Drugs / Vildagliptin
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Vildagliptin

Other / unclassified targets DPP4 via inhibition

Developed for
type 2 diabetes mellitus · diabetes mellitus · coronary artery disorder · impaired renal function disease · congestive heart failure · prediabetes syndrome · chronic kidney disease · chronic ulcer of skin
+14 more · cognitive impairment with or without cerebellar ataxia · glucose intolerance · hyperlipidemia · major depressive disorder · metabolic syndrome X · NAFLD1 · Parkinson disease · type 1 diabetes mellitus · vascular disorder · benign neoplasm of pancreas · gestational diabetes · metabolic dysfunction-associated steatohepatitis · obesity disorder · polycystic ovary syndrome
Investigated by
Novartis Pharmaceuticals · Novartis · Damanhour University · Lund University · Merck Sharp & Dohme LLC · Royal Devon and Exeter NHS Foundation Trust
+62 more · Sadat City University · Tanta University · University of Campania Luigi Vanvitelli · Al-Azhar University · Alexandria University · Azienda Ospedaliero-Universitaria di Parma · Beni-Suef University · Bio-innova Co., Ltd · Cairo University · Centro de Diabetes Curitiba Ltda · Changhua Christian Hospital · European Union · Eva Pharma · Faculty of Medicine, Toulouse · Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · First Affiliated Hospital, Sun Yat-Sen University · Fundación para la Investigación del Hospital Clínico de Valencia · General Committee of Teaching Hospitals and Institutes, Egypt · Getz Pharma · Handok Inc. · Hanmi Pharmaceutical Company Limited · Hospital de Clinicas de Porto Alegre · IKFE Institute for Clinical Research and Development · India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals · Institute of Molecular Medicine of Rangueil (I2MR) · Instituto de Salud Carlos III · Italian Diabetes Foundation · Korea University Anam Hospital · Laboratorios Silanes S.A. de C.V. · Laboratory for Clinical and Experimental Research on Vascular Biology · Lin Liao · MTI University · Marcus Saemann · Mayo Clinic · Minia University · Mitsui Memorial Hospital · Mitsukoshi Health and Welfare Foundation · NIHR Exeter Clinical Research Facility · National Institute for Health Research, United Kingdom · Piemonti Lorenzo · Pusan National University Hospital · Radboud University Medical Center · Rio de Janeiro State University · Samsung Medical Center · Sarawak General Hospital · Seoul National University Bundang Hospital · Seoul National University Hospital · Sheba Medical Center · Tanta University · The First Affiliated Hospital of Xiamen University · The University of Texas Health Science Center at San Antonio · Universitaire Ziekenhuizen KU Leuven · University Hospital, Gentofte, Copenhagen · University Hospital, Strasbourg, France · University Hospital, Toulouse · University Malaysia Sarawak · University of Catania · University of Copenhagen · University of Jordan · University of Zurich · Yanbing Li · ikfe-CRO GmbH

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Galvus 2007-09-25 europa.eu

Trials 147 · started per year

today
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200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT06248801 Sep → Oct 2024 Bio-innova Co., Ltd Unknown No outcome recorded
Phase 1 NCT04087525 Oct → Nov 2018 Hanmi Pharmaceutical Company Limited Completed No outcome recorded
Phase 1 NCT01582308 Jun → Dec 2012 type 2 diabetes mellitus Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT01537120 Dec 2011 → Oct 2012 type 2 diabetes mellitus Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT00567047 Jul 2007 → Jan 2009 type 2 diabetes mellitus Novartis Completed No outcome recorded
Phase 1 NCT00419887 Sep 2006 → ? Novartis Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT04410341 May 2020 → Dec 2024 major depressive disorder Sadat City University Withdrawn No outcome recorded
Phase 1/2 NCT00818571 Dec 2008 → May 2009 diabetes mellitus, impaired renal function disease Novartis Pharmaceuticals Completed No outcome recorded
Phase 1/2 NCT00633997 Feb → Dec 2008 type 2 diabetes mellitus Novartis Terminated No outcome recorded
Phase 26 trials
Phase 2 NCT04761861 Feb 2021 → Dec 2025 hyperlipidemia, schizophrenia Sadat City University Withdrawn No outcome recorded
Phase 2 NCT02803892 May 2016 → Dec 2018 type 1 diabetes mellitus Piemonti Lorenzo Completed No outcome recorded
Phase 2 NCT01452113 Oct 2010 → Jan 2013 diabetes mellitus University Hospital, Toulouse Completed No outcome recorded
Phase 2 NCT01346254 Dec 2009 → Nov 2011 glucose intolerance Marcus Saemann Completed No outcome recorded
Phase 2 NCT00238498 Jul 2004 → Jun 2005 type 2 diabetes mellitus Novartis Completed No outcome recorded
Phase 2 NCT00099957 Sep 2003 → Jun 2005 type 2 diabetes mellitus Novartis Pharmaceuticals Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT00860288 Feb 2009 → Mar 2011 type 2 diabetes mellitus Novartis Pharmaceuticals Completed No outcome recorded
Phase 2/3 NCT00821977 Nov 2008 → Oct 2010 type 2 diabetes mellitus Novartis Completed No outcome recorded
Phase 371 trials
Phase 3 NCT04841096 Mar 2023 → Mar 2024 type 2 diabetes mellitus Laboratorios Silanes S.A. de C.V. Completed No outcome recorded
Phase 3 NCT03925701 Apr 2019 → Dec 2028 expected Tanta University Recruiting No outcome recorded
Phase 3 NCT01871558 Jun 2013 → Feb 2015 type 2 diabetes mellitus Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01811485 May 2013 → Feb 2014 type 2 diabetes mellitus Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01582230 Apr 2012 → May 2013 type 2 diabetes mellitus Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01497522 Dec 2011 → Feb 2013 type 2 diabetes mellitus Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01357252 Apr 2011 → Jan 2013 type 2 diabetes mellitus Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01257451 Dec 2010 → Mar 2012 type 2 diabetes mellitus Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01262586 Nov 2010 → Mar 2011 type 2 diabetes mellitus Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01233622 Oct 2010 → Nov 2011 type 2 diabetes mellitus Novartis Completed No outcome recorded
Phase 451 trials
Phase 4 NCT06851962 May 2025 → Jun 2026 overdue type 2 diabetes mellitus Fundación para la Investigación del Hospital Clínico de Valencia Active not recruiting No outcome recorded
Phase 4 NCT07077525 Jun 2023 → Aug 2024 type 2 diabetes mellitus Al-Azhar University Completed No outcome recorded
Phase 4 NCT05359432 Jul 2020 → Aug 2021 type 2 diabetes mellitus Getz Pharma Completed No outcome recorded
Phase 4 NCT04916093 Dec 2019 → Jun 2020 type 2 diabetes mellitus Beni-Suef University Completed No outcome recorded
Phase 4 NCT04485845 Nov 2019 → Aug 2020 impaired renal function disease, metabolic syndrome X, type 2 diabetes mellitus Cairo University Unknown No outcome recorded
Phase 4 NCT03958591 May 2019 → Jan 2025 type 2 diabetes mellitus Yanbing Li Completed No outcome recorded
Phase 4 NCT03693560 Oct 2018 → Sep 2019 coronary artery disorder, type 2 diabetes mellitus Damanhour University Completed No outcome recorded
Phase 4 NCT04654676 Sep 2018 → Aug 2019 type 2 diabetes mellitus University Malaysia Sarawak Completed No outcome recorded
Phase 4 NCT03563794 Jun 2018 → Jun 2019 type 2 diabetes mellitus The First Affiliated Hospital of Xiamen University Unknown No outcome recorded
Phase 4 NCT03804411 Aug 2017 → Mar 2020 type 2 diabetes mellitus Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health Unknown No outcome recorded
Phase not applicable8 trials
NCT06951334 Jun 2025 → Dec 2026 expected Parkinson disease First Affiliated Hospital, Sun Yat-Sen University Not yet recruiting No outcome recorded
NCT06313008 Aug 2023 → Sep 2024 coronary artery disorder, type 2 diabetes mellitus Damanhour University Completed No outcome recorded
NCT06068686 Oct 2022 → Nov 2024 type 2 diabetes mellitus Damanhour University Completed No outcome recorded
NCT05041673 Feb → Sep 2021 NAFLD1, type 2 diabetes mellitus Alexandria University Unknown No outcome recorded
NCT03500900 Mar 2016 → Jan 2017 Universitaire Ziekenhuizen KU Leuven Completed No outcome recorded
NCT02506296 Oct 2014 → Nov 2015 type 2 diabetes mellitus Royal Devon and Exeter NHS Foundation Trust Completed No outcome recorded
NCT01703637 Oct 2012 → Dec 2016 type 2 diabetes mellitus Lin Liao Unknown No outcome recorded
NCT01176760 Aug 2009 → Oct 2011 University Hospital, Gentofte, Copenhagen Unknown No outcome recorded
Also used as a comparator or background therapy in 35 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT02749032 Comparator Nov 2011 → Mar 2014 type 2 diabetes mellitus Michael A. Nauck Completed No outcome recorded
Phase 1 NCT00572650 Comparator Oct → Nov 2007 type 2 diabetes mellitus Novartis Completed No outcome recorded
Phase 23 trials
Phase 2 NCT04300790 Background Oct 2020 → Jun 2022 breast cancer MedSIR Completed No outcome recorded
Phase 2 NCT00980356 Comparator Sep 2009 → Aug 2012 diabetes mellitus Medical University of Vienna Completed No outcome recorded
Phase 2 NCT01018602 Comparator Jan 2008 → Jun 2012 gestational diabetes Institute of Diabetes Research, Helmholtz Zentrum München Unknown No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT06142656 Comparator Nov 2023 → Dec 2025 overdue polycystic ovary syndrome October 6 University Recruiting No outcome recorded
Phase 2/3 NCT00936234 Comparator Jul 2009 → Sep 2011 Johann Wolfgang Goethe University Hospital Withdrawn No outcome recorded
Phase 39 trials
Phase 3 NCT06021119 Comparator Mar → Apr 2023 Ain Shams University Completed No outcome recorded
Phase 3 NCT06348706 Comparator Nov 2022 → Dec 2023 metabolic dysfunction-associated steatohepatitis, type 1 diabetes mellitus Ain Shams University Completed No outcome recorded
Phase 3 NCT05369793 Comparator Aug 2022 → Oct 2023 diabetic neuropathy, type 2 diabetes mellitus Tanta University Completed No outcome recorded
Phase 3 NCT05102149 Comparator Sep 2021 → Nov 2023 type 2 diabetes mellitus PegBio Co., Ltd. Unknown No outcome recorded
Phase 3 NCT02849899 Comparator Oct 2018 → Jul 2024 diabetes mellitus, disease related to solid organ transplantation Centre Hospitalier Universitaire de Besancon Unknown No outcome recorded
Phase 413 trials
Phase 4 NCT06449235 Comparator Sep 2024 → Apr 2025 overdue type 2 diabetes mellitus Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders Not yet recruiting No outcome recorded
Phase 4 NCT05366868 Comparator May 2022 → Aug 2026 overdue type 2 diabetes mellitus National Center for Global Health and Medicine, Japan Active not recruiting No outcome recorded
Phase 4 NCT03014479 Comparator Feb → Oct 2017 type 2 diabetes mellitus Takeda Completed No outcome recorded
Phase 4 NCT02999841 Comparator Mar 2016 → Dec 2017 obesity disorder, type 2 diabetes mellitus Peking University Unknown No outcome recorded
Phase 4 NCT02832999 Comparator Jan → Sep 2016 type 2 diabetes mellitus Yaounde Central Hospital Completed No outcome recorded
Phase not applicable6 trials
NCT06889909 Comparator Dec 2024 → Jun 2025 overdue type 2 diabetes mellitus Lahore General Hospital Active not recruiting No outcome recorded
NCT06913101 Comparator Nov 2024 → May 2025 overdue type 2 diabetes mellitus PNS Hafeez - Naval Hospital Active not recruiting No outcome recorded
NCT02244164 Comparator Oct 2014 → Feb 2023 type 2 diabetes mellitus Erasme University Hospital Terminated No outcome recorded
NCT01083992 Background Apr 2012 → Jan 2013 NAFLD1 Ziv Hospital Unknown No outcome recorded
NCT01176708 Background Jul 2009 → Aug 2012 University Hospital, Gentofte, Copenhagen Unknown No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2019-09-18 Novartis Pharmaceuticals Positive results from Novartis five-year VERIFY study in type 2 diabetes demonstrate long-term clinical benefits of early combination treatment with Galvus® and metformin novartis.com

Evidence & citations 18 cited values

Every value below carries the sentence it was read from. 186 sources stand behind the page.

FieldValueCited text
Known as Vildagliptin “AIM: To investigate the efficacy and safety of vildagliptin as an add-on therapy on glucose excursions of Iftar Ramadan meals among adolescents and young adults with type 1...” PMID 38057844 Dec 2023
177

“DPP-4 inhibitor (sitagliptin, vildagliptin, alogliptin, linagliptin, teneligliptin, anagliptin or saxagliptin) will be suspended for one month and serum BNP will be measured.” NCT02312427

Vildagliptin added on the insufficient glycemic control with monotherapy. Starting dose of 50mg per day and dose adjustment as needed to control blood glucose.” NCT01922492

“50 g-oral glucose tolerance test (OGTT)±vildagliptin, a DPP4 inhibitor (DPP4i) and isoglycaemic i.v. glucose infusion (IIGI), copying the OGTT without DPP4i.” PMID 23704713 Jul 2013

“Subsequently, patients are assigned to receive either the DPP-4 inhibitor Vildagliptin 50 mg twice daily or the sulfonylurea Glimepiride 2 mg twice daily.” NCT03983551

“Efficacy of Vildagliptin, Liraglutide and Empagliflozin in the Management of Fatty Liver Disease Among Patients With Type 2 Diabetes” NCT05041673

“Chemical Names: Sitagliptin, Vildagliptin, Saxagliptin, Linagliptin, Alogliptin Class: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors” NCT06449235

“Administration of alpha-lipoic acid 600mg plus vildagliptin/metformin combination (50/1000mg) orally once daily for 3 months.” NCT05369793

“Alogliptin, anagliptin, linagliptin, saxagliptin, sitagliptin, teneligliptin or vildagliptinNCT03014479

Vildagliptin, an oral antihyperglycemic agent that competitively inhibits DPP-4.” NCT06348706

“Corresponds to vildagliptin 50 mg twice daily and metformin 250 mg twice daily” NCT01811485

“combination therapy of basal insulin, metformin and vildagliptinNCT03958591

“with or without a DPPIV inhibitor (Vildagliptin 50mg) tablet.” NCT02506296

“subgroup 1A- addition of vildagliptin 100 mg/day” NCT03804411

vildagliptin (50-100mg daily)” NCT02528019

“LAF237 = vildagliptinNCT00952991

VildagliptinNCT02002221

VildagliptinNCT04087525

NCT00102388

NCT01867502

NCT00572650

NCT00138541

NCT00980356

NCT03253562

NCT01159249

NCT06889909

NCT00138593

NCT01147276

NCT00651105

NCT01882907

NCT02176681

NCT01339143

NCT00138580

NCT02002221

NCT05102149

NCT00894868

NCT00380380

NCT00390520

NCT00633997

NCT04300790

NCT00936234

NCT04916093

NCT03088670

NCT00312130

NCT01122641

NCT01822548

NCT00351884

NCT01346254

NCT02999841

NCT00101712

NCT00351832

NCT00351585

NCT00351546

NCT00818571

NCT03178591

NCT01862263

NCT00351507

NCT01257451

NCT02343926

NCT00300287

NCT03563794

NCT00765830

NCT03500900

NCT04761861

NCT04237493

NCT01541956

NCT04654676

NCT00567047

NCT00975065

NCT00260156

NCT06068686

NCT00099892

NCT06951334

NCT01398592

NCT00138606

NCT01604213

NCT00389415

NCT01309698

NCT01356381

NCT00101673

NCT01193296

NCT02007278

NCT01827280

NCT00325117

NCT01497522

NCT03819127

NCT04410341

NCT00368134

NCT02475070

NCT01426802

NCT01910441

NCT00821977

NCT00325429

NCT01871558

NCT02145611

NCT01018602

NCT01766778

NCT01559025

NCT01357252

NCT00238498

NCT01452113

NCT03925701

NCT02832999

NCT01099137

NCT01518101

NCT00860288

NCT01238978

NCT01000688

NCT01812122

NCT00110240

NCT01233622

NCT01757587

NCT01262586

NCT01242228

NCT00383578

NCT00646542

NCT02853630

NCT01582308

NCT01582243

NCT01565096

NCT00380445

NCT01426737

NCT00419887

NCT00138554

NCT04485845

NCT01582230

NCT05359432

NCT00822211

NCT00770081

NCT00382096

NCT00138567

NCT00120536

NCT00616811

NCT00099853

NCT00237250

NCT01528254

NCT02089438

NCT00099866

NCT02749032

NCT00101803

NCT01537120

NCT00396071

NCT01404676

NCT02803892

NCT06142656

NCT01679899

NCT01196546

NCT00237237

NCT00396227

NCT00396357

NCT00106340

NCT00138515

NCT06851962

NCT06313008

NCT01758380

NCT01472432

NCT00138619

NCT00468039

NCT01224366

NCT06913101

NCT00099905

NCT07077525

NCT01703637

NCT00099918

NCT05366868

NCT00099957

NCT01219400

NCT02849899

NCT01686932

NCT06248801

NCT03693560

NCT00728351

NCT00099944

NCT00099931

NCT00102466

NCT02142309

NCT00494884

NCT04841096

Known as - vildagliptine (Galvus) “- vildagliptine (Galvus®)” NCT02244164
Known as Equa ChEMBL registry synonym — accepted as the source's own label CHEMBL142703
Known as Galvus “Patients who exhibit impaired glucose tolerance (IGT) after kidney transplantation are randomized to either receive vildagliptin (Galvus), pioglitazone(Actos) or placebo for...” NCT01346254
7

“Patients were randomized to vildagliptin (Galvus) 100 mg given in the morning (AM), vildagliptin 100 mg given in the evening (PM), or placebo.” PMID 19221978 Feb 2009

“Evaluation of Galvus (Vildagliptin) Efficacy Versus Placebo” NCT01757587

Galvus (vildagliptin)” NCT01339143

“Vildagliptin (Galvus)” NCT06851962

“Vildagliptin (Galvus)” NCT02176681

Galvus (vitagliptin)” NCT01083992

GalvusNCT01176708

Known as Jalra ChEMBL registry synonym — accepted as the source's own label CHEMBL142703
Known as LAF237 “This study will evaluate the pharmacokinetics of vildagliptin (LAF237) and its metabolites in patients with mild renal impairment compared to their sex, age and weigh based...” NCT00572650
5

“Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks.” NCT02002221

“Vildagliptin (LAF237)” NCT00419887

NCT01649466

NCT00230464

NCT00952991

Known as NVP-LAF 237 ChEMBL registry synonym — accepted as the source's own label CHEMBL142703
Known as Vilda “The overarching hypothesis of this study is that vildagliptin (vilda) as add on therapy to metformin (met) in Egyptian type 2 diabetic obese patient will produce an equal, if...” NCT07077525
Known as Vildagliptin (galvus) Vildagliptin (galvus)NCT01827280
Known as Vildagliptin (Galvus) LAF237 Vildagliptin (Galvus) LAF237NCT01686932
Known as Vildagliptina ChEMBL registry synonym — accepted as the source's own label CHEMBL142703
Known as vildagliptine “- vildagliptine (Galvus®)” NCT02244164
Known as vitagliptin ClinicalTrials.gov intervention name — accepted as the source's own label NCT01083992
Known as Xiliarx ChEMBL registry synonym — accepted as the source's own label CHEMBL142703
Action Inhibit “the dipeptidyl peptidase-4 inhibitor vildagliptin” PMID 17300592 Mar 2007
Modality Other / unclassified “Vildagliptin is a novel dipeptidyl peptidase-4 (DPP-4) inhibitor that improves pancreatic islet function by enhancing both α- and β-cell responsiveness to increased blood glucose.” PMID 20925938 Oct 2010
Route Oral “patients will ingest 100 mg of LAF237 or placebo with 200 ml of water” NCT00230464
Target DPP4 “the dipeptidyl peptidase-4 inhibitor vildagliptin” PMID 17300592 Mar 2007