Last update 20 Jun 2024

Bumetanide

Last update 20 Jun 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

3-(aminosulfonyl)-5-(butylamino)-4-phenoxybenzoic acid, 3-butylamino-4-(phenoxy)-5-sulfamoylbenzoic acid, 3-butylamino-4-phenoxy-5-sulfamoyl-benzoic acid

+ [17]

Target

NKCC1 x NKCC2 x SLC12A4

Mechanism

NKCC1 inhibitors(Solute carrier family 12 member 2 inhibitors), NKCC2 inhibitors(Sodium-(potassium)-chloride cotransporter 2 inhibitors), SLC12A4 inhibitors(solute carrier family 12 member 4 inhibitors)

Therapeutic Areas

Cardiovascular DiseasesEndocrinology and Metabolic DiseaseOther Diseases

Active Indication

Heart FailureHypercalcemiaHyperkalemia+ [4]

Inactive Indication-

Originator Organization

Daiichi Sankyo Co., Ltd.

Active Organization

Guilin Pharmaceutical Group Co., Ltd.

Knight Therapeutics, Inc.Chemidex Pharma Ltd.

+ [2]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

JP (08 Apr 1976),

Edema

Regulation-

Structure

Molecular FormulaC17H20N2O5S

InChIKeyMAEIEVLCKWDQJH-UHFFFAOYSA-N

CAS Registry28395-03-1

Clinical Trials associated with Bumetanide

NCT06036914 / Enrolling by invitationPhase 2

Ultra High Dose Diuretic Strategy for Management of Acute Decompensated Heart Failure - A Randomized, Double-Blind Pilot Trial

The purpose of this study is to determine the safety and effectiveness of ultrahigh dose diuretics compared to standard dose diuretics over 24 hours in patients with decompensated heart failure.

Start Date27 Nov 2023

Sponsor / Collaborator

Mayo Clinic

NCT06052163 / RecruitingPhase 2IIT

Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Tolerability of Bumetanide in Patients With Alzheimer's Disease.

This study aims to investigate bumetanide in patients with biologically confirmed Alzheimer's disease (AD). Bumetanide is a potent diuretic administered orally and is FDA approved for the treatment of edema and hypertension. Repurposing bumetanide as a medication for AD has been proposed based on data that demonstrated its ability to "flip" the APOE genotype-dependent transcriptomic signatures in AD mouse and cell culture models. Critically, this discovery was subsequently explored in Electronic Health Record cohorts, which revealed that among individuals over the age of 65, bumetanide exposure was significantly associated with a lower prevalence of AD in three independent datasets.
Primary Objective: To evaluate the safety and tolerability of bumetanide when administered to participants with biomarker-confirmed Alzheimer's disease.
Secondary Objective: To evaluate the clinical and biomarker effects of bumetanide in participants with mild cognitive impairment or mild dementia due to Alzheimer's disease.

Start Date10 Apr 2023

Sponsor / Collaborator

Stanford University

NCT05171686 / RecruitingPhase 4

Association of Diuretics With Change in Extracellular Volume, Natriuretic Peptides, Symptoms, and Cardiovascular Outcomes in CKD

Almost 15% of Americans have chronic kidney disease (CKD), with an even higher rate in Veterans due to common risk factors such as high blood pressure and diabetes. People with CKD have a high risk of cardiovascular (CV) diseases, such as heart attacks, heart failure, and strokes. Extra fluid in the body, called volume overload, may lead to CV disease in people with CKD. It is unknown if volume overload develops in the earliest stages of CKD, when treating it with common, inexpensive medicines called diuretics may improve long-term CV outcomes. This study will lay important groundwork to answer this question in Veterans with early CKD by comparing two ways to measure volume overload and studying the change in common symptoms like fatigue and short-term CV function after treatment with diuretic medicines.

Start Date01 Feb 2023

Sponsor / Collaborator

VA Office of Research and Development

100 Clinical Results associated with Bumetanide

100 Translational Medicine associated with Bumetanide

100 Patents (Medical) associated with Bumetanide

2,668

Literatures (Medical) associated with Bumetanide

01 Apr 2024·CNS & neurological disorders drug targets

Bumetanide, a Diuretic That Can Help Children with Autism Spectrum Disorder

Author: El Agami, Osama ; Shaker, Esraa ; Salamah, Abeer

Background::

Autism Spectrum Disorder (ASD) is a common child neurodevelopmental disorder, whose pathogenesis is not completely understood. Until now, there is no proven treatment for the core symptoms of ASD. However, some evidence indicates a crucial link between this disorder and GABAergic signals which are altered in ASD. Bumetanide is a diuretic that reduces chloride, shifts gamma-amino-butyric acid (GABA) from excitation to inhibition, and may play a significant role in the treatment of ASD.

Objective::

The objective of this study is to assess the safety and efficacy of bumetanide as a treatment for ASD.

Methods::

Eighty children, aged 3-12 years, with ASD diagnosed by Childhood Autism Rating Scale (CARS), ⩾ 30 were included in this double-blind, randomized, and controlled study. Group 1 received Bumetanide, Group 2 received a placebo for 6 months. Follow-up by CARS rating scale was performed before and after 1, 3, and 6 months of treatment.

Results::

The use of bumetanide in group 1 improved the core symptoms of ASD in a shorter time with minimal and tolerable adverse effects. There was a statistically significant decrease in CARS and most of its fifteen items in group 1 versus group 2 after 6 months of treatment (p-value <0.001).

Conclusion::

Bumetanide has an important role in the treatment of core symptoms of ASD.

01 Feb 2024·Neuromuscular disorders : NMD

Crossover randomized controlled trial of bumetanide to rescue an attack of exercise induced hand weakness in hypokalaemic periodic paralysis

Article

Author: Scalco, Renata Siciliani ; Manole, Andreea ; Skorupinska, Iwona ; Ricciardi, Federico ; Matthews, Emma ; Fialho, Doreen ; Hanna, Michael G ; Morrow, Jasper M

The aim of this study was to establish whether bumetanide can abort an acute attack of weakness in patients with HypoPP. This was a randomised, double-blind, cross-over, placebo-controlled phase II clinical trial. Focal attack of weakness was induced by isometric exercise of ADM followed by rest (McManis protocol). Participants had two study visits and received either placebo or 2 mg bumetanide at attack onset (defined as 40 % decrement in the abductor digiti minimi CMAP amplitude from peak). CMAP measurements assessed attack severity and duration. Nine participants completed both visits. CMAP percentage of peak amplitudes in the bumetanide (40.6 %) versus placebo (34.9 %) group at 1hr following treatment did not differ significantly (estimated effect difference 5.9 % (95 % CI: (-5.7 %; 17.5 %), p = 0.27, primary outcome). CMAP amplitudes assessed by the area under the curve for early (0-2hr post-treatment) and late (2-4 h post-treatment) efficacy were not statistically different between bumetanide and placebo (early effect estimate 0.043, p = 0.3; late effect estimate 0.085, p = 0.1). Two participants recovered from the attack following bumetanide intake; none recovered following placebo. Bumetanide was well tolerated but not efficacious to rescue a focal attack in an immobilised hand in the majority of patients, although data supports further studies of this agent.

01 Jan 2024·Anesthesia and analgesia

γ-Aminobutyric Acid-Ergic Development Contributes to the Enhancement of Electroencephalogram Slow-Delta Oscillations Under Volatile Anesthesia in Neonatal Rats

Article

Author: Zhang, Donghang ; Zhu, Tao ; Kurth, Charles D ; Zhang, Mingyue ; Yuan, Ian ; Wang, Rurong ; Liu, Jin ; Zhou, Cheng ; Chen, Yali ; Jiang, Jingyao ; Xu, Ting ; Huang, Han

BACKGROUND::

General anesthetics (eg, propofol and volatile anesthetics) enhance the slow-delta oscillations of the cortical electroencephalogram (EEG), which partly results from the enhancement of (γ-aminobutyric acid [GABA]) γ-aminobutyric acid-ergic (GABAergic) transmission. There is a GABAergic excitatory-inhibitory shift during postnatal development. Whether general anesthetics can enhance slow-delta oscillations in the immature brain has not yet been unequivocally determined.

METHODS::

Perforated patch-clamp recording was used to confirm the reversal potential of GABAergic currents throughout GABAergic development in acute brain slices of neonatal rats. The power density of the electrocorticogram and the minimum alveolar concentrations (MAC) of isoflurane and/or sevoflurane were measured in P4–P21 rats. Then, the effects of bumetanide, an inhibitor of the Na+-K+-2Cl− cotransporter (NKCC1) and K+-Cl− cotransporter (KCC2) knockdown on the potency of volatile anesthetics and the power density of the EEG were determined in vivo.

RESULTS::

Reversal potential of GABAergic currents were gradually hyperpolarized from P4 to P21 in cortical pyramidal neurons. Bumetanide enhanced the hypnotic effects of volatile anesthetics at P5 (for MACLORR, isoflurane: 0.63% ± 0.07% vs 0.81% ± 0.05%, 95% confidence interval [CI], −0.257 to −0.103, P < .001; sevoflurane: 1.46% ± 0.12% vs 1.66% ± 0.09%, 95% CI, −0.319 to −0.081, P < .001); while knockdown of KCC2 weakened their hypnotic effects at P21 in rats (for MACLORR, isoflurane: 0.58% ± 0.05% to 0.77% ± 0.20%, 95% CI, 0.013–0.357, P = .003; sevoflurane: 1.17% ± 0.04% to 1.33% ± 0.04%, 95% CI, 0.078–0.244, P < .001). For cortical EEG, slow-delta oscillations were the predominant components of the EEG spectrum in neonatal rats. Isoflurane and/or sevoflurane suppressed the power density of slow-delta oscillations rather than enhancement of it until GABAergic maturity. Enhancement of slow-delta oscillations under volatile anesthetics was simulated by preinjection of bumetanide at P5 (isoflurane: slow-delta changed ratio from −0.31 ± 0.22 to 1.57 ± 1.15, 95% CI, 0.67–3.08, P = .007; sevoflurane: slow-delta changed ratio from −0.46 ± 0.25 to 0.95 ± 0.97, 95% CI, 0.38–2.45, P = .014); and suppressed by KCC2-siRNA at P21 (isoflurane: slow-delta changed ratio from 16.13 ± 5.69 to 3.98 ± 2.35, 95% CI, −18.50 to −5.80, P = .002; sevoflurane: slow-delta changed ratio from 0.13 ± 2.82 to 3.23 ± 2.49, 95% CI, 3.02–10.79, P = .003).

CONCLUSIONS::

Enhancement of cortical EEG slow-delta oscillations by volatile anesthetics may require mature GABAergic inhibitory transmission during neonatal development.

News (Medical) associated with Bumetanide

17 Jan 2024

·www.pharmaceutical-technology.com

Stalica raises $17.5m to advance neurology programmes

The ASD pipeline consists of 127 drugs spanning all stages of development, with only 7% of drugs present in Phase III and 11.8% in Phase II clinical development. Image Credit: Alex and Maria photo / Shutterstock. Switzerland-based Stalica has raised $17.5m in Series B financing to fund clinical trials for its neuropsychiatric and neurological disorders pipeline. The clinical programmes that the company plans to use the Series B proceeds include the fixed-dose combination drug STP1 and mavoglurant (STP7). Furthermore, the company will also strengthen the data package for STP2. Stalica’s clinical pipeline STP1 is a fixed dose combination of ibudilast, a phosphodiesterase (PDE) 4/3 inhibitor, and bumetanide, a sodium (Na)- potassium (K)- chloride (Cl) cotransporter (NKCC) 1 agonist. Stalica is developing the precision therapy as a treatment for autism spectrum disorder (ASD) in a specific sub-group of patients, phenotype 1 (Phen1). Phen1 patients have been identified by Stalica and validated using two independent clinical observational/bio-sampling studies (NCT05590715 and NCT04644003). The company is planning a Phase II trial for STP1 in patients with ASD, the preparation of which will be funded by the proceeds from the current financing round. Mavoglurant is a negative allosteric modulator of the glutamate receptor 5 (mGluR5). Stalica signed an in-licencing agreement with Novartis to develop the drug as a treatment for substance-use disorders and neurodevelopmental disorders (NDDs) in January 2023. As per the agreement, the company is entitled to receive up to $270m in upfront and milestone-based payments along with royalties on net sales. The company is planning a Phase III trial for mavoglurant in patients with cocaine use disorder in 2025. The trial will be funded by the US National Institute on Drug Abuse (NIDA), part of the US National Institutes of Health (NIH). It is expected to enrol up to 330 patients. STP2 is a stabilised synthetic form of sulforaphane. Stalica acquired the rights to the therapy from the UK-based Evgen Pharma in October 2022. Stalica is developing STP2 as a treatment for ASD in Phen2 sub-population. The company plans to start Phase II trial for the therapy in 2023. ASD landscape The total diagnosed prevalence of ASD was more than 9.81 million in 2023 and is expected to be approximately 9.65 million diagnosed prevalent cases of ASD in 2028, as per a 2023 Globaldata report . The ASD pipeline consists of 127 drugs spanning all stages of development, with only 7% of drugs present in Phase III and 11.8% in Phase II clinical development. GlobalData is the parent company of Pharmaceutical Technology . In November 2023, SciSparc started a clinical trial for SCI-210 to treat ASD symptoms in children. SCI-210 is a combination of cannabidiol (CBD) and palmitoylethanolamide. The trial is expected to enrol 60 patients aged five and 18 years. Apart from ASD treatment, strides have been made in developing diagnostics for the disorder. In September 2023, EarliTech positive data from two studies showing the efficacy and accuracy of its EarliPoint Evaluation device in diagnosing and assessing autism in children aged 30 months and older.

Phase 2Phase 3

10 Jan 2023

·www.biospace.com

Glenmark Pharmaceuticals launches Bumetanide Injection USP, 1 mg/4 mL (0.25 mg/mL) Single-Dose Vials and 2.5 mg/10 mL (0.25 mg/mL) Multi-Dose Vials

MAHWAH, N.J., Jan. 10, 2023 /PRNewswire/ -- Glenmark Pharmaceuticals Inc., USA (Glenmark) is pleased to announce it has launched Bumetanide Injection USP, 1 mg/4 mL (0.25 mg/mL) Single-Dose Vials and 2.5 mg/10 mL (0.25 mg/mL) Multi-Dose Vials, the generic version of Bumex®1 Injection, 0.25 mg/mL, of Validus Pharmaceuticals, Inc. Commenting on the launch, Vijay Raghavan, Senior Vice President, Business Development Portfolio, Product Launch & Strategy, said, "We are very pleased to bring to market a lower cost alternative to Bumex® Injection, 0.25 mg/mL. This launch of Bumetanide Injection USP, 1 mg/4 mL (0.25 mg/mL) Single-Dose Vials and 2.5 mg/10 mL (0.25 mg/mL) Multi-Dose Vials affirms our commitment to Glenmark's continued focus on institutional business." According to IQVIATM sales data for the 12-month period ending November 2022, the Bumex® Injection, 0.25 mg/mL market2 achieved annual sales of approximately $16.5 million*. Glenmark's current portfolio consists of 179 products authorized for distribution in the U.S. marketplace and 46 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio. About Glenmark Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd. (BSE: 532296) (NSE: GLENMARK) is an innovation–driven global pharmaceutical company with a presence across Specialty, Generics and OTC businesses. It focuses on the key therapeutic areas of respiratory, dermatology and oncology. The company has 10 world–class manufacturing facilities spread across 4 continents and operations in over 80 countries. Glenmark is ranked among the world's top 100 biopharmaceutical companies (Top 100 Companies Ranked by Research and Development, and Pharmaceutical Sales, 2021, by In Vivo/Scrip 100); and among the world's top 50 companies in the off–patent sector (Top 50 Generics and Biosimilars Companies ranked by Sales, 2021, by Generics Bulletin/In Vivo). The company was listed on the Dow Jones Sustainability Index (DJSI), one of the world's most respected and widely accepted sustainability benchmarks, under the category of emerging markets (2021) for the fourth consecutive year. For more information, visit , LinkedIn (Glenmark Pharmaceuticals), Instagram (glenmark_pharma). References 1 All brand names and trademarks are the property of their respective owners. 2 Market includes brand and all available therapeutic equivalents * IQVIATM National Sales Perspectives: Retail & Non-Retail, November 2022 Logo: Company Codes: Bombay:532296, Bombay:GLENMARK.BO, India:GLENMARK.NS

Drug Approval

12 Oct 2021

·www.biospace.com

NIH Believes Common Diuretic Drug Could Lower Risk of Alzheimer's

The National Institutes of Health (NIH) reports that a common and potent diuretic might hold the key to lowering the prevalence of Alzheimer's disease, particularly in people who are genetically predisposed to the illness. In a study published in Nature Aging, the NIH revealed that bumetanide, a drug typically used as a diuretic, may be a potential treatment for those genetically at risk for Alzheimer's. One of the primary risk factors for late-onset Alzheimer's is the presence of the apolipoprotein E genotype, which can also lead to dementia and cardiovascular disease. APOE is responsible for transporting fat-soluble vitamins, lipids, and cholesterol into the blood. The APOE gene test is used to evaluate human DNA and determine which forms or alleles of APOE are present, with the most common and "neutral" one being e3/e3. It is the e4 version of the gene that predisposes a person to develop late-onset AD. "We know that Alzheimer's disease will likely require specific types of treatments, perhaps multiple therapies, including some that may target an individual's unique genetic and disease characteristics — much like cancer treatments that are available today. The data in this paper make a good case to conduct a proof-of-concept trial of bumetanide in people with genetic risk," said Jean Yuan, M.D., Ph.D., the program director of the Translational Bioinformatics and Drug Development unit of the NIA Division of Neuroscience, in a statement. Scientists analyzed databases of brain tissue samples against over 1,300 FDA-approved medications and tested these on mouse models and induced pluripotent stem cell-derived human neurons. They observed that mouse brains that expressed the human APOE4 gene exhibited lower memory and learning deficits, which is the same as what they found in human cell-based models. This led them to hypothesize that people already on bumetanide would be at a much lower risk for Alzheimer's. Researchers looked at health records of over five million people aged over 65 years old, half of whom had been taking bumetanide. It was found that those who were genetically predisposed and were taking the drug had a 35 to 75 percent lower prevalence compared to those who had not been taking it. The NIH admits that more research and clinical trials are required to verify the effectiveness of bumetanide. However, it also said that it is hopeful that some existing FDA-approved drugs may turn out to be candidates for drug repurposing to treat Alzheimer's disease. The research team is composed of scientists from the Gladstone Institutes, the University of California, and the Icahn School of Medicine at Mount Sinai. The study was funded by the National Institute on Aging, which is part of the NIH, through grants R01AG057683, R01AG048017, F31AG058439, R01AG061150, F31AG057150, R21TR001743, and K01ES028047.

100 Deals associated with Bumetanide

External Link

KEGG	Wiki	ATC	Drug Bank
D00247	Bumetanide	C03CA02	DB00887

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Heart Failure	CA	Knight Therapeutics, Inc.	31 Dec 1993
Hypercalcemia	CN	Guilin Pharmaceutical Group Co., Ltd.	01 Jan 1982
Hyperkalemia	CN	Guilin Pharmaceutical Group Co., Ltd.	01 Jan 1982
Hypertension	CN	Guilin Pharmaceutical Group Co., Ltd.	01 Jan 1982
Hyponatremia	CN	Guilin Pharmaceutical Group Co., Ltd.	01 Jan 1982
Poisoning	CN	Guilin Pharmaceutical Group Co., Ltd.	01 Jan 1982
Edema	JP	Daiichi Sankyo Co., Ltd.	08 Apr 1976

