Drugs / Glyburide
last change Sep 2026 re-read 9 days ago

Glyburide

Small molecule targets ABCC8

Developed for
type 2 diabetes mellitus · gestational diabetes · traumatic brain injury · type 1 diabetes mellitus · diabetes mellitus · ischemic stroke · permanent neonatal diabetes mellitus · spinal cord injury
+12 more · acquired aneurysmal subarachnoid hemorrhage · brain edema · coronary artery disorder · intracerebral hemorrhage · maturity-onset diabetes of the young type 1 · maturity-onset diabetes of the young type 3 · multiple sclerosis · neonatal diabetes mellitus · neuropathy, painful · stroke disorder · subarachnoid hemorrhage · carotid artery disorder
Investigated by
Assistance Publique - Hôpitaux de Paris · GlaxoSmithKline · URC-CIC Paris Descartes Necker Cochin · Haukeland University Hospital · Novo Nordisk A/S · Remedy Pharmaceuticals, Inc.
+63 more · Actavis Inc. · Beijing Tiantan Hospital · Beijing Tongren Hospital · Bristol-Myers Squibb · French National Institute of Health and Medical Research · Necker-Enfants Malades Hospital · Royal Devon and Exeter NHS Foundation Trust · Teva Pharmaceuticals USA · University of Bergen · University of Exeter · University of Rome Tor Vergata · Assaf-Harofeh Medical Center · Assiut University · Associazione Medici Diabetologi (AMD) · Associazione Nazionale Medici Cardiologi Ospedalieri · AstraZeneca · Biogen · Boehringer Ingelheim · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Changhua Christian Hospital · Dr. Milan Gupta · Fogarty International Center of the National Institute of Health · Fonds de la Recherche en Santé du Québec · Francis Farhadi · Hoffmann-La Roche · Hospital de Clinicas de Porto Alegre · INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium · Ironwood Pharmaceuticals, Inc. · Italian Society of Diabetology · Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · King's College Hospital NHS Trust · Kyunghee University Medical Center · Massachusetts General Hospital · Middle-Eastern College of Obstetricians and Gynecologists · Ministry of Health & Welfare, Korea · National Institute of Medical Sciences and Nutrition Salvador Zubiran · Nishtar Medical University · Northwestern University · Ohio State University · Oxford University Hospitals NHS Trust · Papworth Hospital NHS Foundation Trust · Regional Obstetrical Consultants · Sanofi · São Paulo Research Foundation · Taichung Veterans General Hospital · Taipei Veterans General Hospital, Taiwan · Tripler Army Medical Center · U.S. Army Medical Research and Development Command · University Hospital, Basel, Switzerland · University of Abuja · University of Alabama at Birmingham · University of British Columbia · University of Campinas, Brazil · University of Maryland · University of Maryland, Baltimore · University of Michigan · University of Oxford · University of Pittsburgh · University of Sao Paulo General Hospital · University of Sherbrooke · Vanderbilt University · Washington University School of Medicine · Xijing Hospital

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Amglidia — 2018-05-24 europa.eu ↗
Approved US (FDA) DIABETA — 1984-05-01 fda.gov ↗

Trials 58

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 113 trials · 2 met primary
Phase 1 NCT07221799 Sep 2026 → Sep 2028 expected multiple sclerosis, neuropathy, painful University of Maryland, Baltimore Not yet recruiting No outcome recorded
Phase 1 NCT05426681 Jul 2022 → May 2027 expected spinal cord injury Francis Farhadi Recruiting No outcome recorded
Phase 1 NCT04859452 May → Jul 2021 — CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Completed No outcome recorded
Phase 1 NCT03856970 Mar → Jun 2019 — Ironwood Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT02128022 Jul 2014 → Mar 2016 coronary artery disorder Papworth Hospital NHS Foundation Trust Completed No outcome recorded
Phase 1 NCT01132703 Jan → May 2010 stroke disorder, traumatic brain injury Biogen Completed No outcome recorded
Phase 1 NCT01733108 Jul → Sep 2008 — Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Completed No outcome recorded
Phase 1 NCT02183428 May → Jul 2008 — Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT00388986 Oct 2006 → Jul 2007 type 2 diabetes mellitus Hoffmann-La Roche Completed No outcome recorded
Phase 1 NCT00865436 Apr 2004 — Actavis Inc. Completed No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT05148403 Oct 2021 → Oct 2022 traumatic brain injury Beijing Tiantan Hospital Unknown No outcome recorded
Phase 1/2 NCT02460874 Aug 2017 → May 2021 brain edema, metastatic malignant neoplasm in the brain University of Alabama at Birmingham Terminated No outcome recorded Stop: Enrollment
Phase 1/2 NCT02524379 Feb 2017 → Feb 2021 spinal cord injury Ohio State University Terminated No outcome recorded
Phase 1/2 NCT01268683 May 2011 → Jun 2012 ischemic stroke Remedy Pharmaceuticals, Inc. Completed No outcome recorded
Phase 26 trials · 1 missed
Phase 2 NCT05687500 May 2023 → Oct 2025 — Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
Phase 2 NCT02830048 Jul 2016 → Mar 2017 type 2 diabetes mellitus University of Oxford Completed No outcome recorded
Phase 2 NCT01794182 Jun 2013 → Apr 2016 ischemic stroke Remedy Pharmaceuticals, Inc. Completed Missed primary
Phase 2 NCT01454154 Dec 2011 → Feb 2015 traumatic brain injury Remedy Pharmaceuticals, Inc. Completed No outcome recorded
Phase 2 NCT00610038 Jul 2006 → Aug 2010 diabetes mellitus Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
Phase 2 NCT00451620 Nov 2003 → Sep 2011 type 2 diabetes mellitus University of British Columbia Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT00515801 Jun 2007 → ? type 1 diabetes mellitus University Hospital, Basel, Switzerland Completed No outcome recorded
Phase 39 trials · 1 met primary · 2 missed
Phase 3 NCT02375828 Mar 2015 → Mar 2016 neonatal diabetes mellitus Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
Phase 3 NCT01731431 May 2012 → Mar 2017 gestational diabetes Assistance Publique - Hôpitaux de Paris Completed Missed primary
Phase 3 NCT01215331 Aug 2010 → Apr 2014 gestational diabetes University of Sherbrooke Completed No outcome recorded
Phase 3 NCT00267683 Dec 2005 → Apr 2006 type 2 diabetes mellitus Novo Nordisk A/S Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT00255541 Sep 2004 → Dec 2006 type 2 diabetes mellitus AstraZeneca Terminated No outcome recorded
Phase 3 NCT00035542 Dec 2001 → Oct 2003 type 2 diabetes mellitus Bristol-Myers Squibb Completed No outcome recorded
Phase 3 NCT00046462 Nov 2001 → Nov 2004 type 2 diabetes mellitus Sanofi Completed Missed primary
Phase 3 NCT00379769 Apr 2001 → Dec 2008 type 2 diabetes mellitus GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT00279045 Jan 2000 → Jun 2006 type 2 diabetes mellitus GlaxoSmithKline Completed Met primary
Phase 416 trials · 1 met primary · 2 missed
Phase 4 NCT07802561 Apr → Oct 2026 expected gestational diabetes Nishtar Medical University Recruiting No outcome recorded
Phase 4 NCT05137678 Oct 2021 → Oct 2022 subarachnoid hemorrhage Beijing Tiantan Hospital Unknown Missed primary
Phase 4 NCT02624830 Feb 2019 → Feb 2020 permanent neonatal diabetes mellitus Haukeland University Hospital Unknown No outcome recorded
Phase 4 NCT03569540 Jul 2018 → Jul 2019 acquired aneurysmal subarachnoid hemorrhage University of Sao Paulo General Hospital Unknown No outcome recorded
Phase 4 NCT04239586 Apr 2017 → Apr 2022 maturity-onset diabetes of the young type 1, maturity-onset diabetes of the young type 3, type 1 diabetes mellitus Haukeland University Hospital Unknown No outcome recorded
Phase 4 NCT03089333 Jul 2016 → Oct 2017 hypertensive disorder, obesity disorder, proteinuria, type 2 diabetes mellitus University of Campinas, Brazil Completed No outcome recorded
Phase 4 NCT02624817 Dec 2015 → Aug 2016 permanent neonatal diabetes mellitus Haukeland University Hospital Completed No outcome recorded
Phase 4 NCT01867502 Apr 2014 → Aug 2015 hyperglycemia, hypoglycemia, type 2 diabetes mellitus Hospital de Clinicas de Porto Alegre Unknown No outcome recorded
Phase 4 NCT01947699 Sep 2013 → Sep 2014 gestational diabetes University of Pittsburgh Withdrawn No outcome recorded Stop: Enrollment
Phase 4 NCT01456650 Mar 2011 → Nov 2012 type 2 diabetes mellitus National Institute of Medical Sciences and Nutrition Salvador Zubiran Completed Met primary
Phase not applicable9 trials · 1 missed
— NCT06907472 Sep 2025 → Jun 2026 overdue type 2 diabetes mellitus University of Abuja Active not recruiting No outcome recorded
— NCT06589141 Jan → Dec 2025 overdue gestational diabetes Assiut University Not yet recruiting No outcome recorded
— NCT03741530 Dec 2018 → Sep 2020 intracerebral hemorrhage Xijing Hospital Completed Missed primary
— NCT02255006 May → Oct 2014 — Kyunghee University Medical Center Unknown No outcome recorded
— NCT00696982 Jun 2008 → Jun 2009 arteriosclerosis disorder, diabetes mellitus Assaf-Harofeh Medical Center Unknown No outcome recorded
— NCT00486187 Apr 2006 → Jun 2009 type 2 diabetes mellitus Dr. Milan Gupta Completed No outcome recorded
— NCT00371306 Sep 2002 → Sep 2008 gestational diabetes, type 2 diabetes mellitus Regional Obstetrical Consultants Unknown No outcome recorded
— NCT00608179 Aug 2002 → Sep 2004 type 2 diabetes mellitus Vanderbilt University Completed No outcome recorded
— NCT00549874 Feb 2002 → Nov 2006 type 2 diabetes mellitus University of Michigan Completed No outcome recorded
Comparator or background therapy46 trials
Phase 0 NCT02726490 Comparator Jul 2016 → Aug 2018 gestational diabetes Texas Tech University Health Sciences Center, El Paso Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT02815787 Comparator Mar → Jul 2014 type 2 diabetes mellitus Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 1 NCT01716338 Comparator Jan 2013 → May 2014 — Washington University School of Medicine Completed No outcome recorded
Phase 1 NCT01319734 Comparator Feb 2011 → Dec 2015 type 2 diabetes mellitus Al-Neelain University Unknown No outcome recorded
Phase 1 NCT00935363 Comparator Feb → Mar 2010 — University of California, San Francisco Withdrawn No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2005-01-28 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Approval Of Glyburide/Metformin Hcl Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the company's ANDA for Glyburide and Metformin HCl Tablets, 1.25 mg/250 mg, 2.5 mg/500 mg and 5 mg/500 mg.

Evidence & citations 34 cited values

Every value below carries the sentence it was read from. 109 sources stand behind the page.

FieldValueCited text
Known as glyburide “Subjects taking metformin before randomization were randomly assigned to the addition of glyburide (2.5 mg BID titrated to 5 mg BID if baseline A1C ≥7.5% and ≤8.0%, or 5 mg BID...” NCT00486187 ↗
58

“Glyburide is an oral antidiabetic agent of the sulfonylurea class, and impacts glycemic control by stimulating the pancreas to release insulin, an effect that is dependent upon...” NCT00494312 ↗

“Glibenclamide (US adopted name, glyburide), a long-acting sulfonylurea, shows promising result in treating AIS from both preclinical and clinical studies.” PMID 32527232 ↗ Jun 2020

“Group 1 will receive GlucoNorm 1 mg during the 1st Standard Meal Test and Glyburide 2.5 mg during the 2nd Standard Meal Test.” NCT00451620 ↗

NCT00160485 ↗

NCT01107717 ↗

NCT00347100 ↗

NCT00046462 ↗

NCT01029795 ↗

NCT02091336 ↗

NCT00451620 ↗

Show 48 more sources

Known as Amglidia “CONCLUSION: The glibenclamide oral suspension Amglidia, the first anti-diabetic drug specifically developed for pediatric patients, is acceptable, effective, and safe in...” PMID 30684309 ↗ Feb 2019
1

“Amglidia®: glibenclamide oral suspension 6 mg/ml administered by gastric tube after dilution to 1/6th in human milk” NCT05687500 ↗

Known as BIIB093 “intravenous (IV) glibenclamide (BIIB093; glyburide) treatment was the only independent predictor of 3-month mRS in multivariate regression analysis” PMID 31787498 ↗ Nov 2019
Known as CALABREN ChEMBL registry synonym — accepted as the source's own label CHEMBL472 ↗
Known as CIRARA ChEMBL registry synonym — accepted as the source's own label CHEMBL472 ↗
Known as DAONIL ChEMBL registry synonym — accepted as the source's own label CHEMBL472 ↗
Known as DiaBeta “Glyburide (Dia-Beta) 10 mg oral dose during protocol, given once during each protocol.” NCT00608179 ↗
1

“oral Glyburide (DiaBeta) in Patients With Acute Traumatic Spinal Cord Injury” NCT02524379 ↗

Known as DIABETAMIDE 2.5 ChEMBL registry synonym — accepted as the source's own label CHEMBL472 ↗
Known as DIABETAMIDE 5 ChEMBL registry synonym — accepted as the source's own label CHEMBL472 ↗
Known as Euglucon “8 healthy volunteers are administered 5 mg of glibenclamide (Euglucon, Roche Pharma) 3 hour before FMD measurement.” NCT02255006 ↗
Known as GLIBENCLAMIDA ChEMBL registry synonym — accepted as the source's own label CHEMBL472 ↗
Known as glibenclamide “Step 1: Metformin 500 mg daily Step 2: Metformin 1000 mg daily Step 3: Metformin 1000 mg twice daily Step 4: Metformin 1000 mg twice daily + glibenclamide 5 mg daily Step 5:...” NCT06907472 ↗
46

“The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4...” NCT00379769 ↗

“Patients in the glibenclamide + rosiglitazone treatment group who have FPG \< 270mg/dL after the glibenclamide 5mg om run-in will receive glibenclamide 5mg om + rosiglitazone 4mg om.” NCT01045590 ↗

“Sulfonylurea tablets (glibenclamide, other forms of sulfonylureas) were administered at the time of intervention (before November 1, 2006).” NCT02624830 ↗

“Sulfonylurea (glibenclamide, glimepiride, or gliclazide) administered orally daily over the Ramadan period as per physician's prescription” NCT01131182 ↗

“OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).” NCT01584232 ↗

“each added to SU monotherapy (glibenclamide, glicazide or glimeprimide) in a 24-week, double-blind, parallel-group trial.” PMID 20380655 ↗ Apr 2010

“a sulfonylurea (5-15 mg glibenclamide, 2-6 mg glimepiride, or 30-120 mg gliclazide, in accordance with local practice)” PMID 28917544 ↗ Sep 2017

“8 healthy volunteers are administered 5 mg of glibenclamide (Euglucon, Roche Pharma) 3 hour before FMD measurement.” NCT02255006 ↗

“Glibenclamide was introduced in increasing doses to investigate whether sulfonylurea could replace insulin.” PMID 15448106 ↗ Oct 2004

“in which 2097 patients with type 2 diabetes received either pioglitazone or glibenclamide (glyburide).” PMID 19670918 ↗ 2009

Show 36 more sources

Known as GLIBENCLAMIDUM ChEMBL registry synonym — accepted as the source's own label CHEMBL472 ↗
Known as GLIKEN ChEMBL registry synonym — accepted as the source's own label CHEMBL472 ↗
Known as Glinbentek “The aim of this study is then to determine the tolerance and acceptability of an oral solution of glibenclamide (Glinbentek) developed and dedicated to pediatric patients with...” NCT02375828 ↗
Known as glybenclamide ClinicalTrials.gov intervention name — accepted as the source's own label NCT01563120 ↗
Known as GLYBURIDE (GLIBENCLAMIDE) ChEMBL registry synonym — accepted as the source's own label CHEMBL472 ↗
Known as GLYBURIDE (MICRONIZED) ChEMBL registry synonym — accepted as the source's own label CHEMBL472 ↗
Known as GLYBURIDE COMPONENT OF GLUCOVANCE ChEMBL registry synonym — accepted as the source's own label CHEMBL472 ↗
Known as GLYBURIDE10238-21-8 ChEMBL registry synonym — accepted as the source's own label CHEMBL472 ↗
Known as GLYNASE ChEMBL registry synonym — accepted as the source's own label CHEMBL472 ↗
Known as HB 419 ChEMBL registry synonym — accepted as the source's own label CHEMBL472 ↗
Known as LEDERGLIB ChEMBL registry synonym — accepted as the source's own label CHEMBL472 ↗
Known as LIBANIL ChEMBL registry synonym — accepted as the source's own label CHEMBL472 ↗
Known as MALIX ChEMBL registry synonym — accepted as the source's own label CHEMBL472 ↗