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indapamide

Trade name: lozol

Small moleculeapproved

Approved

Jul 6, 1983

Indapamide is an antihypertensive and a diuretic. It contains both a polar sulfamoyl chlorobenzamide moiety and a lipid- soluble methylindoline moiety. Indapamide blocks the slow component of delayed rectifier potassium current (IKs) without altering the rapid component (IKr) or the inward rectifier current. Specifically it blocks or antagonizes the action the proteins KCNQ1 and KCNE1. Indapamide is also thought to stimulate the synthesis of the vasodilatory hypotensive prostaglandin PGE2. Indapamide is used for the treatment of hypertension, alone or in combination with other antihypertensive drugs, as well as for the treatment of salt and fluid retention associated with congestive heart failure or edema from pregnancy (appropriate only in the management of edema of pathologic origin during pregnancy when clearly needed). Also used for the management of edema as a result of various causes. — NCATS

Clinical trial activity

49 trials · 61 clinical orgs · 12 marketing orgs

Phase 1
4
Phase 2
21
Phase 3
14
Phase 4
19

Earliest trial started Mar 1, 2000 (NCT00295542)

Timeline

1980s

  1. Jul 6, 1983

    Sanofi-Aventis — Earliest FDA Approval

  2. Jul 6, 1983

    Sanofi-Aventis — NDA Organization

  3. Jul 6, 1983

    Sanofi-Aventis — NDA Secondary Org

1990s

  1. Jul 27, 1995

    Ani Pharmaceuticals — Marketing Organization

  2. Mar 27, 1996

    Mylan — Marketing Organization

  3. Mar 27, 1996

    Rising Pharmaceuticals — Marketing Organization

  4. May 23, 1996

    Chartwell Pharmaceuticals — Marketing Organization

  5. May 23, 1996

    Fosun — Marketing Organization

  6. Jun 17, 1996

    Actavis — Marketing Organization

  7. Sep 26, 1996

    Watson Pharmaceuticals — Marketing Organization

  8. Jul 23, 1998

    Aurobindo Pharma — Marketing Organization

  9. Dec 4, 1998

    Amerigen Pharmaceuticals — Marketing Organization

2000s

  1. Jan 1, 2001

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2012

    Earliest Phase 2 Sponsor(trial)

2020s

  1. Jan 1, 2021

    Earliest Phase 1 Sponsor(trial)

  2. Jun 5, 2025

    Azurity — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedJul 6, 1983

Chemistry & pharmacology

Loading structure…

SMILES

CC1CC2=CC=CC=C2N1NC(=O)C3=CC(=C(Cl)C=C3)S(N)(=O)=O
Mol. weight
365.835 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • cardide sr
  • ethibide xl
  • flupamid
  • indaflex
  • indamide
  • indamol
  • indapamid
  • indapamid
  • indapamida
  • indapamida
  • indapamide
  • indapamide
  • indapamide
  • indapamide
  • indapamide
  • indapamide
  • indapamide
  • indapamide
  • indapamide
  • (+/-)-indapamide
  • indapamide hemihydrate
  • indapamidum
  • indapamidum
  • indaxa 2.5
  • indipamide
  • indipam xl
  • lozol
  • lozol
  • lozol
  • mapemid xl
  • metindamide
  • metindamide
  • metindamide
  • metindamide
  • metindamide
  • metindamide
  • natrilix
  • natrilix
  • natrilix sr
  • nindaxa 2.5
  • opumide 2.5
  • rawel xl
  • tensaid xl
  • varbim xl
  • veroxil

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07034677Phase 4Aug 31, 2025Aarhus University
NCT06826872Phase 2Jun 12, 2024Shin Poong Pharmaceuticals
NCT06111885Phase 2Apr 30, 2024University of Bern
NCT06275763Phase 4Oct 20, 2023Instituto Nacional de Cardiologia de Laranjeiras, Medical University of Warsaw
NCT06012487Phase 1Sep 1, 2023Cedars-Sinai Medical Center
NCT07259733N/AJul 15, 2023Instituto Dante Pazzanese de Cardiologia, Servier
NCT05940909Phase 1Jun 24, 2023Ligand Research, LLC, Pharmtechnology LLC
NCT05878561Phase 3Nov 9, 2022Boryung Pharmaceutical Company
NCT05503953Phase 3Sep 5, 2022Ahn-Gook Pharmaceuticals Co.,Ltd, Daehwa Pharmaceutical Co., Ltd.
NCT05683301Phase 4Aug 30, 2022All India Institute of Medical Sciences, Government of India, Imperial College London
NCT05110898Phase 3Apr 1, 2022Brainfarma Industria Química e Farmacêutica S/A
NCT06212648Phase 2Mar 25, 2022Shin Poong Pharmaceuticals
NCT05294484Phase 4Mar 15, 2022Ain Shams University, Assiut University
NCT06500689Phase 3Dec 30, 2021Shenzhen Salubris Pharmaceuticals Co., Ltd.
NCT05103332Phase 2Oct 26, 2021Alnylam Pharmaceuticals
NCT05013463Phase 2Sep 1, 2021University of Calgary
NCT04518293Phase 3Jun 26, 2021George Medicines PTY Limited, University of New South Wales
NCT04518306Phase 3Jun 6, 2021George Medicines PTY Limited, University of New South Wales
NCT05470764Phase 1May 30, 2021Darnitsa Pharmaceutical Company, International Partnership for Microbicides
NCT05464745Phase 1May 19, 2021Darnitsa Pharmaceutical Company, International Partnership for Microbicides
Showing 20 of 49 trials
Page 1 / 3

Organizations

Research & Development (61)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
University of New South WalesAcademic/Hospital6432001
ServierFor profit4132000
University of SydneyAcademic/Hospital4032001
EMS S/AFor profit3312017
Ahn-Gook Pharmaceuticals Co.,LtdFor profit2212021
Boryung Pharmaceutical CompanyFor profit2212017
Darnitsa Pharmaceutical CompanyFor profit2212021
George Medicines PTY LimitedFor profit2212021
International Partnership for MicrobicidesAcademic/Hospital2012021
Shin Poong PharmaceuticalsFor profit2212022
University of Roma La SapienzaAcademic/Hospital2212016
Aarhus UniversityAcademic/Hospital1112025
Access Community Health NetworkAcademic/Hospital1012019
Ain Shams UniversityAcademic/Hospital1112022
All India Institute of Medical SciencesAcademic/Hospital1012022
Alnylam PharmaceuticalsFor profit1112021
Assiut UniversityAcademic/Hospital1012022
Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'AragonaAcademic/Hospital1112014
Brainfarma Industria Química e Farmacêutica S/AFor profit1112022
British Heart FoundationAcademic/Hospital1012000
61 organizations
Page 1 / 4

Marketing (15)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGJun 17, 1996
Amerigen PharmaceuticalsFor profitMKTGDec 4, 1998
Ani PharmaceuticalsFor profitMKTGJul 27, 1995
Ani PharmaceuticalsFor profitSYNJul 27, 1995
Aurobindo PharmaFor profitMKTGJul 23, 1998
AzurityFor profitNDA2Jun 5, 2025
Chartwell PharmaceuticalsFor profitMKTGMay 23, 1996
FosunFor profitMKTGMay 23, 1996
MylanFor profitMKTGMar 27, 1996
MylanFor profitSYNJul 23, 1998
Rising PharmaceuticalsFor profitMKTGMar 27, 1996
Sanofi-AventisFor profitNDAJul 6, 1983
Sanofi-AventisFor profitNDA2Jul 6, 1983
TevaFor profitMKTG—
Watson PharmaceuticalsFor profitMKTGSep 26, 1996