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amorolfine 5%

Polichem S.A. · Phase 3 active Small molecule

amorolfine 5% is a Antifungal Small molecule drug developed by Polichem S.A.. It is currently in Phase 3 development for Onychomycosis. Also known as: Loceryl®.

Amorolfine is an antifungal agent that inhibits the growth of fungi by interfering with the synthesis of ergosterol, an essential component of fungal cell membranes.

Amorolfine is an antifungal agent that inhibits the growth of fungi by interfering with the synthesis of ergosterol, an essential component of fungal cell membranes. Used for Onychomycosis.

Likelihood of approval
58.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • 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).
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameamorolfine 5%
Also known asLoceryl®
SponsorPolichem S.A.
Drug classAntifungal
TargetLanosterol 14α-demethylase
ModalitySmall molecule
Therapeutic areaDermatology
PhasePhase 3

Mechanism of action

Amorolfine works by competitively inhibiting the enzyme lanosterol 14α-demethylase, which is necessary for the conversion of lanosterol to ergosterol. This leads to an accumulation of toxic compounds and ultimately results in the death of the fungal cells. Amorolfine is effective against a wide range of dermatophytes and yeasts.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about amorolfine 5%

What is amorolfine 5%?

amorolfine 5% is a Antifungal drug developed by Polichem S.A., indicated for Onychomycosis.

How does amorolfine 5% work?

Amorolfine is an antifungal agent that inhibits the growth of fungi by interfering with the synthesis of ergosterol, an essential component of fungal cell membranes.

What is amorolfine 5% used for?

amorolfine 5% is indicated for Onychomycosis.

Who makes amorolfine 5%?

amorolfine 5% is developed by Polichem S.A. (see full Polichem S.A. pipeline at /company/polichem-s-a).

Is amorolfine 5% also known as anything else?

amorolfine 5% is also known as Loceryl®.

What drug class is amorolfine 5% in?

amorolfine 5% belongs to the Antifungal class. See all Antifungal drugs at /class/antifungal.

What development phase is amorolfine 5% in?

amorolfine 5% is in Phase 3.

What are the side effects of amorolfine 5%?

Common side effects of amorolfine 5% include Skin irritation.

What does amorolfine 5% target?

amorolfine 5% targets Lanosterol 14α-demethylase and is a Antifungal.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing