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prabotulinumtoxinA · 1 trial · 1 indication
Time to return to baseline Glabellar Line Scale (GLS) score at maximum frown, as assessed by the blinded evaluating investigator. The Glabellar Line Scale (GLS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles.
| Arm | Type | Description |
|---|---|---|
| OLD (4 U per 0.1 mL) | ACTIVE_COMPARATOR | The total Jeuveau dose will be 20U divided into 5 injections. Each subject will receive a total of 0.5 mL of Jeuveau during the treatment. |
| COLD (4 U per 0.02 mL group) | ACTIVE_COMPARATOR | The total Jeuveau dose will be 20U divided into 5 injections. Each injection will receive a total of 0.1 mL of Jeuveau during the treatment. |
| Name | Type | Description |
|---|---|---|
| prabotulinumtoxinA | DRUG | Injection of glabellar rhytids |
Inclusion Criteria: * At least 18 years of age at the time of signing the informed consent. * Overtly healthy as determined by medical evaluation (includes: medical history, physical examination, and vital signs). * Subjects have moderate or severe dynamic glabellar lines on maximum frown as assess...
PrabotulinumtoxinA is used for glabellar frown lines, the vertical wrinkles between the eyebrows. It is being developed by Evolus, Inc. (EOLS) as a dermatology treatment. The drug is currently in Phase 1 clinical development and is considered investigational, meaning it is not yet approved for commercial use.
PrabotulinumtoxinA is a small molecule that targets the neuromuscular junction. It works by blocking the release of acetylcholine, which temporarily relaxes the muscles that cause glabellar frown lines. This mechanism reduces the appearance of wrinkles between the eyebrows.
PrabotulinumtoxinA is being developed by Evolus, Inc., a company traded on the stock exchange under the ticker symbol EOLS. Evolus is focused on aesthetic medicine and is advancing this product for the treatment of glabellar frown lines.
PrabotulinumtoxinA is in Phase 1 clinical development. It is an investigational drug, meaning it has not received FDA approval and is still undergoing clinical trials to evaluate its safety and efficacy for treating glabellar frown lines.
PrabotulinumtoxinA has one completed clinical trial, NCT05129319, titled 'Jeuveau Treatment of Glabellar Lines Using OLD Versus COLD'. This early Phase 1 study enrolled 30 female healthy volunteers in the United States and was randomized, double-blind, and active-controlled.
PrabotulinumtoxinA is the active ingredient in the product Jeuveau, as indicated by the clinical trial title. The study NCT05129319 compares Jeuveau treatment using old versus cold methods, confirming that prabotulinumtoxinA is the drug substance in the Jeuveau formulation.