Numerous clinical trials, spanning Phase 1 through Phase 4, evaluate the therapeutic profile of bumetanide across diverse indications, including acute and congestive heart failure, neonatal seizures, hypokalemic periodic paralysis, chronic kidney insufficiency, and autism spectrum disorder. Sponsored by academic centers, research foundations, public health institutes such as NINDS and NIDDK, and industry partners, these studies encompass actively recruiting, completed, and terminated protocols. Together, these evaluations reflect broad clinical interest in assessing bumetanide's diuretic kinetics, safety, and neurodevelopmental potential.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04766177 | RECRUITING | Autism |
Sherief Abd-Elsalam |
2021-01-01 | PHASE3 |
| NCT06941415 | RECRUITING | Cirrhosis |
Stacy Johnson |
2026-06-03 | PHASE3 |
| NCT05323487 | RECRUITING | Heart Failure |
Yale University |
2022-06-01 | PHASE1 |
| NCT03107416 | ACTIVE_NOT_RECRUITING | Unresectable Hepatocellular Carcinoma |
Memorial Sloan Kettering Cancer Center |
2017-04-05 | PHASE1; PHASE2 |
| NCT06052163 | RECRUITING | Alzheimer Disease |
Stanford University |
2023-04-10 | PHASE2 |
| NCT07005414 | COMPLETED | Autism Spectrum Disorder |
Fei Li |
2025-06-04 | PHASE2 |
| NCT07375212 | WITHDRAWN | Heart Failure Congestive |
Prisma Health-Upstate |
2026-01-21 | PHASE4 |
| NCT06218199 | RECRUITING | Heart Failure, Congestive |
Heart Center Research, LLC |
2021-07-08 | PHASE4 |
| NCT06465823 | RECRUITING | Down Syndrome |
Stefano Vicari |
2023-01-11 | PHASE2 |
| NCT05171686 | COMPLETED | Chronic Kidney Disease; Hypertension |
VA Office of Research and Development |
2023-02-01 | PHASE4 |
| NCT06036914 | COMPLETED | Heart Failure; With Decompensation |
Mayo Clinic |
2023-11-27 | PHASE2 |
| NCT06362668 | COMPLETED | Acute Decompensated Heart Failure |
Reprieve Cardiovascular, Inc |
2024-05-17 | |
| NCT05411991 | COMPLETED | Acute Heart Failure; Diuretics Drug Reactions |
Vrije Universiteit Brussel |
2022-06-12 | PHASE4 |
| NCT05753059 | Recruiting | Heart Failure |
Yale University|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2023-08-10 | Phase 1 |
| NCT05503511 | COMPLETED | Epilepsy; Alzheimer Disease; Epilepsy Intractable |
NeuroPro Therapeutics, Inc. |
2022-10-20 | PHASE1 |
| NCT05323487 | Recruiting | Heart Failure |
Yale University |
2022-06-01 | Not Applicable |
| NCT02593526 | TERMINATED | Chronic Kidney Insufficiency |
University of New Mexico |
2017-01 | |
| NCT04697485 | WITHDRAWN | HF - Heart Failure; Diabetes Mellitus |
Northwestern University |
2021-01-08 | PHASE4 |
| NCT03715153 | TERMINATED | Autism Spectrum Disorder (ASD) |
Institut de Recherches Internationales Servier |
2018-10-04 | PHASE3 |
| NCT03715166 | TERMINATED | Autism Spectrum Disorder (ASD) |
Institut de Recherches Internationales Servier |
2018-09-24 | PHASE3 |
| NCT03899324 | UNKNOWN | Parkinson Disease |
B&A Therapeutics |
2019-04-26 | PHASE2 |
| NCT02546583 | COMPLETED | Heart Failure |
Yale University |
2015-08-31 | PHASE1 |
| NCT02947880 | WITHDRAWN | Autistic Disorder |
University Hospital, Limoges |
2016-12 | PHASE2 |
| NCT03923933 | COMPLETED | Renal Insufficiency, Chronic |
Hospital General de México Dr. Eduardo Liceaga |
2019-06-18 | PHASE2 |
| NCT03709160 | UNKNOWN | Heart Failure; Congestive Heart Failure |
Centro en Insuficiencia Cardiaca, Mexico |
2018-10-15 | PHASE4 |
| NCT03156153 | COMPLETED | Autism Spectrum Disorder |
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
2017-05-24 | PHASE2 |
| NCT00830531 | COMPLETED | Seizures |
Soul, Janet , M.D. |
2010-01 | PHASE1 |
| NCT02582476 | TERMINATED | Hypokalemic Periodic Paralysis |
University College, London |
2015-01 | PHASE2 |
| NCT02582476 | Terminated | Hypokalemic Periodic Paralysis |
University College London |
2015-01 | Phase 2 |
| NCT01434225 | COMPLETED | Neonatal Seizures |
Great Ormond Street Hospital for Children NHS Foundation Trust |
2011-08 | PHASE1; PHASE2 |
| NCT01457053 | TERMINATED | Acute Decompensated Heart Failure |
University of Cincinnati |
2011-11 | |
| NCT00372762 | WITHDRAWN | Heart Failure |
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
2011-01 | PHASE3 |
| NCT01078714 | COMPLETED | Autistics Children |
University Hospital, Brest |
2010-03 | PHASE3 |
| NCT00830531 | Completed | Seizures |
Soul Janet M.D.|Citizens United for Research in Epilepsy|Harvard Catalyst- Harvard Clinical and Translational Science Center|Translational Research Program Boston Children''s Hospital|Charles H. Hood Foundation|National Institute of Neurological Disorders and Stroke (NINDS)|Mooney Family Initiative for Translational Studies in Rare Diseases Boston Children''s Hospital |
2010-01 | Phase 1 |
| NCT00930865 | COMPLETED | Type 2 Diabetes Mellitus |
AstraZeneca |
2009-07 | PHASE1 |
| NCT00930865 | Completed | Type 2 Diabetes Mellitus |
AstraZeneca|Bristol-Myers Squibb |
2009-07 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2021-02-23)
Check the
Bumetanide
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.