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Loceryl
Loceryl is a Small molecule drug developed by National Taiwan University Hospital. It is currently in Phase 1 development. Also known as: amorolfine 5% nail lacquer (Loceryl), Amorolfine.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Loceryl |
|---|---|
| Also known as | amorolfine 5% nail lacquer (Loceryl), Amorolfine |
| Sponsor | National Taiwan University Hospital |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- CLINICAL INVESTIGATION FOR THE EVALUATION OF EFFICACY AND SAFETY OF TWO PRODUCTS FOR THE TREATMENT OF ONYCHOMYCOSIS (NA)
- Mycosis Culture Collection From Dermatological Isolated
- Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis (NA)
- Clinical Investigation for the Evaluation of Efficacy and Safety of Two Medical Devices for Onychomycosis Treatment (NA)
- Antifungal Activity of Loceryl Nail Lacquer in Combination With a Cosmetic Varnish (PHASE4)
- Comparison Between Long-pulsed Nd:YAG, Amorolfine and Combination Treatment in Treating Non-dermatophyte Onychomycosis (PHASE4)
- Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis (NA)
- Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer (PHASE4)
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:
- Loceryl CI brief — competitive landscape report
- Loceryl updates RSS · CI watch RSS
- National Taiwan University Hospital portfolio CI
Frequently asked questions about Loceryl
What is Loceryl?
Who makes Loceryl?
Is Loceryl also known as anything else?
What development phase is Loceryl in?
Related
- Manufacturer: National Taiwan University Hospital — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: amorolfine 5% nail lacquer (Loceryl), Amorolfine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing