Lobeglitazone

Overview

Lobeglitazone is an antidiabetic medication from the thiazolidinedione class of drugs. It primarily functions as an insulin sensitizer by binding and activating Peroxisome Proliferator-Activated Receptors (PPAR) gamma within fat cells. By activating PPAR-gamma and promoting the binding of insulin at fat cells, lobeglitazone thereby has been shown to reduce blood sugar levels, lower hemoglobain A1C (HbA1C) levels, and improve lipid and liver profiles . Unlike Pioglitazone, which is a dual PPAR agonist at PPAR-alpha and PPAR-gamma, Lobeglitazone is a pure PPAR-alpha agonist. Lobeglitazone was approved by the Ministry of Food and Drug Safety (South Korea) in 2013, and is being monitored by postmarketing surveillance until 2019. Lobeglitazone is not approved for use by either the Food and Drug Administration (USA), Health Canada, or by the European Medicines Agency for use in the management of diabetes.

Indication

Lobeglitazone was approved by the Ministry of Food and Drug Safety (South Korea) in 2013, and is being monitored by postmarketing surveillance until 2019. Lobeglitazone is not approved for use by either the Food and Drug Administration (USA), Health Canada, or by the European Medicines Agency for use in the management of diabetes.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Comparison of Dapagliflozin, Lobeglitazone, and Its Combination in Efficacy and Safety	2023/06/23	NCT05915949	Phase 4	Recruiting	Seoul National University Bundang Hospital
A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of CKD-501, D759 and D150 (CKD-393)	2020/06/16	NCT04431687	Phase 1	Completed	Chong Kun Dang Pharmaceutical
A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of CKD-501, D745 and D150	2020/04/06	NCT04334213	Phase 1	Completed	Chong Kun Dang Pharmaceutical
Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie	2018/12/10	NCT03770052	Phase 4	Completed	Pusan National University Hospital
Evaluate the Drug-drugs Interaction Between Lobeglitazone and Empagliflozin	2016/08/03	NCT02854748	Phase 1	UNKNOWN	Chong Kun Dang Pharmaceutical
Triple Combination Therapy in Type 2 Diabetic Patients Who Had Inadequate Glycemic Control With Combination Therapy	2015/01/14	NCT02338921	Phase 4	Completed	Seoul National University Bundang Hospital
Comparison of Lobeglitazone With Pioglitazone as Initial Triple Therapy for Diabetes Management	2014/12/11	NCT02315287	Phase 4	UNKNOWN	Seoul National University Bundang Hospital
A 24 Week, Multicenter, Prospective, Open-labeled, Single-arm, Exploratory Phase 4 Clinical Trial to Evaluate the Safety and Efficacy of Lobeglitazone in Decreasing Intrahepatic Fat Contents in Type 2 Diabetes With NAFLD	2014/11/06	NCT02285205	Phase 4	Completed	Yonsei University
Comparative Evaluation of Pharmacokinetics After CKD-501 Between Renal Impaired and Normal Renal Function Subjects	2013/12/11	NCT02007941	Phase 1	Completed	Chong Kun Dang Pharmaceutical
A Pharmacokinetic Study of CKD-501 in Patients With Impaired Hepatic Function	2013/12/09	NCT02005744	Phase 1	Completed	Chong Kun Dang Pharmaceutical

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.

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