Back to discover
Drug

Glyburide

Approved · FDA / EMA
ClassSulfonylurea receptor 1, Kir6.2 blockerEmerging researchLate-stage developmentRising momentum
Also known as 1-((p-(2-(5-chloro-o-anisamido)ethyl)phenyl)sulfonyl)-3-cyclohexylurea, 1-(p-(2-(5-chloro-2-methoxybenzamido)ethyl)benzenesulfonyl)-3-cyclohexylurea, 5-chloro-N-(2-(4-((((cyclohexylamino)carbonyl)amino)sulfonyl)phenyl)ethyl)-2-methoxybenzamide, DiaBeta+9 more

1-((p-(2-(5-chloro-o-anisamido)ethyl)phenyl)sulfonyl)-3-cyclohexylurea, 1-(p-(2-(5-chloro-2-methoxybenzamido)ethyl)benzenesulfonyl)-3-cyclohexylurea, 5-chloro-N-(2-(4-((((cyclohexylamino)carbonyl)amino)sulfonyl)phenyl)ethyl)-2-methoxybenzamide, DiaBeta, Glibenclamida, Glibenclamide, Glibenclamidum, Glucovance, GlyBURIDE, Micronized, Glyburide-Metformin, Glycron, Glynase, Micronase.

3
Research papers
4
Active clinical trials
2
Protein targets
4
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Oral Glibenclamide in Preterm Infants With Hyperglycaemia (GALOP)

Clinical trial2025-10-30Primary completion · ClinicalTrials.gov

Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus

Clinical trial2024-11-29Results posted · ClinicalTrials.gov

Pharmacological Inhibitors of the NLRP3 Inflammasome.

Research2019-10-25Frontiers in immunology

Approval: Amglidia (EMA)

Regulatory2018-05-24EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Glyburide
Aliases & brands
1-((p-(2-(5-chloro-o-anisamido)ethyl)phenyl)sulfonyl)-3-cyclohexylurea1-(p-(2-(5-chloro-2-methoxybenzamido)ethyl)benzenesulfonyl)-3-cyclohexylurea5-chloro-N-(2-(4-((((cyclohexylamino)carbonyl)amino)sulfonyl)phenyl)ethyl)-2-methoxybenzamideDiaBetaGlibenclamidaGlibenclamideGlibenclamidumGlucovanceGlyBURIDE, MicronizedGlyburide-MetforminGlycronGlynaseMicronase
RxNorm CUI
4815
ChEMBL ID
CHEMBL472
ATC codes
A10BB01
UNII
SX6K58TVWC
Primary mechanism
Sulfonylurea receptor 1, Kir6.2 blocker
Regulatory jurisdictions
emafda

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

BLOCKERSulfonylurea receptor 1, Kir6.2 blocker
BLOCKERSulfonylurea receptor 1, Kir6.2 blocker

Regulatory timeline

4 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2016-02-29
Latest approval
2018-05-24
Authorities
FDA · EMA
Total events
4
fdaU.S. Food and Drug Administration· 3 events
2026-06-30Label change
Label change: GLYBURIDE AND METFORMIN HYDROCHLORIDE (ANDA206748)
Evidence ↗
2026-06-30Label change
Label change: GLYBURIDE AND METFORMIN HYDROCHLORIDE (ANDA206748)
Evidence ↗
2016-02-29Approval
Approval: GLYBURIDE AND METFORMIN HYDROCHLORIDE (ANDA206748)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2018-05-24Approval
Approval: Amglidia (EMA)
Indication: Amglidia is indicated for the treatment of neonatal diabetes mellitus, for use in newborns, infants and children. Sulphonylureas like Amglidia have been shown to be effective inShow full indication

Amglidia is indicated for the treatment of neonatal diabetes mellitus, for use in newborns, infants and children. Sulphonylureas like Amglidia have been shown to be effective in patients with mutations in the genes coding for the ?-cell ATP-sensitive potassium channel and chromosome 6q24-related transient neonatal diabetes mellitus.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

71 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
71
registered trials across all phases
LATEST COMPLETION 2023
4
Active studies
3
Recruiting
47
Late-stage (III+)
48
Completed
19
Discontinued
PHASE DISTRIBUTIONn = 71
Early Phase 11Phase 112Phase 1 / 25Phase 26Phase 2 / 32Phase 315Phase 420Phase N / A10

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20092019
Major research themes2
Diabetes, Gestational1Glyburide1
Journals, researchers & institutions
Top journals
  • Diabetes, obesity & metabolism1
  • Frontiers in immunology1
  • Obstetrics and gynecology1
Leading researchers
  • Abbassi-Ghanavati M1
  • Casey BM1
  • Duryea EL1
  • Fleck PR1
  • Jin T1
  • Kipnes MS1
  • Kombe AJK1
  • Leveno KJ1
Leading institutions
free-text, unnormalised
  • CAS Center for Excellence in Molecular Cell Science1
  • Hefei National Laboratory for Physical Sciences at Microscale1
  • The First Affiliated Hospital of USTC1
  • University of Texas Southwestern Medical Center1
  • University of Vermont College of Medicine1

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Frequently co-studied with Glyburide in the research literature.

1 shared paper

Frequently co-studied with Glyburide in the research literature.

1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.