sulfadoxine

Small moleculeapproved

Approved

Oct 28, 1981

Sulfadoxine is an antimalarial agent which, together with pyrimethamine, composes an FDA-approved drug, Fansidar. Sulfadoxine acts by inhibiting dihydropteroate synthase; it crosses the blood-brain barrier and achieves 30% to 60% of the plasma concentration. — NCATS

Clinical trial activity

155 trials · 175 clinical orgs · 1 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Jan 1, 1998 (NCT00951106)

Timeline

1980s

Oct 28, 1981
Roche — Earliest FDA Approval
Oct 28, 1981
Roche — NDA Secondary Org
Oct 28, 1981
Roche — NDA Organization

1990s

Jan 1, 1999
Earliest Phase 3 Sponsor(trial)

2000s

Jan 1, 2000
Earliest Phase 2 Sponsor(trial)
Jan 1, 2001
Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Dihydropteroate synthetaseINHIBITOR
PPPK-DHPS inhibitor
- 7,8-dihydro-6-hydroxymethylpterin pyrophosphokinase-dihydropteroate synthase (PPPK-DHPS) ↗

Combination products

fansidar
with pyrimethamine

Approval history

approvedPriority reviewOct 28, 1981

Chemistry & pharmacology

Loading structure…

SMILES

COC1=C(OC)C(NS(=O)(=O)C2=CC=C(N)C=C2)=NC=N1

Mol. weight: 310.329 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Achiral Molecule
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Discontinued

Oral

Yes

Parenteral

Topical

Sources

Also known as

4-sulfanilamido-5,6-dimethoxypyrimidine
4-sulfanilamido-5,6-dimethoxypyrimidine
fanasil
fanasil
fanasil
fanasil
fanasil
fanasil
fansidar
fansidar
fanzil
fanzil
orthosulfin
ro-44393
ro-44393
sulfadoxin
sulfadoxina
sulfadoxina
sulfadoxine
sulfadoxine
sulfadoxine
sulfadoxine
sulfadoxine
sulfadoxine
sulfadoxine
sulfadoxine
sulfadoxinum
sulfadoxinum
sulformethoxine
sulformetoxin
sulformetoxine
sulforthamidine
sulforthodimethoxine
sulforthomidine
sulforthomidine
sulforthomidine
sulphadoxine
sulphadoxine
sulphadoxine
sulphormethoxine
sulphormethoxine
sulphormethoxine

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT06083688	Phase 4	Oct 31, 2024	Kamuzu University of Health Sciences, University of Liverpool
NCT06182176	N/A	May 27, 2024	Kintampo Health Research Centre, Ghana, University of London
NCT06173206	Phase 3	Mar 15, 2024	University of London
NCT06166498	Phase 3	Feb 15, 2024	University of London
NCT06002438	N/A	Oct 9, 2023	Government of Sierra Leone, Project Peanut Butter, Thrasher Research Fund, Washington University in St. Louis
NCT05949190	N/A	Aug 18, 2023	Government of Sierra Leone, Open Philanthropy Project, Project Peanut Butter, United States Department of Agriculture, Washington University in St. Louis
NCT05946642	Phase 3	Jul 15, 2023	Malaria Consortium
NCT05980156	Phase 4	Feb 13, 2023	Doris Duke Charitable Foundation, Kamuzu University of Health Sciences, University of Maryland
NCT05497063	Phase 1	Dec 31, 2022	Emzor Pharmaceutical Industries Limited
NCT05426434	Phase 3	Aug 31, 2022	Curtin University, Government of Papua New Guinea, Menzies School of Health Research, University of Liverpool, University of Melbourne
NCT05471544	Phase 3	Jul 18, 2022	Malaria Consortium
NCT05478954	Phase 4	Jul 15, 2022	Malaria Consortium
NCT05354258	N/A	Jun 16, 2022	University of London
NCT05323721	Phase 4	Jun 1, 2022	Government of Uganda, Malaria Consortium
NCT05081089	Phase 2	Oct 12, 2021	Malaria Research and Training Center, Bamako, Mali, University of London
NCT04783051	Phase 3	May 6, 2021	European and Developing Countries Clinical Trials Partnership (EDCTP), Novartis, University of Kinshasa
NCT04577469	Phase 1	Dec 31, 2020	ACDIMA Biocenter, Emzor Pharmaceutical Industries Limited
NCT04336189	Phase 3	Jun 30, 2020	Infectious Disease Institute, Kampala, Uganda, Makerere University, National Institutes of Health (NIH), University of California, San Francisco
NCT04319380	Phase 3	May 31, 2020	Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest (IRSS-DRO), Institut et Haute école de la Santé, La Source, Malaria Research and Training Center, Bamako, Mali, University of London
NCT04235816	Phase 3	May 1, 2020	Bill and Melinda Gates Foundation, Government of Sierra Leone, University of Barcelona, University of Sierra Leone

Showing 20 of 155 trials

Page 1 / 8

Organizations

Research & Development (175)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
University of London	Academic/Hospital	57	47	4	2000
Centers for Disease Control and Prevention (CDC)	Government	15	9	3	2000
University of Copenhagen	Academic/Hospital	10	2	3	2002
World Health Organization	Government	9	0	3	2001
Bill and Melinda Gates Foundation	Academic/Hospital	7	0	4	2002
Cheikh Anta Diop University, Senegal	Academic/Hospital	7	1	4	2002
Government of France	Government	7	2	3	2002
Kenya Medical Research Institute	Academic/Hospital	7	0	4	2002
Malaria Research and Training Center, Bamako, Mali	Academic/Hospital	7	0	3	2005
University of Barcelona	Academic/Hospital	7	5	3	2002
University of California, San Francisco	Academic/Hospital	7	7	3	2004
Institute of Tropical Medicine, Belgium	Academic/Hospital	6	6	3	2003
Kilimanjaro Christian Medical College, Tanzania	Academic/Hospital	6	0	4	2005
Makerere University	Academic/Hospital	6	1	2	2005
Medical Research Council	Government	6	0	3	2003
National Institute of Allergy and Infectious Diseases (NIAID)	Government	6	5	3	1999
University of Liverpool	Academic/Hospital	6	3	2	2004
University of Malawi	Academic/Hospital	6	1	3	2003
University of Melbourne	Academic/Hospital	6	1	3	2003
Albert Schweitzer Hospital	Academic/Hospital	5	4	3	2002

175 organizations

Page 1 / 9

Marketing (2)

Organization	Org type	Relationship	Date
Roche	For profit	NDA2	Oct 28, 1981
Roche	For profit	NDA	Oct 28, 1981