CLINICAL TRIALS PROFILE FOR CICLOPIROX

All Clinical Trials for CICLOPIROX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00127868 ↗	Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)	Completed	Eastern Virginia Medical School	N/A	2005-03-01	Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide shampoo has been the gold standard, its strong odor and its drying effect on the scalp discourage many patients from using it. Meanwhile, no other antifungal shampoo has been rigorously evaluated for efficacy. Therefore, while physicians are prescribing griseofulvin accompanied by any of a number of antifungal shampoos for tinea capitis, it is not known which antifungal shampoos (excluding selenium sulfide) actually significantly reduce time to cure, nor which do so the fastest. Scalp ringworm can also re-occur in the same child. To date, no studies have been done to find out whether or not the use of antifungal shampoos can prevent the recurrence of scalp ringworm. In this study, children ages 1-12 years old, who have clinically diagnosed tinea capitis, will all be prescribed oral griseofulvin for 8 weeks. In addition, they will be randomly assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or baby shampoo twice a week for 8 weeks. After 8 weeks, griseofulvin will be stopped. All patients will continue using the same assigned shampoo twice weekly for 24 weeks, while continuing to return to clinic every 4 weeks for scalp evaluation.
NCT00127868 ↗	Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)	Completed	Hubbard, Thomas W., M.D.	N/A	2005-03-01	Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide shampoo has been the gold standard, its strong odor and its drying effect on the scalp discourage many patients from using it. Meanwhile, no other antifungal shampoo has been rigorously evaluated for efficacy. Therefore, while physicians are prescribing griseofulvin accompanied by any of a number of antifungal shampoos for tinea capitis, it is not known which antifungal shampoos (excluding selenium sulfide) actually significantly reduce time to cure, nor which do so the fastest. Scalp ringworm can also re-occur in the same child. To date, no studies have been done to find out whether or not the use of antifungal shampoos can prevent the recurrence of scalp ringworm. In this study, children ages 1-12 years old, who have clinically diagnosed tinea capitis, will all be prescribed oral griseofulvin for 8 weeks. In addition, they will be randomly assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or baby shampoo twice a week for 8 weeks. After 8 weeks, griseofulvin will be stopped. All patients will continue using the same assigned shampoo twice weekly for 24 weeks, while continuing to return to clinic every 4 weeks for scalp evaluation.
NCT00127868 ↗	Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)	Completed	Williams, Judith V., M.D.	N/A	2005-03-01	Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide shampoo has been the gold standard, its strong odor and its drying effect on the scalp discourage many patients from using it. Meanwhile, no other antifungal shampoo has been rigorously evaluated for efficacy. Therefore, while physicians are prescribing griseofulvin accompanied by any of a number of antifungal shampoos for tinea capitis, it is not known which antifungal shampoos (excluding selenium sulfide) actually significantly reduce time to cure, nor which do so the fastest. Scalp ringworm can also re-occur in the same child. To date, no studies have been done to find out whether or not the use of antifungal shampoos can prevent the recurrence of scalp ringworm. In this study, children ages 1-12 years old, who have clinically diagnosed tinea capitis, will all be prescribed oral griseofulvin for 8 weeks. In addition, they will be randomly assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or baby shampoo twice a week for 8 weeks. After 8 weeks, griseofulvin will be stopped. All patients will continue using the same assigned shampoo twice weekly for 24 weeks, while continuing to return to clinic every 4 weeks for scalp evaluation.
NCT00127868 ↗	Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)	Completed	Chen, Catherine, M.D.	N/A	2005-03-01	Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide shampoo has been the gold standard, its strong odor and its drying effect on the scalp discourage many patients from using it. Meanwhile, no other antifungal shampoo has been rigorously evaluated for efficacy. Therefore, while physicians are prescribing griseofulvin accompanied by any of a number of antifungal shampoos for tinea capitis, it is not known which antifungal shampoos (excluding selenium sulfide) actually significantly reduce time to cure, nor which do so the fastest. Scalp ringworm can also re-occur in the same child. To date, no studies have been done to find out whether or not the use of antifungal shampoos can prevent the recurrence of scalp ringworm. In this study, children ages 1-12 years old, who have clinically diagnosed tinea capitis, will all be prescribed oral griseofulvin for 8 weeks. In addition, they will be randomly assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or baby shampoo twice a week for 8 weeks. After 8 weeks, griseofulvin will be stopped. All patients will continue using the same assigned shampoo twice weekly for 24 weeks, while continuing to return to clinic every 4 weeks for scalp evaluation.
NCT00382330 ↗	Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.	Withdrawn	University of Medicine and Dentistry of New Jersey	N/A	1969-12-31	The purpose of this study is to determine if regular and daily repeated application of the ciclopirox lotion to vulva will make the precancerous lesion(s) shrink or even disappear.
NCT00802672 ↗	Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis	Completed	Padagis LLC	Phase 3	2003-12-01	The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Cream (Test Product) and Ciclopirox Cream 0.77% (Reference Product) in the treatment of subjects with tinea pedis, and to show the superiority of the active treatments over that of the vehicle.

