Bumex

(bumetanide)

ApprovedSmall molecule

Bumetanide is a water pill that helps remove excess fluid from the body by increasing urine production, used to treat swelling and fluid buildup in conditions like heart failure, liver disease, and kidney disease.[2] Bumex is currently approved and in use across 15 indications[4].[1]

Bumex is one of 477 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

476

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Cardiovascular DiseaseActive, not recruiting

Hepatocellular CarcinomaApproved

Alzheimer DiseaseApproved

Type 2 Diabetes MellitusApproved

Hypokalemic Periodic ParalysisApproved

Kidney DiseaseActive, not recruiting

Nephrotic SyndromeActive, not recruiting

Congestive Heart FailureActive, not recruiting

TrialTerminated

Down SyndromeRecruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Hepatocellular CarcinomaApproved

Approved

Alzheimer DiseaseApproved

Approved

Type 2 Diabetes MellitusApproved

Approved

Hypokalemic Periodic ParalysisApproved

Approved

Kidney DiseaseApproved

Active, not recruiting

Nephrotic SyndromeApproved

Active, not recruiting

Congestive Heart FailureApproved

Active, not recruiting

TrialPreclinical

Terminated

Down SyndromePhase 2

Recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

265 competitors in Hepatocellular Carcinoma

#DrugCompanyPhaseTrials

Bumex

VValidus Pharmaceuticals

Approved

21 2

Viread

Gilead

Preclinical

1 3

Sovaldi

Gilead

Preclinical

1 4

Cysteine Hydrochloride

Novartis

Preclinical

1 5

Ibrance

Pfizer

Preclinical

1 6

Hepsera

Coreg

2 8

Doptelet

AAkarx

Preclinical

1 9

Lyrica

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Valemetostat

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Down Syndrome

NCT06465823

Q4 2026

Phase 1Recruiting

Heart Failure

NCT05323487

Phase 2Recruiting

Alzheimer's Disease

NCT06052163

Post-ApprovalRecruiting

Treatment

NCT06218199

Q1 2029

Phase 3Not yet recruiting

Cirrhosis

NCT06941415

Q4 2030

Phase 3Recruiting

Autism

NCT04766177

Clinical

Trials by Indication[1]

Heart Failure4 trials

Oral dIuretics in Very Intensive Treatment, an Early Intervention in Outpatients With Heart Failure

Unknown status·CCentro en Insuficiencia Cardiaca, Mexico·Phase 4·NCT03709160·40 enrolled

Mechanisms of Diuretic Resistance in Heart Failure, Aim 1

Recruiting·YYale University·Phase 1·NCT05323487·75 enrolled

A Study of Ultra High Dose Diuretics to Treat Heart Failure

Completed·MMayo Clinic·Phase 2·NCT06036914·20 enrolled

Show 1 more trial

Bumetanide Versus Furosemide in Heart Failure

Withdrawn·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 3·NCT00372762

Autism Spectrum Disorder3 trials

Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children and Adolescents Aged From 7 to Less Than 18 Years Old With Autism Spectrum Disorder

Terminated· Institut de Recherches Internationales Servier logo

Institut de Recherches Internationales Servier·Phase 3·NCT03715166·211 enrolled

A Study of Bumetanide for the Treatment of Autism Spectrum Disorders

Completed·XXinhua Hospital, Shanghai Jiao Tong University School of Medicine·Phase 2·NCT03156153·120 enrolled

Efficacy of Bumetanide in Children With Autism Spectrum Disorder Guided by Peripheral Blood Biomarkers and Machine Learning Models

Recruiting·FFei Li·Phase 2·NCT07005414·66 enrolled

Treatment2 trials

Evaluation of the Efficiency of Treatment by BUMETANIDE on Autistic Children With a Known Ethiology

Withdrawn·UUniversity Hospital, Limoges·Phase 2·NCT02947880

Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts

Recruiting·HHeart Center Research, LLC·Phase 4·NCT06218199·80 enrolled

Dapagliflozin1 trial

Study to Evaluate the Potential Pharmacokinetic Interaction and Pharmacodynamic Effects on Renal Parameters of Bumetanide (1mg) and Dapagliflozin (10 mg) When Co-administered in Healthy Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00930865·42 enrolled

Liver Cancer1 trial

Delivering a Diuretic Into the Liver Artery Followed by Plugging up the Artery to Starve Out Liver Cancer Cells

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT03107416·30 enrolled

10 more indications

Trial1 trial

Diuretic/Cool Dialysate Trial

Terminated·UUniversity of New Mexico·N/A·NCT02593526·11 enrolled

Children1 trial

Efficiency of Bumetanide in Autistic Children

Completed·UUniversity Hospital, Brest·Phase 3·NCT01078714·60 enrolled

Down syndrome1 trial

Efficacy of Bumetanide to Improve Cognitive Functions in Down Syndrome

Recruiting·SStefano Vicari·Phase 2·NCT06465823·64 enrolled

Chronic Kidney Disease1 trial

Chlortalidone and Bumetanide in Advanced Chronic Kidney Disease: HEBE-CKD Trial

Completed·HHospital General de México Dr. Eduardo Liceaga·Phase 2·NCT03923933·34 enrolled

Paralysis1 trial

Bumetanide in Hypokalaemic Periodic Paralysis

Terminated·UUniversity College, London·Phase 2·NCT02582476·12 enrolled

Cirrhosis1 trial

Bumetanide vs. Furosemide in Cirrhosis

Not yet recruiting·SStacy Johnson·Phase 3·NCT06941415·500 enrolled

Seizure1 trial

Pilot Study of Bumetanide for Newborn Seizures

Completed·—·Phase 1·NCT00830531·43 enrolled

Alzheimer's Disease1 trial

Bumetanide in Patients With Alzheimer's Disease

Recruiting·SStanford University·Phase 2·NCT06052163·40 enrolled

Neonatal seizure1 trial

NEMO1:NEonatal Seizure Using Medication Off-patent

Completed·GGreat Ormond Street Hospital for Children NHS Foundation Trust·Phase 1/2·NCT01434225·14 enrolled

Autism1 trial

Role of Bumetanide in Treatment of Autism

Recruiting·SSherief Abd-Elsalam·Phase 3·NCT04766177·80 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 28, 1983

BUMEX

NDA NDA018226

Feb 28, 1983

BUMEX

NDA NDA018225

Sep 12, 2025

ENBUMYST

NDA NDA219500

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for bumetanide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Bumex drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — bumetanide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for bumetanide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA219500). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Bumex. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Validus Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sodium-(potassium)-Chloride Cotransporter 2 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: VValidus Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Dec 4, 2040

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12329731Dec 4, 2040

11260038Dec 4, 2040

11123319Dec 4, 2040

12558330May 14, 2045

Bumex

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2029

Q4 2030

Trials by Indication[1]

Heart Failure4 trials

Autism Spectrum Disorder3 trials

Treatment2 trials

Dapagliflozin1 trial

Liver Cancer1 trial

Trial1 trial

Children1 trial

Down syndrome1 trial

Chronic Kidney Disease1 trial

Paralysis1 trial

Cirrhosis1 trial

Seizure1 trial

Alzheimer's Disease1 trial

Neonatal seizure1 trial

Autism1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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