Clinical Trials

Numerous clinical trials evaluate the therapeutic utility and pharmacokinetic profile of probenecid across Early Phase 1 through Phase 4 studies. These investigations target conditions such as chronic pain, opioid withdrawal, alcohol use disorder, bacterial infections, cytomegalovirus retinitis, systolic heart failure, and drug-drug interactions in healthy adults. Driven by academic, governmental, and pharmaceutical sponsors, the studies exhibit varying recruitment statuses, ranging from actively recruiting and completed to active, not recruiting, and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07118618 RECRUITING
Alcohol Use Disorder (AUD); Alcohol Consumption; Craving
Brown University
 2026-03-14 PHASE2
NCT07318870 NOT_YET_RECRUITING
Focal Epilepsy
Fondation Ophtalmologique Adolphe de Rothschild
 2026-01 PHASE2
NCT07764302 NOT_YET_RECRUITING
Osteoarticular Infections (OAIs)
Assistance Publique - Hôpitaux de Paris
 2026-12 PHASE3
NCT05903859 RECRUITING
Infertility, Male
University of Miami
 2024-01-18 PHASE3
NCT04939623 RECRUITING
Chronic Pain; Drug Dependence of Morphine Type; Symptom, Withdrawal
University of Calgary
 2023-10-31 PHASE2
NCT07796191 NOT_YET_RECRUITING
Healthy Adult Participants
Jiangsu vcare pharmaceutical technology co., LTD
 2026-09-20 PHASE1
NCT07661108 ACTIVE_NOT_RECRUITING
Healthy
Merck Sharp & Dohme LLC
 2026-06-30 PHASE1
NCT07092813 RECRUITING
Pharmacokinetics After Oral Intake
Iterum Therapeutics, International Limited
 2026-04 PHASE1
NCT04551222 COMPLETED
Heart Failure
VA Office of Research and Development
 2021-06-09 PHASE2; PHASE3
NCT07160738 COMPLETED
Healthy Adults
Pfizer
 2025-09-22 PHASE1
NCT06416800 COMPLETED
Healthy Participants
Incyte Corporation
 2024-06-19 PHASE1
NCT06647810 COMPLETED
Healthy
Boehringer Ingelheim
 2024-11-13 PHASE1
NCT06025344 COMPLETED
Relative Bioavailability
TrippBio, Inc.
 2024-09-01 PHASE1
NCT05618314 COMPLETED
Healthy Volunteer; Renal Impairment
Atea Pharmaceuticals, Inc.
 2022-10-17 PHASE1
NCT05954624 COMPLETED
Drug Drug Interaction
Guangdong Raynovent Biotech Co., Ltd
 2023-07-10 PHASE1
NCT05584657 COMPLETED
Urinary Tract Infections; Cystitis
Iterum Therapeutics, International Limited
 2022-10-18 PHASE3
NCT04939623 Recruiting
Chronic Pain|Drug Dependence of Morphine Type|Symptom Withdrawal
University of Calgary
 2023-10-31 Phase 2
NCT05365451 COMPLETED
Interaction; Endogenous Biomarkers
Washington State University
 2022-04-11 EARLY_PHASE1
NCT04218357 COMPLETED
Alcohol Use Disorder
Brown University
 2020-12-02 PHASE1
NCT05881811 COMPLETED
PHN - Post-Herpetic Neuritis
Haisco Pharmaceutical Group Co., Ltd.
 2023-03-20 PHASE1
NCT05442983 COMPLETED
COVID-19
TrippBio, Inc.
 2022-07-12 PHASE2
NCT05280054 UNKNOWN
Drug Drug Interaction
VistaGen Therapeutics, Inc.
 2021-12-23 PHASE1
NCT05497674 COMPLETED
Type 2 Diabetes Mellitus
Sunshine Lake Pharma Co., Ltd.
 2022-02-21 PHASE1
NCT05082909 COMPLETED
Infection, Bacterial
Imperial College London
 2021-12-21 PHASE1; PHASE2
NCT04700787 WITHDRAWN
Urinary Tract Infections; Pyelonephritis Acute; Intraabdominal Infections
Iterum Therapeutics, International Limited
 2021-04-30 PHASE1
NCT05497674 Completed
Type 2 Diabetes Mellitus
Sunshine Lake Pharma Co. Ltd.
 2022-02-21 Phase 1
NCT05045313 COMPLETED
Healthy Subjects
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
 2021-10-20 PHASE1
NCT05082909 Unknown status
Infection Bacterial
Imperial College London
 2021-12-21 Phase 1|Phase 2
NCT02243631 COMPLETED
Calcium Pyrophosphate Deposition Disease
VA Office of Research and Development
 2014-10-15 EARLY_PHASE1
NCT03965351 COMPLETED
Fontan
Children's Hospital Medical Center, Cincinnati
 2017-03-21 PHASE4
NCT03354598 COMPLETED
Uncomplicated Urinary Tract Infections
Iterum Therapeutics, International Limited
 2018-08-01 PHASE3
NCT03357614 COMPLETED
