Drugs / SAXAGLIPTIN ANHYDROUS
last change Jun 2025 re-read 8 days 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 · 12 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed type 2 diabetes mellitus 4 milestones
Filed US (FDA) — type 2 diabetes mellitus 2015-02-05

“Saxagliptin/dapagliflozin FDC: filed in the US.” astrazeneca.com ↗

Filed US (FDA) — type 2 diabetes mellitus 2009-12-29

“Bristol-Myers Squibb and AstraZeneca submitted the NDA with the U.S. FDA for saxagliptin/metformin HCl extended-release tablets on December 29, 2009.” bms.com ↗

Filed EU (EMA) ONGLYZA type 2 diabetes mellitus 2008-07-01

“a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for ONGLYZA ™ (saxagliptin)” bms.com ↗

Filed US (FDA) ONGLYZA type 2 diabetes mellitus 2008-06-30

“In December, Bristol-Myers Squibb and AstraZeneca submitted an application with the U.S. Food and Drug Administration (FDA) for a fixed dose combination of ONGLYZA® (saxagliptin)” bms.com ↗

“The new drug application for ONGLYZA was submitted to the FDA on June 30, 2008” bms.com ↗

“The new drug application for ONGLYZA was submitted to the FDA on 30 June 2008” astrazeneca.com ↗

“The NDA for ONGLYZA was submitted to the FDA on June 30, 2008.” bms.com ↗

“The NDA for ONGLYZA was submitted to the FDA on 30 June 2008.” astrazeneca.com ↗

Approved Indication not stated 3 milestones
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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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 18 trials · 3 met primary
Phase 1 NCT03169959 May → Aug 2017 type 2 diabetes mellitus AstraZeneca Completed Met primary
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 Met primary
Phase 1 NCT01582308 Jun → Dec 2012 type 2 diabetes mellitus Merck Sharp & Dohme LLC Completed Met primary
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 · 1 missed
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 Missed primary
Phase 2/32 trials · 1 met primary
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 Met primary
Phase 332 trials · 23 met primary
Phase 3 NCT03199053 Oct 2017 → Feb 2023 type 2 diabetes mellitus AstraZeneca Completed Mixed
Phase 3 NCT02946632 Dec 2016 → Dec 2019 type 2 diabetes mellitus Korea University Anam Hospital Unknown Met primary
Phase 3 NCT02551874 Oct 2015 → May 2017 type 2 diabetes mellitus AstraZeneca Completed Met primary
Phase 3 NCT02419612 Aug 2015 → Aug 2017 type 2 diabetes mellitus AstraZeneca Completed Met primary
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 Met primary
Phase 3 NCT02284893 Sep 2014 → Sep 2016 type 2 diabetes mellitus AstraZeneca Completed Met primary
Phase 3 NCT02104804 May 2014 → Feb 2016 type 2 diabetes mellitus AstraZeneca Completed Met primary
Phase 3 NCT02022007 Mar 2014 → Aug 2016 glucose metabolism disease, polycystic ovary syndrome Woman's Completed Met primary
Phase 3 NCT01606007 Jul 2012 → Jan 2014 type 2 diabetes mellitus AstraZeneca Completed Met primary
Phase 428 trials · 2 met primary · 5 missed
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 Missed primary
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
Comparator or background therapy32 trials
Phase 0 NCT03933787 Comparator Jun → Jul 2018 disorder of catecholamine synthesis, sympathetic nervous system disorder Eric Grouzmann Completed No outcome recorded
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 Missed primary
Phase 2 NCT01782261 Comparator Feb 2012 → Feb 2015 type 1 diabetes mellitus Medical University of Graz Completed No outcome recorded
Phase 3 NCT06107153 Comparator Nov 2023 → Nov 2024 type 2 diabetes mellitus University of Basrah Completed No outcome recorded

News releases announcing trial results or a regulatory action · 57

DateIssuerRelease
2023-08-01 Glenmark Pharmaceuticals Ltd. India Regulatory Glenmark Pharmaceuticals receives ANDA approval for Saxagliptin Tablets, 2.5 mg and 5 mg glenmarkpharma.com ↗
Glenmark Pharmaceuticals receives ANDA approval for Saxagliptin Tablets, 2.5 mg and 5 mg
2023-02-17 Glenmark Pharmaceuticals Ltd. India Regulatory Glenmark Pharmaceuticals receives 2nd ANDA tentative approval for Saxagliptin Tablets, 2.5 mg and 5 mg glenmarkpharma.com ↗
Glenmark Pharmaceuticals receives 2nd ANDA tentative approval for Saxagliptin Tablets, 2.5 mg and 5 mg
2019-11-15 AstraZeneca Regulatory Qtrilmet approved in the EU for the treatment of type-2 diabetes astrazeneca.com ↗
AstraZeneca today announced that the European Commission (EC) has approved Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets to improve glycaemic control in adults with type-2 diabetes (T2D).
2019-05-03 AstraZeneca Regulatory Qternmet XR approved in the US for the treatment of type-2 diabetes astrazeneca.com ↗
The US Food and Drug Administration (FDA) has approved Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) extended release tablets as an oral adjunct treatment to diet and exercise to improve glycaemic control in adults with type-2 diabetes (T2D).
2017-02-28 AstraZeneca Regulatory FDA approves once-daily Qtern (dapagliflozin and saxagliptin) tablets for adults with type-2 diabetes astrazeneca.com ↗
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily Qtern (10mg dapagliflozin and 5mg saxagliptin) for the treatment of type-2 diabetes.
2016-07-19 AstraZeneca Regulatory AstraZeneca receives approval in the EU for Qtern (saxagliptin and dapagliflozin) for treatment of Type 2 diabetes astrazeneca.com ↗
AstraZeneca today announced that the European Commission (EC) has approved Qtern (saxagliptin/dapagliflozin) tablets for the treatment of type 2 diabetes in all 28 EU member countries plus Iceland, Liechtenstein and Norway.
2016-05-27 AstraZeneca Regulatory Positive CHMP opinion in EU for saxa/dapa (saxagliptin and dapagliflozin) for adults with type-2 diabetes astrazeneca.com ↗
27 May 2016 AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion, recommending the approval of saxa/dapa (saxagliptin and dapagliflozin) tablets for the treatment of adults with type-2 diabetes.
2015-10-16 AstraZeneca Regulatory AstraZeneca receives Complete Response Letter from US FDA for saxagliptin / dapagliflozin fixed-dose-combination astrazeneca.com ↗
The CRL states that more clinical data are required to support the application.
2015-06-08 AstraZeneca Results New real-world data analysis finds no evidence of increased risk of hospitalisation for heart failure with saxagliptin compared with sitagliptin astrazeneca.com ↗
AstraZeneca today announced results from an observational, retrospective study which found no evidence of increased risk of hospitalisation for heart failure (hHF) with saxagliptin, compared with sitagliptin, both of which are dipeptidyl peptidase-4 (DPP-4) inhibitors, in patients with type 2 diabetes.
2015-06-06 AstraZeneca Results AstraZeneca presents new positive phase III data on triple therapy approach with dapagliflozin, saxagliptin and metformin for the treatment of type 2 diabetes astrazeneca.com ↗
Data in oral presentation demonstrate that the investigational combination of dapagliflozin, saxagliptin and metformin resulted in statistically significant reductions in HbA1c in patients uncontrolled on saxagliptin and metformin
2015-04-14 AstraZeneca Regulatory FDA Advisory Committee reviews SAVOR outcomes study results for ONGLYZA® (saxagliptin) and KOMBIGLYZE® XR (saxagliptin and metformin HCI extended-release) astrazeneca.com ↗
In addition, 14 out of 15 Committee members recommended that the FDA supplement the products’ labeling to add new safety information, with one vote to withdraw saxagliptin from the market.
2014-05-15 AstraZeneca Results Continuing progress in accelerating late stage pipeline reinforces confidence in AstraZeneca’s strategy as an independent company astrazeneca.com ↗
Positive results from Phase III study of saxagliptin/dapagliflozin combination in patients with type 2 diabetes inadequately controlled on metformin and outlines future development plans for the oral antidiabetic franchise.

All press releases naming this drug 60 releases

DateIssuerRelease

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, Onglyza” NCT02551874 ↗

“Onglyza” NCT02243176 ↗

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 Saxagliptin” NCT03700801 ↗

“saxagliptin (2.5-5mg daily)” NCT02528019 ↗

“Drug: Saxagliptin” NCT03199053 ↗

NCT02022007 ↗

Show 97 more sources

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