Last reviewed · How we verify
Xeomin (INCOBOTULINUMTOXINA)
Xeomin works by blocking the release of a chemical messenger called acetylcholine, which signals muscles to contract.
Xeomin, marketed by Merz Pharms, is a botulinum toxin type A indicated for chronic sialorrhea, currently holding a position in a niche but growing therapeutic area. Its key strength lies in its mechanism of action, which effectively blocks the release of acetylcholine, thereby reducing muscle contractions and managing symptoms. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | INCOBOTULINUMTOXINA |
|---|---|
| Sponsor | Merz Pharms |
| Drug class | Acetylcholine Release Inhibitor [EPC] |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2015 |
Mechanism of action
XEOMIN blocks cholinergic transmission at the neuromuscular and salivary neuroglandular junction by inhibiting the release of acetylcholine from peripheral cholinergic nerve endings. This inhibition occurs according to the following sequence: neurotoxin binding to cholinergic nerve terminals, internalization of the neurotoxin into the nerve terminal, translocation of the light-chain part of the molecule into the cytosol of the nerve terminal, and enzymatic cleavage of SNAP25, a presynaptic target protein essential for the release of acetylcholine. In both muscles and glands, impulse transmission is re-established by the formation of new nerve endings.
Approved indications
- Chronic sialorrhea
- Upper limb spasticity in adults
- Upper limb spasticity in pediatric patients (excluding cerebral palsy)
- Cervical dystonia in adults
- Blepharospasm in adults
- Moderate to severe glabellar lines
- Moderate to severe horizontal forehead lines
- Moderate to severe lateral canthal lines
Boxed warnings
- 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 )
Common side effects
- Tooth extraction
- Dry mouth
- Diarrhea
- Hypertension
- Fall
- Bronchitis
- Dysphonia
- Back pain
- Dry eye
- Seizure
- Nasopharyngitis
- Upper respiratory tract infection
Drug interactions
- Aminoglycosides
- Other agents that interfere with neuromuscular transmission
- Anticholinergic drugs
- Other Botulinum Neurotoxin Products
- Muscle relaxants
Key clinical trials
- Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Arm(s) or of Arm(s) and Leg(s) in Cerebral Palsy (PHASE3)
- IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm (PHASE3)
- Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Abnormal Contraction or Twitch of the Eyelid (PHASE3)
- IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Post-stroke Spasticity of the Upper Limb (PHASE3)
- Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troublesome Drooling Associated With Neurological Disorders and/or Intellectual Disability (PHASE3)
- IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia (PHASE3)
- Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke (PHASE3)
- Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions (PHASE3)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Xeomin CI brief — competitive landscape report
- Xeomin updates RSS · CI watch RSS
- Merz Pharms portfolio CI