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Botulinum Toxin A - Open Label
Botulinum Toxin A blocks acetylcholine release at the neuromuscular junction by cleaving SNARE proteins, causing temporary muscle paralysis.
Botulinum Toxin A blocks acetylcholine release at the neuromuscular junction by cleaving SNARE proteins, causing temporary muscle paralysis. Used for Cervical dystonia, Blepharospasm, Hemifacial spasm.
At a glance
| Generic name | Botulinum Toxin A - Open Label |
|---|---|
| Also known as | BoNT/A-DP |
| Sponsor | Croma-Pharma GmbH |
| Drug class | Neurotoxin; Acetylcholine release inhibitor |
| Target | SNAP-25 (synaptosome-associated protein of 25 kDa) |
| Modality | Small molecule |
| Therapeutic area | Neurology; Aesthetics; Pain Management |
| Phase | Phase 3 |
Mechanism of action
Botulinum Toxin A is a neurotoxin that irreversibly cleaves SNARE proteins (specifically SNAP-25) required for acetylcholine vesicle fusion and release at the presynaptic terminal. This prevents neuromuscular transmission, resulting in temporary flaccid paralysis of injected muscles. The effect is reversible over 3-4 months as new nerve terminals form and acetylcholine signaling is restored.
Approved indications
- Cervical dystonia
- Blepharospasm
- Hemifacial spasm
- Chronic migraine
- Spasticity
- Hyperhidrosis
- Cosmetic wrinkle reduction
Common side effects
- Injection site pain or bruising
- Headache
- Muscle weakness or paralysis (off-target)
- Ptosis (eyelid drooping)
- Dry mouth
- Neck pain
- Antibody formation (neutralizing)
Key clinical trials
- 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)
- Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury (PHASE3)
- A Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in Multiple Treatments of Adult Upper Limb Spasticity (PHASE3)
- Perineural Incobotulinumtoxin-A for Complex Regional Pain Syndrome - An Open-label Feasibility Study (NA)
- A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection (CU-20101) (PHASE3)
- A Study to Assess BOTOX Injections in Adult Participants for the Change of Masseter Muscle Prominence (PHASE3)
- A Study to Assess the Effectiveness of BOTOX (Botulinum Toxin Type A) Injections for the Change of Masseter Muscle Prominence in Adult Participants (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 |
|---|---|
| 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 A - Open Label CI brief — competitive landscape report
- Botulinum Toxin A - Open Label updates RSS · CI watch RSS
- Croma-Pharma GmbH portfolio CI