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Botulinum Toxin
Botulinum Toxin, marketed by the University Health Network in Toronto, is positioned in the glabellar lines segment of the cosmetic market. The drug's key strength lies in its well-established mechanism and market presence, with a key composition patent expiring in 2028. The primary risk is the potential increase in competition as the patent expiration approaches.
At a glance
| Generic name | Botulinum Toxin |
|---|---|
| Also known as | Botox, botulinum toxins, Botox (Allergan, Irvine, CA), BOTOX, botox |
| Sponsor | University Health Network, Toronto |
| Drug class | Acetylcholine Release Inhibitor [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
- Glabellar Lines
- Cervical Dystonia
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
- 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
Drug interactions
- Aminoglycosides
- Anticholinergic drugs
- Botulinum neurotoxin products
- Muscle relaxants
Key clinical trials
- DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia (PHASE1, PHASE2)
- Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome (PHASE2)
- Botulinum Toxin for the Treatment of Involuntary Movement Disorders
- A Study to Evaluate Patient Satisfaction With the Overall Face and Neck Appearance After Combined Treatment of OnabotulinumtoxinA, JUVÉDERM® Products, KYBELLA, CoolSculpting Elite and SkinMedica Products (PHASE4)
- DaxibotulinumtoxinA for Blepharospasm (PHASE2)
- Prospective, Non-interventional Study Assessing Periorbital Rejuvenation Procedure
- A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine (PHASE3)
- Evaluation of Spasticity, Neuropathic Pain, and Gait Analysis in Stroke Patients Receiving Tolperison Therapy After Botulinum Toxin Injection
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:
- Botulinum Toxin CI brief — competitive landscape report
- Botulinum Toxin updates RSS · CI watch RSS
- University Health Network, Toronto portfolio CI