Safety and Efficacy of VDPHL01 in Males With AGA

Last updated: February 11, 2026
Sponsor: Veradermics, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Male Pattern Baldness

Hair Loss

Scalp Disorders

Treatment

Placebo

VDPHL01

Clinical Study ID

NCT06972264
250-13951-304
  • Ages 18-65
  • Male

Study Summary

This study will evaluate the safety and efficacy of VDPHL01 in male subjects with Androgenetic Alopecia (AGA).

AGA (or male pattern baldness) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablet is an investigational oral drug to treat male pattern baldness.

This multi-center, double blind, study will last about 13 months and includes 11 study visits (screening, baseline (day 1), week 2, month 1, month 2, month 4, month 6, month 8, month 10, month 12, month 13).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is male aged 18-65 years old;

  • Subject has a clinical diagnosis of mild to moderate AGA;

  • Subject is in good general health and has adequate renal and hepatic function;

  • Subject is willing to maintain at least 1/4 inch length hair during the study withthe same hairstyle, hair length, and hair color throughout the study; maintainconsistent use of general hair care products and regimen through the entire study;

  • Subject is willing and able to administer the test article as directed read,understand, and complete required questionnaires in English;

  • Subject is willing and able to swallow study drug whole;

  • Subject agrees to have a micro dot tattoo placed on their scalp;

  • Subject agrees to have this area photographed at study visits as indicated in theprotocol.

Exclusion

Exclusion Criteria:

  • Subject has uncontrolled blood pressure or orthostatic hypotension;

  • Subject has symptoms or history of certain heart or thyroid conditions;

  • Subject has a history of or active hair loss due to conditions/diseases other thanAGA;

  • Subject has a current or recent history of dietary or weight changes, including useof GLP-1 agonists;

  • Subject has been diagnosed with COVID-19 within 16 weeks of screening;

  • Subject has had previous radiation of the scalp;

  • Use of any of the following treatments within the indicated washout period beforescreening:

  • Subject has used hormone replacement therapy or hormonal modulators within 6months prior to screening

  • Subject has used oral treatments for hair growth or that can affect hairgrowth, including systemic retinoids, within 6 months of screening

  • Subject has used systemic calcium channel blockers or beta blockers within 12weeks prior to screening

  • Subject has used systemic cimetidine, ketoconazole, diazoxide, orcorticosteroids (including intramuscular, intraarticular, and intralesionalinjections) within 12 weeks prior to screening

  • Subject has had any scalp procedures, including surgical, laser, light orenergy treatments, micro-needling, injections, platelet rich plasma within 6months prior to screening

  • Subject has used any topical scalp treatments for hair growth within 12 weeksprior to screening

  • Subject has used any other therapy with any medication either topical or oral thatmight, in the investigator's opinion, interfere with the study;

  • Subject has any other condition that, in the investigator's opinion, interfere withthe study

Study Design

Total Participants: 480
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
March 11, 2025
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • Site 73

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • Site 89

    Birmingham, Alabama 35244
    United States

    Site Not Available

  • Site 73

    Birmingham 4049979, Alabama 4829764 35209
    United States

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  • Site 89

    Birmingham 4049979, Alabama 4829764 35244
    United States

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  • Site 77

    Phoenix, Arizona 85006
    United States

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  • Site 77

    Phoenix 5308655, Arizona 5551752 85006
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  • Site 69

    Encino, California 91436
    United States

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  • Site 64

    Manhattan Beach, California 90266
    United States

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  • Site 93

    Northridge, California 91324
    United States

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  • Site 66

    Santa Monica, California 90404
    United States

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  • Site 94

    Thousand Oaks, California 91320
    United States

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  • Site 69

    Encino 5346649, California 5332921 91436
    United States

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  • Site 64

    Manhattan Beach 5370082, California 5332921 90266
    United States

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  • Site 93

    Northridge 5377985, California 5332921 91324
    United States

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  • Site 66

    Santa Monica 5393212, California 5332921 90404
    United States

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  • Site 94

    Thousand Oaks 5402405, California 5332921 91320
    United States

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  • Site 71

    Boca Raton, Florida 33486
    United States

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  • Site 62

    Coral Gables, Florida 33146
    United States

    Active - Recruiting

  • Site 86

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Site 54

    Ocala, Florida 34470
    United States

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  • Site 71

    Boca Raton 4148411, Florida 4155751 33486
    United States

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  • Site 62

    Coral Gables 4151871, Florida 4155751 33146
    United States

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  • Site 86

    Coral Gables 4151871, Florida 4155751 33134
    United States

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  • Site 99

    Miami 4164138, Florida 4155751 33173
    United States

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  • Site 54

    Ocala 4166673, Florida 4155751 34470
    United States

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  • Site 96

    Tamarac 4174738, Florida 4155751 33321
    United States

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  • Site 90

    Sandy Springs, Georgia 30328
    United States

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  • Site 90

    Sandy Springs 4221333, Georgia 4197000 30328
    United States

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  • Site 61

    Chicago, Illinois 60611
    United States

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  • Site 61

    Chicago 4887398, Illinois 4896861 60611
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  • Site 53

    Clarksville, Indiana 47129
    United States

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  • Site 55

    Plainfield, Indiana 46168
    United States

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  • Site 53

    Clarksville 4255836, Indiana 4921868 47129
    United States

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  • Site 55

    Plainfield 4263108, Indiana 4921868 46168
    United States

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  • Site 79

    Leawood, Kansas 66211
    United States

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  • Site 79

    Leawood 4274317, Kansas 4273857 66211
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  • Site 52

    Louisville, Kentucky 40241
    United States

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  • Site 52

    Louisville 4299276, Kentucky 6254925 40241
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  • Site 75

    New Orleans, Louisiana 70124
    United States

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  • Site 75

    New Orleans 4335045, Louisiana 4331987 70124
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  • Site 84

    Glenn Dale, Maryland 20769
    United States

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  • Site 87

    Rockville, Maryland 20850
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  • Site 84

    Glenn Dale 4356289, Maryland 4361885 20769
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  • Site 87

    Rockville 4367175, Maryland 4361885 20850
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  • Site 80

    Chestnut Hill, Massachusetts 02467
    United States

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  • Site 59

    Quincy, Massachusetts 02169
    United States

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  • Site 80

    Chestnut Hill 4932957, Massachusetts 6254926 02467
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  • Site 59

    Quincy 4948247, Massachusetts 6254926 02169
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  • Site 68

    Clinton Township, Michigan 48038
    United States

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  • Site 83

    Troy, Michigan 48084
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  • Site 68

    Clinton Township 4989133, Michigan 5001836 48038
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  • Site 83

    Troy 5012639, Michigan 5001836 48084
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  • Site 82

    Hickory, North Carolina 28602
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  • Site 92

    Huntersville, North Carolina 28078
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  • Site 82

    Hickory 4470778, North Carolina 4482348 28602
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  • Site 92

    Huntersville 4472370, North Carolina 4482348 28078
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  • Site 72

    Cincinnati, Ohio 45236
    United States

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  • Site 72

    Cincinnati 4508722, Ohio 5165418 45236
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  • Site 57

    Portland, Oregon 97210
    United States

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  • Site 57

    Portland 5746545, Oregon 5744337 97210
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  • Site 81

    East Greenwich, Rhode Island 02818
    United States

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  • Site 81

    East Greenwich 5221875, Rhode Island 5224323 02818
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    Site Not Available

  • Site 60

    Anderson, South Carolina 29625
    United States

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  • Site 60

    Anderson 4569298, South Carolina 4597040 29625
    United States

    Site Not Available

  • Site 95

    Hermitage 4628929, Tennessee 4662168 37076
    United States

    Site Not Available

  • Site 51

    Austin, Texas 78759
    United States

    Active - Recruiting

  • Site 76

    Austin, Texas 78746
    United States

    Site Not Available

  • Site 74

    College Station, Texas 77845
    United States

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  • Site 67

    Dallas, Texas 75230
    United States

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  • Site 78

    Plano, Texas 75024
    United States

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  • Site 88

    San Antonio, Texas 78218
    United States

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  • Site 51

    Austin 4671654, Texas 4736286 78759
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  • Site 76

    Austin 4671654, Texas 4736286 78746
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  • Site 74

    College Station 4682464, Texas 4736286 77845
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  • Site 67

    Dallas 4684888, Texas 4736286 75230
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  • Site 78

    Plano 4719457, Texas 4736286 75024
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  • Site 88

    San Antonio 4726206, Texas 4736286 78218
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  • Site 91

    Sugarland, Texas 4736286 77479
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  • Site 63

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Site 85

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Site 63

    Norfolk 4776222, Virginia 6254928 23502
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  • Site 85

    Norfolk 4776222, Virginia 6254928 23502
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  • Site 70

    Mill Creek, Washington 98012
    United States

    Site Not Available

  • Site 70

    Mill Creek 5803457, Washington 5815135 98012
    United States

    Site Not Available

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