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Data updated: Jun 28, 2026

MINOXIDIL (FOR WOMEN) (minoxidil) · Apotex

Cardiovascular Approved 1996-10-18

MINOXIDIL (FOR WOMEN) is FDA-approved to treat 1 condition (same as MINOXIDIL).

Source: FDA Label
11
Indications
--
Phase 3 Trials
29
Years on Market

Details

Status
Discontinued
First Approved
1996-10-18
Routes
TOPICAL
Dosage Forms
SOLUTION, AEROSOL, FOAM

MINOXIDIL (FOR WOMEN) Approval History

1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
31 FDA actions from 1996 to 2024
Nov 2024 ORIGINAL
Update
Apr 2024 ORIGINAL
Update
Dec 2019 SUPPL
Label · Labeling

What MINOXIDIL (FOR WOMEN) Treats

1 indications

MINOXIDIL (FOR WOMEN) is approved for 1 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as MINOXIDIL (same active ingredient).

Source: FDA Label
📋

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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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

MINOXIDIL (FOR WOMEN) FDA Label Details

Indications & Usage

MINOXIDIL (FOR WOMEN) 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.