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Placebo / Xeomin
Placebo / Xeomin is a Botulinum toxin type A Small molecule drug developed by Innovaderm Research Inc.. It is currently in Phase 3 development for Cervical dystonia, Blepharospasm, Hemifacial spasm. Also known as: Sodium Chloride, Saline.
Xeomin is a botulinum toxin type A that blocks acetylcholine release at the neuromuscular junction, causing temporary muscle paralysis.
Xeomin is a botulinum toxin type A that blocks acetylcholine release at the neuromuscular junction, causing temporary muscle paralysis. Used for Cervical dystonia, Blepharospasm, Hemifacial spasm.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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 | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Placebo / Xeomin |
|---|---|
| Also known as | Sodium Chloride, Saline |
| Sponsor | Innovaderm Research Inc. |
| Drug class | Botulinum toxin type A |
| Target | SNARE complex (synaptosome-associated protein) |
| Modality | Small molecule |
| Therapeutic area | Neurology / Aesthetics |
| Phase | Phase 3 |
Mechanism of action
Xeomin (incobotulinumtoxinA) is a purified botulinum toxin serotype A that cleaves SNARE proteins required for acetylcholine vesicle release. This results in temporary denervation and muscle relaxation at the injection site. The effect is reversible as new neuromuscular junctions form over several months.
Approved indications
- Cervical dystonia
- Blepharospasm
- Hemifacial spasm
- Glabellar lines (aesthetic indication)
- Crow's feet (aesthetic indication)
Common side effects
- Headache
- Injection site pain
- Eyelid ptosis
- Muscle weakness
- Neck pain
Key clinical trials
- IncobotulinumtoxinA for Provoked Vestibulodynia With Overactive Pelvic Floor Muscle Dysfunction (PHASE2)
- A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine (PHASE3)
- A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine (PHASE3)
- 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)
- IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia (PHASE3)
- Dual-Site Botulinum Toxin Type A Injection for Lifelong Premature Ejaculation (NA)
- A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU) (PHASE3)
- Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Severe Primary Dysmenorrhea (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:
- Placebo / Xeomin CI brief — competitive landscape report
- Placebo / Xeomin updates RSS · CI watch RSS
- Innovaderm Research Inc. portfolio CI
Frequently asked questions about Placebo / Xeomin
What is Placebo / Xeomin?
How does Placebo / Xeomin work?
What is Placebo / Xeomin used for?
Who makes Placebo / Xeomin?
Is Placebo / Xeomin also known as anything else?
What drug class is Placebo / Xeomin in?
What development phase is Placebo / Xeomin in?
What are the side effects of Placebo / Xeomin?
What does Placebo / Xeomin target?
Related
- Drug class: All Botulinum toxin type A drugs
- Target: All drugs targeting SNARE complex (synaptosome-associated protein)
- Manufacturer: Innovaderm Research Inc. — full pipeline
- Therapeutic area: All drugs in Neurology / Aesthetics
- Indication: Drugs for Cervical dystonia
- Indication: Drugs for Blepharospasm
- Indication: Drugs for Hemifacial spasm
- Also known as: Sodium Chloride, Saline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing