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Loprox (CICLOPIROX)
Loprox (generic name: CICLOPIROX) is a ciclopirox Small molecule drug developed by Bausch Health. It is currently FDA-approved (first approved 1982) for Onychomycosis Treatment.
Ciclopirox, marketed as Loprox by Bausch Health, is an antifungal agent primarily indicated for the treatment of onychomycosis, currently holding a position in a competitive market with several same-class drugs. Its key strength lies in its mechanism of action, which effectively inhibits fungal cell growth and energy production, leading to cell death. The primary risk is the upcoming key patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | CICLOPIROX |
|---|---|
| Sponsor | Bausch Health |
| Drug class | ciclopirox |
| Target | Poly [ADP-ribose] polymerase 1 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1982 |
Approved indications
- Onychomycosis Treatment
Common side effects
- periungual erythema
- erythema of the proximal nail fold
- nail disorders
- application site reactions and/or burning of the skin
Key clinical trials
- 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 (PHASE1,PHASE2)
- Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox
- Study to Assess the Safety and Pharmacokinetics of ATL-001 (Ciclopirox Olamine) in Healthy Volunteers (PHASE1)
- Photodynamic Therapy and Topical Antifungal for Onychomycosis in Patients With Diabetes. (NA)
- Mycosis Culture Collection From Dermatological Isolated
- Diode Laser and Photodynamic Therapy Vs. Ciclopirox. (PHASE4)
- Safety and Equivalence of a Generic Ciclopirox Olamine Topical Suspension Compared to the Reference Ciclopirox Topical Suspension 0.77% for the Treatment of Tinea Pedis (NA)
- Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis (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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Loprox CI brief — competitive landscape report
- Loprox updates RSS · CI watch RSS
- Bausch Health portfolio CI
Frequently asked questions about Loprox
What is Loprox?
What is Loprox used for?
Who makes Loprox?
What is the generic name of Loprox?
What drug class is Loprox in?
When was Loprox approved?
What development phase is Loprox in?
What are the side effects of Loprox?
What does Loprox target?
Related
- Drug class: All ciclopirox drugs
- Target: All drugs targeting Poly [ADP-ribose] polymerase 1
- Manufacturer: Bausch Health — full pipeline
- Therapeutic area: All drugs in Metabolic
- Indication: Drugs for Onychomycosis Treatment
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing