DAXXIFY (daxibotulinumtoxina-lanm)
DAXXIFY (daxibotulinumtoxinA-lanm) is an acetylcholine release inhibitor and neuromuscular-blocking agent indicated for use in adult patients. It is used for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and procerus muscle activity. The medication is also approved for the treatment of cervical dystonia. It serves a therapeutic role by temporarily reducing muscle activity through the inhibition of neurotransmitter release.
How DAXXIFY Works
DAXXIFY blocks neuromuscular transmission at the neuromuscular junction by inhibiting the release of acetylcholine. The neurotoxin achieves this by cleaving SNAP-25, a protein essential for the docking and release of acetylcholine vesicles within nerve endings. Without the release of this neurotransmitter, muscle contraction is inhibited. Recovery of neurotransmission occurs gradually as the neuromuscular junction recovers from protein cleavage and new nerve endings are formed.
Details
- Status
- Prescription
- First Approved
- 2022-09-07
- Routes
- INTRAMUSCULAR, SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
DAXXIFY Approval History
What DAXXIFY Treats
2 indicationsDAXXIFY is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Glabellar Lines
- Cervical Dystonia
DAXXIFY Boxed Warning
DISTANT SPREAD OF TOXIN EFFECT The effects of all botulinum toxin products, including DAXXIFY, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening, and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, an unapproved use for DAXXIFY, but symptoms can also occur in...
WARNING: DISTANT SPREAD OF TOXIN EFFECT The effects of all botulinum toxin products, including DAXXIFY, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening, and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, an unapproved use for DAXXIFY, but symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms [see Warnings and Precautions (5.1) ]. WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning. The effects of DAXXIFY and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening, and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, an unapproved use for DAXXIFY, but symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms. ( 5.1 )
DAXXIFY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06411002 | 2320201 | Ph 2 | completed | Phase 2a Study of DaxibotulinumtoxinA-lanm for Injection in Dynamic Forehead Lines and Glabellar Lines |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DAXXIFY FDA Label Details
Indications & Usage
FDA Label (PDF)DAXXIFY is indicated for the treatment of Glabellar Lines; Cervical Dystonia.
WARNING: DISTANT SPREAD OF TOXIN EFFECT The effects of all botulinum toxin products, including DAXXIFY, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing diffic...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.