Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Formulation A: OnabotulinumtoxinA · 1 trial · 1 indication
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. Treatment-emergent adverse events/ treatment emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of the study drug.
| Arm | Type | Description |
|---|---|---|
| Formulation A: OnabotulinumtoxinA | EXPERIMENTAL | Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1. |
| Formulation B: OnabotulinumtoxinA | EXPERIMENTAL | Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1. |
| Formulation C: OnabotulinumtoxinA | EXPERIMENTAL | Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1. |
| Name | Type | Description |
|---|---|---|
| Formulation A: OnabotulinumtoxinA | DRUG | Intramuscular Injection |
| Formulation B: OnabotulinumtoxinA | DRUG | Intramuscular Injection |
| Formulation C: OnabotulinumtoxinA | DRUG | Intramuscular Injection |
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 severe GL at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale - G...
Formulation A: OnabotulinumtoxinA is being developed for the treatment of glabellar lines, the vertical frown lines between the eyebrows. It is an investigational formulation studied in adult female participants aged 18 years and older. The program sits in the dermatology therapeutic area.
Formulation A: OnabotulinumtoxinA is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating this formulation in glabellar lines.
Formulation A: OnabotulinumtoxinA is in Phase 2 clinical development. It is an investigational product and has not been approved by the FDA for glabellar lines. The Phase 2 study has been completed, and no trials of this formulation are currently listed as active.
One clinical trial has studied Formulation A: OnabotulinumtoxinA: NCT05013424, titled A Study of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines. The Phase 2 trial was completed, enrolled 92 participants, was randomized and controlled, and was conducted in the United States.
The completed Phase 2 trial NCT05013424 enrolled adult female participants aged 18 years and older with glabellar lines. It was a randomized, controlled study conducted in the United States and enrolled 92 participants. Healthy volunteers were not eligible for this trial.