Alogliptin

Overview

Alogliptin is a selective, orally-bioavailable inhibitor of enzymatic activity of dipeptidyl peptidase-4 (DPP-4). Chemically, alogliptin is prepared as a benzoate salt and exists predominantly as the R-enantiomer (>99%). It undergoes little or no chiral conversion in vivo to the (S)-enantiomer. FDA approved January 25, 2013.

Indication

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Associated Conditions

Type 2 Diabetes Mellitus

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise	2023/03/23	NCT05782192	Phase 3	Completed	Shenzhen Salubris Pharmaceuticals Co., Ltd.
A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 12.5 mg and MET XR 500 mg) in Healthy Volunteers	2022/05/06	NCT05363592	Phase 1	Completed	Celltrion
A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 25 mg and MET XR 1,000 mg) in Healthy Volunteers	2022/05/05	NCT05363384	Phase 1	Completed	Celltrion
A Study for Post-Marketing Surveillance of Nesina® Tablet Monotherapy or Combination Therapy in Participants With Type 2 Diabetes (T2DM) in South Korea	2021/07/28	NCT04980040	N/A	Completed	Takeda
Glimepiride, Alogliptin and Alogliptin+Pioglitazone Combination	2020/07/14	NCT04470310	Phase 4	UNKNOWN	Seoul National University Hospital
Efficacy and Safety of Alogliptin vs. Acarbose in Chinese Type 2 Diabetes Mellitus (T2DM) Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive	2019/01/07	NCT03794336	Phase 4	Completed	Sanofi
Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Renal or Hepatic Impairment or Advanced Age"	2018/06/13	NCT03555565	N/A	Completed	Takeda
A Study to Determine the Bioequivalence of Alogliptin and Pioglitazone When Administered as Individual Tablets and as Fixed-Dose Combination (FDC)-SYR-322-4833 BL Tablets to Healthy Russian Participants	2018/04/18	NCT03501277	Phase 1	Completed	Takeda
A Study to Evaluate the Effect of add-on Pioglitazone or Dapagliflozin in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by DPP-4 Inhibitor and Metformin Therapy	2018/04/17	NCT03499704	Phase 4	Active, not recruiting	Celltrion Pharm, Inc.
Treatment Preference for Weekly Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Versus Daily DPP-4 Inhibitors in Participants With Type 2 Diabetes Mellitus	2017/07/27	NCT03231709	Phase 4	Completed	Takeda

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Alogliptin and Pioglitazone	Padagis Israel Pharmaceuticals Ltd	45802-499	ORAL	25 mg in 1 1	3/31/2022
alogliptin and metformin hydrochloride	Padagis Israel Pharmaceuticals Ltd	45802-211	ORAL	12.5 mg in 1 1	7/12/2023
OSENI	Takeda Pharmaceuticals America, Inc.	64764-123	ORAL	12.5 mg in 1 1	12/4/2023
Nesina	Takeda Pharmaceuticals America, Inc.	64764-250	ORAL	25 mg in 1 1	7/1/2023
Nesina	Takeda Pharmaceuticals America, Inc.	64764-625	ORAL	6.25 mg in 1 1	7/1/2023
Alogliptin	A-S Medication Solutions	50090-5574	ORAL	25 mg in 1 1	3/31/2022
alogliptin and metformin hydrochloride	A-S Medication Solutions	50090-5993	ORAL	12.5 mg in 1 1	3/31/2022
alogliptin and metformin hydrochloride	Padagis Israel Pharmaceuticals Ltd	45802-169	ORAL	12.5 mg in 1 1	7/12/2023
KAZANO	Takeda Pharmaceuticals America, Inc.	64764-337	ORAL	12.5 mg in 1 1	7/31/2023
Alogliptin	Padagis Israel Pharmaceuticals Ltd	45802-150	ORAL	25 mg in 1 1	7/27/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Vipdomet	Takeda Pharma A/S,Delta Park 45,2665 Vallensbaek Strand,Denmark	Authorised	9/18/2013
Incresync	Takeda Pharma A/S,Delta Park 45,2665 Vallensbaek Strand,Denmark	Authorised	9/19/2013
Vipidia	Takeda Pharma A/S,Delta Park 45,2665 Vallensbaek Strand,Denmark	Authorised	9/18/2013

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
Alogliptin Benzoate Tablets	山东鲁宁药业有限公司	国药准字H20244511	化学药品	片剂	7/30/2024
Alogliptin Benzoate Tablets	上海理想制药有限公司	国药准字H20244565	化学药品	片剂	7/30/2024
Alogliptin Benzoate Tablets	亚宝药业集团股份有限公司	国药准字H20193329	化学药品	片剂	11/18/2019
Alogliptin Benzoate Tablets	宜昌东阳光长江药业股份有限公司	国药准字H20203655	化学药品	片剂	12/8/2020
Alogliptin Benzoate Tablets	湖南千金湘江药业股份有限公司	国药准字H20203636	化学药品	片剂	12/2/2020
Alogliptin Benzoate Tablets	石药集团欧意药业有限公司	国药准字H20213303	化学药品	片剂	4/27/2021
Alogliptin Benzoate Tablets	湖南千金湘江药业股份有限公司	国药准字H20203634	化学药品	片剂	12/2/2020
Alogliptin Benzoate Tablets	国药集团国瑞药业有限公司	国药准字H20203522	化学药品	片剂	10/15/2020
Alogliptin Benzoate Tablets	石药集团欧意药业有限公司	国药准字H20213451	化学药品	片剂	6/1/2021
Alogliptin Benzoate Tablets	瑞阳制药股份有限公司	国药准字H20213502	化学药品	片剂	6/16/2021

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
NESINA alogliptin (as benzoate) 12.5 mg film-coated tablet blister pack	199543	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	9/17/2013
NESINA alogliptin (as benzoate) 6.25 mg film-coated tablet blister pack	199541	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	9/17/2013
NESINA MET 12.5/850; 12.5 mg alogliptin (as benzoate) / 850 mg metformin hydrochloride film-coated tablets blister pack	202306	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	10/22/2013
NESINA MET 12.5/500; 12.5 mg alogliptin (as benzoate) / 500 mg metformin hydrochloride film-coated tablets blister pack	202308	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	10/22/2013
NESINA alogliptin (as benzoate) 25 mg film-coated tablet blister pack	199539	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	9/17/2013
NESINA MET 12.5/1000; 12.5 mg alogliptin (as benzoate) / 1000 mg metformin hydrochloride film-coated tablets blister pack	202309	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	10/22/2013

AI-Powered Research

Premium Access