intervals on three occasions...” NCT00944840 ↗ “Sulfadoxine/pyremethamine (SP) given as a single dose per manufacturers recommendation (tablets 500mg sulphadoxine and 15mg pyremethamine; child's body weight 5-10Kgs ½ tablet,...” NCT00361114 ↗ “Amodiaquine (10 mg/kg over 3 days) and Sulfadoxine Pyrimethamine (25 mg of sulfadoxine + 1.25 mg of pyrimethamine per kg in a single dose) or placebo administered over 3 rounds...” NCT00738946 ↗ “This preventive measures involves administering antimalarial drugs (Amodiaquine-Sulfadoxine-Pyrimethamine) to children aged 6- 59 months on a monthly basis during the high...” NCT04238845 ↗ “Co-blister packaging of sulfadoxine-pyrimethamine (SP) dispersible tablets administered on the first day and amodiaquine (AQ) dispersible tablets administered once daily for three days.” NCT05946642 ↗ “Intervention: Random assignment to receive either Cotrifazid, mefloquine or the standard treatment of quinine+sulfadoxine/pyrimethamine (SP).” NCT00322907 ↗ “Sulfadoxine-pyrimethamine (500 mg / 25 mg) given every 4 weeks, beginning at enrollment or at 13 weeks' gestation, whichever is later.” NCT03079388 ↗ “One dose of SP (500 mg sulfadoxine plus 25 mg pyrimethamine, or half of the dose if body weight =\< 10 kg)” NCT01634945 ↗ “IPTp with sulfadoxine-pyrimethamine (SP) is recommended in HIV-negative women to avert malaria” PMID 25915616 ↗ Apr 2015 “For children aged 6-11 months: sulfadoxine 250mg/pyrimethamine 12.5mg and amodiaquine 75mg” NCT03035305 ↗ “sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations” NCT01132248 ↗ “Sulfadoxine/pyrimethamine tablets contain 500mg sulfadoxine and 25mg pyrimethamine.” NCT05081089 ↗ “3 tablets of sulfadoxine (500 mg) and pyrimethamine (25 mg) given at each ANC visit” NCT01669941 ↗ “Children will receive 500mg sulfadoxine plus 25mg pyrimethamine as one tablet” NCT06173206 ↗ “SP(500mg sulfadoxine/25mg pyrimethamine)1.25mg SP per kg stat” NCT00561899 ↗ “One dose of Sulfadoxine 25mg/kg and pyrimethamine 1.25mg/kg” NCT00941785 ↗ “3 days of artesunate sulfadoxine/pyrimethamine on days 0-2” NCT02592408 ↗ “artesunate plus sulfadoxine-pyrimethamine (SP)” PMID 26917051 ↗ Feb 2016 “SP (sulfadoxine 25mg/kg stat)(SP)” NCT00146731 ↗ |
| Known as | Fanasulf | ChEMBL registry synonym — accepted as the source's own label CHEMBL1539 ↗ |
| Known as | J21.373J | ChEMBL registry synonym — accepted as the source's own label CHEMBL1539 ↗ |
| Known as | NSC-759319 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1539 ↗ |
| Known as | RO 4-4393 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1539 ↗ |
| Known as | Sulfadoxin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00168948 ↗ |
| Known as | Sulfadoxina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1539 ↗ |
| Known as | Sulfadoxine component of fansidar | ChEMBL registry synonym — accepted as the source's own label CHEMBL1539 ↗ |
| Known as | Sulfadoxinum | ChEMBL registry synonym — accepted as the source's own label CHEMBL1539 ↗ |
| Known as | Sulforthamidine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1539 ↗ |
| Known as | sulphadoxine | “One cycle of SMC consisting of sulphadoxine - pyrimethamine (SP) 500mg/25 mg, and amodiaquine (AQ) 150mg on day 1, and AQ 150mg on days 2 and 3.” NCT04319380 ↗19“Doses of sulphadoxine (25 mg/kg)-pyrimethamine (1.25 mg/kg) (SP) or placebo will be given by a health assistant according to bodyweight” NCT00209794 ↗ “Sulphadoxine-pyrimethamine (500/25mg) according to age, given on day 1” NCT01454752 ↗ “Sulphadoxine is a slowly eliminated sulphonamide.” NCT05979896 ↗ “sulphadoxine - pyrimethamin (SP) 500mg/25 mg” NCT03143218 ↗ |
| Known as | Sulphormethoxine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1539 ↗ |
| Known as | WR-4073 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1539 ↗ |
| Modality | Small molecule | “Sulphadoxine is a slowly eliminated sulphonamide.” NCT05979896 ↗ |
| Route | Oral | “given as oral tablets” NCT00852371 ↗ |