Data updated: May 26, 2026
DEMADEX (torsemide)
Cardiovascular
Approved 1993-08-23
3
Indications
--
Phase 3 Trials
32
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1993-08-23
- Routes
- ORAL, INTRAVENOUS
- Dosage Forms
- TABLET, SOLUTION
DEMADEX Approval History
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
124 FDA actions from 1993 to 2017 · 1 indication expansions
Nov 2013 SUPPL
Mfg · Manufacturing (CMC)
Nov 2012 SUPPL
Mfg · Manufacturing (CMC)
Sep 2002 SUPPL
Mfg
Apr 1998 SUPPL
Mfg
Mar 1998 SUPPL
Mfg
Feb 1998 SUPPL
Label
Jan 1998 SUPPL
Mfg
Nov 1997 SUPPL
Mfg
Oct 1997 SUPPL
Mfg
Sep 1997 SUPPL
Efficacy
May 1997 SUPPL
Mfg
Oct 1996 SUPPL
Mfg
Jun 1996 SUPPL
Mfg
Feb 1996 SUPPL
Mfg
Nov 1995 SUPPL
Mfg
Nov 1995 SUPPL
Mfg
Nov 1995 SUPPL
Mfg
Oct 1995 SUPPL
Mfg
Sep 1995 SUPPL
Label
Aug 1995 SUPPL
Mfg
May 1995 SUPPL
Mfg
Aug 1993 ORIGINAL
New Drug
What DEMADEX Treats
3 FDA approvalsOriginally approved for its first indication in 1993 . Covers 3 distinct patient populations.
- Other (3)
Other
(3 approvals)- • Approved indication (Aug 1993)
- • Approved indication (Sep 1997)
- • Approved indication (Feb 1998)
📋
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06708611 EXTOR-HF | SAR065-324 | Ph 4 | withdrawn | A Crossover Study of Patients With HF to Compare Natriuretic Effects of IR Torsemide vs. ER Torsemide Over 12 Hrs |
| NCT03296813 TRANSFORM-HF results posted | Pro00080595 U01HL125511-01A1 | Ph 3 | completed | TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure |
| NCT05093621 TFO results posted | 2000029589 | Ph 3 | completed | Torsemide Comparison With Furosemide for Management of Patients With Stable Heart Failure |
| NCT06218199 DART-HA | Dart-HA | Ph 4 | recruiting | Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts |
| NCT03187509 | 2017-7615 | Ph 4 | completed | Weight-Based Torsemide Dosing in Subjects With Heart Failure |
| NCT02813551 TROPHY results posted | HSC-MS-16-0198 | Ph 2 | completed | ToRsemide for pOstpartum HYpertension |
| NCT01558674 results posted | 7145-011 | Ph 1 | terminated | A Study of MK-7145 in Participants With Renal Insufficiency (Part I) and Heart Failure With Renal Insufficiency (Part II) (MK-7145-011) |
| NCT01788254 IKP243 | IKP243 2011-002291-16 | Ph 1 | completed | Open Label Study for the Functional Characterization of Drug Metabolism and Transport |
| NCT01845194 | TWINS-II-v1.9 | Ph 1 | completed | Repeated Dose Study for the Investigation of Heritability of and Genetic Influences on Drug Pharmacokinetics |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DEMADEX FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.