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bumetanide

Trade name: bumex

Small moleculeapproved

Approved

Feb 28, 1983

Bumetanide is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. It blocks the reabsorption of sodium and fluid from the kidney's tubules. The most frequent clinical adverse reactions considered probably or possibly related to bumetanide are muscle cramps (seen in 1.1% of treated patients), dizziness (1.1%), hypotension (0.8%), headache (0.6%), nausea (0.6%) and encephalopathy (in patients with preexisting liver disease) (0.6%). One or more of these adverse reactions have been reported in approximately 4.1% of patients treated with Bumex (bumetanide). Lithium should generally not be given with diuretics (such as Bumex (bumetanide)) because they reduce its renal clearance and add a high risk of lithium toxicity. Bumex (bumetanide) may potentiate the effect of various antihypertensive drugs, necessitating a reduction in the dosage of these drugs. — NCATS

Clinical trial activity

37 trials · 51 clinical orgs · 29 marketing orgs

Phase 1
8
Phase 2
17
Phase 3
6
Phase 4
8

Earliest trial started Jul 1, 2009 (NCT00930865)

Timeline

1980s

  1. Feb 28, 1983

    Earliest FDA Approval

  2. Feb 28, 1983

    Validus Pharmaceuticals — NDA Secondary Org

1990s

  1. Oct 31, 1994

    Hospira — Marketing Organization

  2. Jan 27, 1995

    Athenex, Inc. — Marketing Organization

  3. Jan 27, 1995

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  4. Apr 24, 1995

    Heritage Pharma — Marketing Organization

  5. Nov 21, 1996

    Sandoz — Marketing Organization

  6. Nov 21, 1996

    Novartis — Marketing Organization

  7. Nov 18, 1997

    Teva — Marketing Organization

2000s

  1. Apr 30, 2008

    West-Ward Pharmaceutical — Marketing Organization

  2. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2015

    Earliest Phase 2 Sponsor(trial)

  3. Oct 18, 2017

    Amneal Pharmaceuticals — Marketing Organization

  4. Jan 23, 2018

    Upsher-Smith Laboratories — Marketing Organization

  5. Apr 30, 2018

    Zydus Discovery DMCC — Marketing Organization

  6. Dec 12, 2019

    Rising Pharmaceuticals — Marketing Organization

  7. Dec 12, 2019

    Ceyone Life Sciences — Marketing Organization

2020s

  1. May 26, 2022

    Gland Pharma Ltd — Marketing Organization

  2. May 26, 2022

    Fosun — Marketing Organization

  3. Aug 4, 2022

    MSN Laboratories — Marketing Organization

  4. Jul 24, 2023

    Taro Pharmaceuticals — Marketing Organization

  5. Jul 24, 2023

    Sun Pharmaceuticals — Marketing Organization

  6. Sep 17, 2024

    Lupin — Marketing Organization

  7. Sep 18, 2024

    Appco Pharma — Marketing Organization

  8. Sep 19, 2024

    Qilu Pharmaceutical Co., Ltd. — Marketing Organization

  9. Dec 27, 2024

    Rubicon Research — Marketing Organization

  10. Feb 27, 2025

    Aspiro — Marketing Organization

  11. Apr 3, 2025

    Mankind Pharma — Marketing Organization

  12. Aug 5, 2025

    Jubilant Innovation Ltd. — Marketing Organization

  13. Sep 12, 2025

    CORSTASIS THERAP — Marketing Organization

  14. Feb 26, 2026

    ANTHEA PHARMA — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedFeb 28, 1983

Chemistry & pharmacology

Loading structure…

SMILES

CCCCNC1=C(OC2=CC=CC=C2)C(=CC(=C1)C(O)=O)S(N)(=O)=O
Mol. weight
364.416 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

Black box warning

Sources

Also known as

  • 3-(aminosulfonyl)-5-(butylamino)-4-phenoxybenzoic acid
  • 3-(aminosulfonyl)-5-(butylamino)-4-phenoxybenzoic acid
  • 3-butylamino-4-(phenoxy)-5-sulfamoylbenzoic acid
  • 3-butylamino-4-(phenoxy)-5-sulfamoylbenzoic acid
  • 3-butylamino-4-phenoxy-5-sulfamoyl-benzoic acid
  • 3-butylamino-4-phenoxy-5-sulfamoyl-benzoic acid
  • 3-butylamino-4-phenoxy-5-sulfamoylbenzoic acid
  • 3-butylamino-4-phenoxy-5-sulfamoylbenzoic acid
  • betinex
  • bufenox
  • bumetanida
  • bumetanida
  • bumetanide
  • bumetanide
  • bumetanide
  • bumetanide
  • bumetanide
  • bumetanide
  • bumetanide
  • bumetanide
  • bumetanide
  • bumetanide
  • bumetanide
  • bumetanidum
  • bumetanidum
  • bumethanide
  • bumex
  • bumex
  • bumex
  • bumex
  • burinex
  • burinex
  • burinex
  • lixil
  • lixil
  • ro-106338
  • ro-106338

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06941415Phase 3Mar 1, 2026University of Utah
NCT07222878Phase 1Sep 29, 2025NeuroPro Therapeutics, Inc.
NCT07005414Phase 2Jun 4, 2025Jiao Tong University
NCT06769659Phase 2Mar 11, 2025NeuroPro Therapeutics, Inc.
NCT06644300Phase 1Oct 31, 2024Government of China
NCT06525649Phase 1Aug 21, 2024NeuroPro Therapeutics, Inc., The Epilepsy Study Consortium
NCT06362668N/AMay 17, 2024Reprieve Cardiovascular, Inc
NCT06036914Phase 2Nov 27, 2023Mayo Clinic
NCT06052163Phase 2Oct 15, 2023Stanford University
NCT06465823Phase 2Jan 11, 2023Bambino Gesù Hospital and Research Institute
NCT05503511Phase 1Oct 20, 2022NeuroPro Therapeutics, Inc.
NCT05411991Phase 4Jun 12, 2022Free University of Brussels, Hasselt University, Roche
NCT05323487N/AJun 1, 2022Yale University
NCT05129722Phase 4Feb 1, 2022St Vincent's Centre for Applied Medical Research, University of New South Wales, Victor Chang Cardiac Research Institute
NCT06218199Phase 4Jul 8, 2021Boston Scientific Corporation, Heart Center Research, LLC
NCT04697485Phase 4Jan 8, 2021Northwestern University
NCT04766177Phase 3Jan 1, 2021Kafrelsheikh University, Tanta University
NCT04192110Phase 4Apr 1, 2020Department of Veteran Affairs
NCT03923933Phase 4Jun 18, 2019Hospital General de México Dr. Eduardo Liceaga
NCT03899324Phase 2Apr 30, 2019B&A Therapeutics
Showing 20 of 37 trials
Page 1 / 2

Organizations

Research & Development (51)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NeuroPro Therapeutics, Inc.For profit4422022
Hasselt UniversityAcademic/Hospital3222013
Jiao Tong UniversityAcademic/Hospital2212017
ServierFor profit2212018
University of LondonAcademic/Hospital2212011
Yale UniversityAcademic/Hospital2212015
Ziekenhuis Oost-LimburgAcademic/Hospital2022013
AstraZenecaFor profit1112009
Bambino Gesù Hospital and Research InstituteAcademic/Hospital1112023
B&A TherapeuticsFor profit1112019
Boston Scientific CorporationFor profit1012021
Bristol-Myers SquibbFor profit1012009
Charles H. Hood FoundationAcademic/Hospital1012010
Citizens United for Research in EpilepsyAcademic/Hospital1012010
Department of Veteran AffairsGovernment1112020
Dialysis Clinic, Inc.Academic/Hospital1012016
Erasmus University RotterdamAcademic/Hospital1012011
Free University of BrusselsAcademic/Hospital1112022
Government of ChinaGovernment1112024
Harvard UniversityAcademic/Hospital1112010
51 organizations
Page 1 / 3

Marketing (31)

OrganizationOrg typeRelationshipDate
ANTHEA PHARMAFor profitMKTGFeb 26, 2026
Amneal PharmaceuticalsFor profitMKTGOct 18, 2017
Appco PharmaFor profitMKTGSep 18, 2024
AspiroFor profitMKTGFeb 27, 2025
Athenex, Inc.For profitMKTGJan 27, 1995
CORSTASIS THERAPFor profitMKTGSep 12, 2025
Ceyone Life SciencesFor profitMKTGDec 12, 2019
FosunFor profitMKTGMay 26, 2022
Gland Pharma LtdFor profitMKTGMay 26, 2022
Gland Pharma LtdFor profitSYNMay 26, 2022
Heritage PharmaFor profitMKTGApr 24, 1995
HospiraFor profitMKTGOct 31, 1994
Jubilant Innovation Ltd.For profitMKTGAug 5, 2025
LupinFor profitMKTGSep 17, 2024
LupinFor profitSYNSep 17, 2024
MSN LaboratoriesFor profitMKTGAug 4, 2022
Mankind PharmaFor profitMKTGApr 3, 2025
NovartisFor profitMKTGNov 21, 1996
Qilu Pharmaceutical Co., Ltd.For profitMKTGSep 19, 2024
Rising PharmaceuticalsFor profitMKTGDec 12, 2019
RocheFor profitNDA—
Rubicon ResearchFor profitMKTGDec 27, 2024
Sagent Pharmaceuticals, Inc.For profitMKTGJan 27, 1995
SandozFor profitMKTGNov 21, 1996
Sun PharmaceuticalsFor profitMKTGJul 24, 2023
Taro PharmaceuticalsFor profitMKTGJul 24, 2023
TevaFor profitMKTGNov 18, 1997
Upsher-Smith LaboratoriesFor profitMKTGJan 23, 2018
Validus PharmaceuticalsFor profitNDA2Feb 28, 1983
West-Ward PharmaceuticalFor profitMKTGApr 30, 2008
Zydus Discovery DMCCFor profitMKTGApr 30, 2018