sulfadoxine

also known as sulphadoxine · Fanasulf · J21.373J · NSC-759319 · RO 4-4393 · Sulfadoxin · Sulfadoxina · Sulfadoxine component of fansidar · +4 more

Small molecule

Developed for: malaria · Plasmodium falciparum malaria · anemia · pregnancy disorder · Plasmodium vivax malaria · autoimmune disease · lymphoproliferative syndrome · pneumocystosis
+2 more
· sexually transmitted disease · parasitemia
Investigated by: London School of Hygiene and Tropical Medicine · National Institute of Allergy and Infectious Diseases (NIAID) · Cheikh Anta Diop University, Senegal · Global Fund · Institut de Recherche pour le Developpement, Senegal · Malaria Consortium
+71 more
· Medical Research Council, South Africa · Ministry of Health, Senegal · Radboud University Medical Center · University of California, San Francisco · Centers for Disease Control and Prevention · Department of State for Health and Social Welfare, The Gambia · Deutscher Akademischer Austausch Dienst · European Commission · Hospital Clinic of Barcelona · Institute of Tropical Medicine, Belgium · Malaria Research and Training Center, Bamako, Mali · Medical Research Council Unit, The Gambia · National Institute for Medical Research, Tanzania · Papua New Guinea Institute of Medical Research · Professor Karen I Barnes · QIMR Berghofer Medical Research Institute · Research Institute for Development · Swiss Tropical & Public Health Institute · The PATH Malaria Vaccine Initiative (MVI) · United States Agency for International Development (USAID) · Alliance for International Medical Action · Alliance médicale contre le paludisme, Mali · Bernhard Nocht Institute for Tropical Medicine · Bill and Melinda Gates Foundation · Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland · Centre for Global Health Research, Ghana · Centre national de recherche et de formation sur le paludisme · Charite University, Berlin, Germany · DBL -Institute for Health Research and Development · Department for International Development, United Kingdom · Division Controle Medicale Scolaire, Ministry of Education, Senegal · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Faculté des Sciences de la Santé, Bénin · French National Institute of Health and Medical Research · German Federal Ministry of Education and Research · Harvard University · HealthNet TPO · Heidelberg University · INDEPTH Network · Institut National d'Etude et d'Action pour le Developpement de l'Education, Senegal · Institut de Recherche en Sciences de la Sante, Burkina Faso · Institut des Sciences Biomédicales Appliquées, Bénin · KEMRI-Wellcome Trust Collaborative Research Program · Kenya Medical Research Institute · Kilimanjaro Christian Medical Centre, Tanzania · Kwame Nkrumah University of Science and Technology · Malaria Consortium, UK · Medical Research Council · Ministry of Foreign Affairs, France · Ministry of Health, Malawi · Ministry of health, Mali · National Malaria Control Program, Benin · National Malaria Control Program, Niger · Sanaria Inc. · Swiss Federal Institute of Technology · Swiss National Science Foundation · The Children's Investment Fund Foundation · The University of Western Australia · The Volkswagen Foundation · University of Barcelona · University of Cape Town · University of Copenhagen · University of Ilorin Teaching Hospital · University of Melbourne · University of Nigeria, Enugu Campus · University of Oxford · Walter Reed Army Institute of Research (WRAIR) · Walter and Eliza Hall Institute of Medical Research · Washington University School of Medicine · Wellcome Trust · World Health Organization

