Xeomin
Xeomin (incobotulinumtoxinA) is an acetylcholine release inhibitor and neuromuscular blocking agent used to treat various neurological, glandular, and aesthetic conditions. It is indicated for the treatment of chronic sialorrhea in patients aged two and older, as well as upper limb spasticity in adults and pediatric patients (excluding those with cerebral palsy). The drug is also approved for adult patients to manage cervical dystonia and blepharospasm, and to temporarily improve the appearance of moderate to severe upper facial lines.
How Xeomin Works
Xeomin blocks cholinergic transmission at neuromuscular and salivary neuroglandular junctions by inhibiting the release of the neurotransmitter acetylcholine. The neurotoxin binds to cholinergic nerve terminals and enters the cell, where it enzymatically cleaves SNAP25, a protein essential for acetylcholine release. By preventing this release, the drug inhibits muscle contraction and glandular secretion until impulse transmission is re-established through the formation of new nerve endings.
Details
- Status
- Prescription
- First Approved
- 2010-07-30
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Xeomin Approval History
What Xeomin Treats
7 indicationsXeomin is approved for 7 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Sialorrhea
- Upper Limb Spasticity
- Cervical Dystonia
- Blepharospasm
- Glabellar Lines
- Horizontal Forehead Lines
- Lateral Canthal Lines
Xeomin Boxed Warning
DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties c...
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. 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 but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including lower limb spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses [see Warnings and Precautions (5.1) ] . WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning. The effects of XEOMIN 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 but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms. ( 5.1 )
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Active Pipeline
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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.
Xeomin FDA Label Details
ProIndications & Usage
FDA Label (PDF)XEOMIN is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment or improvement of: Chronic sialorrhea in patients 2 years of age and older Upper limb spasticity in adults Upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy Cervical dystonia in adults Blepharospasm in adults the appearance of upper facial lines in adults: moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity moderate to severe horizontal forehead lines associated with frontalis muscle act...
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blu...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.