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OnabotulinumtoxinA X

Phase 2

Forehead Lines | Small molecule | Other |AbbVie Inc.|Last Updated: Jul 16, 2025

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 Enrollment124
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05152576A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants With Forehead LinesPHASE2 COMPLETED 124Nov 29, 2021Sep 6, 2022Jul 16, 20258 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Adverse Events
Day 1 to Day 180

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

Percentage of Participants With Potentially Clinically Significant Vital Sign Parameters
Day 1 to Day 180

Percentage of participants with potentially clinically significant vital sign measurements like systolic and diastolic blood pressure will be assessed.

Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline on the Investigator-rated Clinician Forehead Lines Scale at Maximum Contraction.
Day 1 to Day 30

Facial Wrinkle Scale - Forehead Lines (FWS-FHL) at maximum contraction (also known as eyebrow elevation) The Clinician Forehead Lines Scale is a four point scale used to assess the severity of forehead lines at maximum contraction ranging from 0 - None to 3 - Severe.

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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo will be injected into the forehead on Day 1.
OnabotulinumtoxinA X Dose AEXPERIMENTALOnabotulinumtoxinA X will be injected into the forehead on Day 1.
OnabotulinumtoxinA X Dose BEXPERIMENTALOnabotulinumtoxinA X will be injected into the forehead on Day 1.
OnabotulinumtoxinA X Dose CEXPERIMENTALOnabotulinumtoxinA X will be injected into the forehead on Day 1.
Interventions
NameTypeDescription
OnabotulinumtoxinA XDRUGIntramuscular Injection
PlaceboDRUGIntramuscular Injection
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Participant has sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their facial lines * Participant has moderate or severe Forehead Lines (FHL) at maximum eyebrow elevation Exclusion Criteria: * History of known immun...

Countries:United States
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