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Data updated: Sep 20, 2026

ZAROXOLYN (metolazone) · I3 PHARMS

Cardiovascular Approved 1973-11-27

ZAROXOLYN is FDA-approved to treat 6 conditions (same as METOLAZONE).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
52
Years on Market

Details

Status
Discontinued
First Approved
1973-11-27
Routes
ORAL
Dosage Forms
TABLET

Companies

I3 PHARMS
Active Ingredient: METOLAZONE

ZAROXOLYN Approval History

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Original
New Indication
New Form
Label Update
102 FDA actions from 1973 to 2019
May 2019 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Mar 2015 SUPPL
Mfg · Manufacturing (CMC)
Nov 2013 SUPPL
Mfg · Manufacturing (CMC)

What ZAROXOLYN Treats

6 indications

ZAROXOLYN is approved for 6 conditions since its original approval in 1973. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as METOLAZONE (same active ingredient).

Source: FDA Label
📋

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NCT05633758 MELT-HF IRB-14-6311 Ph 2 withdrawn Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure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
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

ZAROXOLYN FDA Label Details

Indications & Usage

FDA Label (PDF)

ZAROXOLYN is FDA-approved to treat 6 conditions — same approved indications as METOLAZONE.

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Data Sources

FDA Approval: NDA017386 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.