Drugs / Vildagliptin
last change 21 days ago re-read 9 days ago

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
EU approved 2007
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200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials · 2 met primary
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 Met primary
Phase 1 NCT01537120 Dec 2011 → Oct 2012 type 2 diabetes mellitus Merck Sharp & Dohme LLC Completed Met primary
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 Stop: Business
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 · 1 missed
Phase 2 NCT04761861 Feb 2021 → Dec 2025 hyperlipidemia, schizophrenia Sadat City University Withdrawn No outcome recorded Stop: Business
Phase 2 NCT02803892 May 2016 → Dec 2018 type 1 diabetes mellitus Piemonti Lorenzo Completed Missed primary
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 · 18 met primary · 5 missed
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 Missed primary
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 Met primary
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 Met primary
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 Met primary
Phase 451 trials · 8 met primary · 3 missed
Phase 4 NCT06851962 May 2025 → Jun 2026 type 2 diabetes mellitus Fundación para la Investigación del Hospital Clínico de Valencia Completed 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
Comparator or background therapy36 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 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

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2019-09-18 Novartis Pharmaceuticals Results 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 ↗
Early combination treatment strategy with vildagliptin (Galvus®) and metformin was superior to standard of care in newly diagnosed type 2 diabetes patients[1],[2]

All press releases naming this drug 3 releases

DateIssuerRelease

Evidence & citations 18 cited values

Every value below carries the sentence it was read from. 187 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
178

“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 vildagliptin” NCT03014479 ↗

“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 ↗

Show 168 more sources

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 ↗
8

“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 ↗

“Vildagliptin (Galvus)” NCT07811011 ↗

“Galvus (vildagliptin)” NCT01339143 ↗

“Vildagliptin (Galvus)” NCT02176681 ↗

“Vildagliptin (Galvus)” NCT06851962 ↗

“Galvus (vitagliptin)” NCT01083992 ↗

“Galvus” NCT01176708 ↗

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 ↗

NCT00952991 ↗

NCT00230464 ↗

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) LAF237” NCT01686932 ↗
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