Ciclopirox

Mechanism-of-action class: Protein Synthesis Inhibitors.

• (To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) Ciclopirox Topical Solution, 8% as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum . The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures.ICD-10: B35.1

• Ciclopirox Topical Solution, 8% is contraindicated in individuals who have shown hypersensitivity to any of its components.contraindicated

Ciclopirox Topical Solution, 8% should be used as a component of a comprehensive management program for onychomycosis. Removal of the unattached, infected nail, as frequently as monthly, by a health care professional, weekly trimming by the patient, and daily application of the medication are all integral parts of this therapy. Careful consideration of the appropriate nail management program should be given to patients with diabetes (see PRECAUTIONS ). Nail Care By Health Care Professionals - Removal of the unattached, infected nail, as frequently as monthly, trimming of onycholytic nail, and filing of excess horny material should be performed by professionals trained in treatment of nail disorders. Nail Care By Patient – Patients should file away (with emery board) loose nail material and trim nails, as required, or as directed by the health care professional, every seven days after Ciclopirox Topical Solution, 8% is removed with alcohol. Ciclopirox Topical Solution, 8% should be applied once daily (preferably at bedtime or eight hours before washing) to all affected nails with the applicator brush provided. Ciclopirox Topical Solution, 8% should be applied evenly over the entire nail plate. If possible, Ciclopirox Topical Solution, 8% should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis). Ciclopirox Topical Solution, 8% should not be removed on a daily basis. Daily applications should be made over the previous coat and removed with alcohol every seven days.

Ciclopirox Topical Solution, 8% is not for ophthalmic, oral, or intravaginal use. It is for use on nails and immediately adjacent skin only.

In the vehicle-controlled clinical trials conducted in the United States, 9% (30/327) of patients treated with ciclopirox topical solution, 8%, and 7% (23/328) of patients treated with vehicle reported treatment-emergent adverse events (TEAE) considered by the investigator to be causally related to the test material. The incidence of these adverse events, within each body system, was similar between the treatment groups except for skin and appendages: 8% (27/327) and 4% (14/328) of subjects in the ciclopirox and vehicle groups reported at least one adverse event, respectively. The most common were rash-related adverse events: periungual erythema and erythema of the proximal nail fold were reported more frequently in patients treated with ciclopirox topical solution, 8%, (5% [16/327]) than in patients treated with vehicle (1% [3/328]). Other TEAEs thought to be causally related included nail disorders such as shape change, irritation, ingrown toenail, and discoloration. The incidence of nail disorders was similar between the treatment groups (2% [6/327] in the ciclopirox topical solution, 8%, group and 2% [7/328] in the vehicle group). Moreover, application site reactions and/or burning of the skin occurred in 1% of patients treated with ciclopirox topical solution, 8%, (3/327) and vehicle (4/328). A 21-Day Cumulative Irritancy study was conducted under conditions of semi-occlusion. Mild reactions were seen in 46% of patients with the ciclopirox topical solution, 8%, 32% with the vehicle and 2% with the negative control, but all were reactions of mild transient erythema.

Pregnancy: Teratogenic Effects: Pregnancy Category B - Teratology studies in mice, rats, rabbits, and monkeys at oral doses of up to 77, 23, 23, or 38.5 mg, respectively, of ciclopirox as ciclopirox olamine/kg/day (14, 8, 17, and 28 times MRHTD), or in rats and rabbits receiving topical doses of up to 92.4 and 77 mg/kg/day, respectively (33 and 55 times MRHTD), did not indicate any significant fetal malformations. There are no adequate or well-controlled studies of topically applied ciclopirox in pregnant women. Ciclopirox Topical Solution, 8% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

• Apr 12, 2005ANDAANDA076790Sun Pharma Canada
• Mar 3, 2006ANDAANDA077364Padagis Israel
• Dec 15, 2006ANDAANDA077676Padagis Israel
• Sep 18, 2007ANDAANDA078172Acella
• Sep 18, 2007ANDAANDA077623Padagis Us
• Sep 18, 2007ANDAANDA077687Encube
• Sep 18, 2007ANDAANDA078046Chartwell Rx
• Jan 7, 2009ANDAANDA078266Padagis Us

1. 1Drug Ineffective43015%
2. 2Fatigue1706.0%
3. 3Pain1655.8%
4. 4Diarrhoea1425.0%
5. 5Headache1324.7%
6. 6Off Label Use1314.6%
7. 7Rash1314.6%
8. 8Pruritus1304.6%
9. 9Dyspnoea1134.0%
10. 10Nausea1063.7%
11. 11Arthralgia973.4%
12. 12Fall963.4%
13. 13Device Malfunction953.4%
14. 14Product Use In Unapproved Indication943.3%
15. 15Device Dislocation903.2%

