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Gemigliptin

Generic Name
Gemigliptin
Drug Type
Small Molecule
Chemical Formula
C18H19F8N5O2
CAS Number
911637-19-9
Unique Ingredient Identifier
5DHU18M5D6

Overview

Gemigliptin is under investigation in Type 2 Diabetes Mellitus. Gemigliptin has been investigated for the treatment of Cancer and Cisplatin Adverse Reaction.

Indication

No indication information available.

Associated Conditions

  • Type 2 Diabetes Mellitus

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
Effect of Gemigliptin Versus Glimepiride on Cardiac Diastolic Function in Patients With Type 2 Diabetes
2022/12/23
NCT05663736
Phase 4
Recruiting
Seoul National University Bundang Hospital
Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabetes
2022/01/18
NCT05194592
Phase 4
Recruiting
Wonju Severance Christian Hospital
Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg
2021/11/03
NCT05105698
Phase 1
UNKNOWN
LG Chem
Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification
2021/01/12
NCT04705506
Not Applicable
Completed
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Bioequivalence Study for Fixed Dose Combination Zemimet® SR Tab. 50/1000 and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg.
2020/03/23
NCT04317703
Phase 1
Completed
LG Chem
A Study to Evaluate the Efficacy and Safety of Dual add-on Therapy With Gemigliptin 50 mg and Dapagliflozin 10 mg Added to Metformin Who Have Inadequate Glycemic Control on Metformin Alone
2020/02/05
NCT04255238
Phase 3
UNKNOWN
LG Chem
Bioequivalence Study for Gemigliptin/Metformin 50/1000 mg and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg.
2019/08/08
NCT04050098
Phase 1
UNKNOWN
LG Chem
An Ascending Dose, Single/Multiple Dosing, Food Effect Clinical Trial to Evaluate Pharmacokinetics, Safety and Tolerability in Healthy Subjects After Oral Administration of Gemigliptin (Phase I)
2019/03/06
NCT03864432
Phase 1
Completed
LG Chem
A Study to Evaluate the Efficacy and Safety of Gemigliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Dapagliflozin and Metformin (SOLUTION Study)
2019/02/15
NCT03842267
Phase 3
Completed
LG Chem
Gemigliptin, Dapagliflozin, Empagliflozin DDI Study
2018/06/21
NCT03565458
Phase 1
UNKNOWN
LG Chem

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
No HSA approvals found for this drug.

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

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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