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onabotulinumtoxinA 24 U

Phase 4FDA approved

Facial Rhytides | Monoclonal antibody | Dermatology |AbbVie Inc.|Trials Updated: May 5, 2026

onabotulinumtoxinA 24 U development status

FDA approval on record Dec 21, 2000 as Botox Cosmetic
Approval holderAllergan
ApplicationBLA103000
Highest phase Phase 4 (NCT01516892)
Phase scored for ABBVPhase 3
Registered trials 44 across 7 sponsors since Jun 2009

Label indication BOTOX is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication ( 1.1 ) Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal…

onabotulinumtoxinA 24 U target and mechanism

Molecular targetSNAP25
Target classInhibitor
ModalityMonoclonal antibody

Also known as BOTOX®, BOTOX® Cosmetic, onabotulinumtoxinA

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials18
Total Enrollment6,282

FDA Designations

No designations recorded

onabotulinumtoxinA 24 U clinical trials

onabotulinumtoxinA 24 U · 18 trials · 17 indications

Phase 3 13Phase 2 5
NCT06794866A Study to Assess Adverse Events and Effectiveness of OnabotulinumtoxinA Intramuscular Injections for the Change of Moderate to Severe Forehead Lines in Adult ParticipantsForehead Lines
COMPLETED150 Analytics
NCT05134649A Study To Assess the Safety of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma ProminencePlatysma Prominence
COMPLETED292 Analytics
NCT04994535A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma ProminencePlatysma Prominence
COMPLETED426 Analytics
NCT04949399A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma ProminencePlatysma Prominence
COMPLETED408 Analytics
NCT02261493A Safety and Efficacy Study of OnabotulinumtoxinA in Upper Facial RhytidesFacial Rhytides
COMPLETED787 Analytics
NCT02261467A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial RhytidesForehead Rhytides
COMPLETED421 Analytics
NCT01852058A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor OveractivityUrinary Incontinence
COMPLETED95 Analytics
NCT01852045Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric PatientsUrinary Incontinence
COMPLETED114 Analytics
NCT01600716Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS)Urinary Incontinence
COMPLETED144 Analytics
NCT01189747Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet LinesLateral Canthus Rhytides
COMPLETED446 Analytics
PHASE3COMPLETED
A Study to Assess Adverse Events and Effectiveness of OnabotulinumtoxinA Intramuscular Injections for the Change of Moderate to Severe Forehead Lines in Adult Participants
Forehead LinesUnlock trial analytics
PHASE3COMPLETED
A Study To Assess the Safety of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence
Platysma ProminenceUnlock trial analytics
PHASE3COMPLETED
A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence
Platysma ProminenceUnlock trial analytics
PHASE3COMPLETED
A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma Prominence
Platysma ProminenceUnlock trial analytics
PHASE3COMPLETED
A Safety and Efficacy Study of OnabotulinumtoxinA in Upper Facial Rhytides
Facial RhytidesUnlock trial analytics
PHASE3COMPLETED
A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides
Forehead RhytidesUnlock trial analytics
PHASE3COMPLETED
A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity
Urinary IncontinenceUnlock trial analytics
PHASE3COMPLETED
Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients
Urinary IncontinenceUnlock trial analytics
PHASE3COMPLETED
Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS)
Urinary IncontinenceUnlock trial analytics
PHASE3COMPLETED
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines
Lateral Canthus RhytidesUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants who Achieve 'None' or 'Mild' on Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) According to the Investigator Assessment of Forehead Lines (FHL) Severity at Maximum Contraction
Day 30

The investigator assesses FHL severity using the FWS-A scale ranging from none to severe.

Number of Participants with Adverse Events (AEs)
Up to approximately 12 months

Description: 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.

Number of Participants With Adverse Events
371 days (from enrollment in the lead-in study M21-309 through end of study M21-323)

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.

Composite Achievement of Grade 1 or 2 (Minimal or Mild) and at Least a 2-Grade Improvement From Baseline Based on Both Investigator's Assessment Using C-APPS and Participant's Self-Assessment Using P-APPS, at Maximum Contraction at Day 14
Day 14

The Clinician Allergan Platysma Prominence Scale (C-APPS) evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme. The Participant Allergan Platysma Prominence Scale (P-APPS) evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.

Achievement of at Least a 2-grade Improvement From Baseline Based on the Investigator's Assessment Using C-APPS at Maximum Contraction at Day 14
Day 14

The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.

Achievement of at Least a 2-grade Improvement From Baseline Based on the Participant's Self-Assessment Using P-APPS at Maximum Contraction at Day 14
Day 14

The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.

Achievement of at Least a 2-grade Improvement From Baseline Based on the Participant's Self- Assessment Using P-APPS at Maximum Contraction at Day 14
Day 14

The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.

Percentage of Subjects With ≥2-Grade Improvement From Baseline on Both the Investigator's and Subject's Facial Wrinkle Scale (FWS) Ratings of Forehead Line Severity at Maximum Eyebrow Elevation
Baseline, Day 30

The Investigator and subject each assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 2-grade improvement from baseline assessed by both the Investigator and the subject are reported.

Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1
Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1

Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.

Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 2
Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2

Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.

Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 3
Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3

Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.

Change From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes
Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6

Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 2 consecutive days (normalized to a 12-hour daytime period) prior to the study visit. Daytime was defined as the time between waking up to start the day and first morning catheterization and going to bed to sleep for the night. The number of incontinence episodes were averaged daily during this period. A negative change from Baseline indicates improvement. Least squares estimates were based on an Analysis of Covariance (ANCOVA) model.

Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes
Baseline, Week 6

Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. The number of episodes of urinary incontinence is recorded over a 3-day period the week of the study visit. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change indicates an increase in incontinence episodes (worsening).

Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile
Baseline, Day 30

The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at Day 30. The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline.

Change From Baseline in Number of Daily Episodes of Urinary Incontinence
Baseline, Week 12

A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).

Pain Intensity
Over 7 months

Patient will record the pain intensity by means of a visual analogue scale (VAS, from 0-10 being 0 no pain and 10 the worst possible pain)

Percentage of Participants Who Achieved Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 at Day 90 as Assessed by the Investigator
Day 90

The investigator assessed the severity of the participant's masseter muscle prominence (MMP) using the MMPS 5-point scale where: 1=minimal (best), 2=mild, 3=moderate, 4=marked, and 5=very marked (worst). The percentage of participants where the investigator selected 1=minimal, 2=mild, or 3=moderate are reported.

Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
First dose (Day 1) to the End of Study (Up to Day 180)

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is an AE that occurs or worsens after receiving study drug.

Change From Baseline in Systolic Blood Pressure
Baseline (Day 1) to the End of Study (Up to Day 180)
Change From Baseline in Diastolic Blood Pressure
Baseline (Day 1) to the End of Study (Up to Day 180)
Change From Baseline in Respiratory Rate
Baseline (Day 1) to the End of Study (Up to Day 180)

Respiratory rate is calculated as number of breaths (inhalation and exhalation) in one minute.

Change From Baseline in Pulse Rate
Baseline (Day 1) to the End of Study (Up to Day 180) ]

Pulse rate measures the number of times your heart beats per minute.

Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day
Baseline (3 consecutive days during Day -14 to Day -1) to 3 consecutive days in the Week prior to Week 12

The participant recorded urinary incontinence (lack of voluntary control over urination) in a 3-day bladder diary. The average number of UIEs per day is the average of the 3-day diary entries. A negative change from Baseline indicates improvement. Baseline is defined as the last non-missing assessment before the first dose of study treatment. An analysis of covariance (ANCOVA) model was used for analyses.

Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAEs) in the Treatment Period
Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks)

An adverse event (AE) is any untoward medical occurrence in a participants or clinical study investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receiving study drug.

Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale
Baseline, Week 8

Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.

Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Baseline

The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.

Change From Baseline Values in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 6

The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.

