Data updated: May 26, 2026
LONITEN (minoxidil)
Cardiovascular
Approved 1979-10-18
1
Indication
--
Phase 3 Trials
1
Priority Reviews
46
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1979-10-18
- Routes
- ORAL
- Dosage Forms
- TABLET
LONITEN Approval History
1980
1981
1982
1983
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2026
Original
New Indication
New Form
Label Update
42 FDA actions from 1979 to 2015
Aug 2001 SUPPL Priority
Mfg · Manufacturing (CMC)
Mar 1996 SUPPL Priority
Mfg
Apr 1994 SUPPL
Label
Feb 1993 SUPPL
Label
May 1992 SUPPL
Label
Oct 1987 SUPPL
Label
Dec 1986 SUPPL
Label
Jul 1986 SUPPL Priority
Mfg
Dec 1985 SUPPL
Label
Oct 1985 SUPPL
Label
Nov 1984 SUPPL Priority
Mfg
Feb 1984 SUPPL Priority
Mfg
Jun 1983 SUPPL
Label
Dec 1982 SUPPL
Label
Apr 1982 SUPPL
Label
Feb 1982 SUPPL
Label
Oct 1979 ORIGINAL Priority
New Drug
What LONITEN Treats
1 FDA approvalsOriginally approved for its first indication in 1979 .
- Other (1)
Other
(1 approval)- • Approved indication (Oct 1979) Priority
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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 |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
LONITEN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.