Pyrimethamine Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

Numerous clinical trials evaluate pyrimethamine across early phase 1 through phase 4 studies, focusing primarily on infectious diseases—such as malaria, maternal malaria, and anemia—alongside exploratory applications in head and neck cancer, schizophrenia, and major depression. Sponsored by academic medical centers, tropical health institutes, and government organizations like the National Institute of Allergy and Infectious Diseases, these protocols range from preventative interventions to novel biomarker evaluations. The body of research encompasses various recruitment statuses, including actively recruiting, active but non-recruiting, and fully completed studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07322068	NOT_YET_RECRUITING	Malaria, Falciparum	Stanford University	2026-09	PHASE4
NCT00004317	RECRUITING	Toxoplasmosis	National Institute of Allergy and Infectious Diseases (NIAID)	2000-07	PHASE4
NCT07384624	NOT_YET_RECRUITING	HIV (Human Immunodeficiency Virus); HIV -1 Infection	Erasmus Medical Center	2026-04	PHASE1; PHASE2
NCT06869850	RECRUITING	Severe Acute Malnutrition; Cognitive Impairment; Kwashiorkor; Severe Wasting	Washington University School of Medicine	2025-09-22
NCT05949190	ACTIVE_NOT_RECRUITING	Malnutrition in Pregnancy; Preterm Birth; Child Development; Postpartum Depression; Antepartum Depression	Washington University School of Medicine	2023-08-18
NCT04280692	SUSPENDED	Malaria,Falciparum	University of Oxford	2022-08-22	PHASE1; PHASE2
NCT06083688	COMPLETED	Malaria,Falciparum; Anemia in Children	Liverpool School of Tropical Medicine	2024-10-14	PHASE4
NCT05678348	COMPLETED	Head and Neck Cancer; Cancer of the Head and Neck	Washington University School of Medicine	2023-08-03	EARLY_PHASE1
NCT06240520	UNKNOWN	Hiv	Erasmus Medical Center	2024-04	PHASE1; PHASE2
NCT05426434	ACTIVE_NOT_RECRUITING	Malaria; Malaria in Pregnancy; Pregnancy Related	Menzies School of Health Research	2022-08-31	PHASE3
NCT06002438	COMPLETED	Moderate Acute Malnutrition; Stunting; Environmental Enteric Dysfunction; Severe Acute Malnutrition	Washington University School of Medicine	2023-10-09
NCT05471544	UNKNOWN	Malaria	Malaria Consortium	2022-07-18	PHASE3
NCT06182176	UNKNOWN	Malaria; Soil Transmitted Helminths; Schistosomiasis; Seasonal Malaria Chemoprevention; Mass Drug Administration With Anthelminthic Drugs	London School of Hygiene and Tropical Medicine	2024-05-27
NCT06522763	UNKNOWN	Fasting	Swiss Pharma Nigeria Limited	2024-07	PHASE1
NCT04336189	COMPLETED	Malaria	Grant Dorsey, M.D, Ph.D.	2020-12-28	PHASE3
NCT05946642	UNKNOWN	Malaria	Malaria Consortium	2023-07-15	PHASE3
NCT06337253	UNKNOWN	Malaria,Falciparum; Chemoprevention	Malaria Consortium	2024-03-26	PHASE4
NCT05979896	UNKNOWN	Malaria	Malaria Consortium	2023-07-28	PHASE4
NCT05678348	Recruiting	Head and Neck Cancer\|Cancer of the Head and Neck	Washington University School of Medicine\|Tilde Sciences	2023-08-03	Early Phase 1
NCT06162078	Recruiting	Maternal Malaria During Pregnancy - Baby Not Yet Delivered	Groupe de Recherche Action en Sante\|European Vaccine Initiative	2023-08-25	--
NCT05980156	COMPLETED	Malaria,Falciparum; Anemia in Children	University of Maryland, Baltimore	2023-02-13	PHASE4
NCT05979896	Recruiting	Malaria	Malaria Consortium	2023-07-28	Phase 4
NCT04844099	COMPLETED	Sickle Cell Anemia in Children; Malaria	Liverpool School of Tropical Medicine	2021-04-09	PHASE3
NCT05497063	UNKNOWN	Bioequivalence	Emzor Pharmaceutical Industries Limited	2022-12	PHASE1
NCT04149106	UNKNOWN	Malaria,Falciparum	University Clinical Research Center, Mali	2019-07-01	PHASE3
NCT05354258	UNKNOWN	Malaria; Soil Transmitted Helminths; Schistosomiasis; Integrated Control; Seasonal Malaria Chemoprevention; Mass Drug Administration With Anthelminthic Drugs	London School of Hygiene and Tropical Medicine	2022-06-16
NCT05323721	UNKNOWN	Malaria	Malaria Consortium	2022-06-01	PHASE4
NCT04189744	COMPLETED	Pregnancy Malaria; Bacterial Vaginoses; Trichomonas Vaginitis	London School of Hygiene and Tropical Medicine	2019-12-15	PHASE3
NCT05478954	UNKNOWN	Malaria	Malaria Consortium	2022-07-15	PHASE4
NCT05478954	Active not recruiting	Malaria	Malaria Consortium	2022-07-15	Phase 4
NCT05471544	Active not recruiting	Malaria	Malaria Consortium	2022-07-18	Phase 3
NCT04783051	COMPLETED	Malaria in Pregnancy	University of Kinshasa	2021-05-06	PHASE3
NCT01066663	COMPLETED	Chronic Lymphocytic Leukemia; Small Lymphocytic Leukemia	Dana-Farber Cancer Institute	2010-03	PHASE1; PHASE2
NCT05081089	COMPLETED	Malaria,Falciparum	London School of Hygiene and Tropical Medicine	2021-10-12	PHASE2
NCT03057990	WITHDRAWN	Myelodysplastic Syndromes	Montefiore Medical Center	2019-09-11	PHASE1
NCT03952650	COMPLETED	Malaria	National Institute of Allergy and Infectious Diseases (NIAID)	2019-05-23	PHASE1; PHASE2
NCT04577469	UNKNOWN	Bioequivalence	Emzor Pharmaceutical Industries Limited	2020-12	PHASE1
NCT04160026	COMPLETED	Malaria in Pregnancy; Adherence, Treatment	Liverpool School of Tropical Medicine	2019-11-11	PHASE4
NCT03208179	COMPLETED	Pregnancy; Malaria in Pregnancy; Malaria	Liverpool School of Tropical Medicine	2018-03-29	PHASE3
NCT02909712	COMPLETED	Malaria; Pregnancy Malaria; Cardiotoxicity; Cardiac Safety; Parasitemia	London School of Hygiene and Tropical Medicine	2016-09	PHASE2
NCT03944317	UNKNOWN	Malaria in Pregnancy; Pregnancy	Federal Medical Centre, Owo	2019-06-01
NCT04086719	COMPLETED	Healthy Male Volunteers	Bristol-Myers Squibb	2019-09-12	PHASE1
NCT03525730	COMPLETED	HIV-1-infection	Erasmus Medical Center	2018-04-18	PHASE1; PHASE2
NCT03083847	COMPLETED	Malaria	National Institute of Allergy and Infectious Diseases (NIAID)	2017-06-05	PHASE1
NCT02793622	COMPLETED	Malaria	University of California, San Francisco	2016-09	PHASE3
NCT03599596	UNKNOWN	Malaria	University College Hospital, Ibadan	2018-09-01	PHASE1
NCT03454048	COMPLETED	Malaria,Falciparum; Gametocytes; Controlled Human Malaria Infection; Transmission	Radboud University Medical Center	2018-05-07
NCT03009526	COMPLETED	Malaria; Pregnancy	Kamuzu University of Health Sciences	2017-01-17	PHASE3
NCT02163447	COMPLETED	Malaria	Grant Dorsey, M.D, Ph.D.	2014-06-23	PHASE3
NCT02211729	COMPLETED	Malaria; Respiratory Infections	London School of Hygiene and Tropical Medicine	2014-05	PHASE3
NCT03258762	COMPLETED	Toxoplasmosis	GlaxoSmithKline	2017-09-25	PHASE1
NCT02836002	COMPLETED	Malaria	Radboud University Medical Center	2016-06	PHASE1; PHASE2
NCT02831023	COMPLETED	Malaria	University of California, San Francisco	2016-07	PHASE2
NCT02511054	COMPLETED	Malaria	National Institute of Allergy and Infectious Diseases (NIAID)	2015-07-21	PHASE1
NCT02527005	COMPLETED	Malaria; Pregnant; HIV	University of Ibadan	2015-09	PHASE1
NCT02524444	COMPLETED	Malaria in Pregnant HIV + Patients	ORIYOMI OMOTOYOSI AKINYOTU	2015-09	PHASE1
NCT02575755	UNKNOWN	Pregnancy; Infections, Plasmodia; Drug Kinetics; Clinical Efficacy	Papua New Guinea Institute of Medical Research	2012-10	PHASE4
NCT02351687	COMPLETED	Malnutrition	Washington University School of Medicine	2014-04
NCT02758353	COMPLETED	Malaria; Stillbirths	JSI Research & Training Institute, Inc.	2015-04
NCT01746199	COMPLETED	Malaria in Pregnancy; HIV Infection	Institut Pasteur	2013-12	PHASE3
NCT01083667	COMPLETED	Familial Amyotrophic Lateral Sclerosis	Weill Medical College of Cornell University	2009-11	PHASE1; PHASE2
NCT01443130	COMPLETED	Malaria	National Institute of Allergy and Infectious Diseases (NIAID)	2012-02	PHASE3
NCT01669941	COMPLETED	Pregnancy; Malaria	Kenya Medical Research Institute	2012-08	PHASE4
NCT01189448	COMPLETED	Congenital Toxoplasmosis	Assistance Publique - Hôpitaux de Paris	2010-11	PHASE3
NCT00948896	COMPLETED	Malaria	University of California, San Francisco	2010-06	PHASE3
NCT01707199	COMPLETED	Uncomplicated P. Falciparum Malaria	University of Oxford	2012-10
NCT01722539	COMPLETED	Healthy	Universiteit Antwerpen	2012-11	PHASE3
NCT01103063	TERMINATED	Intermittent Preventive Treatment In Pregnancy (IPTp)	Pfizer	2010-10	PHASE3
NCT01973933	COMPLETED	Healthy	Seoul National University Hospital	2013-06	PHASE1
NCT01319448	COMPLETED	Malaria; Sickle Cell Crisis	London School of Hygiene and Tropical Medicine	2011-09	PHASE1; PHASE2
NCT01136850	COMPLETED	Malaria in Pregnancy; Sexually Transmitted Infections; Anaemia	University of Melbourne	2009-11	PHASE3
NCT01651416	COMPLETED	Malaria; Anaemia	Centre for Global Health Research, Ghana	2012-07	PHASE4
NCT00811421	COMPLETED	Pregnancy; Malaria; HIV Infections	Hospital Clinic of Barcelona	2009-09
NCT01636895	UNKNOWN	Pregnancy Complications Parasitic	Malaria Consortium, UK	2011-01	PHASE4
NCT01084213	COMPLETED	Malaria; Pregnancy; Anaemia	London School of Hygiene and Tropical Medicine	2010-06	PHASE4
NCT00712374	UNKNOWN	Malaria	London School of Hygiene and Tropical Medicine	2008-09	PHASE4
NCT01184911	WITHDRAWN	Intermittent Preventive Treatment; Placental Malaria	University of California, San Francisco	2010-10	PHASE4
NCT01328990	COMPLETED	Malaria	London School of Hygiene and Tropical Medicine	2011-04	PHASE1; PHASE2
NCT01102686	COMPLETED	Gangliosidoses, GM2; Sandhoff Disease; Tay-Sachs Disease	The Hospital for Sick Children	2009-08	PHASE1; PHASE2
NCT00964691	TERMINATED	Malaria; Malaria in Pregnancy	Ministry of Health and Medical Services, Solomon Islands	2009-08	PHASE4
NCT00285662	COMPLETED	Malaria; Anemia	Papua New Guinea Institute of Medical Research	2006-06
NCT00679744	WITHDRAWN	G(M2) Ganglioside; Tay-Sachs Disease Ganglioside; Sandhoff Disease Ganglioside	Exsar Corporation	2008-05	PHASE1
NCT00682578	COMPLETED	Uncomplicated Falciparum Malaria; Vivax Malaria	University of Oxford	2007-07	PHASE3
NCT00711906	TERMINATED	Malaria in Pregnancy	Institute of Tropical Medicine, Belgium	2009-02	PHASE3
NCT01054651	COMPLETED	Schistosoma Mansoni	Kenya Medical Research Institute	2009-10	PHASE3
NCT00164255	COMPLETED	Malaria	Centers for Disease Control and Prevention	2003-01	PHASE4
NCT00231452	COMPLETED	Malaria	Hospital Clinic of Barcelona	2005-09
NCT00432367	COMPLETED	Malaria; Anaemia; Pregnancy	London School of Hygiene and Tropical Medicine	2007-02	PHASE3
NCT00509015	COMPLETED	Malaria, Falciparum	Radboud University Medical Center	2008-02
NCT00372294	UNKNOWN	Chorioretinitis	Shahid Beheshti University of Medical Sciences	2005-07	PHASE3
NCT00229775	COMPLETED	Malaria	Centers for Disease Control and Prevention	2003-07
NCT00852371	COMPLETED	Malaria; Intermittent Preventive Treatment	London School of Hygiene and Tropical Medicine	2008-02	PHASE3
NCT00372632	COMPLETED	Non HIV Infected Pregnant Women	Institute of Tropical Medicine, Belgium	2005-12	PHASE4
NCT00158574	COMPLETED	Malaria	London School of Hygiene and Tropical Medicine	2005-01	PHASE2; PHASE3
NCT00274235	COMPLETED	Malaria	Institut de Recherche pour le Developpement	2005-07	PHASE3
NCT00380146	COMPLETED	Malaria	Professor Karen I Barnes	2006-09
NCT00140361	COMPLETED	Malaria (Uncomplicated)	Centers for Disease Control and Prevention	2000-01	PHASE4
NCT00766662	COMPLETED	Malaria	University of Bamako	2006-10
NCT00529620	COMPLETED	Malaria	London School of Hygiene and Tropical Medicine	2007-09	PHASE3
NCT00152204	UNKNOWN	Malaria, Falciparum; Anemia	Swiss Tropical & Public Health Institute	2005-03	PHASE3
NCT00460369	COMPLETED	Uncomplicated Malaria	Institut de Recherche pour le Developpement	2007-04
NCT00510159	COMPLETED	Schistosoma Haematobium	Dafra Pharma	2007-08	PHASE2; PHASE3
NCT00361114	TERMINATED	Malaria	London School of Hygiene and Tropical Medicine	2006-07	PHASE3
NCT00331708	TERMINATED	Malaria	Professor Karen I Barnes	2006-04
NCT00140517	COMPLETED	Malaria in Pregnancy; Birth Weight; Anaemia	London School of Hygiene and Tropical Medicine	2002-10
NCT00452907	COMPLETED	Malaria	Sanofi	2005-07	PHASE4
NCT00131235	ACTIVE_NOT_RECRUITING	Malaria; Sexually Transmitted Diseases; Preterm Birth; Pregnancy	Tampere University	2003-12	PHASE3
NCT00323622	COMPLETED	Malaria	GlaxoSmithKline	2005-04	PHASE2
NCT00399074	COMPLETED	Sickle Cell Anemia; Malaria	Makerere University	2006-10	PHASE3
NCT00142207	COMPLETED	Malaria, Falciparum	London School of Hygiene and Tropical Medicine	2004-01	PHASE3
NCT00299247	WITHDRAWN	Plasmodium Falciparum Malaria	National Institute of Allergy and Infectious Diseases (NIAID)		PHASE3
NCT00119132	COMPLETED	Malaria	London School of Hygiene and Tropical Medicine	2005-06	PHASE2; PHASE3
NCT00680732	COMPLETED	Malaria; Malaria in Pregnancy	Institute of Tropical Medicine, Belgium	2003-06	PHASE4
NCT00730366	COMPLETED	Malaria in Pregnancy	Institute of Tropical Medicine, Belgium	2004-03	PHASE3
NCT00123552	COMPLETED	Malaria	University of California, San Francisco	2004-11	PHASE3
NCT00111163	COMPLETED	Malaria; Anemia	Centers for Disease Control and Prevention	2004-03
NCT00130065	COMPLETED	Malaria	Centers for Disease Control and Prevention	2003-11	PHASE4
NCT00259142	TERMINATED	Fever; Anaemia; Malaria	DBL -Institute for Health Research and Development	2005-11
NCT00206739	COMPLETED	Malaria; Anemia	Bernhard Nocht Institute for Tropical Medicine	2003-01	PHASE4
NCT00164710	COMPLETED	Malaria, Falciparum	Centers for Disease Control and Prevention	2005-04	PHASE4
NCT00203801	COMPLETED	Malaria	University of Cape Town	2002-01
NCT00959517	COMPLETED	Uncomplicated Falciparum Malaria	London School of Hygiene and Tropical Medicine	2001-07	PHASE2
NCT00623155	COMPLETED	Malaria	University of Bamako	2002-07
NCT00951106	COMPLETED	Malaria, Vivax; Malaria, Falciparum	Walter Reed Army Institute of Research (WRAIR)	1998-01
NCT00000666	COMPLETED	Toxoplasmosis, Cerebral; HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)
NCT00209794	UNKNOWN	Malaria	Hospital Clinic of Barcelona	2002-09	PHASE1; PHASE2
NCT00301054	COMPLETED	Anaemia in Children	Ghana Health Services	2005-06
NCT00158548	COMPLETED	Malaria; Falciparum Malaria; Vivax Malaria	London School of Hygiene and Tropical Medicine	2001-06	PHASE3
NCT00131703	COMPLETED	Malaria; Pregnancy	London School of Hygiene and Tropical Medicine	2003-03	PHASE3
NCT00132548	COMPLETED	Malaria	London School of Hygiene and Tropical Medicine	2004-06	PHASE3
NCT00486694	COMPLETED	Malaria, Vivax	London School of Hygiene and Tropical Medicine	2004-03	PHASE2
NCT00125489	COMPLETED	Malaria; Plasmodium Falciparum Malaria	National Institute of Allergy and Infectious Diseases (NIAID)	2005-05	PHASE4
NCT00158561	COMPLETED	Malaria; Vivax Malaria	London School of Hygiene and Tropical Medicine	2004-02	PHASE3
NCT00144352	COMPLETED	Malaria; HIV; AIDS	Centers for Disease Control and Prevention	2002-09	PHASE4
NCT00157859	COMPLETED	Falciparum Malaria; Vivax Malaria	Menzies School of Health Research	2004-04
NCT00000727	COMPLETED	Pneumonia, Pneumocystis Carinii; HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)		PHASE3
NCT00857077	COMPLETED	Anaemia; Malaria	London School of Hygiene and Tropical Medicine	2000-09
NCT00127998	COMPLETED	Malaria	Centers for Disease Control and Prevention	2005-07
NCT00167739	COMPLETED	Malaria	Albert Schweitzer Hospital	2003-04	PHASE4
NCT00214643	COMPLETED	Malaria	Albert Schweitzer Hospital, Netherlands	2005-06	PHASE3
NCT00000674	COMPLETED	Toxoplasmosis, Cerebral; HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)
NCT00131716	COMPLETED	Anemia	London School of Hygiene and Tropical Medicine	2003-05	PHASE3
NCT00126906	COMPLETED	Malaria, Falciparum; HIV Infections	Centers for Disease Control and Prevention	2002-10
NCT00484900	COMPLETED	Plasmodium Falciparum Malaria	Dafra Pharma	2006-05	PHASE3
NCT00000794	COMPLETED	Toxoplasmosis, Cerebral; HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)		PHASE2
NCT00209781	UNKNOWN	Pregnancy	Hospital Clinic of Barcelona	2003-08
NCT00000966	COMPLETED	Toxoplasmosis, Cerebral; HIV Infections	Pfizer		PHASE1
NCT00646126	COMPLETED	Plasmodium Falciparum; Asymptomatic Parataemia; Sub Patent Parasitaemia	Tropical Medicine Research Institute	2005-08	PHASE3
NCT00118807	COMPLETED	Malaria	London School of Hygiene and Tropical Medicine	2003-08	PHASE3
NCT00287300	COMPLETED	Malaria	University of North Carolina	2003-09
NCT00300404	COMPLETED	Schizophrenia; Major Depression	Zentrum für Integrative Psychiatrie	2002-01	PHASE3
NCT00146783	COMPLETED	Malaria	London School of Hygiene and Tropical Medicine	2004-06	PHASE2; PHASE3
NCT00120809	COMPLETED	Malaria	London School of Hygiene and Tropical Medicine	2002-07	PHASE3
NCT00132561	COMPLETED	Malaria	London School of Hygiene and Tropical Medicine	2002-06	PHASE2; PHASE3
NCT00461578	COMPLETED	Malaria	London School of Hygiene and Tropical Medicine	2005-04
NCT00001994	COMPLETED	Toxoplasmosis, Cerebral; HIV Infections	Glaxo Wellcome
NCT00270530	COMPLETED	Placental Malaria Infection; HIV Infections; Stillbirth; Prematurity; Neonatal Deaths	Center for International Health and Development	2002-11	PHASE4
NCT00084240	TERMINATED	Malaria, Falciparum	Pfizer	2004-03	PHASE2; PHASE3
NCT00120822	COMPLETED	Malaria	London School of Hygiene and Tropical Medicine	2002-07	PHASE3
NCT00330902	COMPLETED	Plasmodium Infections	London School of Hygiene and Tropical Medicine	2004-01	PHASE3
NCT00376155	COMPLETED	Malaria	London School of Hygiene and Tropical Medicine	2006-05	PHASE4
NCT00497471	TERMINATED	Malaria; Anemia	Hospital Clinic of Barcelona	1995-02
NCT00118027	COMPLETED	Malaria; Pregnancy; Anemia	London School of Hygiene and Tropical Medicine	2003-05
NCT00074841	COMPLETED	PLASMODIUM FALCIPARUM MALARIA	Pfizer	2003-09	PHASE2; PHASE3
NCT00367081	COMPLETED	Toxoplasmic Encephalitis; AIDS	Department of Medical Services Ministry of Public Health of Thailand	2003-05	PHASE4
NCT00168948	UNKNOWN	Malaria; Anemia	Charite University, Berlin, Germany	2003-03	PHASE4
NCT00137553	COMPLETED	Malaria, Falciparum	Bandim Health Project	2001-05	PHASE4
NCT00000973	COMPLETED	Toxoplasmosis, Cerebral; HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)		PHASE1
NCT00065390	COMPLETED	Autoimmune Disease; Lymphatic Disease; Lymphoproliferative Disorder	National Institute of Allergy and Infectious Diseases (NIAID)	2003-07	PHASE1
NCT00289250	COMPLETED	Asymptomatic P.Falciparum Malaria	London School of Hygiene and Tropical Medicine	2001-05	PHASE3
NCT00304980	TERMINATED	Plasmodium Falciparum Malaria	Institute of Tropical Medicine, Belgium	2003-03
NCT00146718	COMPLETED	Malaria	London School of Hygiene and Tropical Medicine	2003-08	PHASE2; PHASE3
NCT00203736	COMPLETED	Malaria	University of Cape Town	2003-01
NCT00002064	COMPLETED	Toxoplasmosis, Cerebral; HIV Infections	Palo Alto Medical Foundation
NCT00013689	COMPLETED	Autoimmune Disease; Lymphoproliferative Disorder	National Institute of Allergy and Infectious Diseases (NIAID)	2001-03	PHASE1
NCT00132535	COMPLETED	Malaria in Pregnancy; HIV Infections	London School of Hygiene and Tropical Medicine	2003-08
NCT00167843	COMPLETED	Malaria	Albert Schweitzer Hospital	2002-12	PHASE4
NCT00453856	TERMINATED	Malaria	Albert Schweitzer Hospital, Netherlands	2007-03	PHASE4
NCT00000643	COMPLETED	Toxoplasmosis, Cerebral; HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)		PHASE2
NCT00203814	COMPLETED	Malaria	University of Cape Town	2004-01

(data from https://clinicaltrials.gov, updated on 2026-01-07)

Check the Pyrimethamine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pyrimethamine selectively binds to and inhibits dihydrofolate reductase with an IC50 of 15.4 nM, thereby disrupting folic acid synthesis and halting downstream DNA and RNA production. This enzymatic inhibition impairs nucleic acid assembly and cellular proliferation, offering therapeutic rationale for its clinical use in malaria chemoprevention and ongoing trials in head and neck cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).