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Bimatoprost 1

Phase 2

Alopecia | Small molecule | Rare Disease |AbbVie Inc.|Last Updated: Mar 22, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment244
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01904721A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)PHASE2 COMPLETED 244Aug 1, 2013Jan 1, 2015Mar 22, 20161 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in Target Area Hair Count (TAHC)
Baseline, Month 6

TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm\^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs).

Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Month 6

The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.

Secondary Endpoints
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Month 6
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Month 6
Change From Baseline in Target Area Hair Width (TAHW)
Baseline, Month 6
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Stage 1: Bimatoprost Solution 1 Twice DailyEXPERIMENTALStage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
Stage 1: Bimatoprost Solution 1 Once DailyEXPERIMENTALStage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
Stage 1: Bimatoprost Solution 2 Twice DailyEXPERIMENTALStage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
Stage 1: Bimatoprost Solution 2 Once DailyEXPERIMENTALStage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
Stage 2: Bimatoprost Solution 1 Twice DailyEXPERIMENTALStage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Stage 2: Bimatoprost Solution 2 Twice DailyEXPERIMENTALStage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Stage 2: Bimatoprost Vehicle Twice DailyPLACEBO_COMPARATORStage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Interventions
NameTypeDescription
Bimatoprost Solution 1DRUGBimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Bimatoprost Solution 2DRUGBimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Bimatoprost VehicleDRUGBimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
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Eligibility Criteria
Age Range18 Years — 49 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year * Willingness to maintain same hair style, length and hair color during study * Willingness to have micro-dot-tattoo applied to scalp (Stage 2 only) Exclusion Criteria: * ...

Countries:United States
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