Drugs / Bumetanide
Bumetanide
also known as
Betinex · Bumetanida · Bumex · Bumex, bumetanide · Burinex · Burinex (brand name for bumetanide) · Lixil · PF-1593 · +2 more
Small molecule targets SLC12A1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | BUMEX | — | 1984-08-01 – 1985-06-14 | fda.gov ↗ |
| Approved | US (FDA) | BUMEX | — | 1983-02-28 | fda.gov ↗ |
Trials 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials · 1 met primary | ||||||
| Phase 1 | NCT04644003 | Dec 2020 → Jan 2022 | autism spectrum disorder | Stalicla SA | Completed | No outcome recorded |
| Phase 1 | NCT02546583 | Aug 2015 → Jan 2020 | heart failure | Yale University | Completed | Met primary |
| Phase 1 | NCT00830531 | Jan 2010 → Jan 2019 | epilepsy | Soul, Janet , M.D. | Completed | No outcome recorded |
| Phase 1/22 trials · 1 missed | ||||||
| Phase 1/2 | NCT03107416 | Apr 2017 → Apr 2027 expected | hepatocellular carcinoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT01434225 | Aug 2011 → Jun 2013 | neonatal epilepsy syndrome | Great Ormond Street Hospital for Children NHS Foundation Trust | Completed | Missed primary |
| Phase 27 trials | ||||||
| Phase 2 | NCT07005414 | Jun 2025 → Apr 2026 | autism spectrum disorder | Fei Li | Completed | No outcome recorded |
| Phase 2 | NCT06036914 | Nov 2023 → Oct 2024 | heart failure | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT06465823 | Jan 2023 → Dec 2025 overdue | Down syndrome | Stefano Vicari | Recruiting | No outcome recorded |
| Phase 2 | NCT03899324 | Apr 2019 → Sep 2020 | Parkinson disease | B&A Therapeutics | Unknown | No outcome recorded |
| Phase 2 | NCT03156153 | May 2017 → Jul 2019 | autism spectrum disorder | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT02947880 | Dec 2016 → Dec 2019 | autism | University Hospital, Limoges | Withdrawn | No outcome recorded |
| Phase 2 | NCT02582476 | Jan 2015 → May 2017 | hypokalemic periodic paralysis | University College, London | Terminated | No outcome recorded Stop: Business |
| Phase 35 trials · 1 missed | ||||||
| Phase 3 | NCT06941415 | Jun 2026 → Mar 2029 expected | cirrhosis of liver | Stacy Johnson | Recruiting | No outcome recorded |
| Phase 3 | NCT04766177 | Jan 2021 → Dec 2030 expected | autism | Tanta University | Recruiting | No outcome recorded |
| Phase 3 | NCT03715153 | Oct 2018 → Oct 2021 | autism spectrum disorder | Servier | Terminated | Missed primary |
| Phase 3 | NCT03715166 | Sep 2018 → Sep 2021 | autism spectrum disorder | Servier | Terminated | No outcome recorded |
| Phase 3 | NCT01078714 | Mar 2010 → Jun 2011 | autism spectrum disorder | University Hospital, Brest | Completed | No outcome recorded |
| Phase 48 trials · 2 missed | ||||||
| Phase 4 | NCT07375212 | Jan 2026 | congestive heart failure | Prisma Health-Upstate | Withdrawn | No outcome recorded |
| Phase 4 | NCT05171686 | Feb 2023 → Oct 2025 | chronic kidney disease, hypertensive disorder | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 4 | NCT05129722 | Oct 2022 → May 2024 | diastolic heart failure | The George Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05411991 | Jun 2022 → Jul 2024 | heart failure | Vrije Universiteit Brussel | Completed | Missed primary |
| Phase 4 | NCT04697485 | Jan 2021 → Jan 2022 | diabetes mellitus, heart failure | Northwestern University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04192110 | Aug 2020 | chronic kidney disease | VA Office of Research and Development | Withdrawn | No outcome recorded |
| Phase 4 | NCT03709160 | Oct 2018 → Oct 2019 | congestive heart failure | Centro en Insuficiencia Cardiaca, Mexico | Unknown | No outcome recorded |
| Phase 4 | NCT01973335 | Nov 2013 → Apr 2017 | heart failure | Hasselt University | Completed | Missed primary |
| Phase not applicable2 trials · 1 missed | ||||||
| — | NCT02593526 | Jan 2017 → May 2022 | chronic kidney disease | University of New Mexico | Terminated | No outcome recorded |
| — | NCT02765009 | Jun 2016 → Jul 2019 | — | Central Hospital, Nancy, France | Completed | Missed primary |
| Comparator or background therapy12 trials | ||||||
| Phase 1 | NCT05323487 Comparator | Jun 2022 → May 2027 expected | heart failure | Yale University | Recruiting | No outcome recorded |
| Phase 1 | NCT00930865 Comparator | Jul → Sep 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT06052163 Comparator | Apr 2023 → Dec 2026 expected | Alzheimer disease | Stanford University | Recruiting | No outcome recorded |
| Phase 2 | NCT03923933 Background | Jun → Oct 2019 | chronic kidney disease | Hospital General de México Dr. Eduardo Liceaga | Completed | Met primary |
| Phase 3 | NCT00372762 Comparator | Jan 2011 → Jan 2013 | heart failure | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Withdrawn | No outcome recorded |
| Phase 3 | NCT01138683 Comparator | Feb 2010 → Oct 2011 | heart failure | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 4 | NCT06414759 Background | Jul → Dec 2024 overdue | heart failure | Cairo University | Recruiting | No outcome recorded |
| Phase 4 | NCT06218199 Comparator | Jul 2021 → Dec 2025 overdue | congestive heart failure | Heart Center Research, LLC | Recruiting | No outcome recorded |
| — | NCT06362668 Comparator | May → Oct 2024 | heart failure | Reprieve Cardiovascular, Inc | Completed | No outcome recorded |
| — | NCT04572867 Comparator | Jun → Jul 2021 | congestive heart failure, symptomatic heart failure | Ramona Gelzer Bell | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT01457053 Comparator | Nov 2011 → May 2013 | heart failure | University of Cincinnati | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00684489 Comparator | Sep 2003 → Mar 2005 | essential hypertension | Medical University of South Carolina | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2024-09-18 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Bumetanide Injection, USP lupin.com ↗ |
| 2018-01-30 | Upsher-Smith Laboratories | Regulatory Upsher-Smith Receives FDA Approval for Bumetanide Tablets, USP upsher-smith.com ↗
Maple Grove, MN – January 30, 2018 – Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced that it has received U.S. Food and Drug Administration (FDA) approval of its abbreviated new drug application (ANDA) for Bumetanide Tablets, USP, 0.5 mg, 1 mg, and 2 mg. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-11-19 | Lupin Limited | Lupin Launches Bumetanide Injection, USP in the United States lupin.com ↗ |
| 2024-09-18 | Lupin Limited | Lupin Receives Approval from U.S. FDA for Bumetanide Injection, USP lupin.com ↗ |
| 2023-01-10 | Glenmark Pharmaceuticals Ltd. India | 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 glenmarkpharma.com ↗ |
| 2018-01-30 | Upsher-Smith Laboratories | Upsher-Smith Receives FDA Approval for Bumetanide Tablets, USP upsher-smith.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bumetanide | “The participant's blood pressure medication regimen will then be altered to initiate a thiazide-type (hydrochlorothiazide or chlorthalidone) or loop diuretic (furosemide,...” NCT04192110 ↗37“This study aimed to evaluate the safety and tolerability of STP1, a combination of ibudilast and bumetanide, tailored for the treatment of a clinically and biologically defined...” PMID 39062003 ↗ Jun 2024 “In cases where the patient was not previously on oral diuretics, a starting dose of 40 mg of IV furosemide, IV bumetanide 1 mg or a bolus of 20 mg of IV torsemide can be utilized.” NCT06414759 ↗ “Patients receive 2 mg of intravenous bumetanide immediately after randomization, with 1 mg intravenous bumetanide administered on each consecutive day in the morning” NCT01973335 ↗ “Loop diuretic bumetanide 0.5 mg Mineralocorticoid receptor antagonist eplerenone 25 mg Sodium-glucose co-transporter 2 inhibitor (SGLT2i): empagliflozin 10mg” NCT05129722 ↗ “Bumetanide continuous infusion to reach a prescribed negative fluid balance: dose adjustment according to the diuretic response.” NCT01138683 ↗ “metolazone, bumetanide, furosemide, torsemide, amiloride, triamterene” NCT00684489 ↗ “bumetanide” NCT02765009 ↗ |
| Known as | Betinex | ChEMBL registry synonym — accepted as the source's own label CHEMBL1072 ↗ |
| Known as | Bumetanida | ChEMBL registry synonym — accepted as the source's own label CHEMBL1072 ↗ |
| Known as | Bumex | “to a maximum of 8mg IV Bumex (or 320mg IV Lasix).” NCT04572867 ↗ |
| Known as | Bumex, bumetanide | “Bumex, bumetanide” NCT01457053 ↗ |
| Known as | Burinex | “Eplerenone (inspra), Bumetanide (Burinex) and Empagliflozin (jardiance)” NCT05129722 ↗ |
| Known as | Burinex (brand name for bumetanide) | “Burinex (brand name for bumetanide)” NCT05411991 ↗ |
| Known as | Lixil | ChEMBL registry synonym — accepted as the source's own label CHEMBL1072 ↗ |
| Known as | PF-1593 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1072 ↗ |
| Known as | RO 10-6338 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1072 ↗ |
| Known as | S95008 | “BUMETANIDE (S95008) for week 0 - 26” NCT03715153 ↗ |
| Action | Inhibit | “chloride-importer antagonist bumetanide that reduces intracellular chloride” PMID 23233021 ↗ Dec 20121“Sodium-(potassium)-chloride cotransporter 2 inhibitor” CHEMBL1072 ↗ |
| Modality | Small molecule | — CHEMBL1072 ↗ |
| Route | Oral | “0.5mg to 2mg orally once or twice daily” NCT00372762 ↗ |
| Target | SLC12A1 | “Sodium-(potassium)-chloride cotransporter 2 inhibitor” CHEMBL1072 ↗ |