MINODYL (minoxidil) · QUANTUM PHARMICS
MINODYL is FDA-approved to treat 1 condition (same as MINOXIDIL).
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1988-07-15
- Routes
- ORAL
- Dosage Forms
- TABLET
MINODYL Approval History
What MINODYL Treats
1 indicationsMINODYL is approved for 1 conditions . These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as MINOXIDIL (same active ingredient).
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06924632 | SAM-002 | Ph 3 | completed | Efficacy & Safety of Minoxidil SL Tablets in Men With AGA |
| NCT07264790 | Pro00116354 | Ph 1 | recruiting | Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Recon |
| NCT04207931 CCCA | IRB00043796 | Ph 4 | recruiting | Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study |
| NCT07273799 mina | 02-TERC/NHRC-SZH/Int-SC/651 | Ph 3 | not yet recruiting | Comparison of Outcomes Between Topical Minoxidil Versus Oral Minoxidil for the Treatment of Androgenetic Alopecia |
| NCT00876200 Williams results posted | 2006.437/30 | Ph 2 | completed | Efficacy of Minoxidil in Children With Williams-Beuren Syndrome |
| NCT01319370 | CRC-AGA02 2010-018291-25 | Ph 2 | completed | Effectiveness and Safety of Minoxidil Foam Versus Placebo Foam for Androgenetic Alopecia |
| NCT00958750 | CRC-AGA01 EudraCT: 2008-001770-33 | Ph 3 | completed | Efficacy and Safety Study to Compare Two Minoxidil Formulations on Women With Androgenetic Alopecia |
| NCT07594678 | OSU-24393 NCI-2026-02583 | Ph 2 | not yet recruiting | Minoxidil With or Without Low-Level Red-Light Therapy for Improving Chemotherapy-Induced Alopecia in Breast Cancer Patients |
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.
MINODYL FDA Label Details
Indications & Usage
MINODYL is FDA-approved to treat 1 condition — same approved indications as MINOXIDIL.
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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