Not an actual patient.
Our investigational neuromodulator product, DaxibotulinumtoxinA for Injection, is aiming to establish a new, premium, long-lasting neuromodulator category.
DaxibotulinumtoxinA for Injection is an investigational agent that has not been approved by the FDA and is currently under regulatory review.
The consumer experience has remained largely unchanged since botulinum toxin type A treatments were first introduced over 30 years ago. Once approved, we expect that people treated with DaxibotulinumtoxinA for Injection may achieve frown line correction with as few as two treatments per year.1
DaxibotulinumtoxinA combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components.
150kD Botulinum Toxin Type A
Stabilizing Peptide Excipient
Buffers, Sugar and Polysorbate 20
DaxibotulinumtoxinA for Injection
Revance employs in-house, state-of-the-art manufacturing and analytics capabilities, and holds 418 issued patents in the US, EU, Latin America and Asia, as of December 31, 2019.
Based on results from the SAKURA program (SAKURA 1, 2, 3), we expect that people treated with DaxibotulinumtoxinA for Injection may achieve frown line correction with as few as two treatments per year.1
Not an actual patient.
Subjects achieved a two-grade improvement in glabellar lines as assessed by with the patient and the investigator at week 4 after treatment.1
Response rate for DaxibotulinumtoxinA for Injection across the largest phase 3 program of an aesthetic neuromodulator in glabellar lines.1
*This data point represents percent of subjects achieving glabellar line severity of none/mild at week 4
The median time to loss of none or mild wrinkle severity in clinical trials with DaxibotulinumtoxinA for Injection.2
The median time to return to baseline wrinkle severity in the SAKURA program2
The FDA accepted for review the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection in the treatment of moderate to severe glabellar (frown) lines. The BLA under review includes results from three Phase 3 trials (SAKURA 1,2,3), the largest aesthetic neuromodulator clinical program ever conducted for the treatment of glabellar (frown) lines. DaxibotulinumtoxinA for Injection has also been evaluated in a Phase 2 head-to-head, active comparator study (BELMONT). DaxibotulinumtoxinA for Injection is an investigational agent that has not been approved by the FDA and is currently under regulatory review.
DaxibotulinumtoxinA for Injection is being evaluated in a Phase 2 open-label study for the treatment of moderate to severe dynamic forehead lines (frontalis) following glabellar line injection. An interim analysis from the study found that treatment with DaxibotulinumtoxinA for Injection substantially improved the appearance of forehead lines versus placebo at all doses tested 4 weeks after treatment and resulted in high patient satisfaction.3
DaxibotulinumtoxinA for Injection is being evaluated in a Phase 2 open-label study for the treatment of moderate to severe lateral canthal lines, commonly known as crow’s feet. Clinical data demonstrated positive efficacy results and that DaxibotulinumtoxinA for Injection was well tolerated.
Revance evaluated DaxibotulinumtoxinA for Injection in an open-label Phase 2 study for treatment of the full upper face, including glabellar (frown) lines, forehead lines and crow’s feet (lateral canthal lines). The study was conducted to understand the safety and efficacy, including potential dosing and injection patterns, of DaxibotulinumtoxinA for Injection. In December 2020, Revance announced positive topline efficacy and safety results from its Phase 2 study.
For the latest information regarding our clinical development programs, please see our public filings with the Securities and Exchange Commission or visit clinicaltrials.gov.
DaxibotulinumtoxinA for Injection is an investigational product. It is currently undergoing clinical studies for both therapeutic and aesthetic indications.
