Vildagliptin

Overview

Vildagliptin (LAF237) is an orally active antihyperglycemic agent that selectively inhibits the dipeptidyl peptidase-4 (DPP-4) enzyme. It is used to manage type II diabetes mellitus, where GLP-1 secretion and insulinotropic effects are impaired. By inhibiting DPP-4, vildagliptin prevents the degradation of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which are incretin hormones that promote insulin secretion and regulate blood glucose levels. Elevated levels of GLP-1 and GIP consequently results in improved glycemic control. In clinical trials, vildagliptin has a relatively low risk of hypoglycemia. Oral vildagliptin was approved by the European Medicines Agency in 2008 for the treatment of type II diabetes mellitus in adults as monotherapy or in combination with metformin, a sulfonylurea, or a thiazolidinedione in patients with inadequate glycemic control following monotherapy. It is marketed as Galvus. Vildagliptin is also available as Eucreas, a fixed-dose formulation with metformin for adults in who do not adequately glycemic control from monotherapy. Vildagliptin is currently under investigation in the US.

Indication

Vildagliptin is indicated in the treatment of type II diabetes mellitus in adults. As monotherapy, vildagliptin is indicated in adults inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. It is also indicated as dual therapy in combination with metformin, a sulphonylurea, or a thiazolidinedione in adults patients with insufficient glycemic control despite maximal tolerated dose of monotherapy. Vildagliptin is also marketed in a combination product with metformin for the treatment of adults with type II diabetes mellitus who inadequately respond to either monotherapy of vildagliptin or metformin. This fixed-dose formulation can be used in combination with a sulphonylurea or insulin (i.e., triple therapy) as an adjunct to diet and exercise in adults who do not achieve adequate glycemic control with monotherapy or dual therapy.

Associated Conditions

Type 2 Diabetes Mellitus

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Clinical Trial of Vildagliptin in Early Parkinson's Disease	2025/04/30	NCT06951334	Not Applicable	Not yet recruiting	First Affiliated Hospital, Sun Yat-Sen University
Comparison of Once-Weekly Trelagliptin vs. Once-Daily Vildagliptin for HbA1c Reduction in Type 2 Diabetes	2025/04/06	NCT06913101	Not Applicable	Active, not recruiting	PNS Hafeez - Naval Hospital
Comparison of Once-Weekly Trelagliptin Vs. Once-Daily Vildagliptin for HbA1c Reduction in Type 2 Diabetes	2025/03/21	NCT06889909	Not Applicable	Active, not recruiting	Lahore General Hospital
Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes Clinical Trial	2025/02/28	NCT06851962	Phase 4	Not yet recruiting	Fundación para la Investigación del Hospital Clínico de Valencia
Empagliflozin Versus Vildagliptin in CAD Patients With T2DM	2024/03/15	NCT06313008	Not Applicable	Completed	Damanhour University
Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets	2024/02/08	NCT06248801	Phase 1	Not yet recruiting	Bio-innova Co., Ltd
The Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin HCI 50/1000 mg FCT Under Fed Conditions	2024/02/06	NCT06244407	Phase 1	Not yet recruiting	International Bio service
Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome	2023/11/21	NCT06142656	Phase 2	Recruiting	October 6 University
Vildagliptin Versus Glimepiride in Type 2 Diabetic Patients	2023/10/05	NCT06068686	Not Applicable	Completed	Damanhour University
The Effect of Metformin and DPP4 Inhibitors on Cognition and Cardiovascular Protection in Type 2 Diabetic Patients	2022/06/23	NCT05429554	N/A	UNKNOWN	MTI University

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
Eucreas	Novartis Europharm Limited,Vista Building,Elm Park,Merrion Road,Dublin 4,Ireland	Authorised	11/14/2007
Vildagliptin / Metformin hydrochloride Accord	Accord Healthcare S.L.U.,Edificio Este Planta 6a,World Trade Center,Moll De Barcelona S/n,08039 Barcelona,SPAIN	Authorised	3/24/2022
Vildagliptin / Metformin hydrochloride Accord	Accord Healthcare S.L.U.,Edificio Este Planta 6a,World Trade Center,Moll De Barcelona S/n,08039 Barcelona,SPAIN	Authorised	3/24/2022
Icandra (previously Vildagliptin / metformin hydrochloride Novartis)	Novartis Europharm Limited,Vista Building,Elm Park,Merrion Road,Dublin 4,Ireland	Authorised	11/30/2008
Zomarist	Novartis Europharm Limited,Vista Building,Elm Park,Merrion Road,Dublin 4,D04 A9N6,Ireland	Authorised	11/30/2008
Jalra	Novartis Europharm Limited,Vista Building,Elm Park,Merrion Road,Dublin 4,Ireland	Authorised	11/19/2008
Xiliarx	Novartis Europharm Limited,Vista Building,Elm Park,Merrion Road,Dublin 4,Ireland	Authorised	11/19/2008
Galvus	Novartis Europharm Limited,Vista Building,Elm Park,Merrion Road,Dublin 4,Ireland	Authorised	9/25/2007

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
Galvus Met Tablet 50mg/1000mg	Novartis Pharma Produktions GmbH, NOVARTIS SINGAPORE PHARMACEUTICAL MANUFACTURING PTE. LTD., Novartis Saglik, Gida Ve Tarim Urunleri San.Ve.Tic.A.S, Lek Pharmaceuticals d.d., Poslovna enota PROIZVODNJA LENDAVA (Primary and Secondary packager)	SIN13684P	TABLET, FILM COATED	50.0 mg	8/11/2009
Galvus Tablet 50mg	Siegfried Barbera S.L., Lek Pharmaceuticals d.d.	SIN13407P	TABLET	50mg	2/14/2008
Galvus Met Tablet 50mg/500mg	Novartis Pharma Produktions GmbH, NOVARTIS SINGAPORE PHARMACEUTICAL MANUFACTURING PTE. LTD., Novartis Saglik, Gida Ve Tarim Urunleri San.Ve.Tic.A.S, Lek Pharmaceuticals d.d., Poslovna enota PROIZVODNJA LENDAVA (Primary and Secondary Packager)	SIN13952P	TABLET, FILM COATED	50.0mg	5/3/2011
Galvus Met Tablet 50mg/850mg	Novartis Pharma Produktions GmbH, NOVARTIS SINGAPORE PHARMACEUTICAL MANUFACTURING PTE. LTD., Novartis Saglik, Gida Ve Tarim Urunleri San.Ve.Tic.A.S, Lek Pharmaceuticals d.d., Poslovna enota PROIZVODNJA LENDAVA (Primary and Secondary Packager)	SIN13685P	TABLET, FILM COATED	50 mg	8/11/2009

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
GALVUSMET TAB 50/850MG	N/A	NOVARTIS PHARMACEUTICALS (HK) LIMITED	N/A	N/A	12/30/2009
GALVUS MET TABLETS 50/1000MG	N/A	NOVARTIS PHARMACEUTICALS (HK) LIMITED	N/A	N/A	5/31/2016
GALVUS MET TABLETS 50MG/1000MG (GERMANY)	N/A	NOVARTIS PHARMACEUTICALS (HK) LIMITED	N/A	N/A	7/16/2013
GALVUSMET TAB 50/500MG	N/A	NOVARTIS PHARMACEUTICALS (HK) LIMITED	N/A	N/A	7/9/2010
GALVUS MET TABLETS 50/850MG	N/A	NOVARTIS PHARMACEUTICALS (HK) LIMITED	N/A	N/A	5/31/2016

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
GALVUMET 50/850 vildagliptin 50 mg/metformin hydrochloride 850 mg film coated tablet blister pack	161217	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	12/13/2010
GALVUMET 50/500 vildagliptin 50 mg/metformin hydrochloride 500 mg film coated tablet blister pack	161216	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	12/13/2010
GALVUMET 50/1000 vildagliptin 50 mg/metformin hydrochloride 1000 mg film coated tablet blister pack	161218	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	12/13/2010
GALVUS vildagliptin 50 mg tablets blister pack	159561	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	3/2/2010

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
VILDAGLIPTINA/METFORMINA ALTER 50 MG/1.000 MG COMPRIMIDOS EFG	Laboratorios Alter S.A.	86040	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
VILDAGLIPTINA TARBIS 50 MG COMPRIMIDOS EFG	Tarbis Farma S.L.	85317	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
VILDAGLIPTINA CINFA 50 MG COMPRIMIDOS EFG	Laboratorios Cinfa S.A.	86023	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
XILIARX 50 mg COMPRIMIDOS	Novartis Europharm Limited	08486003	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
VILDAGLIPTINA/METFORMINA ALMUS 50 MG/1000 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Almus Farmaceutica S.A.U.	88016	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
VILDAGLIPTINA/METFORMINA CINFA 50 MG/1000 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorios Cinfa S.A.	85622	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
VILDAGLIPTINA/METFORMINA RATIOPHARM 50 MG/850 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Ratiopharm Espana S.A.	84114	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
VILDAGLIPTINA/METFORMINA TEVA 50 MG/850 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Teva B.V.	84112	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
VILDAGLIPTINA/METFORMINA KRKA 50 MG/1.000 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Krka D.D. Novo Mesto	86167	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
EUCREAS 50 mg/850 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Novartis Europharm Limited	07425003IP3	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.

AI-Powered Research

Premium Access