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AGN-151586

Phase 3

Glabellar Lines | Small molecule | Other |AbbVie Inc.|Last Updated: Feb 18, 2026

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-BlindCONTROLLEDDMCBiomarker
Total Trials7
Total Enrollment2,514
FDA Designations
No designations recorded
Clinical Trials (7)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06308198A Study to Evaluate AGN-151586 Intramuscular Injections in Adult Participants for Treatment of Glabellar LinesPHASE3 COMPLETED 161Mar 29, 2024Feb 26, 2025Mar 19, 202512 China, Japan +1
NCT05248867A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar LinesPHASE3 COMPLETED 638Mar 16, 2022Mar 17, 2023May 24, 202438 United States, Canada +3
NCT05248880A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar LinesPHASE3 COMPLETED 309Mar 8, 2022Feb 1, 2023Feb 18, 202617 United States, Canada
NCT05248893A Study to Assess Adverse Events of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar LinesPHASE3 COMPLETED 986Feb 25, 2022Jun 26, 2023May 29, 202443 United States, Puerto Rico
NCT04096326AGN-151586 Dose-Ranging Study for Treatment of Glabellar LinesPHASE2 COMPLETED 198Sep 26, 2019Sep 9, 2020Jul 28, 20239 United States
NCT06834789A Study to Assess the Adverse Events of Intramuscular Injections of AGN-151586 and OnabotulinumtoxinA in Adult Participants for the Change of Glabellar Lines (GL)PHASE1 COMPLETED 132Feb 18, 2025Nov 3, 2025Nov 17, 20258 United States
NCT05496335A Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) Injections in Adult Participants for Treatment of Glabellar LinesPHASE1 COMPLETED 90Aug 30, 2022May 30, 2023Jun 8, 202310 United States
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Study Endpoints
Primary Endpoints
Percentage of Participants with a >= 2-Grade Improvement from Baseline on the Facial Wrinkle Scale with Asian (FWS-A) Guide According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown
Day 7

Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Participant Assessment of GL Severity at Maximum Frown
Day 7

Participants' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

Number of Participants with Adverse Events (AEs)
Up to approximately Day 84

An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Subject Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [US FDA]
Baseline, Day 7 (Double-blind period)

\[Primary endpoint for the United States FDA\] Percentage of participants achieving a Grade 0 or 1 (none or mild) and a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to both investigator and participant assessments of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [European Union Regulatory Agencies]
Baseline, Day 7 (Double-blind period)

\[Primary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [European Union Regulatory Agencies]
Baseline, Day 7 (Double-blind Period)

\[Primary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

Number of Participants With Adverse Events
From time of informed consent to end of study; median time on follow-up was 85 days for Double-blind Placebo, AGN-151586, Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for Placebo/None group, and 53 days for AGN-151586/None group

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 causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. 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.

Change in Vital Sign Measurements
Day 1 to Day 126

Percentage of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.

Change in Electrocardiogram (ECG) Measurements
Day 1 to Day 126

12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).

Presence of binding and neutralizing antidrug antibodies
Day 1 to Day 126

Blood samples for immunogenicity testing will be collected from all participants treated with AGN-151586 at predetermined timepoints. Collected samples will be processed to yield serum for detection of binding and neutralizing antibodies to AGN-151586.

Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7
Baseline (Day 1) through Day 7

Percentage of participants achieving a ≥ 2-grade improvement from baseline on the FWS according to investigator assessments of GL severity at maximum frown at any postintervention timepoint through Day 7 were reported. Investigators' assessments of the severity of GL at rest and maximum frown using the validated FWS was assessed using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs)
From first dose of study drug until the end of study (up to 42 days)

An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. TEAEs were defined as events event began on or after the date and time of the study intervention; or the adverse event was present before the date and time of the study intervention, but increased in severity or became serious on or after the date and time of the study intervention.

Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention
From first dose of study drug until the end of study (up to 42 days)

Potentially clinically significant post intervention laboratory values included hematology, chemistry, and urinalysis as defined in the SAP.

Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention
From first dose of study drug until the end of study (up to 42 days)

Potentially clinically significant post intervention vital sign measurements included systolic and diastolic blood pressure, pulse rate, respiration rate, body temperature as defined in the SAP.

Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention
From first dose of study drug until the end of study (up to 42 days)

Potentially clinically significant post intervention values in 12-lead ECG recordings included heart rate and measures PR, QRS, QT and QTcF intervals. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semi-supine or supine position as defined in the SAP. A post-baseline value is considered potentially clinically significant if it meets either the observed-value or the change-from-baseline criteria such as QRS interval observed value: ≥ 150 msec; PR interval observed value: ≥ 250 msec; QTcB observed value: \> 500 msec or change from baseline value: increase of \> 60 msec; QTcF observed value: \> 500 msec or change from baseline value: increase of \> 60 msec.

Number of Participants With Anti-drug Antibodies (ADAs)
Up to Day 42

Number of participants with positive anti-drug antibodies are reported. Binding and neutralizing anti-bodies are evaluated as anti-drug antibodies. Only participants with positive samples for binding antibodies have been analyzed for presence of neutralizing antibodies.

Number of Participants with the Presence of Binding and Neutralizing Antidrug Antibodies to AGN-151586 and/or OnabotulinumtoxinA
Up to approximately 10.4 months

Samples collected from participants treated with AGN-151586 and OnabotulinumtoxinA will be analyzed for antibodies against both AGN-151586 and OnabotulinumtoxinA.

Percentage of Participants achieving "none" or "mild" on the Facial Wrinkle Scale (FWS) according to the investigator assessment of Glabellar Lines (GL) severity at maximum frown
At Day 60

The investigator assessment of GL severity at maximum frown using a 4-grade scale (0 to 3) where 0=none and 3=severe.

Secondary Endpoints
Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Participant Assessment of GL Severity at Maximum Frown
Hour 24
Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Investigator Assessment of GL Severity at Maximum Frown
Hour 24
Percentage of Participants Achieving Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-Up Version Item 5 (overall satisfaction) for GL
Hour 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Double-Blind Period: AGN-151586EXPERIMENTALParticipants will receive AGN-151586 in the glabellar complex on Day 1.
Double-Blind Period: PlaceboPLACEBO_COMPARATORParticipants will receive Placebo in the glabellar complex on Day 1.
Open-Label: AGN-151586EXPERIMENTALParticipants who meet all retreatment criteria will receive AGN-151586 in the glabellar complex on Day 43.
PlaceboPLACEBO_COMPARATORParticipants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.
AGN-151586EXPERIMENTALParticipants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.
Cohort 1: PlaceboPLACEBO_COMPARATORParticipants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1.
Cohort 1: AGN-151586EXPERIMENTALParticipants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1.
Cohort 2: PlaceboPLACEBO_COMPARATORParticipants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2.
Cohort 2: AGN-151586EXPERIMENTALParticipants received AGN-151586, IM injections in the glabellar complex on Day 1.
Cohort 3: PlaceboPLACEBO_COMPARATORParticipants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3.
Cohort 3: AGN-151586EXPERIMENTALParticipants received AGN-151586, IM injections in the glabellar complex on Day 1.
Cohort 4: PlaceboPLACEBO_COMPARATORParticipants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4.
Cohort 4: AGN-151586EXPERIMENTALParticipants received AGN-151586, IM injections in the glabellar complex on Day 1.
Cohort 5: PlaceboPLACEBO_COMPARATORParticipants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5.
Cohort 5: AGN-151586EXPERIMENTALParticipants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1.
Cohort 1: AGN-151586 Dose A and OnabotulinumtoxinAEXPERIMENTALParticipants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA.
Cohort 2: AGN-151586 Dose B and OnabotulinumtoxinAEXPERIMENTALParticipants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA.
Cohort 3: AGN-151586 Dose A and OnabotulinumtoxinAEXPERIMENTALParticipants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA.
Cohort 3: AGN-151586 Dose B and OnabotulinumtoxinAEXPERIMENTALParticipants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA.
Cohort 3: Placebo and OnabotulinumtoxinAEXPERIMENTALParticipants will receive a single treatment of Placebo and OnabotulinumtoxinA.
AGN-151586, BOTOXEXPERIMENTALParticipants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Eligible participants will receive BOTOX injections and will be followed for up to 4 months.
Placebo, BOTOXEXPERIMENTALParticipants will receive 5 intramuscular injections of placebo in the glabellar complex on Day 1. Eligible participants will receive BOTOX injections and will be followed for up to 4 months.
Interventions
NameTypeDescription
AGN-151586DRUGIntramuscular Injections
PlaceboDRUGIntramuscular Injections
OnabotulinumtoxinADRUGIntramuscular injection
BOTOXDRUGIntramuscular Injection
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Must have Moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the FWS-A at Screening and Baseline Day 1 visit. The investigator and participant ratings must match within a visit but do not have to match between Sc...

Countries:ChinaJapanTaiwanUnited StatesCanadaGermanyHungaryPolandPuerto Rico
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