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

today

US approved 1981

198119821983198419851986198719881989199019911992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 11 trial
Phase 1	NCT00013689	Mar 2001 → Mar 2003	autoimmune disease, lymphoproliferative syndrome	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1/24 trials
Phase 1/2	NCT04280692	Aug 2022 → Dec 2025	Plasmodium falciparum malaria	University of Oxford	Suspended	No outcome recorded
Phase 1/2	NCT02836002	Jun 2016 → Jun 2017	malaria	Radboud University Medical Center	Completed	No outcome recorded
Phase 1/2	NCT01319448	Sep 2011 → Apr 2013	malaria, sickle cell disease	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
Phase 1/2	NCT00209794	Sep 2002 → Dec 2005	malaria	Hospital Clinic of Barcelona	Unknown	No outcome recorded
Phase 23 trials · 1 met primary
Phase 2	NCT05081089	Oct → Dec 2021	Plasmodium falciparum malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
Phase 2	NCT02831023	Jul 2016 → Jan 2017	malaria	University of California, San Francisco	Completed	Met primary
Phase 2	NCT00322907	Apr 2000 → Jan 2003	malaria	Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland	Terminated	No outcome recorded
Phase 2/34 trials · 3 met primary
Phase 2/3	NCT00561899	Aug 2007 → Feb 2008	malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
Phase 2/3	NCT00119132	Jun 2005 → Dec 2006	malaria	London School of Hygiene and Tropical Medicine	Completed	Met primary
Phase 2/3	NCT00158574	Jan 2005 → Apr 2008	malaria	London School of Hygiene and Tropical Medicine	Completed	Met primary
Phase 2/3	NCT00132561	Jun 2002 → Dec 2003	malaria	London School of Hygiene and Tropical Medicine	Completed	Met primary
Phase 312 trials · 5 met primary
Phase 3	NCT05946642	Jul 2023 → May 2024	malaria	Malaria Consortium	Unknown	No outcome recorded
Phase 3	NCT00948896	Jun 2010 → Apr 2014	malaria	University of California, San Francisco	Completed	Mixed
Phase 3	NCT01136850	Nov 2009 → Dec 2012	anemia, malaria, sexually transmitted disease	University of Melbourne	Completed	Met primary
Phase 3	NCT00432367	Feb 2007 → Feb 2009	anemia, malaria, pregnancy disorder	London School of Hygiene and Tropical Medicine	Completed	Met primary
Phase 3	NCT00274235	Jul 2005 → Mar 2008	malaria	Research Institute for Development	Completed	Met primary
Phase 3	NCT00123552	Nov 2004 → Jun 2006	malaria	University of California, San Francisco	Completed	Met primary
Phase 3	NCT00132548	Jun → Dec 2004	malaria	London School of Hygiene and Tropical Medicine	Completed	Met primary
Phase 3	NCT00158561	Feb 2004 → Mar 2006	Plasmodium vivax malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
Phase 3	NCT00146731	Jan 2004 → Sep 2007	malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
Phase 3	NCT00120809	Jul 2002 → Sep 2004	malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
Phase 3	NCT00299247	? → Dec 2006	Plasmodium falciparum malaria	National Institute of Allergy and Infectious Diseases (NIAID)	Withdrawn	No outcome recorded
Phase 3	NCT00000727	? → Aug 1991	HIV infectious disease, pneumocystosis	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded

Phase 412 trials · 1 met primary · 1 missed
Phase 4	NCT06337253	Mar → May 2024	Plasmodium falciparum malaria	Malaria Consortium	Unknown	No outcome recorded
Phase 4	NCT05979896	Jul → Sep 2023	malaria	Malaria Consortium	Unknown	No outcome recorded
Phase 4	NCT04816461	Jul 2021 → Jun 2023	malaria	Institut de Recherche en Sciences de la Sante, Burkina Faso	Completed	No outcome recorded
Phase 4	NCT01651416	Jul → Dec 2012	anemia, malaria	Centre for Global Health Research, Ghana	Completed	No outcome recorded
Phase 4	NCT01636895	Jan 2011 → Nov 2012	pregnancy disorder	Malaria Consortium, UK	Unknown	No outcome recorded
Phase 4	NCT00376155	May 2006 → Feb 2007	malaria	London School of Hygiene and Tropical Medicine	Completed	Missed primary
Phase 4	NCT00372632	Dec 2005 → Apr 2008	—	Institute of Tropical Medicine, Belgium	Completed	No outcome recorded
Phase 4	NCT00125489	May → Dec 2005	Plasmodium falciparum malaria	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Met primary
Phase 4	NCT00164710	Apr → Sep 2005	Plasmodium falciparum malaria	Centers for Disease Control and Prevention	Completed	No outcome recorded
Phase 4	NCT00168948	Mar 2003 → Aug 2005	anemia, malaria	Charite University, Berlin, Germany	Unknown	No outcome recorded
Phase 4	NCT00206739	Jan 2003 → Sep 2005	anemia, malaria	Bernhard Nocht Institute for Tropical Medicine	Completed	No outcome recorded
Phase 4	NCT00140361	Jan 2000 → Jan 2008	malaria	Centers for Disease Control and Prevention	Completed	No outcome recorded

