Clinical Trials

Trimethoprim has undergone numerous clinical trials spanning Phase 1 through Phase 4 to evaluate its therapeutic efficacy, safety, and pharmacokinetic properties across completed, active, and recruiting protocols. Sponsored by academic institutions and government agencies, including the National Institute of Allergy and Infectious Diseases and the National Institute of Arthritis and Musculoskeletal and Skin Diseases, research focuses primarily on infectious and dermatological conditions. Key indications investigated include uncomplicated urinary tract infections, bacterial abscesses, Pneumocystis jirovecii pneumonia in immunocompromised individuals, and atopic dermatitis.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07485010 NOT_YET_RECRUITING
Mycobacterium Abscessus Pulmonary Disease; Mycobacterium Abscessus Infection; Non-Tuberculous Mycobacterial (NTM) Infections; Non-Tuberculous Mycobacteria Pulmonary Disease
The University of Queensland
 2027-04 PHASE2
NCT04851015 RECRUITING
Pneumocystis; Pneumocystis Pneumonia; Pneumocystis Jirovecii Infection; Pneumocystis Infections; Pneumocystis Carinii Infection; Pneumocystosis; Pneumonia (Etiology); Pneumocystis Carinii; Infection, Resulting From HIV Disease; Pneumocystosis Associated With AIDS
Todd C. Lee MD MPH FIDSA
 2025-11-28 PHASE3
NCT07665359 NOT_YET_RECRUITING
Chronic Obstructive Pulmonary Disease (COPD)
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2026-07-01
NCT07106125 NOT_YET_RECRUITING
Kidney Transplant; Urinary Tract Infection(UTI); Antibiotic Prophylaxis; Remote Patient Monitoring; Feasibility Pilot Study
University of California, San Francisco
 2026-11 PHASE4
NCT07619027 NOT_YET_RECRUITING
Pneumocystis Jirovecii Pneumonia; Kidney Transplantation
Anhui Provincial Hospital
 2026-06 PHASE4
NCT05268120 RECRUITING
MRSA
Leiden University Medical Center
 2022-07-25
NCT03178149 RECRUITING
Age-Related Macular Degeneration
Astellas Institute for Regenerative Medicine
 2018-07-13 PHASE1
NCT03919435 ACTIVE_NOT_RECRUITING
Granulomatosis With Polyangiitis; Wegener Granulomatosis
University of Pennsylvania
 2019-03-27 PHASE1; PHASE2
NCT06536374 NOT_YET_RECRUITING
Prostate Cancer
University of California, San Diego
 2026-06 PHASE2
NCT07343934 RECRUITING
Relapsed or Refractory Follicular Lymphoma
University of Pennsylvania
 2026-05-18 PHASE1
NCT07228702 ENROLLING_BY_INVITATION
Non-Tuberculous Mycobacterial (NTM) Pneumonia; Mycobacterium Abscessus Infection
Vancouver Coastal Health
 2026-01-11 PHASE1
NCT05224401 RECRUITING
Urinary Tract Infections; Bacteremia; Antibiotic Resistant Infection
Lund University
 2023-05-29 PHASE3
NCT07224997 NOT_YET_RECRUITING
Acute Kidney Injuries; Acute Kidney Disease; Acute Kidney Injury (AKI)
Hospital Civil de Guadalajara
 2025-12-01 PHASE2
NCT06982105 RECRUITING
Methicillin Resistant Staphylococcus Aureus; Osteomyelitis Acute; Septic Arthritis; Orbital Cellulitis; Facial Cellulitis; Mastoiditis; Cervical Adenitis; Retropharyngeal Abscess; Peritonsillar Abscess
Indiana University
 2025-05-20 PHASE4
NCT05678621 RECRUITING
Haematological Malignancy; Hypogammaglobulinemia
Monash University
 2022-11-30 PHASE2; PHASE3
NCT07202078 RECRUITING
Myeloma; Non Hodgkin's Lymphoma; Leukemia
Monash University
 2025-05-07 PHASE2; PHASE3
NCT07202091 RECRUITING
Myeloma; Leukemia; Non Hodgkin's Lymphoma
Monash University
 2025-05-06 PHASE2; PHASE3
NCT07202052 RECRUITING
Myeloma; Non-Hodgkin's Lymphoma; Leukemia
Monash University
 2025-05-06 PHASE2; PHASE3
NCT01631617 RECRUITING
Eczema; Dermatitis; Skin Diseases, Genetic; Dermatitis, Atopic; Skin Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
 2012-09-18 PHASE2
NCT06709196 RECRUITING
Cystectomy; Bladder Cancer Requiring Cystectomy; Postoperative Infections; Antibiotic Prophylaxis; Ileal Conduit
Rigshospitalet, Denmark
 2025-01-07 PHASE4
NCT05398679 RECRUITING
Endocarditis Infective
Fundacion Clinic per a la Recerca Biomédica
 2022-08-17 PHASE4
NCT07451171 RECRUITING
Small Intestine Bacterial Overgrowth
University of Virginia
 2026-04-18 PHASE2
NCT06841705 RECRUITING
Immune Checkpoint Inhibitor-Related Colitis
Shilpa Grover, MD, MPH
 2025-07-15 PHASE2
NCT05331664 RECRUITING
Rhegmatogenous Retinal Detachment
Massachusetts Eye and Ear Infirmary
 2022-07-25 PHASE4
NCT06499233 RECRUITING
Pneumonia, Pneumocystis; Autoimmune Inflammatory Rheumatic Disease; Autoimmune Diseases; Connective Tissue Disease; Prevention
Tongji Hospital
 2024-07-20 PHASE4
NCT04263792 RECRUITING
Bacterial Infections
University of Pennsylvania
 2020-02-07 PHASE1
NCT05199324 COMPLETED
Gram-negative Bacteraemia
Tan Tock Seng Hospital
 2022-06-03 PHASE4
NCT06737016 RECRUITING
Posterior Urethral Valve
Mansoura University
 2024-11-01 PHASE3
NCT04368559 COMPLETED
Candidemia; Mycoses; Fungal Infection; Fungemia; Invasive Candidiasis; Pneumocystis; Mold Infection; Invasive Fungal Disease; Prophylaxis of Invasive Fungal Infections; Aspergillus
Mundipharma Research Limited
 2020-05-11 PHASE3
NCT03489629 COMPLETED
Cystic Fibrosis
University of North Carolina, Chapel Hill
 2018-04-03 PHASE2
NCT06336824 UNKNOWN
Staphylococcus Aureus Bacteremia
Clinical Research Centre, Malaysia
 2024-06-28 PHASE3
NCT04502095 COMPLETED
Bladder Carcinoma; Refractory Bladder Carcinoma; Urinary Tract Infection
Roswell Park Cancer Institute
 2020-09-02 PHASE4
NCT05274672 WITHDRAWN
Benign Prostatic Hyperplasia; Urinary Tract Infections
Baylor Research Institute
 2023-03-01 PHASE4
NCT02944825 COMPLETED
Urolithiasis; UTI
University of California, San Diego
 2016-01
NCT05302531 UNKNOWN
Short Bowel Syndrome; Infection, Bacterial
Central Hospital, Nancy, France
 2022-12-09 PHASE1
NCT01140516 UNKNOWN
Hydronephrosis; Urinary Tract Infection
McMaster University
 2010-07
NCT03637400 COMPLETED
Methicillin-resistant Staphylococcus Aureus; Skin Infection
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
 2018-11-26 PHASE2
NCT02375295 UNKNOWN
Kidney Stones
University of British Columbia
 2015-03 PHASE4
NCT03424525 COMPLETED
Bacterial Infections
University of Pennsylvania
 2018-02-01 PHASE1
NCT05577273 UNKNOWN
Urologic Diseases; Urinary Tract Disease
Omri Schwarztuch Gildor
 2018-08-14
NCT05063422 COMPLETED
Retentive Strength of Denture Adhesives
Altamash Institute of Dental Medicine
 2022-08-18 PHASE1
NCT03746106 COMPLETED
Vitamin B1 Deficiency; Thiamine Deficiency
University of California, San Francisco
 2019-01-28 PHASE4
NCT03920007 ACTIVE_NOT_RECRUITING
Leber Congenital Amaurosis; LCA; LCA1
Atsena Therapeutics Inc.