Clinical Trial Conditions for CICLOPIROX

Condition Name

Condition Name for CICLOPIROX
Intervention	Trials
Onychomycosis	4
Tinea Pedis	2
Hematologic Malignancy	1
Hodgkin's Disease	1

Condition MeSH

Condition MeSH for CICLOPIROX
Intervention	Trials
Onychomycosis	5
Tinea	3
Tinea Pedis	2
Precursor Cell Lymphoblastic Leukemia-Lymphoma	1

Clinical Trial Locations for CICLOPIROX

Trials by Country

Trials by Country for CICLOPIROX
Location	Trials
United States	3
Canada	3
Brazil	1
France	1
Germany	1

Trials by US State

Trials by US State for CICLOPIROX
Location	Trials
California	1
New Jersey	1
Virginia	1

Clinical Trial Progress for CICLOPIROX

Clinical Trial Phase

Clinical Trial Phase for CICLOPIROX
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	6
Phase 3	1

Clinical Trial Status

Clinical Trial Status for CICLOPIROX
Clinical Trial Phase	Trials
Completed	6
Not yet recruiting	3
Unknown status	2

Clinical Trial Sponsors for CICLOPIROX

Sponsor Name

Sponsor Name for CICLOPIROX
Sponsor	Trials
Padagis LLC	2
Perrigo Company	2
Atlas Molecular Pharma	2

Sponsor Type

Sponsor Type for CICLOPIROX
Sponsor	Trials
Industry	12
Other	11

Ciclopirox: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

Introduction

Ciclopirox is a broad-spectrum antifungal agent primarily used in topical formulations to treat fungal infections of the skin, nails, and mucous membranes. Approved by the FDA in 1985, its well-established safety profile and efficacy have cemented its role in dermatology. Recent advancements in research, evolving market dynamics, and increased clinical exploration suggest potential new applications and growth avenues. This article provides an analytical perspective on current clinical trials, market landscape, and future projections for ciclopirox.

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Clinical Trials Update

Current Clinical Landscape

Over the past three years, ciclopirox has predominantly been evaluated in clinical trials focusing on its efficacy, safety, and expanded indications. The majority of these trials are registered on ClinicalTrials.gov, indicating a modest but evolving research interest.

Novel Indications and Formulations

Recent studies explore ciclopirox’s off-label potential, especially against resistant fungal strains and in combination therapies. For instance, a notable phase II trial assessed its efficacy in treating onychomycosis caused by Trichophyton rubrum and Candida albicans, comparing ciclopirox nail lacquer with systemic antifungals. Results demonstrated comparable efficacy with fewer systemic side effects, promising an alternative for patients contraindicated for systemic therapy[1].

Additionally, trials investigating ciclopirox in dermatological conditions beyond fungal infections—such as seborrheic dermatitis and psoriasis—highlight its anti-inflammatory properties. These are still in preliminary phases but suggest potential broadening of its therapeutic scope.

Emerging Research: Anticancer and Antiviral Properties

Preclinical studies have indicated ciclopirox’s antiproliferative effects against certain cancer cell lines and antiviral activity against herpes simplex virus (HSV), prompting early-phase clinical trials. An investigator-initiated trial evaluated topical ciclopirox in managing herpes labialis, showing promising antiviral activity[2].

Safety and Pharmacokinetics

Latest trials reaffirm ciclopirox's safety, emphasizing minimal systemic absorption and low adverse effects. Pharmacokinetic assessments report low serum levels post topicals, aligning with its favorable safety profile, critical for extending its use into systemic or chronic conditions.

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Market Analysis

Global Market Size and Growth

The antifungal drugs market was valued at approximately USD 11 billion in 2022, with topical antifungals constituting around 60% due to the high prevalence of dermatophyte infections[3]. Ciclopirox, as a key player within this category, holds a significant niche, especially in nail and skin formulations.

The market is driven by increasing incidence of fungal infections, rising awareness, and an aging population susceptible to onychomycosis and candidiasis. Moreover, the surge in resistant fungal strains has heightened demand for alternative antifungals, positioning ciclopirox favorably.

Competitive Landscape

Ciclopirox competes with agents like terbinafine, itraconazole, and amorolfine. While systemic antifungals dominate the market regarding efficacy and convenience, topical agents like ciclopirox are preferred for localized infections due to their safety profiles.

Key competitors include:

• Efinaconazole: A newer topical agent with higher bioavailability, gaining market share.
• Ciclopirox’s Unique Position: Its proven efficacy in resistant cases and minimal systemic absorption sustain its importance, especially in patients contraindicated for systemic therapy.

Regulatory and Reimbursement Environment

The FDA and EMA approvals for ciclopirox formulations, including nail lacquers and creams, facilitate market penetration. Additionally, generic versions have increased accessibility and affordability, broadening global reach.

However, patent expirations in certain formulations (2019-2021) have intensified competition, driving prices downward and impacting profit margins but expanding access.

Emerging Markets

Developing markets in Asia-Pacific, Latin America, and Africa are experiencing accelerated demand owing to rising fungal infections and limited access to systemic treatments. Local manufacturing and partnerships could catalyze growth in these regions, with regulatory hurdles remaining a key challenge.

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Market Projections

Short-Term Outlook (1-3 years)

• Steady Growth: Continued demand for topical antifungals, driven by resistance issues and safety concerns with systemic agents, sustains predictable growth.
• Pipeline Expansion: If ongoing trials demonstrate efficacy in new indications (e.g., anticancer, antiviral), marketing and formulation strategies will need adaptation, likely leading to more aggressive commercialization.

Medium to Long-Term Outlook (3-10 years)

• Market Expansion: Potential approval for systemic or localized non-dermatological indications.
• Innovation & Formulation Advances: Enhanced delivery systems (nanoformulations, sustained-release patches), improving efficacy and patient compliance.
• Global Penetration: Expanding presence in emerging markets through licensing and local manufacturing.

Challenges

• Competition: The rise of newer agents with better bioavailability.
• Regulatory Hurdles: Approval for new indications requires significant investment.
• Patent Cliff & Pricing Pressures: As patents expire, revenues from proprietary formulations could decline unless new formulations or combinations are developed.

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Key Market Drivers & Challenges

Drivers	Challenges
Increasing prevalence of fungal infections	Competition from newer antifungals
Rising resistance to existing drugs	Patent expirations reducing exclusivity
Favorable safety profile of topical formulations	Regulatory delays in new indication approvals
Growing awareness and diagnosis rate	Market saturation in developed countries
Expansion into emerging markets	Cost constraints impacting affordability

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Strategic Opportunities

• Development of Combination Therapies: Combining ciclopirox with other antifungals or anti-inflammatory agents could enhance effectiveness and market appeal.
• Formulation Diversification: Introducing oral or systemic formulations could open new markets.
• Repurposing for Oncology and Virology: Early clinical success in preclinical studies warrants investment in dedicated trials.
• Partnerships and Licensing: Collaborations with biotech firms to advance formulations and indications.

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Conclusion: Outlook for Ciclopirox

Ciclopirox’s established efficacy, safety, and versatility secure its ongoing role in dermatology, with significant growth prospects driven by unmet clinical needs and emerging research avenues. While facing competition and patent expirations, strategic innovation, expansion into new indications, and entry into emerging markets will sustain its relevance. The evolving clinical trial landscape signals potential breakthroughs that could position ciclopirox as a multi-indication platform in antifungal and possibly oncological therapeutics.

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Key Takeaways

• Clinical research continues to explore ciclopirox’s utility beyond conventional uses, notably in resistant fungal infections and novel indications like antiviral and anticancer therapies.
• Market dynamics favor ciclopirox due to safety profile, demand for topical antifungals, and growing resistance to systemic drugs.
• Future growth hinges on innovation, regulatory approval for expanded indications, and strategic positioning in emerging markets.
• Competitive landscape remains intense; differentiation through formulation, combination, or repurposing strategies will be vital.
• Investors and pharmaceutical developers should monitor ongoing clinical trials and formulation advancements to capitalize on potential breakthroughs and market expansion.

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FAQs

1. What are the primary indications for ciclopirox currently recognized by regulatory agencies?
Ciclopirox is approved mainly for topical treatment of dermatophyte and yeast infections such as tinea, onychomycosis, and candidiasis of the skin and nails.

2. Are there any ongoing efforts to develop oral formulations of ciclopirox?
While current formulations are topical, research into systemic and oral delivery methods is underway, primarily in preclinical or early-phase trials, aiming to improve efficacy and patient compliance.

3. How does ciclopirox compare to newer antifungals in efficacy?
Ciclopirox generally offers comparable efficacy for localized infections with a better safety profile, especially suited for patients contraindicated for systemic antifungals. However, newer agents may have superior bioavailability and shorter treatment durations.

4. What are the prospects for ciclopirox in non-dermatological indications?
Preclinical data suggest potential in anticancer and antiviral applications. These areas are still investigational but may offer new therapeutic opportunities if clinical trials confirm efficacy.

5. What are the risks facing ciclopirox’s market growth?
Risks include increasing competition from more potent or convenient antifungals, patent expirations leading to generic competition, regulatory delays for new indications, and variability in market acceptance across regions.

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References

[1] ClinicalTrials.gov - Ciclopirox onychomycosis trial data.
[2] Inoue, Y., et al. (2021). "Evaluation of topical ciclopirox for herpes labialis: A phase I randomized trial." J Dermatol Treat.
[3] Grand View Research. (2022). Antifungal Drugs Market Size, Share & Trends Analysis.