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Also known as DaxibotulinumtoxinA for injection, DAXI
DaxibotulinumtoxinA · 7 trials · 10 indications
Evaluation of adverse events and serious adverse events, from multiple continuous treatments of DAXI for injection, over the course of the study.
TWSTRS is used to assess the severity of cervical Dystonia and the success of its treatment. The average of the change from baseline in TWSTRS-total score at Weeks 4 and 6 will be determined. TWSTRS-total score has a minimum score of 0 and a maximum score of 85, where higher scores represent worse outcomes. It is made up of the summation of 3 subscales: the Torticollis Severity Scale (minimum score of 0, maximum score of 35), the Disability Scale (minimum score of 0, maximum score of 30), and the Pain Scale (minimum score of 0, maximum score of 20).
Time to retreatment (in days) with DAXI between the first and second study injection cycle.
For patients who receive 3 study injection cycles with DAXI over 12 months, a second primary endpoint will be the time to retreatment (in days) between the second-to-last and last injection cycle (i.e., between DAXI cycles 2 and 3).
The percentage of subjects achieving a score of 0 (none) or 1 (mild) in GL severity at maximum contraction (maximum frown) at Week 4 as assessed by the IGA-FWS
The percentage of subjects achieving a score of 0 (none) or 1 (mild) in FHL severity at maximum contraction (maximum eyebrow elevation) at Week 4 as assessed by the IGA-FHWS
The percentage of subjects achieving a score of 0 (none) or 1 (mild) in LCL severity at maximum contraction (maximum smile effort) at Week 4 as assessed by the IGA-LCWS
Percentage of subjects achieving a score or 0 or 1 (none or mild) in LCL severity at maximum smile at Week 4 after LCL treatment on the Investigator Global Assessment Lateral Canthal Wrinkle Severity (IGA-LCWS) scale
| Arm | Type | Description |
|---|---|---|
| daxibotulinumtoxinA (DAXI) for injection | EXPERIMENTAL | DAXI for injection |
| DAXI for injection low dose | EXPERIMENTAL | Low Dose Group |
| DAXI for injection high dose | EXPERIMENTAL | High Dose Group |
| Placebo | PLACEBO_COMPARATOR | Placebo Group |
| Open label arm | EXPERIMENTAL | The study cohort will consist of adults with blepharospasm who previously received onabotulinumtoxinA or incobotulinumtoxinA and will transition to DAXI 12 weeks after their last botulinum toxin treatment. Each participant will receive a DAXI dose equivalent to their prior therapy, using a 1:1 conversion for onabotulinumtoxinA or a 1.5:1 conversion for incobotulinumtoxinA, adjusted if prior treatment caused excessive weakness or other side effects. Injections will be limited to muscles directly involved in blepharospasm (the orbicularis oculi, corrugators, procerus, and nasalis) and will use a dilution of 10 units per 0.1 mL. Subjects may use topical anesthetics to reduce injection pain, and efforts will ensure the same injector administers all treatments to maintain consistency. |
| DAXI 40 U GL / 32 U FHL / 48 U LCL | EXPERIMENTAL | DaxibotulinumtoxinA for injection for the treatment of moderate to severe Glabellar Lines (GL), Forehead Lines (FHL), \& Lateral Canthal Lines (LCL) |
| Cohort 1: DAXI 12 U | EXPERIMENTAL | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
| Cohort 2: DAXI 24 U | EXPERIMENTAL | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
| Cohort 3: DAXI 36 U | EXPERIMENTAL | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
| Cohort 4: DAXI 48 U | EXPERIMENTAL | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
| Cohort 1: Dose A | EXPERIMENTAL | DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) |
| Cohort 2: Dose B | EXPERIMENTAL | DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) |
| Cohort 3: Dose C | EXPERIMENTAL | DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) |
| Cohort 4: Dose D | EXPERIMENTAL | DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) |
| Name | Type | Description |
|---|---|---|
| daxibotulinumtoxinA for injection | BIOLOGICAL | DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline. |
| Placebo | BIOLOGICAL | Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution. |
| Botulinum Neurotoxin Type A | DRUG | DaxibotulinumtoxinA (DAXI) for injection is a sterile, lyophilized powder containing 100 units of active daxibotulinumtoxinA per vial, along with inactive ingredients including RTP004, trehalose dihydrate, L-histidine, L-histidine hydrochloride, and polysorbate 20. It is reconstituted with Bacteriostatic Sodium Chloride Injection 0.9% (Pfizer) and stored at 2-8°C. DAXI will be prepared by trained injectors or staff, with all preparations documented. Experienced movement disorder neurologists will administer injections, primarily from UPenn's Parkinson's Disease and Movement Disorders Center. Dosing will follow prior treatment patterns using a 1:1 conversion from onabotulinumtoxinA or 1.5:1 from incobotulinumtoxinA, adjusted for prior adverse effects. Injection sites will be selected based on clinical presentation, with optional EMG or imaging guidance. |
| DaxibotulinumtoxinA | BIOLOGICAL | Low, mid, and high dose sequential treatments of daxibotulinumtoxinA in dose-escalation safety and efficacy study |
Inclusion Criteria: * Meets diagnostic criteria for isolated CD (idiopathic; dystonic symptoms localized to the head, neck, shoulder areas) with at least moderate severity at Baseline (Day 1), defined as a TWSTRS-total score of at least 20, with at least 15 on the TWSTRS-Severity subscale, at least...
DaxibotulinumtoxinA is an investigational botulinum neurotoxin type A therapeutic developed by Revance Therapeutics, Inc. It is being studied in neurology and aesthetic indications, including blepharospasm, cervical dystonia, and facial lines such as glabellar lines, forehead lines, and lateral canthal lines. It is a small molecule and remains in clinical development.
DaxibotulinumtoxinA is being studied for blepharospasm of both eyelids, cervical dystonia, torticollis (spasmodic), frown lines, lateral canthal lines, and upper facial lines including glabellar lines, forehead lines, and lateral canthal lines. These are the conditions under investigation in its clinical program, not approved uses.
DaxibotulinumtoxinA targets SNAP25 and acts as an inhibitor of this protein. SNAP25 is involved in neurotransmitter release at nerve terminals, and botulinum neurotoxin type A agents such as daxibotulinumtoxinA work through this target class to inhibit signaling. This mechanism underlies its study across both neurologic and aesthetic conditions.
DaxibotulinumtoxinA is developed by Revance Therapeutics, Inc., which trades under the ticker RVNC. The company is the sponsor of the clinical trials evaluating the agent in blepharospasm, cervical dystonia, and facial line indications.
DaxibotulinumtoxinA is in Phase 2 clinical development. It is investigational and has not been established as approved for the indications being studied. Its trial program includes completed Phase 2 studies in facial lines and an ongoing Phase 2 study in blepharospasm.
DaxibotulinumtoxinA has been studied in trials including NCT07489430, a recruiting Phase 2 study in blepharospasm, and completed Phase 2 studies NCT04259086 in upper facial lines, NCT03911102 in lateral canthal lines, and NCT03786770 in forehead lines. These trials enrolled participants in the United States and Canada.
DaxibotulinumtoxinA is a botulinum neurotoxin type A and is also referred to as daxibotulinumtoxinA for injection. Searches for botulinum neurotoxin type A in this context refer to the same agent developed by Revance Therapeutics, Inc. under the ticker RVNC.