MINOXIDIL
MINOXIDIL is indicated for the treatment of Hypertension.
Details
- Status
- Prescription
- First Approved
- 1987-03-03
- Routes
- ORAL, TOPICAL
- Dosage Forms
- TABLET, AEROSOL, FOAM
MINOXIDIL Approval History
What MINOXIDIL Treats
1 indicationsMINOXIDIL is approved for 1 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
MINOXIDIL Boxed Warning
WARNINGS Minoxidil tablets contain the powerful antihypertensive agent, minoxidil, which may produce serious adverse effects. It can cause pericardial effusion, occasionally progressing to tamponade, and angina pectoris may be exacerbated. Minoxidil should be reserved for hypertensive patients who do not respond adequately to maximum therapeutic doses of a diuretic and two other antihypertensive agents. In experimental animals, minoxidil caused several kinds of myocardial lesions as well as othe...
WARNINGS Minoxidil tablets contain the powerful antihypertensive agent, minoxidil, which may produce serious adverse effects. It can cause pericardial effusion, occasionally progressing to tamponade, and angina pectoris may be exacerbated. Minoxidil should be reserved for hypertensive patients who do not respond adequately to maximum therapeutic doses of a diuretic and two other antihypertensive agents. In experimental animals, minoxidil caused several kinds of myocardial lesions as well as other adverse cardiac effects (see Cardiac Lesions in Animals ). Minoxidil must be administered under close supervision, usually concomitantly with therapeutic doses of a beta-adrenergic blocking agent to prevent tachycardia and increased myocardial workload. It must also usually be given with a diuretic, frequently one acting in the ascending limb of the loop of Henle, to prevent serious fluid accumulation. Patients with malignant hypertension and those already receiving guanethidine (see WARNINGS ) should be hospitalized when minoxidil is first administered so that they can be monitored to avoid too rapid, or large orthostatic, decreases in blood pressure.
MINOXIDIL 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 MINOXIDIL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications MINOXIDIL treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to MINOXIDIL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
MINOXIDIL FDA Label Details
Indications & Usage
MINOXIDIL is indicated for the treatment of Hypertension.
WARNINGS Minoxidil tablets contain the powerful antihypertensive agent, minoxidil, which may produce serious adverse effects. It can cause pericardial effusion, occasionally progressing to tamponade, and angina pectoris may be exacerbated. Minoxidil should be reserved for hypertensive patients who d...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.