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Hutox Inj
Hutox Inj is a Botulinum toxin type A Biologic drug developed by Huons Co., Ltd.. It is currently in Phase 3 development for Facial wrinkles and dynamic expression lines (aesthetic indication), Muscle hyperactivity disorders (therapeutic indication).
Hutox is a botulinum toxin type A preparation that blocks acetylcholine release at the neuromuscular junction to reduce muscle contractions.
Hutox is a botulinum toxin type A preparation that blocks acetylcholine release at the neuromuscular junction to reduce muscle contractions. Used for Facial wrinkles and dynamic expression lines (aesthetic indication), Muscle hyperactivity disorders (therapeutic indication).
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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 | Hutox Inj |
|---|---|
| Sponsor | Huons Co., Ltd. |
| Drug class | Botulinum toxin type A |
| Target | SNARE complex (acetylcholine release machinery) |
| Modality | Biologic |
| Therapeutic area | Aesthetics, Neurology |
| Phase | Phase 3 |
Mechanism of action
Hutox works by cleaving SNARE proteins required for acetylcholine vesicle fusion and release at motor nerve terminals. This leads to temporary paralysis of injected muscles, reducing dynamic wrinkles and muscle hyperactivity. The effect is reversible as new neuromuscular junctions form over several months.
Approved indications
- Facial wrinkles and dynamic expression lines (aesthetic indication)
- Muscle hyperactivity disorders (therapeutic indication)
Common side effects
- Injection site pain or bruising
- Headache
- Facial asymmetry or drooping
- Temporary muscle weakness
Key clinical trials
- A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines (PHASE3)
- The Safety and Efficacy Study of Hutox Versus Botox® in Subject With Moderate to Severe Glabellar Lines (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:
- Hutox Inj CI brief — competitive landscape report
- Hutox Inj updates RSS · CI watch RSS
- Huons Co., Ltd. portfolio CI
Frequently asked questions about Hutox Inj
What is Hutox Inj?
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What does Hutox Inj target?
Related
- Drug class: All Botulinum toxin type A drugs
- Target: All drugs targeting SNARE complex (acetylcholine release machinery)
- Manufacturer: Huons Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Aesthetics, Neurology
- Indication: Drugs for Facial wrinkles and dynamic expression lines (aesthetic indication)
- Indication: Drugs for Muscle hyperactivity disorders (therapeutic indication)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing