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amorolfine 5% — Competitive Intelligence Brief

amorolfine 5% (amorolfine 5%) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antifungal. Area: Dermatology.

phase 3 Antifungal Lanosterol 14α-demethylase Dermatology Small molecule Live · refreshed every 30 min

Target snapshot

amorolfine 5% (amorolfine 5%) — Polichem S.A.. 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.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / PDUFA
amorolfine 5% TARGET amorolfine 5% Polichem S.A. phase 3 Antifungal Lanosterol 14α-demethylase
Voriconazole preemptive genotyping strategy Voriconazole preemptive genotyping strategy Instituto de Investigación Hospital Universitario La Paz marketed Triazole antifungal with pharmacogenomic optimization CYP2C19 enzyme (pharmacogenomic target); fungal lanosterol 14α-demethylase (therapeutic target)
Topical Sertaconazole 2% Topical Sertaconazole 2% Jinnah Postgraduate Medical Centre marketed Imidazole antifungal Lanosterol 14α-demethylase (CYP51)
Nizoral® Nizoral® Ache Laboratorios Farmaceuticos S.A. marketed Imidazole antifungal Lanosterol 14α-demethylase (CYP51)
Loceryl NL 12 weeks Loceryl NL 12 weeks Galderma R&D marketed Allylamine antifungal Lanosterol 14α-demethylase (CYP51)
Clotrimazole vaginal tablets+ Lactobacillus Clotrimazole vaginal tablets+ Lactobacillus Peking University Shenzhen Hospital marketed Antifungal + probiotic combination Fungal lanosterol 14α-demethylase (CYP51); Lactobacillus competitive exclusion and microbiota restoration
Loceryl Nail Lacquer Loceryl Nail Lacquer Galderma R&D marketed Morpholine antifungal Lanosterol 14α-demethylase (CYP51)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Antifungal class)

  1. Cidara Therapeutics Inc. · 1 drug in this class
  2. Drugs for Neglected Diseases · 1 drug in this class
  3. Fernanda P Silveira, MD, MS · 1 drug in this class
  4. LI YAN · 1 drug in this class
  5. Novartis · 1 drug in this class
  6. Polichem S.A. · 1 drug in this class

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Cite this brief

Drug Landscape (2026). amorolfine 5% — Competitive Intelligence Brief. https://druglandscape.com/ci/amorolfine-5. Accessed 2026-06-10.

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