Last reviewed · How we verify
DAXXIFY (DAXIBOTULINUMTOXINA-LANM)
DAXXIFY (generic name: DAXIBOTULINUMTOXINA-LANM) is a Acetylcholine Release Inhibitor [EPC] drug developed by REVANCE THERAPEUTICS, INC.. It is currently FDA-approved.
DAXXIFY is a botulinum toxin inhibitor that targets Synaptosomal-associated protein 25 (SNAP-25), a protein involved in neurotransmitter release. It is being studied for the treatment of conditions such as Benign Essential Blepharospasm, Hemifacial Spasm, Glabellar Frown Lines, and Wrinkles.
At a glance
| Generic name | DAXIBOTULINUMTOXINA-LANM |
|---|---|
| Sponsor | REVANCE THERAPEUTICS, INC. |
| Drug class | Acetylcholine Release Inhibitor [EPC] |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- 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 )
Common side effects
- Headache
- Injection site pain
- Injection site erythema
- Muscular weakness
- Upper respiratory tract infection
- Headache (Glabellar Lines)
- Eyelid ptosis
- Facial paresis
- Injection site reactions (overall)
- Edema
- Erythema
- Injection site oedema
Serious adverse events
- Spread of Toxin Effect
- Hypersensitivity Reactions
- Cardiovascular System Adverse Reactions
- Increased Neuromuscular Compromise in Patients with Pre-Existing Neuromuscular Disorders
- Dysphagia and Breathing Difficulties
- Ophthalmic Adverse Reactions
Key clinical trials
- A Phase 2a Study to Evaluate the Effects of DaxibotulinumtoxinA for Injection on the Treatment of Dynamic Forehead Lines and Glabellar Lines (Phase 2)
- Use of DaxibotulinimtoxinA Injection for Platysma Bands of the Neck (Phase 4)
- The Safety and Efficacy of DaxibotulinumtoxinA-Lanm for Benign Essential Blepharospasm and Hemifacial Spasm (Phase 4)
- Head-to-Head Comparison of the Efficacy and Safety of All Five Commercially Available Botulinum Neurotoxin Type A Products for the Treatment of Glabellar Rhytides: A Multicenter, Triple-Blind, Randomi (Phase 4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- DAXXIFY CI brief — competitive landscape report
- DAXXIFY updates RSS · CI watch RSS
- REVANCE THERAPEUTICS, INC. portfolio CI
Frequently asked questions about DAXXIFY
What is DAXXIFY?
Who makes DAXXIFY?
What is the generic name of DAXXIFY?
What drug class is DAXXIFY in?
What development phase is DAXXIFY in?
What are the side effects of DAXXIFY?
Related
- Drug class: All Acetylcholine Release Inhibitor [EPC] drugs
- Manufacturer: REVANCE THERAPEUTICS, INC. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing