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ertugliflozin

Trade name: Steglatro

Small moleculeapproved

Approved

Dec 19, 2017

Ertugliflozin (PF-04971729) is a potent and selective sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor incorporating a unique dioxa-bicyclo[3.2.1]octane (bridged ketal) ring system. SGLT2 has become an important therapeutic target and several SGLT2-selective inhibitors are either approved or in clinical development for the management of blood glucose in patients with type 2 diabetes. Ertugliflozin demonstrated robust urinary glucose excretion in rats and an excellent preclinical safety profile. It was announced that FDA and EMA filing acceptances of three marketing applications for ertugliflozin-containing medicines for adults with type 2 diabetes. — NCATS

Clinical trial activity

38 trials · 28 clinical orgs · 5 marketing orgs

Phase 1
9
Phase 2
18
Phase 3
14
Phase 4
10

Earliest trial started Oct 1, 2009 (NCT00989079)

Timeline

2000s

  1. Jan 1, 2009

    Merck — Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Merck — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2013

    Merck — Earliest Phase 3 Sponsor(trial)

  3. Dec 19, 2017

    Earliest FDA Approval

  4. Dec 19, 2017

    Merck — NDA Secondary Org

  5. Dec 22, 2017

    Merck — First NDA Organization

  6. Dec 22, 2017

    Merck — NDA Organization

2020s

  1. Apr 4, 2023

    ZENARA — Marketing Organization

  2. Jul 13, 2023

    Aurobindo Pharma — Marketing Organization

  3. Apr 17, 2024

    Hetero Labs Ltd — Marketing Organization

  4. Jan 21, 2025

    Hikma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedDec 19, 2017

Chemistry & pharmacology

Loading structure…

SMILES

CCOC1=CC=C(CC2=C(Cl)C=CC(=C2)[C@]34OC[C@](CO)(O3)[C@@H](O)[C@H](O)[C@H]4O)C=C1
Mol. weight
436.883 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-hydroxymethyl-6,8-dioxabicyclo(3.2.1)octane-2,3,4-triol
  • ertugliflozin
  • ertugliflozin
  • ertugliflozin
  • ertugliflozin
  • ertugliflozin
  • ertugliflozin
  • ertugliflozin
  • ertugliflozin l-pyroglutamic acid
  • ertugliflozin l-pyroglutamic acid/ metformin hydrochloride
  • ertugliflozin l-pyroglutamic acid / sitagliptin phosphate monohydrate
  • pf04971729
  • pf 04971729
  • pf-04971729
  • pf-04971729
  • pf-04971729
  • pf-04971729-00
  • pf-04971729-00

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06983054Phase 4Jul 25, 2023Free University of Amsterdam, University of Colorado
NCT05644717Phase 4Mar 1, 2023Getz Pharma, Shifa International Hospital
NCT05612594Phase 4Nov 30, 2022Case Western Reserve University, Yale University
NCT05152940Phase 4Feb 28, 2022Icahn School of Medicine at Mount Sinai
NCT04600921Phase 3Jun 24, 2021Johannes Kepler University, KH Elisabethinen Linz, Klinik Ottakring, Klinikum Klagenfurt, Klinikum Wiener Neustadt, Medical University Innsbruck, Medical University of Graz, Medical University of Vienna
NCT04490681Phase 3Aug 31, 2020Yonsei University
NCT04438213Phase 2Jul 31, 2020Merck, Yale University
NCT04231331Phase 3Mar 31, 2020Merck, University of Ulsan
NCT04167761Phase 4Dec 1, 2019Merck, Stanford University
NCT04029480Phase 3Oct 21, 2019Merck, Pfizer
NCT04071626Phase 4Oct 1, 2019Case Western Reserve University
NCT04027530Phase 4Sep 30, 2019Free University of Amsterdam
NCT03813316Phase 4May 1, 2019LMC Diabetes & Endocrinology Ltd., Merck, Syreon Corporation
NCT03717194Phase 3Apr 1, 2019Merck, Seoul National University
NCT03917758N/AOct 10, 2018University of Turin
NCT03640221Phase 4Sep 1, 2018Cedars-Sinai Medical Center, Merck
NCT03631134Phase 4Aug 15, 2018Nanjing Medical University
NCT03416270Phase 2May 7, 2018Merck, University of Groningen, University of Toronto
NCT02630706Phase 3Dec 16, 2015Merck, Pfizer
NCT02411929Phase 1Oct 1, 2014Merck, Pfizer
Showing 20 of 38 trials
Page 1 / 2

Organizations

Research & Development (28)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerckFor profit282142009
PfizerFor profit21032009
Case Western Reserve UniversityAcademic/Hospital2112019
Free University of AmsterdamAcademic/Hospital2212019
Yale UniversityAcademic/Hospital2222020
Cedars-Sinai Medical CenterAcademic/Hospital1112018
Getz PharmaFor profit1112023
Icahn School of Medicine at Mount SinaiAcademic/Hospital1112022
Johannes Kepler UniversityAcademic/Hospital1012021
KH Elisabethinen LinzAcademic/Hospital1012021
Klinik OttakringAcademic/Hospital1012021
Klinikum KlagenfurtAcademic/Hospital1012021
Klinikum Wiener NeustadtAcademic/Hospital1012021
LMC Diabetes & Endocrinology Ltd.Academic/Hospital1112019
Medical University InnsbruckAcademic/Hospital1012021
Medical University of GrazAcademic/Hospital1112021
Medical University of ViennaAcademic/Hospital1012021
Nanjing Medical UniversityAcademic/Hospital1112018
Seoul National UniversityAcademic/Hospital1112019
Shifa International HospitalAcademic/Hospital1012023
28 organizations
Page 1 / 2

Marketing (8)

OrganizationOrg typeRelationshipDate
Aurobindo PharmaFor profitMKTGJul 13, 2023
Hetero Labs LtdFor profitSYNSep 17, 2024
Hetero Labs LtdFor profitMKTGApr 17, 2024
HikmaFor profitMKTGJan 21, 2025
MerckFor profitNDA2Dec 19, 2017
MerckFor profitNDADec 22, 2017
MerckFor profitSYNDec 19, 2017
ZENARAFor profitMKTGApr 4, 2023