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Drug

Gliclazide

Approved medicine
ClassSulfonylurea receptor 1, Kir6.2 blockerResearchOngoing clinical research

Also known as 1-(3-azabicyclo(3.3.0)oct-3-yl)-3-(p-tolylsulfonyl)urea, 1-(hexahydrocyclopenta(c)pyrrol-2(1H)-yl)-3-(p-tolylsulfonyl)urea, Gliclazida, Gliclazidum.

RxNorm4816ChEMBLCHEMBL427216ATCA10BB09UNIIG4PX8C4HKV
1
Active clinical trials
2
Protein targets
Latest activity
beta

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

Sustainable stability-indicating spectra manipulations for the concurrent quantification of gliclazide and its impurity A as the possible alkaline degradation product: Multi-Color Analytical Profile Assessment

Industry2026-08-22Nature — Environmental Sciences

A Prospective, Randomized, Open Label, Parallel, 6-month Study to Explore and Evaluate the Therapeutic Effects of Henagliflozin on the Cognitive Function, Olfactory Function, and Odor-induced Brain Activation in T2DM Patients With Mild Cognitive Impairment.

Clinical trial2025-06-30Completed · ClinicalTrials.gov

A Multicentric, Prospective, Randomized Study Evaluating the Improvement of Renal Function Outcomes With Dorzagliatin in Patients With Type 2 Diabetes Mellitus With Early Kidney Injury.

Clinical trial2025-05-31Primary completion · ClinicalTrials.gov

Efficacy Comparison of Polyethylene Glycol Loxenatide and Gliclazide on the Brain Function in T2DM Patients: a Randomized, Parallel Controlled Clinical Trial

Clinical trial2024-02-01Primary completion · ClinicalTrials.gov

Does Glycated Hemoglobin Variability in Type 2 Diabetes Differ Depending on the Diabetes Treatment Threshold Used in the Qatari Population: Implication on Diabetes Complication Risk?

Clinical trial2023-10-01Primary completion · ClinicalTrials.gov

Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers

Clinical trial2021-08-18Results posted · ClinicalTrials.gov

Co-administration of Cabergoline and Gliclazide Improve Glycemic Parameters and Lipid Profile in T2DM Patients

Clinical trial2020-10-01Primary completion · ClinicalTrials.gov

Dipeptidyl Peptidase-4 Inhibition in Psoriasis Patients With Diabetes (DIP): A Randomized Clinical Trial.

Clinical trial2020-05-14Results posted · ClinicalTrials.gov

Randomized, Open Label, Single Dose, 4 Treatment, 4 Period, Crossover Design (4 x 4) Trial to Evaluate the Bioequivalence and Secondarily Drug - Drug Interaction of Fixed Combination of Metformin Tablets 1000 mg/Gliclazide 30 mg MR, Compared With the Co-administration of Individual Tablets and Individual Administration of Each Single Tablet (Metformin 1000 mg XR and Gliclazide 30 mg MR) in Healthy Volunteers

Clinical trial2019-07-16Results posted · ClinicalTrials.gov

Study of Sulphonylurea Synergy With Incretins

Clinical trial2019-06-26Completed · ClinicalTrials.gov

A Randomised Controlled Trial for People With Established Type 2 Diabetes During Ramadan: Canagliflozin (Invokana™) vs. Standard Dual Therapy Regimen: The 'Can Do Ramadan' Study

Clinical trial2018-09-13Completed · ClinicalTrials.gov

Effect of Dapagliflozin, a Sodium Glucose Co-transporter 2 Inhibitor, on Vascular Functions in Patients With Type 2 Diabetes Compared to Gliclazide

Clinical trial2018-09-01Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

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

Canonical name
Gliclazide
Aliases & brands
1-(3-azabicyclo(3.3.0)oct-3-yl)-3-(p-tolylsulfonyl)urea1-(hexahydrocyclopenta(c)pyrrol-2(1H)-yl)-3-(p-tolylsulfonyl)ureaGliclazidaGliclazidum
RxNorm CUI
4816
ChEMBL ID
CHEMBL427216
ATC codes
A10BB09
UNII
G4PX8C4HKV
Primary mechanism
Sulfonylurea receptor 1, Kir6.2 blocker

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

ATP-sensitive inward rectifier potassium channel 11
KCNJ11 · Q14654
BLOCKERSulfonylurea receptor 1, Kir6.2 blocker
ATP-binding cassette sub-family C member 8
ABCC8 · Q09428
BLOCKERSulfonylurea receptor 1, Kir6.2 blocker

Clinical trials

25 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
25
registered trials across all phases
LATEST COMPLETION 2025
1
Active studies
21
Late-stage (III+)
18
Completed
6
Discontinued
PHASE DISTRIBUTIONn = 25
Phase 13Phase 21Phase 35Phase 410Phase N / A6

Late-stage studies

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

A Randomised Controlled Trial for People With Established Type 2 Diabetes During Ramadan: Canagliflozin (Invokana™) vs. Standard Dual Therapy Regimen: The 'Can Do Ramadan' Study

CompletedPH IVUniversity of Leicestern=252018

Effect of Dapagliflozin, a Sodium Glucose Co-transporter 2 Inhibitor, on Vascular Functions in Patients With Type 2 Diabetes Compared to Gliclazide

CompletedPH IVSeoul National University Bundang Hospitaln=322018

Safety Evaluation of Adverse Reactions in Diabetes

CompletedPH IVCharles University, Czech Republicn=422016

Sulphonylurea Receptor Mutation and Responsiveness to Gliclazide - a Pilot Proof of Concept, Randomised Cross-over Study

CompletedPH IVKhoo Teck Puat Hospitaln=82016

Comparison of Efficacy of Liraglutide, Metformin and Gliclazide MR on Hepatic Lipid Content in Patients With Type 2 Diabetes (T2DM) and Non-alcoholic Fatty Liver (NAFLD)

CompletedPH IVThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical Schooln=872015

Recent completions

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

A Prospective, Randomized, Open Label, Parallel, 6-month Study to Explore and Evaluate the Therapeutic Effects of Henagliflozin on the Cognitive Function, Olfactory Function, and Odor-induced Brain Activation in T2DM Patients With Mild Cognitive Impairment.

CompletedN/AThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical Schooln=242025

Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers

CompletedPH IUniversity of Sarajevon=152019

Study of Sulphonylurea Synergy With Incretins

CompletedN/AUniversity of Dundeen=202019

A Randomised Controlled Trial for People With Established Type 2 Diabetes During Ramadan: Canagliflozin (Invokana™) vs. Standard Dual Therapy Regimen: The 'Can Do Ramadan' Study

CompletedPH IVUniversity of Leicestern=252018

Effect of Dapagliflozin, a Sodium Glucose Co-transporter 2 Inhibitor, on Vascular Functions in Patients With Type 2 Diabetes Compared to Gliclazide

CompletedPH IVSeoul National University Bundang Hospitaln=322018

Randomized, Open Label, Single Dose, 4 Treatment, 4 Period, Crossover Design (4 x 4) Trial to Evaluate the Bioequivalence and Secondarily Drug - Drug Interaction of Fixed Combination of Metformin Tablets 1000 mg/Gliclazide 30 mg MR, Compared With the Co-administration of Individual Tablets and Individual Administration of Each Single Tablet (Metformin 1000 mg XR and Gliclazide 30 mg MR) in Healthy Volunteers

CompletedPH IMerck KGaA, Darmstadt, Germanyn=402018
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials