Clinical Trials

Glyburide (glibenclamide) has been evaluated in numerous clinical trials spanning Early Phase 1 through Phase 4, primarily investigating type 2 diabetes mellitus, gestational diabetes, and acute neurological conditions such as acute spinal cord injury, ischemic stroke, and malignant edema. Sponsored by academic medical centers, governmental institutes, and pharmaceutical companies, these studies encompass various recruitment statuses—including actively recruiting, completed, terminated, and withdrawn—to evaluate both metabolic responses and novel neuroprotective indications.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07221799 NOT_YET_RECRUITING
Multiple Sclerosis; Neuropathic Pain
University of Maryland, Baltimore
 2026-09-01 PHASE1
NCT05426681 RECRUITING
Acute Spinal Cord Injury
Francis Farhadi
 2022-07-07 PHASE1
NCT07802561 RECRUITING
Gestational Diabetes Mellitus (GDM)
Nishtar Medical University
 2026-04-18 PHASE4
NCT06589141 UNKNOWN
Gestational Diabetes Mellitus in Pregnancy
Assiut University
 2025-01-01
NCT05687500 ACTIVE_NOT_RECRUITING
Transient; Hypoglycemia, Neonatal; Preterm; Glibenclamide Adverse Reaction
Assistance Publique - Hôpitaux de Paris
 2023-05-20 PHASE2
NCT05688332 UNKNOWN
Diabetes Mellitus Type 2 Without Complication
University of Zambia
 2023-08 PHASE3
NCT03029702 COMPLETED
Gestational Diabetes; Diabetes, Gestational; Pregnancy in Diabetes
Maisa N. Feghali, MD
 2018-02-28 PHASE4
NCT03886922 UNKNOWN
Hemodynamics of Cranial Arteries; Headache; Cerebral Blood Flow
Danish Headache Center
 2019-04-01
NCT02864953 TERMINATED
Brain Edema; Stroke, Acute
Remedy Pharmaceuticals, Inc.
 2018-08-29 PHASE3
NCT01107717 COMPLETED
Diabetes
The University of Texas Health Science Center at San Antonio
 2009-01 PHASE4
NCT05137678 UNKNOWN
Subarachnoid Hemorrhage
Beijing Tiantan Hospital
 2021-10-19 PHASE4
NCT05148403 UNKNOWN
Traumatic Brain Injury
Beijing Tiantan Hospital
 2021-10-22 PHASE1; PHASE2
NCT03284463 COMPLETED
Acute Stroke
Nanfang Hospital, Southern Medical University
 2018-01-01 PHASE2; PHASE3
NCT05426681 Recruiting
Acute Spinal Cord Injury
University of Kentucky
 2022-07-07 Phase 1
NCT04859452 COMPLETED
Healthy Subjects
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
 2021-05-26 PHASE1
NCT02460874 TERMINATED
Cerebral Edema; Brain Metastases
University of Alabama at Birmingham
 2017-08-16 PHASE1; PHASE2
NCT04960657 COMPLETED
Migraine; Headache; Pain
Danish Headache Center
 2020-10-20
NCT02524379 TERMINATED
Acute Spinal Cord Injury
Ohio State University
 2017-02-14 PHASE1; PHASE2
NCT03741530 COMPLETED
Intracerebral Hemorrhage
Xijing Hospital
 2018-12-15
NCT04231617 COMPLETED
Hemodynamics of Cranial Arteries; Headache; Cerebral Blood Flow
Danish Headache Center
 2020-01-20
NCT03569540 UNKNOWN
Subarachnoid Hemorrhage, Aneurysmal
University of Sao Paulo General Hospital
 2018-07-03 PHASE4
NCT03856970 COMPLETED
Healthy Volunteers
Ironwood Pharmaceuticals, Inc.
 2019-03-11 PHASE1
NCT03832595 Completed
Chronic Kidney Diseases
University of Pittsburgh|Vanderbilt University Medical Center|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2019-05-01 Not Applicable
NCT02919345 COMPLETED
Diabetes Mellitus, Type 2; Coronary Artery Disease; Carotid Artery Diseases
University of Campinas, Brazil
 2017-01 PHASE4
NCT02726490 TERMINATED
Gestational Diabetes
Texas Tech University Health Sciences Center, El Paso
 2016-07 EARLY_PHASE1
NCT03855306 COMPLETED
Healthy
Genuine Research Center, Egypt
 2018-06-30 PHASE1
NCT03078725 WITHDRAWN
Gestational Diabetes Mellitus, Class A2
The University of Texas Health Science Center, Houston
 2017-06-20 PHASE4
NCT03089333 COMPLETED
Hypertension; Diabetes Mellitus, Type 2; Blood Pressure; Obesity; Cardiac Hypertrophy; Microalbuminuria; Vascular Stiffness
University of Campinas, Brazil
 2016-07 PHASE4
NCT01731431 COMPLETED
Diabetes; Gestational
Assistance Publique - Hôpitaux de Paris
 2012-05-18 PHASE3
NCT02830048 COMPLETED
Diabetes Mellitus, Type 2
University of Oxford
 2016-07 PHASE2
NCT02201602 COMPLETED
Diabetes
Khoo Teck Puat Hospital
 2014-08 PHASE4
NCT02145611 COMPLETED
Type 2 Diabetes Mellitus; Hypertension; Endothelial Dysfunction
Dr. José Fernando Vilela-Martin MD PhD
 2013-07 PHASE4
NCT01794182 COMPLETED
Ischemic Stroke; Malignant Edema
Remedy Pharmaceuticals, Inc.
 2013-06-13 PHASE2
NCT02375828 COMPLETED
Neonatal Diabetes Secondary to Mutation in the Potassium Channel
Assistance Publique - Hôpitaux de Paris
 2015-03-20 PHASE3
NCT02128022 COMPLETED
Angina Pectoris
Papworth Hospital NHS Foundation Trust
 2014-07 PHASE1
NCT02318693 COMPLETED
Type 2 Diabetes Mellitus
Merck Sharp & Dohme LLC
 2015-02-04 PHASE4
NCT01319734 UNKNOWN
Type 2 Diabetes Mellitus
Al-Neelain University
 2011-02 PHASE1
NCT02080377 COMPLETED
Pregnancy; Gestational Diabetes
University of Edinburgh
 2014-07 PHASE3
NCT01867502 UNKNOWN
Diabetes Mellitus, Type 2; Hypoglycemic Agents; Diabetic Blood Glucose Monitoring; Exercise
Hospital de Clinicas de Porto Alegre
 2014-04 PHASE4
NCT01329016 COMPLETED
Gestational Diabetes Mellitus
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 2011-07 PHASE1; PHASE2
NCT01454154 COMPLETED
Traumatic Brain Injury
Remedy Pharmaceuticals, Inc.
 2011-12-17 PHASE2
NCT02091336 UNKNOWN
Gestational Diabetes
Hospital de Clinicas de Porto Alegre
 2014-01 PHASE4
NCT01822548 COMPLETED
Type 2 Diabetes
Azienda Ospedaliero-Universitaria di Parma
 2010-10 PHASE3
NCT01947699 WITHDRAWN
Gestational Diabetes
University of Pittsburgh
 2013-09 PHASE4
NCT02815787 COMPLETED
Type 2 Diabetes
Jiangsu HengRui Medicine Co., Ltd.
 2014-03 PHASE1
NCT01716338 COMPLETED
Healthy Volunteers
Washington University School of Medicine
 2013-01 PHASE1
NCT01215331 COMPLETED
Gestational Diabetes Mellitus
Université de Sherbrooke
 2010-08 PHASE3
NCT00744965 COMPLETED
Mild Gestational Diabetes
University of Texas Southwestern Medical Center
 2008-09-16 PHASE4
NCT01456650 COMPLETED
Type 2 Diabetes
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
 2011-03 PHASE4
NCT01268683 COMPLETED
Ischemic Stroke
Remedy Pharmaceuticals, Inc.
 2011-05-26 PHASE1; PHASE2
NCT00232583 COMPLETED
Type 2 Diabetes Mellitus
University of Texas Southwestern Medical Center
 2003-11
NCT00451620 COMPLETED
Type 2 Diabetes
University of British Columbia
 2003-11 PHASE2
NCT00770835 COMPLETED
Diabetes Mellitus
Takeda
 2009-03 PHASE4
NCT00610038 COMPLETED
Diabetes Mellitus
Assistance Publique - Hôpitaux de Paris
 2006-07 PHASE2
NCT01029795 TERMINATED
Diabetes Mellitus, Type 2
Eli Lilly and Company
 2010-02 PHASE2
NCT01132703 COMPLETED
Traumatic Brain Injury; Stroke
Biogen
 2010-01-07 PHASE1
NCT00935363 WITHDRAWN
Healthy
University of California, San Francisco
 2010-02 PHASE1
NCT01145534 COMPLETED
Diabetes
Federal University of Paraíba
 2009-01 PHASE1; PHASE2
NCT00160485 WITHDRAWN
Gestational Diabetes
Tripler Army Medical Center
 2004-06 PHASE4
NCT00696982 UNKNOWN
Diabetes Mellitus; Arterial Stiffness
Assaf-Harofeh Medical Center
 2008-06
NCT00417729 COMPLETED
Diabetes Mellitus
Taichung Veterans General Hospital
 2007-01 PHASE4
NCT01733108 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2008-07 PHASE1
NCT00194896 COMPLETED
Type 2 Diabetes Mellitus
University of Washington
 2000-02
NCT02183428 COMPLETED
Healthy
Boehringer Ingelheim
 2008-05 PHASE1
NCT00965991 COMPLETED
Gestational Diabetes
University of New Mexico
 2003-07
NCT00347100 COMPLETED
Diabetes Mellitus, Type 2
Sanofi
 2006-06 PHASE4
NCT00393718 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
 2006-11 PHASE3
NCT00313313 COMPLETED
Diabetes
AstraZeneca
 2006-04 PHASE3
NCT00388986 COMPLETED
Diabetes Mellitus Type 2
Hoffmann-La Roche
 2006-10 PHASE1
NCT00286468 COMPLETED
Diabetes Mellitus
Takeda
 2006-04 PHASE3
NCT00279045 COMPLETED
Diabetes Mellitus, Type 2
GlaxoSmithKline
 2000-01-03 PHASE3
NCT00267683 TERMINATED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
 2005-12 PHASE3
NCT01045590 COMPLETED
Diabetes Mellitus, Type 2
GlaxoSmithKline
 2003-12 PHASE4
NCT00123643 COMPLETED
Type 2 Diabetes Mellitus
St. Paul Heart Clinic
 2003-05 PHASE4
NCT00162175 COMPLETED
Metabolics Diabetes Nos
Bristol-Myers Squibb
 2003-07 PHASE3
NCT00494312 COMPLETED
Diabetes Mellitus; Liver
Takeda
 2000-10 PHASE4
NCT00238472 COMPLETED
Diabetes Mellitus, Type 2
Novartis Pharmaceuticals
 2003-05 PHASE4
NCT00759720 TERMINATED
Diabetes Mellitus
Takeda
 2003-11 PHASE3
NCT00046462 COMPLETED
Diabetes Mellitus
Sanofi
 2001-11 PHASE3
NCT00608179 COMPLETED
Type 2 Diabetes
Vanderbilt University
 2002-08
NCT00865436 COMPLETED
Healthy
Actavis Inc.
 2004-04 PHASE1
NCT00521820 TERMINATED
Diabetes Mellitus
Takeda
 2000-06 PHASE3
NCT00035542 COMPLETED
Diabetes Mellitus, Non-Insulin-Dependent
Bristol-Myers Squibb
 2001-12 PHASE3
NCT00035568 COMPLETED
Diabetes Mellitus, Non-Insulin-Dependent
Bristol-Myers Squibb
 2002-02 PHASE4
NCT00836472 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2003-04 PHASE1
NCT01605773 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
 2001-11-08 PHASE4
NCT01698931 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
 2002-04-26 PHASE4
NCT00835991 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2003-02 PHASE1
NCT00333723 COMPLETED
Diabetes Mellitus, Type 2
GlaxoSmithKline
 2000-07-28 PHASE4
NCT00521742 COMPLETED
Diabetes Mellitus
Takeda
 2001-03 PHASE3
NCT00865241 COMPLETED
Healthy
Actavis Inc.
 2002-11 PHASE1
NCT00864734 COMPLETED
Healthy
Actavis Inc.
 2002-11 PHASE1
NCT00371306 UNKNOWN
Gestational Diabetes; Type 2 Diabetes; Pregnancy
Regional Obstetrical Consultants
 2002-09
NCT00549874 COMPLETED
Type 2 Diabetes
University of Michigan
 2002-02
NCT00251940 TERMINATED
Type 2 Diabetes
AstraZeneca
 2004-07 PHASE3
NCT00300105 TERMINATED
Type 2 Diabetes
AstraZeneca
 2005-10 PHASE3
NCT00255541 TERMINATED
Type 2 Diabetes
AstraZeneca
 2004-09 PHASE3
NCT00472875 UNKNOWN
Type 1 Diabetes Mellitus
King's College Hospital NHS Trust
 2007-05 PHASE4
NCT00515801 COMPLETED
Diabetes Mellitus, Type 1
University Hospital, Basel, Switzerland
 2007-06 PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2025-10-28)

Check the Glyburide (Glibenclamide) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Glyburide selectively binds to and inhibits ATP-sensitive potassium (KATP) channels in pancreatic beta cells, preventing potassium efflux and inducing cell membrane depolarization. This depolarization opens voltage-dependent calcium channels to elevate intracellular calcium levels, triggering insulin secretion to improve glycemic control in type 2 and gestational diabetes while reducing central nervous system edema in acute spinal cord injury and stroke.

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.