Retagliptin

Overview

Retagliptin is under investigation in clinical trial NCT02822534 (The Pharmacokinetics and Pharmacodynamics Study of Single and Multiple Dose of SP2086 in Type 2 Diabetes Patients).

Indication

用于改善成人2型糖尿病患者的血糖控制。 ①单药：本品单药可配合饮食控制和运动，改善成人2型糖尿病患者的血糖控制。 ②与盐酸二甲双胍联合使用：在单独使用盐酸二甲双胍血糖控制不佳时，本品可与盐酸二甲双胍联合使用，配合饮食和运动改善成人2型糖尿病患者的血糖控制。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Trial of SP2086 With Hepatic Insufficiency	2023/09/13	NCT06035406	Phase 1	Not yet recruiting	Jiangsu HengRui Medicine Co., Ltd.
Clinical Study of Retagliptin Phosphate Combined With Metformin in the Treatment of Type 2 Diabetes	2021/09/23	NCT05054842	Phase 3	Active, not recruiting	Jiangsu HengRui Medicine Co., Ltd.
The Pharmacokinetics Study of Single and Multiple Dose of SP2086 in Healthy Volunteers	2016/07/07	NCT02826044	Phase 1	UNKNOWN	Jiangsu HengRui Medicine Co., Ltd.
The Pharmacokinetics and Pharmacodynamics Study of Single and Multiple Dose of SP2086 in Type 2 Diabetes Patients	2016/07/04	NCT02822534	Phase 1	UNKNOWN	Jiangsu HengRui Medicine Co., Ltd.
the Food Effect Pharmacokinetic, Material Balance and Metabolite Identification of SP2086 in Healthy Volunteers	2016/07/04	NCT02821871	Phase 1	UNKNOWN	Jiangsu HengRui Medicine Co., Ltd.
The DDI Study of SP2086 and Simvastatin	2016/06/29	NCT02817243	Phase 1	UNKNOWN	Jiangsu HengRui Medicine Co., Ltd.
The DDI Study of SP2086 and Valsartan	2016/06/29	NCT02817217	Phase 1	UNKNOWN	Jiangsu HengRui Medicine Co., Ltd.
The Metabolite Identification and Material Balance Study of SP2086	2016/06/28	NCT02815748	Phase 1	Completed	Jiangsu HengRui Medicine Co., Ltd.
SP2086 Pharmacokinetic Study in Renal Insufficiency Patients	2016/06/28	NCT02815774	Phase 1	Completed	Jiangsu HengRui Medicine Co., Ltd.
The Drug-drug Interaction of SP2086 and Valsartan	2016/06/28	NCT02815657	Phase 1	Completed	Jiangsu HengRui Medicine Co., Ltd.

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
Retagliptin Phosphate Tablets	江苏恒瑞医药股份有限公司	国药准字H20230017	化学药品	片剂	6/27/2023
Retagliptin Phosphate Tablets	江苏恒瑞医药股份有限公司	国药准字H20230018	化学药品	片剂	6/27/2023

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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