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Incobotulinumtoxin A
Incobotulinumtoxin A is a Neurotoxin Small molecule drug developed by Ulthera, Inc. It is currently in Phase 2 development for Cervical dystonia, Blepharospasm, Glabellar lines. Also known as: Xeomin, Botox.
Incobotulinumtoxin A is a neurotoxin that blocks the release of acetylcholine at neuromuscular junctions, leading to temporary muscle paralysis.
Incobotulinumtoxin A is a neurotoxin that blocks the release of acetylcholine at neuromuscular junctions, leading to temporary muscle paralysis. Used for Cervical dystonia, Blepharospasm, Glabellar lines.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Incobotulinumtoxin A |
|---|---|
| Also known as | Xeomin, Botox |
| Sponsor | Ulthera, Inc |
| Drug class | Neurotoxin |
| Target | SNARE proteins |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 2 |
Mechanism of action
This toxin specifically targets and binds to presynaptic nerve terminals, inhibiting the release of acetylcholine, which results in a reversible blockage of neuromuscular transmission and subsequent muscle relaxation.
Approved indications
- Cervical dystonia
- Blepharospasm
- Glabellar lines
Common side effects
- Headache
- Muscle weakness
Key clinical trials
- 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)
- Perineural Incobotulinumtoxin-A for Complex Regional Pain Syndrome - An Open-label Feasibility Study (NA)
- Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities (PHASE2)
- Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF) (PHASE3)
- A Study to Investigate the Efficacy and Safety of NT 201 (Botulinum Toxin) Compared With Placebo for the Treatment of Adult Participants With Essential Tremor in the Arm (PHASE2)
- Use of Botulinum Toxin in the Treatment of Androgenic Alopecia (PHASE2)
- Evaluation of BTX Injections in Treatment of Bruxism (PHASE3)
- Incobotulinumtoxin A and Yoga-like Isometric Exercise in Adolescent Idiopathic Lumbar Scoliosis (PHASE2)
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:
- Incobotulinumtoxin A CI brief — competitive landscape report
- Incobotulinumtoxin A updates RSS · CI watch RSS
- Ulthera, Inc portfolio CI
Frequently asked questions about Incobotulinumtoxin A
What is Incobotulinumtoxin A?
How does Incobotulinumtoxin A work?
What is Incobotulinumtoxin A used for?
Who makes Incobotulinumtoxin A?
Is Incobotulinumtoxin A also known as anything else?
What drug class is Incobotulinumtoxin A in?
What development phase is Incobotulinumtoxin A in?
What are the side effects of Incobotulinumtoxin A?
What does Incobotulinumtoxin A target?
Related
- Drug class: All Neurotoxin drugs
- Target: All drugs targeting SNARE proteins
- Manufacturer: Ulthera, Inc — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Cervical dystonia
- Indication: Drugs for Blepharospasm
- Indication: Drugs for Glabellar lines
- Also known as: Xeomin, Botox
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing