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Drug

Vildagliptin

Approved · EMA
Emerging researchLate-stage development

Also known as Vildagliptina.

RxNorm596554ChEMBLCHEMBL142703UNIII6B4B2U96P
1
Research papers
6
Active clinical trials
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Open-label, Double-arm, Controlled, Randomized, Multicentre Clinical Trial to Evaluate the Impact of Pharmacogenetic-guided Treatment in Patients With Insufficiently Controlled Type 2 Diabetes.

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus: a Multicenter, Open-label, Randomized, Controlled Trial (DIGNITY Trial)

Clinical trial2026-04-09Results expected Q3 2026 · ClinicalTrials.gov

Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia: a Randomized, Double-blind, Placebo-controlled Study

Clinical trial2025-12-31Withdrawn · ClinicalTrials.gov

Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome: A Randomized Clinical Trial

Clinical trial2025-12-01Primary completion · ClinicalTrials.gov

Comparison of Efficacy of Once Weekly Dose of Trelagliptin Versus Once Daily Dose of Vildagliptin on the Levels of HbA1c in Type-2 Diabetes Patients

Clinical trial2025-06-15Primary completion · ClinicalTrials.gov

Comparison of Efficacy of Once Weekly Dose of Trelagliptin Versus Once Daily Dose of Vildagliptin on the Levels of HbA1c in Type-2 Diabetes Patients

Clinical trial2025-05-15Primary completion · ClinicalTrials.gov

Study to Evaluate the Effect of Metformin in the Prevention of Hyperglycemia in HR[+]/HER2[-] PIK3CA-mutation Advanced Breast Cancer Patients Treated With Alpelisib Plus Endocrine Therapy. Study Metallica

Clinical trial2025-03-16Completed · ClinicalTrials.gov

Effect of Vildagliptin Versus Glimepiride on Copeptin and Fetuin-A in Type 2 Diabetic Patients

Clinical trial2024-12-01Completed · ClinicalTrials.gov

Dipeptidyl peptidase 4 inhibition may facilitate healing of chronic foot ulcers in patients with type 2 diabetes.

Research2012-11-01Experimental diabetes research

Approval: Jalra (EMA)

Regulatory2008-11-19EMA

Approval: Xiliarx (EMA)

Regulatory2008-11-19EMA

Approval: Galvus (EMA)

Regulatory2007-09-25EMA

Evidence confidence

1 claim

How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.

Improves HbA1c in type 2 diabetes
44%Low confidence
Uncertainty ±15%Evidence coverage: SubstantialUpdated 30 June 2026

Evidence is mixed — 3 supporting evidence families · 1 well-powered no-effect result

Confidence is moderated by well-powered no-effect evidence and limited publication incorporation, despite broad trial support.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Vildagliptin
Aliases & brands
Vildagliptina
RxNorm CUI
596554
ChEMBL ID
CHEMBL142703
UNII
I6B4B2U96P
Regulatory jurisdictions
ema

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2007-09-25
Latest approval
2008-11-19
Authorities
EMA
Total events
3
emaEuropean Medicines Agency· 3 events
2008-11-19Approval
Approval: Jalra (EMA)
Indication: Vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: as monotherapy in patients in whom metformin is… Show full indication

Vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

Evidence ↗
2008-11-19Approval
Approval: Xiliarx (EMA)
Indication: Vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: as monotherapy in patients in whom metformin is… Show full indication

Vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

Evidence ↗
2007-09-25Approval
Approval: Galvus (EMA)
Indication: Vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: as monotherapy in patients in whom metformin is… Show full indication

Vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

141 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
141
registered trials across all phases
LATEST COMPLETION 2025
6
Active studies
2
Recruiting
121
Late-stage (III+)
119
Completed
16
Discontinued
PHASE DISTRIBUTIONn = 141
Phase 18Phase 1 / 23Phase 29Phase 2 / 34Phase 366Phase 444Phase N / A7

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus: a Multicenter, Open-label, Randomized, Controlled Trial (DIGNITY Trial)

Active, not recruitingPH IVNational Center for Global Health and Medicine, Japann=5672027

Open-label, Double-arm, Controlled, Randomized, Multicentre Clinical Trial to Evaluate the Impact of Pharmacogenetic-guided Treatment in Patients With Insufficiently Controlled Type 2 Diabetes.

Active, not recruitingPH IVFundación para la Investigación del Hospital Clínico de Valencian=5042026

Comparison of Empaglifozin and Vildagliptin in Efficacy and Safety in Type 2 Diabetes Mellitus

CompletedPH IVGetz Pharman=1202021

Safety and Efficacy of Sitagliptin, Vildagliptin, and Metformin in Recently Diagnosed Drug-naïve Patients With Type 2 Diabetes

CompletedPH IVBeni-Suef Universityn=602020

Comparative Effecacy of Metformin and Vildagliptin on Cardiometabolic Risk Factors, Metabolic Syndrome, and Diabetic Nephropathy Progression

Unknown statusPH IVCairo Universityn=392020

Recent completions

Trials that read out recently, adding to the completed evidence base.

Study to Evaluate the Effect of Metformin in the Prevention of Hyperglycemia in HR[+]/HER2[-] PIK3CA-mutation Advanced Breast Cancer Patients Treated With Alpelisib Plus Endocrine Therapy. Study Metallica

CompletedPH IIMedSIRn=692025

Effect of Vildagliptin Versus Glimepiride on Copeptin and Fetuin-A in Type 2 Diabetic Patients

CompletedN/ADamanhour Universityn=702024

A Clinical Study Comparing Effects of Empagliflozin Versus Vildagliptin on Inflammatory Biomarkers, and Atrial Function in Coronary Artery Disease Patients With Type 2 Diabetes: EMBA-VILDA-Response Trial.

CompletedN/ADamanhour Universityn=1202024

Comparison of Empaglifozin and Vildagliptin in Efficacy and Safety in Type 2 Diabetes Mellitus

CompletedPH IVGetz Pharman=1202021

Safety and Efficacy of Sitagliptin, Vildagliptin, and Metformin in Recently Diagnosed Drug-naïve Patients With Type 2 Diabetes

CompletedPH IVBeni-Suef Universityn=602020

The Effect of Adding Vildagliptin Versus Glimepiride to Metformin on Markers of Inflammation, Thrombosis, and Atherosclerosis in Diabetic Patients With Symptomatic Coronary Artery Diseases

CompletedPH IVDamanhour Universityn=802019

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • Experimental diabetes research1
Leading researchers
  • Barbieri M1
  • Campitiello F1
  • Canonico R1
  • Canonico S1
  • Carbonara O1
  • Della Corte A1
  • Ferraraccio F1
  • Gualdiero P1
Leading institutions
free-text, unnormalised
  • Second University of Naples1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.