Drugs / Torsemide
Torsemide
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | DEMADEX | — | 1997-09-09 – 1998-02-13 | fda.gov ↗ |
| Approved | US (FDA) | DEMADEX | — | 1993-08-23 | fda.gov ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials · 1 met primary | ||||||
| Phase 1 | NCT06292091 | Feb → Mar 2024 | hypertensive disorder | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 1 | NCT03509545 | Jun 2021 → Jun 2022 | — | Sarfez Pharmaceuticals, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03215875 | Oct 2017 → Mar 2018 | — | Sarfez Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03214874 | Jun → Jul 2017 | chronic kidney disease, congestive heart failure | Sarfez Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 1 | NCT01788254 | Jan 2012 → May 2015 | — | Matthias Schwab | Completed | No outcome recorded |
| Phase 1 | NCT01845194 | Dec 2009 → Oct 2013 | mitochondrial membrane transport disorder | Institute of Application-oriented Research and Clinical Trials GmbH | Completed | No outcome recorded |
| Phase 1 | NCT00654043 | Apr → May 2001 | — | Par Pharmaceutical, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00653549 | Apr → May 2001 | — | Par Pharmaceutical, Inc. | Completed | No outcome recorded |
| Phase 23 trials · 1 missed | ||||||
| Phase 2 | NCT06176794 | Nov 2024 → Mar 2025 | heart failure | Sarfez Pharmaceuticals, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06206512 | Jun 2024 → Nov 2025 | congestive heart failure, overactive bladder | Sarfez Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02813551 | Aug 2016 → Jul 2017 | preeclampsia | The University of Texas Health Science Center, Houston | Completed | Missed primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT07043634 | Jun → Dec 2025 | — | Sarfez Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT06708611 | Jan → Mar 2025 | heart failure | Sarfez Pharmaceuticals, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05171686 | Feb 2023 → Oct 2025 | chronic kidney disease, hypertensive disorder | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 4 | NCT04192110 | Aug 2020 | chronic kidney disease | VA Office of Research and Development | Withdrawn | No outcome recorded |
| Phase 4 | NCT03187509 | Apr 2018 → Mar 2022 | heart failure | New York City Health and Hospitals Corporation | Completed | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 1 | NCT01558674 Comparator | May → Dec 2014 | heart failure, impaired renal function disease | Merck Sharp & Dohme LLC | Terminated | Missed primary |
| Phase 2/3 | NCT00953303 Comparator | Jan 2009 → Sep 2011 | heart failure | Hebei Medical University | Completed | No outcome recorded |
| Phase 3 | NCT07223502 Comparator | May 2025 → Sep 2026 | hypertensive disorder | Sarfez Pharmaceuticals, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT05093621 Comparator | Feb 2021 → Jun 2023 | heart failure | Yale University | Completed | No outcome recorded |
| Phase 3 | NCT03296813 Comparator | Jul 2018 → Jul 2022 | heart failure | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT06995144 Comparator | May 2025 → Sep 2026 | heart failure | Sarfez Pharmaceuticals, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
| 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 |
| — | 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 |
|---|---|---|
| 2008-02-27 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma gets USFDA approval to market generic Demadex ® Tablets sunpharma.com ↗
Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the Company’s Abbreviated New Drug Application (ANDA) to market its generic version of Hoffman la Roche’s Demadex®, torsemide tablets. |
| 2002-05-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Approval of Torsemide Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U. S. Food and Drug Administration has issued final approval for the company's ANDA for Torsemide Tablets, 5 mg, 10 mg, 20 mg and 100 mg. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2008-02-27 | Sun Pharmaceutical Industries, Inc. | Sun Pharma gets USFDA approval to market generic Demadex ® Tablets sunpharma.com ↗ |
| 2002-05-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces FDA Approval of Torsemide Tablets tevapharm.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Torsemide | “The participant's blood pressure medication regimen will then be altered to initiate a thiazide-type (hydrochlorothiazide or chlorthalidone) or loop diuretic (furosemide,...” NCT04192110 ↗26“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 ↗ “metolazone, bumetanide, furosemide, torsemide, amiloride, triamterene” NCT00684489 ↗ “Furosemide; torsemide; nitroglycerin; dopamine; Dobutamine” NCT00953303 ↗ “Immediate Release (IR) Torsemide” NCT03214874 ↗ |
| Known as | Demadex | “Demadex (IR Torsemide) 20mg tablet once daily is the reference listed drug (RLD)” NCT03214874 ↗ |
| Known as | Demadex, torasemide | “Demadex, torasemide” NCT02813551 ↗ |
| Known as | Demadex, torsemide | “Demadex, torsemide” NCT01457053 ↗ |
| Modality | Other / unclassified | “pharmacokinetically predictable loop-diuretic” NCT02813551 ↗ |
| Route | Intravenous | “Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide).” NCT01457053 ↗ |