Complicated Urinary Tract Infections
Iterum Therapeutics, International Limited
 2018-09-18 PHASE3
NCT03358576 COMPLETED
Intra Abdominal Infections
Iterum Therapeutics, International Limited
 2018-09-18 PHASE3
NCT03937258 COMPLETED
Healthy
Pfizer
 2019-05-21 PHASE1
NCT03801746 COMPLETED
Drug Interaction Potentiation
Akebia Therapeutics
 2018-07-20 PHASE1
NCT03466567 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
 2018-03-15 PHASE1
NCT03202511 COMPLETED
Pre-Exposure Prophylaxis
Indiana University
 2017-06-23 EARLY_PHASE1
NCT03307252 COMPLETED
Healthy
Boehringer Ingelheim
 2017-10-25 PHASE1
NCT03296800 COMPLETED
Type 2 Diabetes Mellitus
Theracos
 2017-09-27 PHASE1
NCT03105986 COMPLETED
Healthy
Janssen-Cilag International NV
 2017-04-05 PHASE1
NCT03138759 COMPLETED
Pharmacokinetics in Healthy Volunteers
Daiichi Sankyo
 2017-02-27 PHASE1
NCT01816646 COMPLETED
Blood And Marrow Transplantation
M.D. Anderson Cancer Center
 2013-09 PHASE1
NCT01814319 COMPLETED
Systolic Heart Failure
University of Cincinnati
 2013-03 PHASE2
NCT01320722 COMPLETED
Renal Function; Endothelial Function; Blood Pressure; Overweight; Obesity
Brigham and Women's Hospital
 2011-03 PHASE3
NCT01029782 COMPLETED
Cellulitis
Kelowna General Hospital
 2010-05 PHASE2
NCT01322009 COMPLETED
Pediatric Traumatic Brain Injury
University of Pittsburgh
 2011-03 PHASE1; PHASE2
NCT01937026 COMPLETED
Healthy Volunteers
Eli Lilly and Company
 2013-09 PHASE1
NCT00323219 COMPLETED
Cellulitis
University of British Columbia
 2004-01 PHASE3
NCT01634100 COMPLETED
Healthy
Boehringer Ingelheim
 2012-06 PHASE1
NCT01428284 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2011-08 PHASE1
NCT00610532 TERMINATED
Epilepsy
Jim McAuley
 2006-03 PHASE4
NCT00288158 COMPLETED
Obesity; Pre-Hypertension; Hyperuricemia
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2008-09 PHASE2
NCT01907373 COMPLETED
Drug Interaction of Olmesartan in Healthy Chinese Volunteers
Central South University
 2009-08 PHASE4
NCT00842400 COMPLETED
Obesity
VIVUS LLC
 2009-02 PHASE1
NCT01021020 COMPLETED
Healthy
Mutual Pharmaceutical Company, Inc.
 2007-09 PHASE1
NCT00439530 COMPLETED
Avian Influenza A Virus
Mahidol University
 2006-11 PHASE1
NCT00690014 COMPLETED
Kidney Disease
University of Maryland, Baltimore
 2006-08
NCT00304434 COMPLETED
Influenza
US Department of Veterans Affairs
 2005-02 PHASE4
NCT00000894 COMPLETED
Cytomegalovirus Retinitis; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE4
NCT00000799 COMPLETED
Cytomegalovirus Retinitis; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00002142 COMPLETED
Cytomegalovirus Retinitis; HIV Infections
Gilead Sciences
NCT00000881 WITHDRAWN
Cytomegalovirus Infections; Cytomegalovirus Retinitis; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00000706 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00002437 COMPLETED
Cytomegalovirus Retinitis; HIV Infections
Gilead Sciences
 PHASE2
NCT00000670 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00024245 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
Memorial Sloan Kettering Cancer Center
 2001-05 PHASE1
NCT00000945 COMPLETED
HIV Infections; Leukoencephalopathy, Progressive Multifocal
National Institute of Allergy and Infectious Diseases (NIAID)

(data from https://clinicaltrials.gov, updated on 2026-03-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Probenecid acts as a competitive inhibitor of organic anion transporters and Pannexin1 channels, blocking transporter-mediated uptake and extracellular ATP signaling pathways. This inhibition reduces the renal clearance of co-administered therapeutics and modulates neuroinflammatory cellular responses, providing clinical relevance in optimizing drug pharmacokinetics and managing conditions such as opioid withdrawal and alcohol use disorder.

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.