Drugs / SAXAGLIPTIN ANHYDROUS
last change Jun 2025 re-read 2 minutes ago

SAXAGLIPTIN ANHYDROUS

Small molecule targets DPP4

Developed for
type 2 diabetes mellitus · diabetes mellitus · glucose intolerance · prediabetes syndrome · type 1 diabetes mellitus · congestive heart failure · cystic fibrosis · glucose metabolism disease
+9 more · heart failure · polycystic ovary syndrome · proteinuria · ulcer of lower limbs · cardiovascular disorder · coronary artery disorder · hyperglycemia · NAFLD1 · platelet aggregation, spontaneous
Investigated by
AstraZeneca · Bristol-Myers Squibb · Shanghai Jiao Tong University School of Medicine · Chinese Medical Association · Kyowa Kirin, Inc. · Ain Shams University
+45 more · Assistance Publique - Hôpitaux de Paris · Baylor College of Medicine · Beijing Chao Yang Hospital · Beijing Hospital · Brigham and Women's Hospital · Dongguan Kanghua Hospital · Fifth Affiliated Hospital, Sun Yat-Sen University · First Affiliated Hospital of Chongqing Medical University · First People's Hospital, Shunde China · Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair · IKFE Institute for Clinical Research and Development · Korea University Anam Hospital · Lin Liao · Long Min,MD · Lund University · Merck Sharp & Dohme LLC · Mitsui Memorial Hospital · Mitsukoshi Health and Welfare Foundation · Nanjing Medical University · Oregon Health and Science University · Parexel · Peking University Shenzhen Hospital · Phoenix VA Health Care System · Pontificia Universidad Catolica de Chile · Ram Weiss · Second Xiangya Hospital of Central South University · Shandong Provincial Hospital · Shanghai Zhongshan Hospital · Shenzhen Sixth People's Hospital · The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston · The Fifth Affiliated Hospital of Zunyi Medical College · The First Affiliated Hospital of Guangdong Pharmaceutical University · The First Affiliated Hospital of Henan University of Science and Technology · The First Affiliated Hospital with Nanjing Medical University · The Second Hospital of Nanjing Medical University · The Sixth Affiliated Hospital of Guangzhou Medical University · The University of Texas Health Science Center, Houston · Third Affiliated Hospital, Sun Yat-Sen University · UnitedHealthcare · Unity Health Toronto · Uppsala University · Woman's · Zhujiang Hospital · Zilin Sun · ikfe-CRO GmbH

Regulatory milestones approvals, filings & regulatory actions · 8 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (6) US (FDA) ONGLYZA 2011-02-18 – 2024-10-11 fda.gov
Approved EU (EMA) Onglyza 2009-09-30 europa.eu
Approved US (FDA) ONGLYZA 2009-07-31 fda.gov

Trials 77 · started per year

today
US approved 2009
EU approved 2009
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5
1
7
7
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3
13
4
11
11
2
2
1
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2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 18 trials
Phase 1 NCT03169959 May → Aug 2017 type 2 diabetes mellitus AstraZeneca Completed No outcome recorded
Phase 1 NCT01525225 Sep 2012 → Jun 2013 type 2 diabetes mellitus AstraZeneca Terminated No outcome recorded
Phase 1 NCT01662999 Aug → Nov 2012 type 2 diabetes mellitus AstraZeneca Completed No outcome recorded
Phase 1 NCT01582308 Jun → Dec 2012 type 2 diabetes mellitus Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT01441869 Oct → Dec 2011 AstraZeneca Completed No outcome recorded
Phase 1 NCT01305551 Mar 2011 type 2 diabetes mellitus AstraZeneca Withdrawn No outcome recorded
Phase 1 NCT00935467 Jul → Aug 2009 type 2 diabetes mellitus AstraZeneca Completed No outcome recorded
Phase 1 NCT00770302 Oct 2008 type 2 diabetes mellitus AstraZeneca Completed No outcome recorded
Phase 23 trials
Phase 2 NCT01521312 Sep 2012 → Sep 2014 glucose intolerance Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
Phase 2 NCT00857558 Jan 2009 → Mar 2010 type 2 diabetes mellitus Kyowa Kirin, Inc. Completed No outcome recorded
Phase 2 NCT00950599 May 2003 → May 2004 type 2 diabetes mellitus AstraZeneca Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT07033585 Jun 2025 → Oct 2026 expected type 2 diabetes mellitus Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair Active not recruiting No outcome recorded
Phase 2/3 NCT02547935 Sep 2015 → May 2018 type 2 diabetes mellitus AstraZeneca Completed No outcome recorded
Phase 332 trials
Phase 3 NCT03199053 Oct 2017 → Feb 2023 type 2 diabetes mellitus AstraZeneca Completed No outcome recorded
Phase 3 NCT02946632 Dec 2016 → Dec 2019 type 2 diabetes mellitus Korea University Anam Hospital Unknown No outcome recorded
Phase 3 NCT02551874 Oct 2015 → May 2017 type 2 diabetes mellitus AstraZeneca Completed No outcome recorded
Phase 3 NCT02419612 Aug 2015 → Aug 2017 type 2 diabetes mellitus AstraZeneca Completed No outcome recorded
Phase 3 NCT02315495 Apr 2015 → Aug 2016 type 2 diabetes mellitus Zilin Sun Completed No outcome recorded
Phase 3 NCT02273050 Dec 2014 → Aug 2016 type 2 diabetes mellitus AstraZeneca Completed No outcome recorded
Phase 3 NCT02284893 Sep 2014 → Sep 2016 type 2 diabetes mellitus AstraZeneca Completed No outcome recorded
Phase 3 NCT02104804 May 2014 → Feb 2016 type 2 diabetes mellitus AstraZeneca Completed No outcome recorded
Phase 3 NCT02022007 Mar 2014 → Aug 2016 glucose metabolism disease, polycystic ovary syndrome Woman's Completed No outcome recorded
Phase 3 NCT01606007 Jul 2012 → Jan 2014 type 2 diabetes mellitus AstraZeneca Completed No outcome recorded
Phase 428 trials
Phase 4 NCT04445714 Apr 2021 → Mar 2023 type 2 diabetes mellitus AstraZeneca Completed No outcome recorded
Phase 4 NCT03700801 Oct 2018 → Dec 2019 type 2 diabetes mellitus Zhujiang Hospital Completed No outcome recorded
Phase 4 NCT02765204 Mar → Dec 2016 type 2 diabetes mellitus Uppsala University Completed No outcome recorded
Phase 4 NCT02605772 Dec 2015 → Nov 2016 type 2 diabetes mellitus Fifth Affiliated Hospital, Sun Yat-Sen University Unknown No outcome recorded
Phase 4 NCT02742233 Nov 2015 → Oct 2017 ulcer of lower limbs Long Min,MD Unknown No outcome recorded
Phase 4 NCT02583438 Oct 2015 → Oct 2017 obesity disorder, type 2 diabetes mellitus Beijing Chao Yang Hospital Unknown No outcome recorded
Phase 4 NCT02462369 Jun 2015 → Apr 2017 proteinuria The Second Hospital of Nanjing Medical University Unknown No outcome recorded
Phase 4 NCT02481479 Jun 2015 → Aug 2018 heart failure, type 2 diabetes mellitus Unity Health Toronto Completed No outcome recorded
Phase 4 NCT02407899 Mar 2015 → Dec 2020 type 1 diabetes mellitus Second Xiangya Hospital of Central South University Completed No outcome recorded
Phase 4 NCT02312427 Jan 2015 → Mar 2016 congestive heart failure, diabetes mellitus Mitsui Memorial Hospital Completed No outcome recorded
Phase not applicable4 trials
NCT04170790 Dec 2019 erectile dysfunction, type 2 diabetes mellitus Ain Shams University Unknown No outcome recorded
NCT02148978 Mar 2014 → Aug 2015 cystic fibrosis Ram Weiss Unknown No outcome recorded
NCT01974544 May 2013 → Dec 2015 type 2 diabetes mellitus Pontificia Universidad Catolica de Chile Unknown No outcome recorded
NCT01703637 Oct 2012 → Dec 2016 type 2 diabetes mellitus Lin Liao Unknown No outcome recorded
Also used as a comparator or background therapy in 32 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT03933787 Comparator Jun → Jul 2018 disorder of catecholamine synthesis, sympathetic nervous system disorder Eric Grouzmann Completed No outcome recorded
Phase 23 trials
Phase 2 NCT03714594 Comparator Jul 2018 → Aug 2022 type 2 diabetes mellitus University of Pisa Completed No outcome recorded
Phase 2 NCT02597101 Background Nov 2015 → Jun 2019 type 2 diabetes mellitus Nick Giannoukakis, PhD Completed No outcome recorded
Phase 2 NCT01782261 Comparator Feb 2012 → Feb 2015 type 1 diabetes mellitus Medical University of Graz Completed No outcome recorded
Phase 39 trials
Phase 3 NCT06107153 Comparator Nov 2023 → Nov 2024 type 2 diabetes mellitus University of Basrah Completed No outcome recorded
Phase 3 NCT03608358 Background Feb 2019 → Aug 2020 type 2 diabetes mellitus AstraZeneca Terminated No outcome recorded
Phase 3 NCT02377388 Comparator Feb 2017 → Feb 2020 platelet aggregation, spontaneous University of Sao Paulo General Hospital Completed No outcome recorded
Phase 3 NCT02681094 Comparator Feb 2016 → Jul 2017 type 2 diabetes mellitus AstraZeneca Completed No outcome recorded
Phase 3 NCT01646320 Background Sep 2012 → Aug 2014 type 2 diabetes mellitus AstraZeneca Completed No outcome recorded
Phase 415 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 NCT04521049 Comparator Mar 2019 → Mar 2020 type 2 diabetes mellitus Beni-Suef University Completed No outcome recorded
Phase 4 NCT03660683 Comparator Oct 2018 → Mar 2021 cardiovascular disorder, type 2 diabetes mellitus Sabyasachi Sen Terminated No outcome recorded
Phase 4 NCT02965443 Comparator Feb 2018 → Feb 2020 type 2 diabetes mellitus University Hospital Tuebingen Terminated No outcome recorded
Phase 4 NCT03014479 Comparator Feb → Oct 2017 type 2 diabetes mellitus Takeda Completed No outcome recorded
Phase not applicable4 trials
NCT02613897 Comparator Jan 2016 → Jun 2018 type 2 diabetes mellitus The University of Texas Health Science Center at San Antonio Completed No outcome recorded
NCT02239458 Comparator Jun 2015 → Jun 2016 cystic fibrosis Ram Weiss Unknown No outcome recorded
NCT02244164 Comparator Oct 2014 → Feb 2023 type 2 diabetes mellitus Erasme University Hospital Terminated No outcome recorded
NCT02969798 Comparator Jan 2014 → Dec 2026 expected glucose intolerance, prediabetes syndrome, type 2 diabetes mellitus The University of Texas Health Science Center at San Antonio Recruiting No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2013-03-25 Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka Obtains Marketing Approval in Japan for Onglyza Tablets to Treat Type 2 Diabetes; Transferred Rights to Kyowa Hakko Kirin® otsuka.co.jp

Evidence & citations 24 cited values

Every value below carries the sentence it was read from. 112 sources stand behind the page.

FieldValueCited text
Known as SAXAGLIPTIN ANHYDROUS ChEMBL registry synonym — accepted as the source's own label CHEMBL385517
Known as - saxagliptine (Onglyza) “- saxagliptine (Onglyza®)” NCT02244164
Known as BMS-477118 “The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated...” NCT01606007
2

“hydroxyadamantyl compound BMS-477118 (saxagliptin), a highly efficacious, stable, and long-acting DPP-IV inhibitor” PMID 16033281 Jul 2005

“Saxagliptin (BMS-477118)” NCT01434186

Known as BMS-477118-11 ChEMBL registry synonym — accepted as the source's own label CHEMBL385517
Known as NSC-760407 ChEMBL registry synonym — accepted as the source's own label CHEMBL385517
Known as Onglyza “Patients would be assigned to saxagliptin (Onglyza® AstraZeneca Pharmaceuticals LP, Indiana, USA), either received a dose of 5 mg or 2.5 mg daily if patients had eGFR \<50...” NCT04521049
4

Onglyza® (saxagliptin) 5 mg” NCT07033585

Onglyza (saxagliptin)” NCT01441869

“Saxagliptin, OnglyzaNCT02551874

OnglyzaNCT02243176

Known as SAXA “dipeptidyl peptidase-4 inhibitor saxagliptin (SAXA)” PMID 28228317 Oct 2016
Known as Saxagliptin “DPP-4 inhibitor (sitagliptin, vildagliptin, alogliptin, linagliptin, teneligliptin, anagliptin or saxagliptin) will be suspended for one month and serum BNP will be measured.” NCT02312427
107

“The recommended dose of the dipeptidyl peptidase-4 inhibitor saxagliptin is 2.5 mg in patients with moderate or severe renal impairment” PMID 27402391 Jul 2016

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

“Alogliptin, anagliptin, linagliptin, saxagliptin, sitagliptin, teneligliptin or vildagliptin” NCT03014479

“A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus” NCT01162876

“Xigduo (metformin 1000mg + dapagliflozin 10mg) saxagliptin 5mg” NCT02946632

“Sitagliptin, 100 mg/day or Saxagliptin, 5 mg/day” NCT02365233

“Metformin, Dapagliflozin and SaxagliptinNCT03700801

saxagliptin (2.5-5mg daily)” NCT02528019

“Drug: SaxagliptinNCT03199053

NCT01608724

NCT03608358

NCT01552018

NCT02022007

NCT06107153

NCT00885378

NCT04521049

NCT02285985

NCT01765270

NCT01434186

NCT02284893

NCT02462369

NCT01548651

NCT01768208

NCT02471404

NCT01521312

NCT01703637

NCT02024477

NCT00770302

NCT00960076

NCT02089438

NCT00950599

NCT02280486

NCT01527747

NCT01107886

NCT00666458

NCT02481479

NCT01305551

NCT02681094

NCT01782261

NCT00683657

NCT00313313

NCT01319357

NCT01662999

NCT03714594

NCT04445714

NCT02969798

NCT02273050

NCT07033585

NCT02965443

NCT02182895

NCT01006590

NCT01660386

NCT01006603

NCT02407899

NCT02304081

NCT00614939

NCT01922817

NCT01619059

NCT02419612

NCT01204775

NCT00698932

NCT02148978

NCT02547935

NCT02742233

NCT02315495

NCT01974544

NCT01206647

NCT00374907

NCT02613897

NCT01582308

NCT01242228

NCT01646320

NCT02551874

NCT04170790

NCT00327015

NCT02243176

NCT02605772

NCT00575588

NCT01441869

NCT03169959

NCT02386943

NCT02765204

NCT02239458

NCT00918879

NCT01525225

NCT02307695

NCT00757588

NCT03933787

NCT02597101

NCT00121641

NCT03660683

NCT00121667

NCT02104739

NCT02104804

NCT00661362

NCT01960205

NCT00295633

NCT00918138

NCT01128153

NCT02917031

NCT02583438

NCT00935467

NCT00857558

NCT01267448

NCT02377388

NCT01606007

NCT02920801

Known as Saxagliptin component of qternmet ChEMBL registry synonym — accepted as the source's own label CHEMBL385517
Known as Saxagliptin hcl ChEMBL registry synonym — accepted as the source's own label CHEMBL385517
Known as Saxagliptin hydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL385517
Known as SAXAGLIPTIN HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL385517
Known as Saxagliptin hydrochloride component of kombiglyze ChEMBL registry synonym — accepted as the source's own label CHEMBL385517
Known as Saxagliptin hydrochloride component of qtern ChEMBL registry synonym — accepted as the source's own label CHEMBL385517
Known as Saxagliptin hydrochloride component of qternmet xr ChEMBL registry synonym — accepted as the source's own label CHEMBL385517
Known as Saxagliptin monohydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL385517
Known as Saxagliptin/Metformin XR FDC ClinicalTrials.gov intervention name — accepted as the source's own label NCT01305551
Known as Saxagliptina ChEMBL registry synonym — accepted as the source's own label CHEMBL385517
Known as saxagliptine “- saxagliptine (Onglyza®)” NCT02244164
Known as SBMS-477118 ChEMBL registry synonym — accepted as the source's own label CHEMBL385517
Action Inhibit “dipeptidyl peptidase-4 inhibitor saxagliptin” PMID 27402391 Jul 2016
Modality Small molecule CHEMBL385517
Route Oral “Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)” NCT00121667
Target DPP4 “dipeptidyl peptidase-4 inhibitor” PMID 27402391 Jul 2016