Phase not applicable13 trials · 2 met primary · 2 missed
—	NCT03454048	May → Nov 2018	Plasmodium falciparum malaria	Radboud University Medical Center	Completed	No outcome recorded
—	NCT03079388	Feb 2017 → Sep 2019	nutritional disorder, pregnancy disorder	Washington University School of Medicine	Completed	No outcome recorded
—	NCT03035305	Aug → Nov 2016	malaria	Alliance for International Medical Action	Completed	No outcome recorded
—	NCT01634945	Apr 2012 → May 2013	anemia	Swiss Federal Institute of Technology	Completed	Missed primary
—	NCT01454752	Nov 2011 → Feb 2012	anemia, malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
—	NCT00738946	Aug → Dec 2008	malaria	London School of Hygiene and Tropical Medicine	Completed	Met primary
—	NCT00380146	Sep 2006 → Feb 2008	malaria	Professor Karen I Barnes	Completed	No outcome recorded
—	NCT00331708	Apr 2006 → Jul 2007	malaria	Professor Karen I Barnes	Terminated	No outcome recorded
—	NCT00258024	Nov 2005 → Sep 2007	anemia, malaria	DBL -Institute for Health Research and Development	Completed	No outcome recorded
—	NCT00231452	Sep 2005 → Mar 2009	malaria	Hospital Clinic of Barcelona	Completed	Missed primary
—	NCT00304980	Mar 2003 → Apr 2005	Plasmodium falciparum malaria	Institute of Tropical Medicine, Belgium	Terminated	No outcome recorded
—	NCT00203736	Jan → Oct 2003	malaria	University of Cape Town	Completed	Met primary
—	NCT00951106	Jan 1998 → Jun 1999	Plasmodium falciparum malaria, Plasmodium vivax malaria	Walter Reed Army Institute of Research (WRAIR)	Completed	No outcome recorded

Comparator or background therapy31 trials
Phase 1	NCT03599596 Comparator	Sep → Dec 2018	malaria	University College Hospital, Ibadan	Unknown	No outcome recorded
Phase 1	NCT02524444 Comparator	Sep 2015 → Aug 2016	—	ORIYOMI OMOTOYOSI AKINYOTU	Completed	No outcome recorded
Phase 1	NCT02527005 Comparator	Sep 2015 → Aug 2016	HIV infectious disease, malaria	University of Ibadan	Completed	No outcome recorded
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 2/3	NCT00941785 Comparator	Jul → Dec 2009	malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
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	Missed primary
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	Met primary
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 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	Mixed
Phase 4	NCT00964691 Comparator	Aug 2009 → Aug 2010	malaria	Ministry of Health and Medical Services, Solomon Islands	Terminated	No outcome recorded
—	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	Missed primary
—	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 2009 60 “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 ↗ Show 50 more sources
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 ↗ NCT02527005 ↗ NCT00258024 ↗ NCT00432367 ↗ NCT01746199 ↗ NCT02831023 ↗ NCT01651416 ↗ Show 9 more sources
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 ↗ 1 CHEMBL1539 ↗
Route	Oral	“given as oral tablets” NCT00852371 ↗