METOLAZONE · IXORA LIFESCIENCE
Metolazone is indicated for the treatment of salt and water retention including: • edema accompanying congestive heart failure; • edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. Mykrox tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension.
Details
- Status
- Prescription
- First Approved
- 1973-11-27
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
METOLAZONE Approval History
What METOLAZONE Treats
6 indicationsMETOLAZONE is approved for 6 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Salt and Water Retention
- Edema
- Congestive Heart Failure
- Renal Disease
- Nephrotic Syndrome
- Hypertension
METOLAZONE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in METOLAZONE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications METOLAZONE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to METOLAZONE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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| NCT05633758 MELT-HF | IRB-14-6311 | Ph 2 | withdrawn | Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure |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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
METOLAZONE FDA Label Details
Indications & Usage
Metolazone is indicated for the treatment of salt and water retention including: • edema accompanying congestive heart failure; • edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. Metolazone is also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. Mykrox ® tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension. A dose titration is necessary if Mykrox ® tablets are to be substituted...
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DIULO
Full clinical data, patents, trials, and competitive landscape for metolazone.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.