Data updated: May 26, 2026
ZAROXOLYN (metolazone)
Cardiovascular
Approved 1973-11-27
1
Indication
--
Phase 3 Trials
52
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1973-11-27
- Routes
- ORAL
- Dosage Forms
- TABLET
ZAROXOLYN Approval History
1974
1975
1976
1977
1978
1979
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
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
102 FDA actions from 1973 to 2019
Mar 2015 SUPPL
Mfg · Manufacturing (CMC)
Nov 2013 SUPPL
Mfg · Manufacturing (CMC)
Apr 2002 SUPPL
Mfg
Oct 2001 SUPPL
Mfg
Aug 1999 SUPPL
Label
Jul 1997 SUPPL
Mfg
Jan 1997 SUPPL
Mfg
May 1995 SUPPL
Label
May 1994 SUPPL
Mfg
Jan 1994 SUPPL
Label
Jan 1993 SUPPL
Label
Oct 1989 SUPPL
Label
Sep 1989 SUPPL
Mfg
Dec 1988 SUPPL
Mfg
Feb 1988 SUPPL
Mfg
Sep 1987 SUPPL
Label
Aug 1987 SUPPL
Mfg
Aug 1985 SUPPL
Label
Feb 1984 SUPPL
Mfg
Jul 1983 SUPPL
Mfg
Feb 1983 SUPPL
Label
Dec 1982 SUPPL
Mfg
Jan 1980 SUPPL
Label
Apr 1978 SUPPL
Label
May 1977 SUPPL
Mfg
Nov 1973 ORIGINAL
New Drug
What ZAROXOLYN Treats
1 FDA approvalsOriginally approved for its first indication in 1973 .
- Other (1)
Other
(1 approval)- • Approved indication (Nov 1973)
📋
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07372040 | Acute Heart Failure 2026 | Ph 2 | recruiting | Add-on Diuretics in Acute Decompensated Heart Failure |
| NCT04438213 | 2000027951 MISP59625 | Ph 2 | recruiting | Ertugliflozin in Chronic Heart Failure |
| NCT04542304 results posted | 56566 | Ph 2 | terminated | Efficacy of Diuretics in Kidney Disease |
| NCT05986773 P-Value-AHF | P-Value-AHF | Ph 4 | terminated | Diuretic Strategies in Acute Heart Failure Patients at High Risk for Diuretic Resistance |
| NCT06414759 | CL3575 IHC00077 | Ph 4 | recruiting | Efficacy and Safety of Combination Diuretic Therapy in Patients With Acute Decompensated Heart Failure and Volume Overload |
| NCT05633758 MELT-HF | IRB-14-6311 | Ph 2 | withdrawn | Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure |
| NCT02606253 results posted | VU-IRB-TBD | Ph 4 | completed | Comparison of Oral or Intravenous Thiazides vs Tolvaptan in Diuretic Resistant Decompensated Heart Failure |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
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.
ZAROXOLYN FDA Label Details
Track ZAROXOLYN with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.