Recent PubMed references pinned to Ciclopirox as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Evaluation of In Vitro Efficiency of Ciclopirox Against Yersinia pestis and Francisella tularensis.
  International journal of molecular sciences · 2026 · Hefetz I, Ber R, Gur D, et al.
  PMID 41752217DOI 10.3390/ijms27042081
• Ciclopirox, a broad-spectrum antifungal drug, moonlights as a pyroptosis agonist to drive hepatocellular carcinoma cell death.
  European journal of pharmacology · 2025 · Yuan H, Xia C, Zhang J, et al.
  PMID 41242597DOI 10.1016/j.ejphar.2025.178358
• Ciclopirox suppresses poxvirus replication by targeting iron metabolism.
  Antiviral research · 2025 · Pant A, Belhaouari DB, Dsouza L, et al.
  PMID 41067563DOI 10.1016/j.antiviral.2025.106290
• Inhibition of autophagy enhances the sensitivity of ciclopirox olamine in human chronic myelogenous leukemia K562 cells.
  International journal of medical sciences · 2025 · Zhou H, Chen H, Luo K, et al.
  PMID 41049452DOI 10.7150/ijms.114452
• Diode Laser and Red-Laser Photodynamic Therapy Versus Ciclopirox 8% HPCH Nail Lacquer for the Treatment of Onychomycosis: A Randomised Controlled Trial.
  Mycoses · 2025 · García-Oreja S, Álvaro-Afonso FJ, Navarro-Pérez D, et al.
  PMID 41024682DOI 10.1111/myc.70121
• Solubility prediction and cytotoxicity of lipidic microemulsion: HSPiP modeling and synergism with ciclopirox olamine.
  Scientific reports · 2025 · Alnemer OA, Hussain A, Altamimi MA, et al.
  PMID 41023106DOI 10.1038/s41598-025-18141-4
• Methylation Enables Sensitive LC-MS/MS Quantification of Ciclopirox in a Mouse Pharmacokinetics Study.
  Molecules (Basel, Switzerland) · 2025 · Katekar R, Wang Z, Xie J, et al.
  PMID 40942125DOI 10.3390/molecules30173599
• Retrospective study of onychomycosis patients treated with ciclopirox 8% HPCH and oral antifungals applying artificial intelligence to electronic health records.
  Scientific reports · 2025 · Roustan G, López Estébaranz JL, De La Cueva P, et al.
  PMID 40744950DOI 10.1038/s41598-025-10875-5

The 10 most recently updated of 20 ClinicalTrials.gov registrations naming Ciclopirox as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• 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
  Recruiting · Phase 1 · Phase 2 · Interventional · 6 enrolled · Atlas Molecular Pharma
  NCT07024316updated 2026-03-24
• Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox
  Not yet recruiting · Observational · 80 enrolled · University of Bologna
  NCT06971341updated 2025-05-20
• Study to Assess the Safety and Pharmacokinetics of ATL-001 (Ciclopirox Olamine) in Healthy Volunteers
  Completed · Phase 1 · Interventional · 42 enrolled · Atlas Molecular Pharma
  NCT05647343updated 2024-07-24
• Photodynamic Therapy and Topical Antifungal for Onychomycosis in Patients With Diabetes.
  Active not recruiting · Interventional · 10 enrolled · Universidad Complutense de Madrid
  NCT06485050updated 2024-07-03
• Mycosis Culture Collection From Dermatological Isolated
  Unknown · Observational · 200 enrolled · University of Rome Tor Vergata
  NCT05482763updated 2024-05-08
• Diode Laser and Photodynamic Therapy Vs. Ciclopirox.
  Unknown · Phase 4 · Interventional · 26 enrolled · Universidad Complutense de Madrid
  NCT05809297updated 2023-05-10
• 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
  Completed · Interventional · 553 enrolled · Padagis LLC
  NCT00804193updated 2021-10-27
• Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis
  Completed · Phase 3 · Interventional · 561 enrolled · Padagis LLC
  NCT00802672updated 2021-10-13
• Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer
  Completed · Phase 4 · Interventional · 20 enrolled · Galderma R&D
  NCT02679911updated 2021-03-22
• Study to Evaluate the Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)
  Completed · Phase 3 · Interventional · 452 enrolled · Moberg Pharma AB
  NCT02866032updated 2020-10-06

Frequently asked questions

How does Ciclopirox work?

Mechanism-of-action class: Protein Synthesis Inhibitors.

What is Ciclopirox used for?

According to FDA labeling, Ciclopirox carries indications including: (To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) Ciclopirox Topical Solution, 8% as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum . The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ciclopirox?

Ciclopirox is classified as Other antifungals for topical use, Other antiinfectives and antiseptics, Protein Synthesis Inhibitors, Decreased DNA Replication, Decreased Protein Synthesis, Decreased RNA Replication.

What are the brand names for Ciclopirox?

Ciclopirox is marketed under brand names including Ciclodan, Loprox.

What are the contraindications for Ciclopirox?

Ciclopirox labeling lists contraindications including: Ciclopirox Topical Solution, 8% is contraindicated in individuals who have shown hypersensitivity to any of its components.. Always consult the full prescribing information and a clinician.