torsemide

Trade name: demadex

Small moleculeapproved

Approved

Aug 23, 1993

Torasemide is a pyridine-sulfonylurea type loop diuretic mainly used for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Also for the treatment of hypertension alone or in combination with other antihypertensive agents. It is also used at low doses for the management of hypertension. It is marketed under the brand name Demadex. Torasemide inhibits the Na+/K+/2Cl--carrier system (via interference of the chloride binding site) in the lumen of the thick ascending portion of the loop of Henle, resulting in a decrease in reabsorption of sodium and chloride. This results in an increase in the rate of delivery of tubular fluid and electrolytes to the distal sites of hydrogen and potassium ion secretion, while plasma volume contraction increases aldosterone production. The increased delivery and high aldosterone levels promote sodium reabsorption at the distal tubules, and by increasing the delivery of sodium to the distal renal tubule, torasemide indirectly increases potassium excretion via the sodium-potassium exchange mechanism. Torasemide's effects in other segments of the nephron have not been demonstrated. Thus torasemide increases the urinary excretion of sodium, chloride, and water, but it does not significantly alter glomerular filtration rate, renal plasma flow, or acid-base balance. Torasemide's effects as a antihypertensive are due to its diuretic actions. By reducing extracellular and plasma fluid volume, blood pressure is reduced temporarily, and cardiac output also decreases. — NCATS

Clinical trial activity

42 trials · 71 clinical orgs · 20 marketing orgs

Phase 1
12
Phase 2
11
Phase 3
7
Phase 4
14

Earliest trial started Mar 1, 2000 (NCT00295542)

Timeline

1990s

  1. Aug 23, 1993

    Mylan — Earliest FDA Approval

  2. Aug 23, 1993

    Roche — NDA Secondary Org

  3. Aug 23, 1993

    Mylan — NDA Secondary Org

  4. Aug 23, 1993

    Mylan — NDA Organization

2000s

  1. Jan 1, 2001

    Par Pharmaceuticals — Earliest Phase 1 Sponsor(trial)

  2. May 14, 2002

    Teva — Marketing Organization

  3. May 27, 2003

    Par Pharmaceuticals — Marketing Organization

  4. May 27, 2003

    Strides Pharma Science — Marketing Organization

  5. May 30, 2003

    Pliva — Marketing Organization

  6. Mar 1, 2005

    West-Ward Pharmaceutical — Marketing Organization

  7. Mar 1, 2005

    Hikma — Marketing Organization

  8. May 31, 2005

    Apotex — Marketing Organization

  9. May 31, 2005

    Corepharma — Marketing Organization

  10. May 31, 2005

    Impax Laboratories — Marketing Organization

  11. Oct 17, 2007

    Aurobindo Pharma — Marketing Organization

  12. Feb 26, 2008

    Sun Pharmaceuticals — Marketing Organization

  13. Jan 27, 2009

    Hetero Labs Ltd — Marketing Organization

2010s

  1. Apr 21, 2010

    Lutipold — Marketing Organization

  2. Apr 21, 2010

    Sankyo — Marketing Organization

  3. Apr 21, 2010

    Daiichi Sankyo — Marketing Organization

  4. Mar 22, 2011

    Vintage — Marketing Organization

  5. Jan 1, 2016

    Earliest Phase 2 Sponsor(trial)

  6. Jan 1, 2018

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Jun 14, 2021

    Sarfez Pharmaceuticals, Inc. — Marketing Organization

  2. Jun 14, 2021

    Sarfe Pharms — Marketing Organization

  3. Jun 14, 2021

    Sarfe Pharms — NDA Secondary Org

Indications

Mechanism of action

Approval history

  • approvedAug 23, 1993

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)NC(=O)NS(=O)(=O)C1=CN=CC=C1NC2=CC=CC(C)=C2
Mol. weight
348.42 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Sources

Also known as

  • 1-isopropyl-3-((4-(3-methylphenylamino)pyridine)-3-sulfonyl)urea
  • 1-isopropyl-3-((4-m-toluidino-3-pyridyl)sulfonyl)urea
  • 1-isopropyl-3-((4-m-toluidino-3-pyridyl)sulfonyl)urea
  • 1-isopropyl-3-((4-m-toluidino-3-pyridyl)sulfonyl)urea
  • ac4464
  • ac4464
  • ac-4464
  • ac-4464
  • bm-02015
  • bm-02015
  • demadex
  • demadex
  • demadex
  • demadex
  • demadex
  • luprac
  • luprac
  • n-(((1-methylethyl)amino)carbonyl)-4-((3-methylphenyl)amino)-3-pyridinesulfonamide
  • n-(((1-methylethyl)amino)carbonyl)-4-((3-methylphenyl)amino)-3-pyridinesulfonamide
  • toradiur
  • torasemida
  • torasemida
  • torasemide
  • torasemide
  • torasemide
  • torasemide
  • torasemide
  • torasemide
  • torasemide
  • torasemide
  • torasemidum
  • torasemidum
  • torem 10
  • torem 2.5
  • torem 5
  • torsemide
  • torsemide
  • torsemide
  • torsemide
  • torsemide
  • torsemide
  • torsemide
  • torsemide
  • torsemide

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07223502Phase 3Dec 1, 2025Sarfez Pharmaceuticals, Inc.
NCT07201584Phase 1Sep 5, 2025Menarini Group
NCT07015671Phase 3Jul 1, 2025Sarfez Pharmaceuticals, Inc.
NCT07043634Phase 3Jun 15, 2025Sarfez Pharmaceuticals, Inc.
NCT07046975Phase 3Jun 15, 2025Sarfez Pharmaceuticals, Inc.
NCT06995144Phase 4May 28, 2025Sarfez Pharmaceuticals, Inc.
NCT06670534Phase 2Jan 31, 2025Jemincare
NCT06708611Phase 4Nov 6, 2024Sarfez Pharmaceuticals, Inc.
NCT06206512Phase 2Jun 30, 2024Sarfez Pharmaceuticals, Inc., The University of Texas, Dallas
NCT06362668N/AMay 17, 2024Reprieve Cardiovascular, Inc
NCT06292091Phase 1Feb 28, 2024Seoul National University
NCT06176794Phase 2Jan 31, 2024Sarfez Pharmaceuticals, Inc., University of Florida
NCT06275763Phase 4Oct 20, 2023Instituto Nacional de Cardiologia de Laranjeiras, Medical University of Warsaw
NCT06218199Phase 4Jul 8, 2021Boston Scientific Corporation, Heart Center Research, LLC
NCT04921566Phase 1Jun 5, 2021CRO ClinPharmInvest, Pharmtechnology LLC
NCT06413082Phase 3Feb 15, 2021Vita-Salute University of Milano. Italy
NCT05093621Phase 3Feb 8, 2021Yale University
NCT04192110Phase 4Apr 1, 2020Department of Veteran Affairs
NCT03296813Phase 3Aug 14, 2018Duke University, National Heart, Lung, and Blood Institute (NHLBI)
NCT03509545Phase 1Jul 17, 2018Sarfez Pharmaceuticals, Inc., Syngene International
Showing 20 of 42 trials
Page 1 / 3

Organizations

Research & Development (71)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Sarfez Pharmaceuticals, Inc.For profit111042017
Ferrer Internacional S.A.For profit3312005
Bio-Kinetic Clinical ApplicationsFor profit2012003
Medical University of WarsawAcademic/Hospital2212013
Par PharmaceuticalsFor profit2212001
Roxane LaboratoriesFor profit2212003
SFBC AnapharmFor profit2012001
University of BarcelonaAcademic/Hospital2012005
Boehringer IngelheimFor profit1112011
Boston Scientific CorporationFor profit1012021
British Heart FoundationAcademic/Hospital1012017
Centre d'Atenció Primaria Bon PastorAcademic/Hospital1012005
Centre de Salut de Guisona, Guisona, Lleida, SpainAcademic/Hospital1012005
Centro de Salud de Chinchilla, Chinchilla, Albacete, SpainAcademic/Hospital1012005
Centro de Salud de Fuentealbilla, Fuentealbilla, Albacete, SpainAcademic/Hospital1012005
Centro de Salud La Roda, La Roda, Albacete, SpainAcademic/Hospital1012005
CRO ClinPharmInvestFor profit1012021
Department of Veteran AffairsGovernment1112020
Duke UniversityAcademic/Hospital1112018
Georgetown UniversityAcademic/Hospital1012017
71 organizations
Page 1 / 4

Marketing (23)

OrganizationOrg typeRelationshipDate
ApotexFor profitMKTGMay 31, 2005
Aurobindo PharmaFor profitMKTGOct 17, 2007
CorepharmaFor profitMKTGMay 31, 2005
Daiichi SankyoFor profitMKTGApr 21, 2010
Hetero Labs LtdFor profitMKTGJan 27, 2009
HikmaFor profitMKTGMar 1, 2005
HikmaFor profitMKTGMar 1, 2005
Impax LaboratoriesFor profitMKTGMay 31, 2005
LutipoldFor profitMKTGApr 21, 2010
MylanFor profitNDA2Aug 23, 1993
MylanFor profitNDAAug 23, 1993
Par PharmaceuticalsFor profitMKTGMay 27, 2003
PlivaFor profitMKTGMay 30, 2003
RocheFor profitNDA2Aug 23, 1993
SankyoFor profitMKTGApr 21, 2010
Sarfe PharmsFor profitMKTGJun 14, 2021
Sarfe PharmsFor profitNDA2Jun 14, 2021
Sarfez Pharmaceuticals, Inc.For profitMKTGJun 14, 2021
Strides Pharma ScienceFor profitMKTGMay 27, 2003
Sun PharmaceuticalsFor profitMKTGFeb 26, 2008
TevaFor profitMKTGMay 14, 2002
VintageFor profitMKTGMar 22, 2011
West-Ward PharmaceuticalFor profitMKTGMar 1, 2005