Gliclazide

Summary

Gliclazide (CHEMBL427216) is an approved small-molecule hypoglycemic agent (ATC A10BB09); indicated across 3 conditions including diabetes mellitus and type 2 diabetes mellitus.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: A10BB09
• Indications: 3 conditions
• Clinical trials: 29
• Chemistry: 323.4 Da · C15H21N3O3S

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL427216
Name	Gliclazide
Type	Small molecule
Max phase	4
FDA approved	no
PubChem CID	3475
ChEBI	CHEBI:31654
ATC	A10BB09
Molecular formula	C15H21N3O3S
Molecular weight	323.4
InChIKey	BOVGTQGAOIONJV-UHFFFAOYSA-N

SMILES: CC1=CC=C(C=C1)S(=O)(=O)NC(=O)NN2CC3CCCC3C2

IUPAC name: 1-(3,3a,4,5,6,6a-hexahydro-1H-cyclopenta[c]pyrrol-2-yl)-3-(4-methylphenyl)sulfonylurea

Pharmacological roles (ChEBI): hypoglycemic agent, radical scavenger, insulin secretagogue.

Also known as: Bilxona, Dacadis mr, Diaglyk, Diamicron, Diamicron mr, Edicil, Gliclazida, Gliclazide, Glimicron, Glimil, J3.151H, Nazdol mr

Patent coverage: 6,203 distinct patent families (22,353 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 5 (assay-derived). Sample: Fructose-bisphosphate aldolase, Inositol monophosphatase 1, 4’-phosphopantetheinyl transferase ffp, Aldehyde dehydrogenase 1A1, Aldo-keto reductase family 1 member C3.

Bioactivity

ChEMBL activities: 2 potent at pChembl ≥ 5 of 5 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
P97697	5.3	Potency	5012	nM	CHEMBL_ACT_4415614
A8B2U2	5.05	Potency	8912	nM	CHEMBL_ACT_4597725

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

3 indications (1 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
diabetes mellitus	4	MONDO:0005015	EFO:0000400
type 2 diabetes mellitus	3	MONDO:0005148	MONDO:0005148
epilepsy	1	MONDO:0005027	EFO:0000474

Clinical trials

Total trials: 29.

Phase distribution

Phase	Trials
PHASE4	14
Not specified	6
PHASE3	5
PHASE1	3
PHASE2	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00347100	PHASE4	COMPLETED	Insulin Glargine in Type 2 Diabetic Patients
NCT00367055	PHASE4	COMPLETED	Rosiglitazone-Metformin Combination Versus Metformin-Sulfonylurea Combination On Beta-Cell Function In Type 2 Diabetes
NCT00568984	PHASE4	COMPLETED	Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes
NCT00738088	PHASE4	TERMINATED	Variation in Sulphonylurea Response in Type 2 Diabetes
NCT01022762	PHASE4	COMPLETED	Comparison of Repaglinide and Gliclazide in Chinese Subjects With Type 2 Diabetes Never Received Oral Antidiabetic Drug Treatment
NCT01269996	PHASE4	COMPLETED	JanUmet Before Insulin Lantus In Eastern Population Evaluation Program (JUBILEE) In Type 2 Diabetic Patients
NCT01709305	PHASE4	COMPLETED	A Study of the Safety and Efficacy of Glimepiride, Gliclazide, Repaglinide or Acarbose When Added to Sitagliptin + Metformin Combination Therapy in Chinese Participants With Diabetes (MK-0431-313)
NCT01758380	PHASE4	COMPLETED	Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan
NCT02092597	PHASE4	COMPLETED	Safety Evaluation of Adverse Reactions in Diabetes
NCT02201602	PHASE4	COMPLETED	Sulphonylurea Receptor Mutation and Responsiveness to Gliclazide - a Pilot Proof of Concept, Randomised Cross-over Study
NCT02610088	PHASE4	COMPLETED	Effect of Dapagliflozin on Vascular Functions in Patients With Type 2 Diabetes Compared to Gliclazide
NCT02694263	PHASE4	COMPLETED	Canagliflozin (Invokana™) vs. Standard Dual Therapy Regimen for T2DM During Ramadan
NCT03068065	PHASE4	COMPLETED	Antidiabetic Effects on Intrahepatic Fat
NCT06613750	PHASE4	COMPLETED	Comparative Study of Sitagliptin and Gliclazide With Metformin in Type 2 Diabetes Patients With Glucotoxicity
NCT00102388	PHASE3	COMPLETED	Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes
NCT00102466	PHASE3	COMPLETED	Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes
NCT00169624	PHASE3	TERMINATED	Peripheral and Coronary Endothelial Dysfunction In Type 2diabetic Patients- Role of Metformin
NCT01590771	PHASE3	COMPLETED	A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)
NCT03313661	PHASE3	UNKNOWN	Co-administration of Cabergoline and Gliclazide Improve Glycemic Parameters and Lipid Profile in T2DM Patients
NCT01991197	PHASE2	COMPLETED	Dipeptidyl Peptidase-4 Inhibition in Psoriasis Patients With Diabetes (DIP): A Randomized Clinical Trial.
NCT02777671	PHASE1	COMPLETED	Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Gliclazide in Healthy Volunteers
NCT03467945	PHASE1	COMPLETED	Bioequivalence and Drug - Drug Interaction Study of Metformin/Gliclazide in Healthy Participants
NCT04198948	PHASE1	COMPLETED	Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers
NCT02879409	Not specified	ACTIVE_NOT_RECRUITING	HbA1c Variability in Type II Diabetes
NCT06222476	Not specified	NOT_YET_RECRUITING	Effect of Dorzagliatin on Renal Function Outcomes in People With Type 2 Diabetes: a Multicentric, Prospective, Randomized Study.
NCT00147836	Not specified	COMPLETED	Evaluation of the Effects of Different Interventions on Glycemic Control in Newly-Diagnosed Type 2 Diabetic Patients
NCT03705195	Not specified	COMPLETED	Study of Sulphonylurea Synergy With Incretins
NCT06085703	Not specified	COMPLETED	Effects of Henagliflozin on the Brain Function in T2DM Patients With Mild Cognitive Impairment: a Randomized, Parallel Controlled Clinical Trial
NCT06217887	Not specified	UNKNOWN	Efficacy Comparison of Polyethylene Glycol Loxenatide and Gliclazide on the Brain Function in T2DM Patients

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

PharmGKB dosing guidelines (2) — CPIC / DPWG genotype-guided dosing for this drug (drug × pharmacogene):

Guideline	Source	Gene(s)	Dosing	Recommendation
Annotation of DPWG Guideline for gliclazide and CYP2C9	DPWG	CYP2C9
Annotation of CPIC Guideline for chlorpropamide, dabrafenib, gliclazid	CPIC	G6PD

PharmGKB also curates 1 clinical and 24 variant annotation(s) for this drug (gene-keyed; see PharmGKB).

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).