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chlorthalidone

Trade name: Hygroton

Small moleculeapproved

Approved

Apr 7, 1960

Chlorthalidone is a diuretic that is used for the treatment of hypertansion and edema. The drug is approved by FDA and either prescribed alone (Chlorthalidone trade name) or in combination with atenolol (Tenoretic trade name), azilsartan kamedoxomil (Edarbyclor) and clonidin (Clorpres). The mechanism of action is associated with activation of sodium and chloride renal excretion. — NCATS

Clinical trial activity

76 trials · 76 clinical orgs · 63 marketing orgs

Phase 1
10
Phase 2
38
Phase 3
31
Phase 4
20

Earliest trial started Sep 1, 1980 (NCT00000499)

Timeline

1960s

  1. Apr 7, 1960

    Earliest FDA Approval

  2. Apr 7, 1960

    Sanofi-Aventis — NDA Secondary Org

1970s

  1. Sep 3, 1974

    Boehringer Ingelheim — Marketing Organization

  2. Sep 3, 1974

    Boehringer Ingelheim — NDA Secondary Org

1980s

  1. Jan 1, 1980

    Earliest Phase 2 Sponsor(trial)

  2. Feb 26, 1981

    Mylan — Marketing Organization

  3. Mar 5, 1981

    Mutual Pharmaceutical — Marketing Organization

  4. Mar 6, 1981

    Abbott — Marketing Organization

  5. Mar 11, 1981

    Lumara Health — Marketing Organization

  6. Apr 3, 1981

    DAVA Pharmaceuticals — Marketing Organization

  7. Apr 13, 1981

    Ivax — Marketing Organization

  8. May 1, 1981

    Sandoz — Marketing Organization

  9. May 1, 1981

    AiPing Pharm Inc — Marketing Organization

  10. Aug 19, 1981

    Watson Pharmaceuticals — Marketing Organization

  11. Aug 19, 1981

    Ani Pharmaceuticals — Marketing Organization

  12. Jul 14, 1982

    Vanguard — Marketing Organization

  13. Feb 9, 1983

    Superpharm — Marketing Organization

  14. Jan 1, 1984

    Earliest Phase 3 Sponsor(trial)

  15. Jun 8, 1984

    Alvogen — NDA Secondary Org

  16. Jun 8, 1984

    Alvogen — Marketing Organization

  17. Jun 8, 1984

    TWi Biotechnology, Inc. — NDA Secondary Org

  18. Jul 13, 1984

    Monarch Pharmaceuticals — Marketing Organization

  19. May 30, 1985

    Cosette — Marketing Organization

  20. May 30, 1985

    G & W Laboratories Inc. — Marketing Organization

  21. May 30, 1985

    ACP Nimble — Marketing Organization

  22. Sep 19, 1985

    Barr Laboratories — Marketing Organization

  23. Jul 21, 1986

    Sun Pharmaceuticals — Marketing Organization

  24. Feb 9, 1987

    Natco Pharma — Marketing Organization

  25. Dec 16, 1987

    Par Pharmaceuticals — Marketing Organization

  26. Dec 20, 1988

    Casper Pharma LLC — NDA Secondary Org

1990s

  1. Oct 31, 1993

    Aurobindo Pharma — Marketing Organization

  2. Sep 24, 1997

    Pliva — Marketing Organization

  3. May 14, 1998

    Nostrum Laboratories — Marketing Organization

2000s

  1. Oct 27, 2005

    King Pharmaceuticals — Marketing Organization

2010s

  1. Dec 20, 2011

    Azurity — NDA Secondary Org

  2. Dec 20, 2011

    Arbor Pharmaceuticals — Marketing Organization

  3. Jan 1, 2012

    Earliest Phase 1 Sponsor(trial)

  4. Mar 30, 2017

    RiconPharma — Marketing Organization

  5. Mar 30, 2017

    Novast Labs — Marketing Organization

  6. Mar 30, 2017

    Ingenus Pharmaceuticals — Marketing Organization

  7. May 24, 2018

    Umedica Labs Pvt Ltd — Marketing Organization

  8. Oct 12, 2018

    Appco Pharma — Marketing Organization

  9. Oct 12, 2018

    Arise Pharmaceuticals — Marketing Organization

  10. Oct 12, 2018

    Dr. Reddy's Laboratories — Marketing Organization

  11. Feb 26, 2019

    Chartwell Pharmaceuticals — Marketing Organization

  12. Feb 26, 2019

    Invatech — Marketing Organization

  13. Feb 26, 2019

    VistaPharm, Inc. — Marketing Organization

  14. Feb 26, 2019

    Athem — Marketing Organization

  15. Mar 8, 2019

    Zydus Discovery DMCC — Marketing Organization

  16. Jul 1, 2019

    Amneal Pharmaceuticals — Marketing Organization

  17. Aug 6, 2019

    Unichem — Marketing Organization

2020s

  1. Feb 11, 2020

    Alkem Labs Ltd — Marketing Organization

  2. Nov 27, 2020

    Ajanta Pharma Ltd — Marketing Organization

  3. Oct 25, 2021

    Novitium Pharma — Marketing Organization

  4. Jan 25, 2022

    Sunny Pharmtech Inc — Marketing Organization

  5. Feb 9, 2022

    Inventia Hlthcare — Marketing Organization

  6. Feb 24, 2022

    Precision Dose — Marketing Organization

  7. Feb 24, 2022

    PHARMOBEDIENT — Marketing Organization

  8. Aug 4, 2022

    Mankind Pharma — Marketing Organization

  9. Aug 26, 2022

    Alembic — Marketing Organization

  10. Nov 12, 2024

    IPCA Laboratories Ltd. — Marketing Organization

  11. Mar 17, 2025

    PRM Pharma, LLC — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewApr 7, 1960

Chemistry & pharmacology

Loading structure…

SMILES

NS(=O)(=O)C1=C(Cl)C=CC(=C1)C2(O)NC(=O)C3=CC=CC=C23
Mol. weight
338.766 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

  • 1-keto-3-(3'-sulfamyl-4'-chlorophenyl)-3-hydroxyisoindoline
  • 1-keto-3-(3'-sulfamyl-4'-chlorophenyl)-3-hydroxyisoindoline
  • 1-oxo-3-(3-sulfamyl-4-chlorophenyl)-3-hydroxyisoindoline
  • 1-oxo-3-(3-sulfamyl-4-chlorophenyl)-3-hydroxyisoindoline
  • 2-chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)benzenesulfonamide
  • 2-chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)benzenesulfonamide
  • 2-chloro-5-(2,3-dihydro-1-hydroxy-3-oxo-1h-isoindol-1-yl)benzenesulfonamide
  • 2-chloro-5-(2,3-dihydro-1-hydroxy-3-oxo-1h-isoindol-1-yl)benzenesulfonamide
  • 3-(4'-chloro-3'-sulfamoylphenyl)-3-hydroxyphthalimidine
  • 3-(4'-chloro-3'-sulfamoylphenyl)-3-hydroxyphthalimidine
  • 3-hydroxy-3-(4-chloro-3-sulfamylphenyl)phthalimidine
  • 3-hydroxy-3-(4-chloro-3-sulfamylphenyl)phthalimidine
  • chlorotalidone
  • chlorphthalidolone
  • chlorphthalidolone
  • chlorphthalidolone
  • chlortalidone
  • chlortalidone
  • chlortalidone
  • chlortalidone
  • chlortalidone
  • chlortalidone
  • chlorthalidon
  • chlorthalidone
  • chlorthalidone
  • chlorthalidone
  • chlorthalidone
  • chlorthalidone
  • chlorthalidone
  • chlorthalidone
  • chlorthalidone
  • clortalidone
  • clortalidone
  • clortalidone
  • clortalidone
  • clortalidone
  • clortalidone
  • g-33182
  • g-33182
  • hygroton
  • hygroton
  • hygroton
  • phthalamodine
  • phthalamodine
  • phthalamudine
  • phthalamudine
  • phthalamudine
  • thalitone
  • thalitone

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07238400Phase 2Dec 1, 2025Harvard University, National Heart, Lung, and Blood Institute (NHLBI)
NCT07225764Phase 4Oct 23, 2025Icahn School of Medicine at Mount Sinai
NCT06287580Early Phase 1 (Phase 1)Aug 15, 2024The University of Texas, Dallas
NCT06111885Phase 2Apr 30, 2024University of Bern
NCT05976438N/AAug 31, 2023University of Cambridge, University of London
NCT05920005Phase 3Aug 22, 2023Albert Einstein Israelite Hospital, Libbs Farmacêutica LTDA
NCT05915286Phase 4May 29, 2023University of Alberta
NCT05593055Phase 4Apr 30, 2023Harvard University
NCT05275907Phase 4Jul 12, 2022American Society for Transplantation, National Heart, Lung, and Blood Institute (NHLBI), Northwestern University
NCT05411991Phase 4Jun 12, 2022Free University of Brussels, Hasselt University, Roche
NCT05370599Phase 2/Phase 3 (Phase 3)Apr 15, 2022University of California, San Francisco
NCT05222191Phase 2Feb 1, 2022Department of Veteran Affairs, Indiana University
NCT05077475Phase 1Sep 24, 2021Aju Pharm
NCT05077462Phase 1Sep 17, 2021Aju Pharm
NCT04927299Phase 3Jun 30, 2021CICMEX Centro de Investigación Clínica de México, Hospital Hispano S.A. de C.V., Instituto de Investigacion de las Alteraciones del Crecimiento, Desarrollo y Enfermedades Metabolicas, Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-GDL), Laboratorios Silanes S.A. de C.V.
NCT04757532Phase 1Dec 3, 2020Institut Hospital del Mar d'Investigacions Mèdiques
NCT04519164Phase 4Dec 1, 2020Harvard University
NCT04192110Phase 4Apr 1, 2020Department of Veteran Affairs
NCT03325114Phase 2Jul 1, 2019National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Rochester
NCT03928145Phase 3Jun 30, 2019Federal University of Health Science of Porto Alegre, Federal University of Rio Grande do Sul
Showing 20 of 76 trials
Page 1 / 4

Organizations

Research & Development (76)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Heart, Lung, and Blood Institute (NHLBI)Government10531980
TakedaFor profit101012007
The University of Texas, DallasAcademic/Hospital5341984
Department of Veteran AffairsGovernment4332014
EMS S/AFor profit4412016
Federal University of Rio Grande do SulAcademic/Hospital4312010
University of Alabama, BirminghamAcademic/Hospital4131980
Hanmi PharmaceuticalFor profit3332014
Harvard UniversityAcademic/Hospital3322020
Indiana UniversityAcademic/Hospital3322012
National Institute on Aging (NIA)Government3021980
Seoul National UniversityAcademic/Hospital3132014
University of CambridgeAcademic/Hospital3222014
Yuhan Pharmaceutical CompanyFor profit3312014
Aju PharmFor profit2212021
Chonbuk National UniversityAcademic/Hospital2012015
Creighton UniversityAcademic/Hospital2212013
Government of BrazilGovernment2012010
Laboratorios Silanes S.A. de C.V.For profit2222019
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government2021999
76 organizations
Page 1 / 4

Marketing (71)

OrganizationOrg typeRelationshipDate
ACP NimbleFor profitMKTGMay 30, 1985
AbbottFor profitMKTGMar 6, 1981
AiPing Pharm IncFor profitMKTGMay 1, 1981
Ajanta Pharma LtdFor profitMKTGNov 27, 2020
AlembicFor profitMKTGAug 26, 2022
Alkem Labs LtdFor profitMKTGFeb 11, 2020
AlvogenFor profitNDA2Jun 8, 1984
AlvogenFor profitMKTGJun 8, 1984
AlvogenFor profitSYNJun 8, 1984
Amneal PharmaceuticalsFor profitMKTGJul 1, 2019
Ani PharmaceuticalsFor profitSYNAug 19, 1981
Ani PharmaceuticalsFor profitMKTGAug 19, 1981
Appco PharmaFor profitMKTGOct 12, 2018
Appco PharmaFor profitSYNOct 12, 2018
Arbor PharmaceuticalsFor profitMKTGDec 20, 2011
Arise PharmaceuticalsFor profitMKTGOct 12, 2018
Ascot PharmaceuticalsFor profitMKTG—
AthemFor profitMKTGFeb 26, 2019
Aurobindo PharmaFor profitMKTGOct 31, 1993
AzurityFor profitNDA2Dec 20, 2011
Barr LaboratoriesFor profitMKTGSep 19, 1985
Boehringer IngelheimFor profitMKTGSep 3, 1974
Boehringer IngelheimFor profitNDA2Sep 3, 1974
Casper Pharma LLCFor profitNDA2Dec 20, 1988
Chartwell PharmaceuticalsFor profitMKTGFeb 26, 2019
CosetteFor profitMKTGMay 30, 1985
DAVA PharmaceuticalsFor profitMKTGApr 3, 1981
Dow ChemicalFor profitMKTG—
Dr. Reddy's LaboratoriesFor profitMKTGOct 12, 2018
G & W Laboratories Inc.For profitMKTGMay 30, 1985
GeigyFor profitNDA—
IPCA Laboratories Ltd.For profitMKTGNov 12, 2024
Ingenus PharmaceuticalsFor profitMKTGMar 30, 2017
InvatechFor profitMKTGFeb 26, 2019
InvatechFor profitSYNFeb 26, 2019
Inventia HlthcareFor profitMKTGFeb 9, 2022
IvaxFor profitMKTGApr 13, 1981
King PharmaceuticalsFor profitMKTGOct 27, 2005
Lumara HealthFor profitMKTGMar 11, 1981
Mankind PharmaFor profitMKTGAug 4, 2022
Monarch PharmaceuticalsFor profitMKTGJul 13, 1984
Mutual PharmaceuticalFor profitMKTGMar 5, 1981
MylanFor profitMKTGFeb 26, 1981
Natco PharmaFor profitMKTGFeb 9, 1987
Nostrum LaboratoriesFor profitMKTGMay 14, 1998
NovartisFor profitNDA2—
Novast LabsFor profitMKTGMar 30, 2017
Novitium PharmaFor profitMKTGOct 25, 2021
PHARMOBEDIENTFor profitMKTGFeb 24, 2022
PRM Pharma, LLCFor profitMKTGMar 17, 2025
Par PharmaceuticalsFor profitMKTGDec 16, 1987
PlivaFor profitMKTGSep 24, 1997
Precision DoseFor profitMKTGFeb 24, 2022
Puracap PharmaceuticalFor profitMKTG—
RiconPharmaFor profitMKTGMar 30, 2017
SandozFor profitMKTGMay 1, 1981
Sanofi-AventisFor profitNDA2Apr 7, 1960
Sun PharmaceuticalsFor profitMKTGJul 21, 1986
Sunny Pharmtech IncFor profitMKTGJan 25, 2022
SuperpharmFor profitMKTGFeb 9, 1983
TWi Biotechnology, Inc.For profitNDA2Jun 8, 1984
Umedica Labs Pvt LtdFor profitMKTGMay 24, 2018
Umedica Labs Pvt LtdFor profitSYNMay 24, 2018
UnichemFor profitMKTGAug 6, 2019
UnichemFor profitSYNAug 6, 2019
Upsher-Smith LaboratoriesFor profitMKTG—
VanguardFor profitMKTGJul 14, 1982
VistaPharm, Inc.For profitMKTGFeb 26, 2019
Warner ChilcottFor profitMKTG—
Watson PharmaceuticalsFor profitMKTGAug 19, 1981
Zydus Discovery DMCCFor profitMKTGMar 8, 2019