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sotagliflozin

Trade name: Inpefa

Small moleculeapproved

Approved

May 26, 2023

Sotagliflozin, sold under the brand name Inpefa among others, is a medication used to reduce the risk of death due to heart failure. It is an inhibitor of sodium-glucose cotransporter 1 and 2. It is taken by mouth. — Wikipedia

Clinical trial activity

58 trials · 44 clinical orgs · 1 marketing orgs

Phase 1
27
Phase 2
28
Phase 3
18
Phase 4
3

Earliest trial started Aug 1, 2009 (NCT00962065)

Timeline

2000s

  1. Jan 1, 2009

    Lexicon Pharmaceuticals — Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Lexicon Pharmaceuticals — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2015

    Lexicon Pharmaceuticals — Earliest Phase 3 Sponsor(trial)

2020s

  1. May 26, 2023

    Lexicon Pharmaceuticals — Earliest FDA Approval

  2. May 26, 2023

    Lexicon Pharmaceuticals — Marketing Organization

  3. May 26, 2023

    Lexicon Pharmaceuticals — NDA Secondary Org

  4. May 26, 2023

    Lexicon Pharmaceuticals — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedMay 26, 2023

Chemistry & pharmacology

Loading structure…

SMILES

CCOc1ccc(Cc2cc([C@@H]3O[C@H](SC)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Mol. weight
424.95 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

  • (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2h-pyran-3,4,5-triol
  • lp-802034
  • lp-802034
  • lx4211
  • lx4211
  • lx4211
  • lx-4211
  • lx-4211
  • sotagliflozin
  • sotagliflozin
  • sotagliflozin
  • sotagliflozin
  • sotagliflozin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07211802Phase 3Jul 1, 2026Abbott, Lexicon Pharmaceuticals, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), University of California, San Diego
NCT06933056Early Phase 1 (Phase 1)Sep 2, 2025Lexicon Pharmaceuticals, University of Michigan
NCT06435156Phase 2Jan 31, 2025Juvenile Diabetes Research Foundation, Lexicon Pharmaceuticals, University of Dundee
NCT06618976Phase 4Oct 31, 2024Icahn School of Medicine at Mount Sinai
NCT06217302Phase 3Oct 15, 2024Breakthrough T1D, Canadian Institutes of Health Research (CIHR), DexCom, Inc., Joslin Diabetes Center, Lexicon Pharmaceuticals, LMC Diabetes & Endocrinology Ltd., McGill University, Northwestern University, Stanford University, State University of New York, Syracuse, The Cleveland Clinic, The Kidney Foundation of Canada, University of Alberta, University of British Columbia, University of Calgary, University of Colorado, Denver, University of Michigan, University of Minnesota, University of Toronto, University of Washington, Washington University in St. Louis, Yeshiva University
NCT06433050Early Phase 1 (Phase 1)Sep 30, 2024National Heart, Lung, and Blood Institute (NHLBI), University of Pennsylvania
NCT06481891Phase 3Sep 24, 2024Lexicon Pharmaceuticals
NCT06072326Phase 2Mar 31, 2024Juvenile Diabetes Research Foundation, Lexicon Pharmaceuticals, University of Groningen
NCT06147232Phase 4Feb 29, 2024Juvenile Diabetes Research Foundation, Steno Diabetes Center Copenhagen, University of Copenhagen, University of London
NCT06082063N/AFeb 1, 2024Aarhus University, Herning Hospital, Hospital of South West Jutland, Hospitalsenhed Midt, Odense University Hospital, Randers Regional Hospital, Regionshospitalet Horsens, Steno Diabetes Center Copenhagen, University of Copenhagen, University of Southern Denmark
NCT05696366Phase 1/Phase 2 (Phase 2)Feb 28, 2023Juvenile Diabetes Research Foundation, University of California, San Diego
NCT05562063Phase 4Oct 26, 2022Icahn School of Medicine at Mount Sinai
NCT03909451Phase 1Apr 28, 2019Sanofi
NCT03776227Phase 1Jan 25, 2019Sanofi
NCT03802487Phase 1Jan 14, 2019Sanofi
NCT03761134Phase 3Nov 30, 2018Sanofi
NCT03760965Phase 3Nov 27, 2018Sanofi
NCT03521934Phase 3Jun 11, 2018Sanofi
NCT03462069Phase 2Mar 12, 2018Sanofi
NCT03386344Phase 3Feb 19, 2018Sanofi
Showing 20 of 58 trials
Page 1 / 3

Organizations

Research & Development (44)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Lexicon PharmaceuticalsFor profit292432009
SanofiFor profit232332016
Juvenile Diabetes Research FoundationAcademic/Hospital5022015
Icahn School of Medicine at Mount SinaiAcademic/Hospital2212022
Steno Diabetes Center CopenhagenAcademic/Hospital2222024
University of California, San DiegoAcademic/Hospital2222023
University of CopenhagenAcademic/Hospital2022024
University of MichiganAcademic/Hospital2122024
Aarhus UniversityAcademic/Hospital1012024
AbbottFor profit1012026
Breakthrough T1DAcademic/Hospital1012024
Canadian Institutes of Health Research (CIHR)Academic/Hospital1012024
DexCom, Inc.For profit1012024
Herning HospitalAcademic/Hospital1012024
Hospital of South West JutlandAcademic/Hospital1012024
Hospitalsenhed MidtAcademic/Hospital1012024
Joslin Diabetes CenterAcademic/Hospital1112024
LMC Diabetes & Endocrinology Ltd.Academic/Hospital1012024
McGill UniversityAcademic/Hospital1012024
National Heart, Lung, and Blood Institute (NHLBI)Government1012024
44 organizations
Page 1 / 3

Marketing (3)

OrganizationOrg typeRelationshipDate
Lexicon PharmaceuticalsFor profitMKTGMay 26, 2023
Lexicon PharmaceuticalsFor profitNDA2May 26, 2023
Lexicon PharmaceuticalsFor profitNDAMay 26, 2023