MYKROX (metolazone) · CHARTWELL MOLECULAR
MYKROX is FDA-approved to treat 6 conditions (same as METOLAZONE).
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1987-10-30
- Routes
- ORAL
- Dosage Forms
- TABLET
MYKROX Approval History
What MYKROX Treats
6 indicationsMYKROX is approved for 6 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Salt and Water Retention
- Edema
- Congestive Heart Failure
- Renal Disease
- Nephrotic Syndrome
- Hypertension
Same approved indications as METOLAZONE (same active ingredient).
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| NCT05633758 MELT-HF | IRB-14-6311 | Ph 2 | withdrawn | Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure |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.
MYKROX FDA Label Details
Indications & Usage
FDA Label (PDF)MYKROX is FDA-approved to treat 6 conditions — same approved indications as METOLAZONE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment