Saxagliptin

Overview

Saxagliptin (rINN) is an orally active hypoglycemic (anti-diabetic drug) of the new dipeptidyl peptidase-4 (DPP-4) inhibitor class of drugs. FDA approved on July 31, 2009.

Indication

Treatment of type 2 diabetes mellitus to improve glycemic control in combination with other agents or as monotherapy.

Associated Conditions

Type 2 Diabetes Mellitus

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Effect of Short-term Basal Insulin Initiation in Newly Diagnosed Type 2 Diabetes on 1-year Glycemic Control	2023/10/30	NCT06107153	Phase 3	Completed	University of Basrah
Harmonizing RCT-Duplicate Emulations In A Real World Replication Program (HARRP)	2023/10/25	NCT06099067	N/A	Completed	AstraZeneca
Cognitive Protective Effect of Newer Antidiabetic Drugs	2022/04/26	NCT05347459	N/A	UNKNOWN	Alexandria University
Comparison of Type 2 Diabetes Pharmacotherapy Regimens	2021/10/11	NCT05073692	N/A	Recruiting	Kaiser Permanente
Tubular Markers in Response to Saxagliptin Therapy	2020/08/20	NCT04521049	Phase 4	Completed	Beni-Suef University
Evaluation of Drug Interactions of Saxagliptin With Sildenafil in Healthy Volunteers	2019/11/20	NCT04170790	Not Applicable	UNKNOWN	Ain Shams University
Replication of the SAVOR-TIMI Diabetes Trial in Healthcare Claims	2019/05/03	NCT03936023	N/A	Completed	Brigham and Women's Hospital
Neuropeptide Y and Sympathovagal Balance	2019/05/01	NCT03933787	Early Phase 1	Completed	Eric Grouzmann
Effects of Dapagliflozin+Saxagliptin in Addition to Metformin v/s Saxagliptin or Dapagliflozin in Patients With DM2.	2018/10/22	NCT03714594	Phase 2	Completed	University of Pisa
Effect of Saxagliptin and Dapagliflozin on Endothelial Progenitor Cell in Patients With Type 2 Diabetes Mellitus	2018/09/06	NCT03660683	Phase 4	Terminated	Sabyasachi Sen

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Saxagliptin and Metformin Hydrochloride	Dr.Reddys Laboratories Inc	43598-619	ORAL	5 mg in 1 1	7/28/2023
Saxagliptin and Metformin	Mylan Pharmaceuticals Inc.	0378-8175	ORAL	5 mg in 1 1	4/22/2023
Saxagliptin	Mylan Pharmaceuticals Inc.	0378-4706	ORAL	5 mg in 1 1	4/23/2023
Saxagliptin and Metformin	Mylan Pharmaceuticals Inc.	0378-8177	ORAL	5 mg in 1 1	4/22/2023
Saxagliptin and Metformin	Mylan Pharmaceuticals Inc.	0378-8176	ORAL	2.5 mg in 1 1	4/22/2023
Saxagliptin	Mylan Pharmaceuticals Inc.	0378-4705	ORAL	2.5 mg in 1 1	4/23/2023
Saxagliptin and Metformin Hydrochloride	Dr.Reddys Laboratories Inc	43598-620	ORAL	5 mg in 1 1	7/28/2023
Saxagliptin and Metformin Hydrochloride	Dr.Reddys Laboratories Inc	43598-618	ORAL	2.5 mg in 1 1	7/28/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Qtern	Astra Zeneca AB,51 85 Södertälje,Sweden	Authorised	7/15/2016
Onglyza	AstraZeneca AB,151 85 Södertälje,Sweden	Authorised	9/30/2009

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
Nutritrace Concentrate for solution for infusion	B.Braun Melsungen AG	SIN14341P	INFUSION, SOLUTION CONCENTRATE	6.958mg/10ml	4/22/2013

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
KOMBIGLYZE XR 2.5/1000 tablets 2.5 mg saxagliptin (as hydrochloride) immediate release and 1000 mg metformin hydrochloride modified release	202207	AstraZeneca Pty Ltd	Medicine	A	10/10/2013
ONGLYZA saxagliptin (as hydrochloride) 5 mg film coated tablet blister pack	157907	AstraZeneca Pty Ltd	Medicine	A	3/18/2011
ONGLYZA saxagliptin (as hydrochloride) 2.5 mg film-coated tablet blister pack	211214	AstraZeneca Pty Ltd	Medicine	A	3/21/2014
KOMBIGLYZE XR 5/500 tablets 5 mg saxagliptin (as hydrochloride) immediate release and 500 mg metformin hydrochloride modified release	202209	AstraZeneca Pty Ltd	Medicine	A	10/10/2013
QTERN 5/10 saxagliptin (as hydrochloride) / dapagliflozin (as propanediol monohydrate) 5 mg / 10 mg film-coated tablet blister pack	255632	AstraZeneca Pty Ltd	Medicine	A	10/25/2016
KOMBIGLYZE XR 5/1000 tablets 5 mg saxagliptin (as hydrochloride) immediate release and 1000 mg metformin hydrochloride modified release	202208	AstraZeneca Pty Ltd	Medicine	A	10/10/2013

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
QTERN 5 MG/10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Astrazeneca Ab	1161108002	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
KOMBOGLYZE 2,5 MG/1000 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Astrazeneca Ab	11731008	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
KOMBOGLYZE 2,5 MG/850 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Astrazeneca Ab	11731002	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
KOMBOGLYZE 2,5 MG/850 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Astrazeneca Ab	11731002IP	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
KOMBOGLYZE 2,5 MG/1000 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Astrazeneca Ab	11731008IP	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not 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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