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03715153 (CTgov)	Phase 3	Autism Spectrum Disorder	211	BUMETANIDE (S95008) for week 0 - 26 (BUMETANIDE (S95008) Followed by Open-Label S95008)	ftsdeglejm(qncjcxxnch) = phgyloedfa qmovvzmaiz (ffwbwrbinn, mpjzdzjaqp - jsddzhqbkz) View more	-	05 Jun 2023
				PLACEBO for week 0 - 26+Open-Label BUMETANIDE (S95008) for weeks 26 - 52 (PLACEBO Followed by Open-Label S95008)	ftsdeglejm(qncjcxxnch) = vvftlbvmxx qmovvzmaiz (ffwbwrbinn, rtnhvfknky - muicwqrzuu) View more
NCT03923933 (HEBE-CKD, Pubmed)	Phase 2	Chronic Kidney Diseases	34	Bumetanide plus chlorthalidone	aqgjtgjnsx(ueksfoccnc) = mosvlszhnu ucqykfwwgo (icicztufwx ) View more	-	20 Sep 2022
				Bumetanide plus placebo	aqgjtgjnsx(ueksfoccnc) = dikmyxgeba ucqykfwwgo (icicztufwx ) View more
EULAR2020	Not Applicable	Acute congestive heart failure	130	Intravenous Bumetanide	ycpxbznjxh(swzcastwfv) = The use of IV bumetanide in patients hospitalized for AHF exacerbations is associated with a 7.17% yearly incidence of acute gout flares rrtolyjggf (frmaiynuqd ) View more	-	03 Jun 2020
NCT03923933 (CTgov)	Phase 2	Chronic Kidney Diseases	34	Bumetanide (Placebo)	zdqghkefel(pjeqvqkwlj) = ifmyrbzutr dmotkivpkv (kvxxlimlpr, kebimwyrgj - xfzgdgyczb) View more	-	10 Mar 2020
				Bumetanide+Chlorthalidone (Treatment Grup)	zdqghkefel(pjeqvqkwlj) = gqcxrgnsxq dmotkivpkv (kvxxlimlpr, mfbdgnnuge - bntccnhwrj) View more
NCT01973335 (CTgov)	Phase 4	Heart Failure	34	oral spironolactone+Combination therapy (Acetazolamide/Low-dose Loop Diuretics, Upfront Spironolactone)	xeccuhaqhw(rukyvtmdjk) = zbjbyoofea htjvydrtjc (yeljxhvpac, jhgwauubna - wceqqpzghq) View more	-	21 Mar 2019
				oral spironolactone+High-dose loop diuretics (High-dose Loop Diuretics, Upfront Spironolactone)	xeccuhaqhw(rukyvtmdjk) = vezrwfxfys htjvydrtjc (yeljxhvpac, ejfpvjxfop - vgdnayvrmc) View more
IRCT201012115368N1 (Pubmed \| CNS Drugs)	Not Applicable	Drug Resistant Epilepsy Add-on	30	Bumetanide	chfolxewpg(fzoekdlssz) = yifafyysgf tfgskpxdet (mzucjzkmyx, 7 - 14.5)	-	01 Mar 2019
ANA2018	Not Applicable	Epilepsy, Benign Neonatal Add-on	-	Phenobarbital + Placebo	zmwwsutfki(gxhukrlkkl) = p=0.02 jkmgssvxrl (cmlxyzpqaw ) View more	Positive	05 Oct 2018
				Phenobarbital + Bumetanide 0.1mg/kg
ANA2015	Not Applicable	Seizures Adjuvant	-	Bumetanide 0.1mg/kg	fsgfkrqdlr(qhzrjfikkh) = comparable between subjects receiving bumetanide vs. phenobarbital alone sixlrggpop (fyepxvckdd ) View more	Positive	25 Sep 2015
				Bumetanide 0.2mg/kg
NCT01457053 (CTgov)	Not Applicable	Acute decompensated heart failure	4	Ultrafiltration (Ultrafiltration)	xxkomacpez(wrtnnsgjud) = uhrxvbizwy nbvlwxswcz (fygsuiyuxa, ijpofswrzk - bfgygkqetq) View more	-	08 Jun 2015
				bumetanide+torsemide+furosemide (Diuretic Therapy)	xxkomacpez(wrtnnsgjud) = ktlsscyrjo nbvlwxswcz (fygsuiyuxa, tmpexdmjfa - ckkqpvqoha) View more

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