NDATOPICALSUSPENSION
Approved
Dec 1988
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
3/8 — Basic
LOPROX (ciclopirox) by Eurofarma Laboratórios is protein synthesis inhibitors [moa]. First approved in 1988.
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LOPROX (ciclopirox) is a topical antifungal suspension approved in 1988 that works by inhibiting fungal protein synthesis. It is used to treat various fungal infections of the skin, nails, and other superficial sites. The drug represents a mature, well-established topical antifungal with a narrow but defined patient population.
LOE Approaching
As a legacy topical antifungal approaching LOE, LOPROX likely operates with a lean, maintenance-focused commercial team focused on defending remaining market share against generic and branded competitors.
Mechanism of Action
Protein Synthesis Inhibitors
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
A Study to Investigate the Improvement of Photosensitivity in Terms of Skin Lesions Associated With CEP Following Administration of Oral ATL-001 (Ciclopirox Oral Solution) in Participants Aged >18 Years of Age With CEP
Started Jan 2026
6 enrolled
Congenital Erythropoietic Porphyria (CEP)
Study to Assess the Safety and Pharmacokinetics of ATL-001 (Ciclopirox Olamine) in Healthy Volunteers
Started Mar 2023
42 enrolled
Adverse Effect of Drugs and Medicaments in Therapeutic Use
Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer
Started Sep 2015
20 enrolled
Foot Dermatoses
Efficacy, Safety and Cost-effectiveness of a Sequential Therapy With RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-forming Solution Compared With Amorolfine Nail Lacquer in Dermatophytic Onychomycosis
Started Aug 2009
260 enrolled
Onychomycosis
Safety Study of Ciclopirox Olamine Cream for Dermatomycoses in Children
Started Oct 2008
21 enrolled
Dermatomycoses
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.