 2019-10-22 PHASE1; PHASE2
NCT05418777 TERMINATED
COPD Exacerbation Acute
Corewell Health East
 2022-09-28 PHASE1; PHASE2
NCT03978559 UNKNOWN
Pneumocystis Pneumonia
Bin Du
 2019-08-14 PHASE4
NCT03173053 TERMINATED
Staphylococcus Aureus; Motility Disorder
Radboud University Medical Center
 2018-02-08
NCT03228108 COMPLETED
Complication; Infection; Prostate Cancer
Radboud University Medical Center
 2018-04-03 PHASE4
NCT05817253 Completed
Clinical Audit|Quality Improvement
University of British Columbia|Ministry of Health British Columbia
 2021-09-23 Not Applicable
NCT03042260 UNKNOWN
Lupus Erythematosus, Systemic
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
 2017-03-01 PHASE4
NCT02734732 UNKNOWN
Prostate Infection
Umeå University
 2015-04 PHASE2
NCT01792804 COMPLETED
Staphylococcus Aureus Infection
Heinrich-Heine University, Duesseldorf
 2013-12 PHASE3
NCT02021006 UNKNOWN
Vesicoureteral Reflux; Renal Hypodysplasia, Nonsyndromic, 1; Chronic Kidney Disease
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
 2013-12 PHASE3
NCT01595529 COMPLETED
Urinary Tract Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2012-05-18 PHASE2
NCT03077711 COMPLETED
Urinary Tract Infections, Recurrent
Endeavor Health
 2016-06 PHASE4
NCT03014687 RECRUITING
Antibiotics; Pituitary Adenoma
St. Joseph's Hospital and Medical Center, Phoenix
 2017-07-01 PHASE4
NCT02096159 ACTIVE_NOT_RECRUITING
Hypospadias
Ann & Robert H Lurie Children's Hospital of Chicago
 2014-03
NCT02475876 COMPLETED
Bacterial Infections
Michael Cohen-Wolkowiez
 2015-11 PHASE1
NCT01650558 COMPLETED
HIV
University of Maryland, Baltimore
 2012-11
NCT03424525 Active not recruiting
Bacterial Infections
University of Pennsylvania
 2018-02-01 Phase 1
NCT01723150 COMPLETED
Liver Abscess, Pyogenic
National University Hospital, Singapore
 2013-11-05 PHASE4
NCT01594827 COMPLETED
Cystic Fibrosis
Johns Hopkins University
 2012-10 PHASE2
NCT03235947 COMPLETED
Urinary Tract Infection; Asymptomatic Bacteriuria
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
 2016-09-07 PHASE4
NCT04306731 COMPLETED
Recurrent Urinary Tract Infection
University of Sulaimani
 2014-09-20
NCT02145338 COMPLETED
Urinary Tract Infections, Recurrent
Newcastle-upon-Tyne Hospitals NHS Trust
 2013-09 PHASE4
NCT02624440 UNKNOWN
Multiple Myeloma; Infection
Henrik Gregersen
 2013-01 PHASE2
NCT01632891 COMPLETED
HIV-1 Infection; Pf Subclinical Parasitemia
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2014-01-10 PHASE1; PHASE2
NCT02282293 COMPLETED
Malaria; Human Immunodeficiency Virus
University of California, San Francisco
 2014-12-09 PHASE3
NCT01757236 UNKNOWN
Hip Prosthetic Joint Infection
University Hospital, Tours
 2012-10 PHASE2
NCT01777737 TERMINATED
Idiopathic Pulmonary Fibrosis
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
 2013-11-25 PHASE3
NCT02475876 Completed
Bacterial Infections
Michael Cohen-Wolkowiez|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|Duke University
 2015-11 Phase 1
NCT02371603 COMPLETED
Anaemia
GlaxoSmithKline
 2015-02-11 PHASE1
NCT01659866 COMPLETED
Infection
Northwestern University
 2012-08 PHASE4
NCT01820897 COMPLETED
Urinary Tract Infection; Asymptomatic Bacteriuria; Allograft Rejection; Microbiologic Resistance; Hospitalization
JOSE MANUEL ARREOLA GUERRA
 2013-04 PHASE4
NCT00730028 COMPLETED
Staphylococcal Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2009-04 PHASE2
NCT01349192 TERMINATED
Cystic Fibrosis; Methicillin-resistant Staphylococcus Aureus
University of North Carolina, Chapel Hill
 2011-04 PHASE2
NCT00752375 WITHDRAWN
Pyelonephritis
University of Alberta
 2009-02 PHASE3
NCT01599806 COMPLETED
Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
Pfizer
 2012-10 PHASE3
NCT01595438 COMPLETED
Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
Pfizer
 2012-10 PHASE3
NCT01507974 COMPLETED
Pregnancy Complications
HaEmek Medical Center, Israel
 2012-01-16
NCT00948896 COMPLETED
Malaria
University of California, San Francisco
 2010-06 PHASE3
NCT00711854 COMPLETED
MRSA Infection
University Hospital, Geneva
 2009-01 PHASE4
NCT01449877 COMPLETED
Ocular Toxoplasmosis
University of Campinas, Brazil
 2011-10 PHASE3
NCT01425073 COMPLETED
HIV Infections; Acquired Immunodeficiency Syndrome; Disease Progression; Immune System Diseases; Malaria; Parasitic Diseases; Pneumonia; Diarrhea; Infectious Disorder of Immune System
University of Washington
 2012-02
NCT01747278 UNKNOWN
Pneumonia, Pneumocystis; Prevention & Control
Peking Union Medical College Hospital
 2012-08 PHASE2; PHASE3
NCT00405704 COMPLETED
Vesicoureteral Reflux; Urinary Tract Infections
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2007-05 PHASE3
NCT00729937 COMPLETED
Staphylococcal Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2009-04 PHASE2; PHASE3
NCT00527800 COMPLETED
Malaria; HIV Infections
University of California, San Francisco
 2007-08 PHASE3
NCT01808755 COMPLETED
Recurrent Urinary Tract Infection
Fondazione IRCCS Policlinico San Matteo di Pavia
 2012-01 PHASE3
NCT00867789 TERMINATED
Abscess
Children's Mercy Hospital Kansas City
 2009-03
NCT00676130 COMPLETED
Cellulitis
Brigham and Women's Hospital
 2007-05
NCT01167452 COMPLETED
Obesity; Pharmacokinetics; MRSA; Tuberculosis; PCP
Texas Tech University Health Sciences Center
 2010-07 PHASE4
NCT02024867 COMPLETED
Skin Disease, Bacterial; Abscess
Lucy Holmes, MD
 2010-02
NCT00613769 COMPLETED
Infection Prophylaxis in Colo Rectal Surgery
Halmstad County Hospital
 2007-09 PHASE4
NCT00900510 WITHDRAWN
Abscess
Wake Forest University
 2009-05
NCT01137903 UNKNOWN
Osteomyelitis; Diabetic Foot; Diabetic Foot Ulcers
Universidad Complutense de Madrid
 2010-04
NCT00002850 COMPLETED
Infection; Multiple Myeloma
Gary Morrow
 1997-03 PHASE3
NCT02188472 COMPLETED
Oxidative Stress
Henrik Enghusen Poulsen
 2010-11 PHASE1
NCT00869518 TERMINATED
Staphylococcus Aureus; HIV Infections
University of California, San Francisco
 2009-07 PHASE2
NCT00691600 COMPLETED
Abscess
Baylor College of Medicine
 2007-12 PHASE3
NCT00078559 COMPLETED
Kidney Transplantation; Kidney Disease
University of Wisconsin, Madison
 2003-11 PHASE1; PHASE2
NCT00080119 TERMINATED
HIV Infection; Tuberculosis; Pneumocystis Jiroveci Pneumonia
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
 2004-02 PHASE2; PHASE3
NCT00302341 TERMINATED
Pneumonia, Interstitial Plasma Cell; Pneumocystis Carinii Pneumonia; Pneumonia, Pneumocystis Carinii; HIV Infections
Immtech Pharmaceuticals, Inc
 2006-05 PHASE3
NCT00679302 COMPLETED
Skin Diseases, Infectious
St. Louis University
 2006-07 PHASE4
NCT00061945 COMPLETED
Acute Undifferentiated Leukemia; B-cell Adult Acute Lymphoblastic Leukemia; B-cell Childhood Acute Lymphoblastic Leukemia; L1 Adult Acute Lymphoblastic Leukemia; L1 Childhood Acute Lymphoblastic Leukemia; L2 Adult Acute Lymphoblastic Leukemia; L2 Childhood Acute Lymphoblastic Leukemia; Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia; Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia; Philadelphia Chromosome Positive Childhood Precursor Acute Lymphoblastic Leukemia; T-cell Adult Acute Lymphoblastic Leukemia; T-cell Childhood Acute Lymphoblastic Leukemia; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Childhood Acute Lymphoblastic Leukemia
National Cancer Institute (NCI)
 2003-06 PHASE1; PHASE2
NCT00380640 COMPLETED
Epidermolysis Bullosa
The Hospital for Sick Children
 2006-09 PHASE2
NCT00324922 COMPLETED
Osteomyelitis; Methicillin-resistant Staphylococcus Aureus
University of Washington
 2006-05-01 PHASE3
NCT00870298 TERMINATED
Prescribers' Drug Orders
University of Pennsylvania
 2006-08
NCT00141037 COMPLETED
Kidney Diseases; Kidney Transplantation; Kidney Transplant; Renal Transplantation; Renal Transplant
National Institute of Allergy and Infectious Diseases (NIAID)
 2004-03 PHASE1; PHASE2
NCT00200616 COMPLETED
Urinary Tract Infection
Nantes University Hospital
 2001-04
NCT00189098 COMPLETED
Chronic Otitis Media
UMC Utrecht
 2003-02
NCT00002524 COMPLETED
Lymphoma
M.D. Anderson Cancer Center
 1993-06 PHASE2
NCT00014911 COMPLETED
Diabetes Mellitus, Insulin-Dependent
National Institute of Allergy and Infectious Diseases (NIAID)
 2001-04 PHASE2
NCT00791505 COMPLETED
Chronic Obstructive Pulmonary Disease; Sepsis; Antibiotics
University of Monastir
 2002-07 PHASE3
NCT00002571 COMPLETED
Lymphoma
SWOG Cancer Research Network
 1994-06 PHASE2
NCT00382343 COMPLETED
Pyelonephritis; Renal Scars
IRCCS Burlo Garofolo
 1999-11 PHASE4
NCT00168532 COMPLETED
Post-Measles Pneumonia; Measles
Bandim Health Project
 1998-01 PHASE3
NCT00000655 COMPLETED
Pneumonia, Pneumocystis Carinii; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000802 COMPLETED
Pneumonia, Pneumocystis Carinii; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00002283 COMPLETED
Pneumonia, Pneumocystis Carinii; HIV Infections
Jacobus Pharmaceutical
NCT00000826 COMPLETED
Bacterial Infections; Mycoses; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002120 COMPLETED
Pneumonia, Pneumocystis Carinii; HIV Infections
U.S. Bioscience
 PHASE1
NCT00002056 COMPLETED
Pneumonia, Pneumocystis Carinii; HIV Infections
LyphoMed
NCT01101412 WITHDRAWN
Chronic Myeloproliferative Disorders; Infection; Leukemia; Lymphoma; Lymphoproliferative Disorder; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Unspecified Adult Solid Tumor, Protocol Specific
M.D. Anderson Cancer Center
 PHASE1; PHASE2
NCT00000640 COMPLETED
Pneumonia, Pneumocystis Carinii; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00002002 COMPLETED
Pneumonia, Pneumocystis Carinii; HIV Infections
Lederle Laboratories
NCT00001990 COMPLETED
Pneumonia, Pneumocystis Carinii; HIV Infections
Glaxo Wellcome
NCT00367081 COMPLETED
Toxoplasmic Encephalitis; AIDS
Department of Medical Services Ministry of Public Health of Thailand
 2003-05 PHASE4
NCT00789464 WITHDRAWN
Recurrent Urinary Tract Infection
Baylor College of Medicine
 PHASE2
NCT00000732 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00000816 COMPLETED
Pneumonia, Pneumocystis Carinii; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE4
NCT00000748 COMPLETED
Pneumonia, Pneumocystis Carinii; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00428818 COMPLETED
Infection
University of Texas Southwestern Medical Center
 2005-08
NCT00001028 COMPLETED
Pneumonia, Pneumocystis Carinii; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00000730 TERMINATED
Pneumonia, Pneumocystis Carinii; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00000734 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00000991 COMPLETED
Pneumonia, Pneumocystis Carinii; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00126698 COMPLETED
Urinary Tract Infection; Bacteriuria
St. Antonius Hospital
 2005-01 PHASE4
NCT00001996 COMPLETED
Pneumonia, Pneumocystis Carinii; HIV Infections
Glaxo Wellcome
 PHASE2
NCT00004216 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
Vion Pharmaceuticals
 1999-08 PHASE1
NCT00001013 COMPLETED
Pneumonia, Pneumocystis Carinii; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00137657 COMPLETED
HIV; Malaria; Diarrhea; Pneumonia; Opportunistic Infections
Centers for Disease Control and Prevention
 2002-02 PHASE4
NCT00001014 COMPLETED
Pneumonia, Pneumocystis Carinii; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00000715 COMPLETED
Pneumonia, Pneumocystis Carinii; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00000811 COMPLETED
Bacterial Infections; Pneumonia, Pneumocystis Carinii; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00892541 COMPLETED
Schizophrenia
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2004-10 PHASE1
NCT00000727 COMPLETED
Pneumonia, Pneumocystis Carinii; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00001027 COMPLETED
Pneumonia, Pneumocystis Carinii; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-03-20)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trimethoprim selectively binds to bacterial dihydrofolate reductase, competitively inhibiting the enzymatic reduction of dihydrofolic acid to tetrahydrofolic acid and thereby halting downstream bacterial purine and nucleic acid biosynthesis. This interruption of essential metabolite production exerts a targeted bacteriostatic effect that impairs bacterial growth and replication, directly underlying its broad application in clinical trials for conditions such as urinary tract infections, bacterial abscesses, and Pneumocystis jirovecii pneumonia.

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>).

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Note: Technical data last updated: Sep 1, 2026.