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Vildagliptin

Generic Name
Vildagliptin
Brand Names
Galvus, Jalra, Xiliarx, Eucreas, Zomarist
Drug Type
Small Molecule
Chemical Formula
C17H25N3O2
CAS Number
274901-16-5
Unique Ingredient Identifier
I6B4B2U96P

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.

Background

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

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Title
Posted
Study ID
Phase
Status
Sponsor
2016/12/21
Phase 4
UNKNOWN
Peking University
2016/08/03
Phase 4
Completed
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
2024/08/13
Phase 3
Not yet recruiting
2016/07/14
Phase 4
Completed
Yaounde Central Hospital
2016/06/29
Phase 1
Completed
Genuine Research Center, Egypt
2016/06/17
Phase 2
Completed
Piemonti Lorenzo
2016/04/22
Phase 1
Completed
2015/06/18
Phase 4
Completed
2015/01/22
Phase 3
Completed
2014/06/27
Phase 4
Completed
University Hospital, Strasbourg, France

FDA Drug Approvals

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No FDA approvals found for this drug.

EMA Drug Approvals

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HSA Drug Approvals

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NMPA Drug Approvals

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Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Vildagliptin Tablets
国药准字H20203360
化学药品
片剂
7/29/2020
Vildagliptin Tablets
国药准字H20213632
化学药品
片剂
8/3/2021

PPB Drug Approvals

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TGA Drug Approvals

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