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Minoxidil

Phase 3FDA approved

Androgenetic Alopecia | Small molecule | Dermatology |Johnson & Johnson|Trials Updated: Sep 30, 2016

Minoxidil development status

FDA approval on record Jan 20, 2006 as Men's Rogaine
Approval holderKenvue Brands
ApplicationNDA021812
Highest phase Phase 3
Registered trials 3 across 3 sponsors since Sep 2005

Minoxidil target and mechanism

Molecular targetKCNJ11, ABCC9
Target classOpener
ModalitySmall molecule
ChEMBLCHEMBL802

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment422

FDA Designations

No designations recorded

Minoxidil clinical trials

Minoxidil · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT00151515A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair LossAndrogenetic Alopecia
COMPLETED352 Analytics
PHASE3COMPLETED
A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss
Androgenetic AlopeciaUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change in non-vellus hair count in the target region as determined by validated computer-assisted dot-mapping technique and subject ratings
Baseline to 16 Weeks
Change of target area non-vellus hair count in the temple region (t-TAHC) [n/cm²] compared to baseline after 24 weeks
Baseline, week 8, week 16, week 24, week 52, week 76, week 104

Secondary Endpoints

Visual assessment of local dermatitis
Each visit, Baseline through Week 16
Vital Signs
Each visit, Baseline through Week 16
Secondary efficacy evaluated by expert panel review of hair regrowth when comparing global photographs
Baseline vs Week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALTopical 5% minoxidil foam formulation used twice daily
vehicle of 5% Minoxidl topical foamPLACEBO_COMPARATORvehicel foam in twice daily application in temple and vertex region
5% Minoxidil topical foamACTIVE_COMPARATOR5% Minoxidil topical in twice daily application in temple and vertex region

Interventions

NameTypeDescription
minoxidilDRUGTopical 5% minoxidil foam, BID, for sixteen weeks
vehicle of 5% Minoxidil topical foamDRUG1 g of vehicle topical foam twice daily over 24 weeks in double-blinded phase and further 80 weeks in open-label-phase
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Eligibility Criteria

Age Range15 Years to 49 Years
SexMALE
Healthy VolunteersYes
Study Sites15

Inclusion Criteria: * presence of androgenetic alopecia with vertex pattern IIIv, IV, or V on the Norwood Hamilton Scale * Male sex, age 15 to 49, good health * Willingness to have a dot tattoo placed in the target area of the scalp during the study * Willingness to maintain normal shampooing habit...

Countries:United StatesGermany
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Frequently asked questions about Minoxidil

What is Minoxidil used for in androgenetic alopecia?

Minoxidil is a small molecule treatment being developed for androgenetic alopecia, a common form of hair loss. It is being studied in male patients with this condition. The clinical program includes trials evaluating minoxidil foam versus placebo foam for androgenetic alopecia and male pattern hair loss.

What does Minoxidil target?

Minoxidil targets KCNJ11 and ABCC9, which are potassium channel proteins. It acts as an opener of these channels. This mechanism is distinct from hormonal approaches to hair loss and is the basis for its investigation in androgenetic alopecia.

Who makes Minoxidil?

Johnson & Johnson, ticker JNJ, is the developer of Minoxidil for androgenetic alopecia. The company is conducting clinical trials of the drug in this indication.

What phase is Minoxidil in?

Minoxidil is in Phase 3 development for androgenetic alopecia. It is an investigational therapy and has not been approved for this indication. The Phase 3 trial has been completed, and no active trials are currently listed.

What clinical trials is Minoxidil in?

Minoxidil has been studied in two clinical trials: NCT01319370, a completed Phase 2 trial of minoxidil foam versus placebo foam in Germany with 70 male participants, and NCT00151515, a completed Phase 3 trial of 5 percent minoxidil foam in the United States with 352 male participants.