Secondary Endpoints

Percentage of Participants who Achieved 'None' or 'Mild' on FWS-A According to the Participant Assessment of FHL Severity
Day 30
Percentage of Participants who Achieved at least 1-Grade Improvement from Baseline on FWS-A According to the Investigator Assessment of FHL Severity at Maximum Contraction
Day 30
Percentage of Participants who Achieved at least 1-Grade Improvement from Baseline on FWS-A According to the Investigator Assessment of FHL Severity at Rest
Day 30
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALParticipants will receive onabotulinumtoxinA Dose A in both Period 1 and Period 2.
Group 2EXPERIMENTALParticipants will receive onabotulinumtoxinA Dose B in both Period 1 and Period 2.
Group 3EXPERIMENTALParticipants will receive placebo in Period 1 and onabotulinumtoxinA Dose A in Period 2.
Group 4EXPERIMENTALParticipants will receive placebo in Period 1 and onabotulinumtoxinA Dose B in Period 2.
BOTOXEXPERIMENTALBOTOX (OnabotulinumtoxinA) will be injected into the platysma muscle for up to 3 Cycles during study M21-323
PlaceboPLACEBO_COMPARATORPlacebo will be injected into the platysma muscle on Day 1
OnabotulinumtoxinA Dose AEXPERIMENTALOnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
OnabotulinumtoxinA Dose BEXPERIMENTALOnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
Placebo followed by OnabotulinumtoxinA Dose APLACEBO_COMPARATORPlacebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
OnabotulinumtoxinAEXPERIMENTALOnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
Placebo followed by OnabotulinumtoxinA in Period 2PLACEBO_COMPARATORPlacebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
OnabotulinumtoxinA 50 UEXPERIMENTALFollowing treatment with onabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
OnabotulinumtoxinA 100 UEXPERIMENTALFollowing treatment with onabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
OnabotulinumtoxinA 200 UEXPERIMENTALFollowing treatment with onabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
Placebo (Normal Saline)OTHERPlacebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
onabotulinumtoxinA 44UEXPERIMENTAL44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
onabotulinumtoxinA 24UOTHER24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
placebo/onabotulinumtoxinAOTHERPlacebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
BOTOX® 72UEXPERIMENTALOnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72 units (U) total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
BOTOX® 48UEXPERIMENTALOnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
100U cohort - BOTOX® plus Hydrogel admixtureEXPERIMENTAL100U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
100U cohort - Placebo plus Hydrogel admixturePLACEBO_COMPARATORPlacebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
300U cohort - BOTOX® plus Hydrogel admixtureEXPERIMENTAL300U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
300U cohort - Placebo plus Hydrogel admixturePLACEBO_COMPARATORPlacebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
400U cohort - BOTOX® plus Hydrogel admixtureEXPERIMENTAL400U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
400U cohort - Placebo plus Hydrogel admixturePLACEBO_COMPARATORPlacebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
500U cohort - BOTOX® plus Hydrogel admixtureEXPERIMENTAL500U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
500U cohort - Placebo plus Hydrogel admixturePLACEBO_COMPARATORPlacebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
OnabotulinumtoxinA 400 UEXPERIMENTALOnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
Placebo for onabotulinumtoxinA 50 UPLACEBO_COMPARATORPlacebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
Placebo for onabotulinumtoxinA 30 UPLACEBO_COMPARATORPlacebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
onabotulinumtoxinA 30 UEXPERIMENTALOnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.

Interventions

NameTypeDescription
OnabotulinumtoxinADRUGIntramuscular Injections
PlaceboDRUGIntramuscular Injections
Normal SalineDRUGPlacebo (normal saline) injected into the protocol-specified areas on Day 1.
Placebo (Normal Saline)DRUGPlacebo (normal saline) is administered into the detrusor at Day 1.
onabotulinumtoxinA 24 UBIOLOGICAL24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart.
onabotulinumtoxinA 44 UBIOLOGICAL44 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart
onabotulinum toxin ADRUGEach subject will receive 50 units (50 U) of BoNT-A constituted in 1 mL of saline solution injected intraorally to the painful area divided in at least 3 sites, 0.5 to 1.0 cm apart depending on the size of the painful area and following a checkerboard pattern.
OnabotulinumtoxinA and Hydrogel admixtureDRUGBOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
Placebo and Hydrogel admixtureDRUGPlacebo and Hydrogel admixture administered as a single intravesical instillation
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Forehead lines (FHL) of moderate or severe rating at maximum contraction as assessed by investigator using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) at Day 1 prior to study treatment. * Glabellar lines (GL) of moderate or severe rating at maximum contracti...

Countries:JapanUnited StatesCanadaBelgiumGermanyUnited KingdomIrelandCzechiaFranceItalyPolandTurkey (Türkiye)PortugalRussiaDenmark
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Frequently asked questions about onabotulinumtoxinA 24 U

What is onabotulinumtoxinA 24 U used for?

OnabotulinumtoxinA 24 U is being studied for the treatment of facial rhytides, including crow's feet lines and glabellar lines. It is an investigational formulation in Phase 3 development for these aesthetic indications. The 24 U designation refers to a specific unit dose evaluated in clinical testing.

What does onabotulinumtoxinA 24 U target?

OnabotulinumtoxinA 24 U targets SNAP25, a protein involved in neurotransmitter release. By inhibiting SNAP25, the drug is designed to reduce muscle contraction that contributes to facial rhytides. This mechanism is consistent with the botulinum toxin class of inhibitors.

Who is developing onabotulinumtoxinA 24 U?

OnabotulinumtoxinA 24 U is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor responsible for the clinical development program in facial rhytides.

What phase is onabotulinumtoxinA 24 U in?

OnabotulinumtoxinA 24 U is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA for the studied indication. The Phase 3 program has completed, with no active trials currently listed.

What clinical trials is onabotulinumtoxinA 24 U in?

OnabotulinumtoxinA 24 U has been evaluated in one completed Phase 3 trial, NCT01189760, titled "Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines." The trial enrolled 917 participants across the United States, Canada, France, and Germany.

What were the design features of the onabotulinumtoxinA 24 U trial?

The Phase 3 trial NCT01189760 was a randomized, double-blind, placebo-controlled study. It enrolled 917 adults aged 18 years and older of all sexes, and evaluated onabotulinumtoxinA 24 U for crow's feet lines and glabellar lines. The trial has been completed.