MedPath

Gliclazide

Generic Name
Gliclazide
Brand Names
Diamicron
Drug Type
Small Molecule
Chemical Formula
C15H21N3O3S
CAS Number
21187-98-4
Unique Ingredient Identifier
G4PX8C4HKV

Overview

Gliclazide is an oral antihyperglycemic agent used for the treatment of non-insulin-dependent diabetes mellitus (NIDDM). It has been classified differently according to its drug properties in which based on its chemical structure, gliclazide is considered a first-generation sulfonylurea due to the structural presence of a sulfonamide group able to release a proton and the presence of one aromatic group. On the other hand, based on the pharmacological efficacy, gliclazide is considered a second-generation sulfonylurea which presents a higher potency and a shorter half-life. Gliclazide belongs to the sulfonylurea class of insulin secretagogues, which act by stimulating β cells of the pancreas to release insulin. Sulfonylureas increase both basal insulin secretion and meal-stimulated insulin release. Medications in this class differ in their dose, rate of absorption, duration of action, route of elimination and binding site on their target pancreatic β cell receptor. Sulfonylureas also increase peripheral glucose utilization, decrease hepatic gluconeogenesis and may increase the number and sensitivity of insulin receptors. Sulfonylureas are associated with weight gain, though less so than insulin. Due to their mechanism of action, sulfonylureas may cause hypoglycemia and require consistent food intake to decrease this risk. The risk of hypoglycemia is increased in elderly, debilitated and malnourished individuals. Gliclazide has been shown to decrease fasting plasma glucose, postprandial blood glucose and glycosolated hemoglobin (HbA1c) levels (reflective of the last 8-10 weeks of glucose control). Gliclazide is extensively metabolized by the liver; its metabolites are excreted in both urine (60-70%) and feces (10-20%).

Indication

For the treatment of NIDDM in conjunction with diet and exercise.

Associated Conditions

  • Type 2 Diabetes Mellitus

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/01/24
Not Applicable
Not yet recruiting
Yan Bi
2024/01/23
Not Applicable
Recruiting
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
2023/10/17
Not Applicable
Completed
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
2019/12/13
Phase 1
Completed
2018/10/15
Not Applicable
Completed
2018/03/16
Phase 1
Completed
2018/02/14
Phase 4
UNKNOWN
M.H.H. Kramer
2017/10/18
Phase 3
UNKNOWN
Sherief Abd-Elsalam
2017/03/01
Phase 4
Completed
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
2016/12/02
Phase 1
Withdrawn
Disphar International B.V.

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
DIAPRO TABLET 80 mg
SIN13085P
TABLET
80 mg
4/12/2005
DIANORM TABLET 80 mg
SIN10123P
TABLET
80 mg
10/2/1998
DIAMICRON MR TABLET 60mg
SIN13868P
TABLET, FILM COATED, EXTENDED RELEASE
60mg
9/22/2010
DIAMICRON TABLET 80 mg
SIN04316P
TABLET
80 mg
4/20/1990
DIAMICRON MR TABLET 30 mg
SIN11761P
TABLET
30 mg
1/10/2002
GLIAVIS MR TABLET 30MG
SIN15478P
TABLET, EXTENDED RELEASE
30 mg
5/8/2018
GLIMICRON TABLET 80 mg
SIN09302P
TABLET
80.00 mg
4/16/1997
MELICRON TABLET 80 mg
SIN11662P
TABLET, FILM COATED
80 mg
9/6/2001
APO-GLICLAZIDE TABLET 80MG
SIN13468P
TABLET
80 mg
5/15/2008
SUN-GLIZIDE TABLET 80 mg
SIN09350P
TABLET
80 mg
5/20/1997

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
DIAMICRON MR TAB 60MG
N/A
servier hong kong limited
N/A
N/A
8/25/2011

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
GLICLAZIDE -TAB 80MG
proval pharma division of servier canada inc
02155850
Tablet - Oral
80 MG
8/13/1997
GLICLAZIDE
sanis health inc
02287072
Tablet - Oral
80 MG
2/25/2010
DIAMICRON MR
servier canada inc
02356422
Tablet (Extended-Release) - Oral
60 MG
12/9/2010
APO-GLICLAZIDE
02245247
Tablet - Oral
80 MG
7/2/2002
SANDOZ GLICLAZIDE
02254719
Tablet - Oral
80 MG
8/9/2004
APO-GLICLAZIDE MR
02407124
Tablet (Extended-Release) - Oral
60 MG
4/14/2015
GLICLAZIDE MR
sanis health inc
02524856
Tablet (Extended-Release) - Oral
30 MG
7/8/2022
GLIC
prempharm inc
02248210
Tablet - Oral
80 MG
10/2/2003
MINT-GLICLAZIDE MR
mint pharmaceuticals inc
02423286
Tablet (Extended-Release) - Oral
30 MG
6/2/2014
GLICLAZIDE-80
PRO DOC LIMITEE
02248453
Tablet - Oral
80 MG
12/10/2003

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
GLICLAZIDA CINFA 30 MG COMPRIMIDOS DE LIBERACION MODIFICADA EFG
Laboratorios Cinfa S.A.
78439
COMPRIMIDO DE LIBERACIÓN MODIFICADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
GULRIKE 60 MG COMPRIMIDOS DE LIBERACION MODIFICADA EFG
Krka D.D. Novo Mesto
77494
COMPRIMIDO DE LIBERACIÓN MODIFICADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Not Commercialized
GLICLAZIDA AUROVITAS 60 MG COMPRIMIDOS DE LIBERACION MODIFICADA EFG
Aurovitas Spain, S.A.U.
88794
COMPRIMIDO DE LIBERACIÓN MODIFICADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
DIAMICRON 30 mg COMPRIMIDOS DE LIBERACION MODIFICADA
63644
COMPRIMIDO DE LIBERACIÓN MODIFICADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
GLICLAZIDA COMBIX 30 MG COMPRIMIDOS DE LIBERACION MODIFICADA EFG
Laboratorios Combix S.L.U.
82907
COMPRIMIDO DE LIBERACIÓN MODIFICADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Not Commercialized
SODOR 30 MG COMPRIMIDOS DE LIBERACION MODIFICADA EFG
Uxa Farma S.A.
84501
COMPRIMIDO DE LIBERACIÓN MODIFICADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Not Commercialized
GLICLAZIDA KRKA 60 MG COMPRIMIDOS DE LIBERACION MODIFICADA EFG
Krka D.D. Novo Mesto
77493
COMPRIMIDO DE LIBERACIÓN MODIFICADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
DIAMICRON 60 mg COMPRIMIDOS DE LIBERACION MODIFICADA
71738
COMPRIMIDO DE LIBERACIÓN MODIFICADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
GLICLAZIDA RATIOPHARM 60 MG COMPRIMIDOS DE LIBERACION MODIFICADA EFG
Teva Pharma S.L.U.
81122
COMPRIMIDO DE LIBERACIÓN MODIFICADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Not Commercialized
GLICLAZIDA SANDOZ 30 MG COMPRIMIDOS DE LIBERACION MODIFICADA EFG
Sandoz Farmaceutica S.A.
79929
COMPRIMIDO DE LIBERACIÓN MODIFICADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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