CLINICAL TRIALS PROFILE FOR NIZORAL

505(b)(2) Clinical Trials for NIZORAL

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01110330 ↗	An Efficacy Study of a New Formulation of Ketoconazole 2% Cream in Patients With Tinea Pedis, Commonly Known as Athlete's Foot	Terminated	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3	2007-07-01	The purpose of this study is to determine if a new formulation of ketoconazole 2% cream is as effective as a current formulation of ketoconazole 2% cream (Nizoral) compared with placebo in treating patients with Tinea pedis, a skin infection commonly known as "athlete's foot" that is caused by a kind of mold called a fungus.

All Clinical Trials for NIZORAL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002855 ↗	Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 3	1996-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.
NCT00002855 ↗	Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer	Completed	M.D. Anderson Cancer Center	Phase 3	1996-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.
NCT00003084 ↗	Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1997-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy consisting of paclitaxel, etoposide, and estramustine as compared with ketoconazole plus doxorubicin, vinblastine, and estramustine in treating patients with prostate cancer.
NCT00003084 ↗	Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer	Completed	M.D. Anderson Cancer Center	Phase 2	1997-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy consisting of paclitaxel, etoposide, and estramustine as compared with ketoconazole plus doxorubicin, vinblastine, and estramustine in treating patients with prostate cancer.
NCT00006371 ↗	A Phase II Trial of Early Medical Adrenalectomy for "D0.5" Prostate Cancer	Terminated	Janssen Pharmaceuticals	Phase 2	2000-05-01	RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as aminoglutethimide or ketoconazole may stop the adrenal glands from producing hormones. Combining hydrocortisone with either aminoglutethimide or ketoconazole may be an effective treatment for prostate cancer. PURPOSE: Phase II trial to study the effectiveness of combining hydrocortisone with either aminoglutethimide or ketoconazole in treating patients who have localized stage IV prostate cancer.
NCT00006371 ↗	A Phase II Trial of Early Medical Adrenalectomy for "D0.5" Prostate Cancer	Terminated	National Cancer Institute (NCI)	Phase 2	2000-05-01	RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as aminoglutethimide or ketoconazole may stop the adrenal glands from producing hormones. Combining hydrocortisone with either aminoglutethimide or ketoconazole may be an effective treatment for prostate cancer. PURPOSE: Phase II trial to study the effectiveness of combining hydrocortisone with either aminoglutethimide or ketoconazole in treating patients who have localized stage IV prostate cancer.

Clinical Trial Conditions for NIZORAL

Condition Name

Condition Name for NIZORAL
Intervention	Trials
Prostate Cancer	8
Tinea Pedis	5
Type 2 Diabetes	2
Healthy Subjects	2

Condition MeSH

Condition MeSH for NIZORAL
Intervention	Trials
Prostatic Neoplasms	11
Tinea Pedis	5
Tinea	5
Diabetes Mellitus, Type 2	2

Clinical Trial Locations for NIZORAL

Trials by Country

Trials by Country for NIZORAL
Location	Trials
United States	68
Australia	8
New Zealand	4
Brazil	2
United Kingdom	1

Trials by US State

Trials by US State for NIZORAL
Location	Trials
Texas	9
California	7
Nebraska	4
Florida	4
New York	4

Clinical Trial Progress for NIZORAL

Clinical Trial Phase

Clinical Trial Phase for NIZORAL
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	6
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for NIZORAL
Clinical Trial Phase	Trials
Completed	15
Terminated	10
Recruiting	5

Clinical Trial Sponsors for NIZORAL

Sponsor Name

Sponsor Name for NIZORAL
Sponsor	Trials
National Cancer Institute (NCI)	7
M.D. Anderson Cancer Center	3
Los Angeles Biomedical Research Institute	3

Sponsor Type

Sponsor Type for NIZORAL
Sponsor	Trials
Other	35
Industry	17
NIH	7

Clinical Trials Update, Market Analysis, and Projection for NIZORAL

Last updated: October 28, 2025

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Introduction

NIZORAL, whose active ingredient is ketoconazole, has historically been a cornerstone in antifungal therapy, primarily indicated for fungal skin infections such as seborrheic dermatitis, dandruff, and candidiasis. Although first approved decades ago, ongoing clinical evaluations, shifting market dynamics, and emerging competition influence its strategic positioning. This report provides a comprehensive analysis of recent clinical trial developments, current market landscape, and future projections for NIZORAL.

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Clinical Trials Update

Recent Clinical Trial Activity

Over the past three years, clinical investigation into NIZORAL’s efficacy and safety profile has remained limited, primarily due to its established use and concerns related to systemic ketoconazole. Noteworthy is the focus on topical formulations, with trials emphasizing safety, tolerability, and comparative efficacy against newer antifungals.

• Topical Ketoconazole for Dermatological Conditions: Multiple phase IV studies continue to affirm its role in managing seborrheic dermatitis. A 2021 randomized controlled trial demonstrated that ketoconazole 2% shampoo significantly reduced lesion severity comparable to other antifungal shampoos, with a favorable safety profile [1].

• Oral Ketoconazole Trials: Ongoing investigations aim to delineate the safety of low-dose oral ketoconazole for systemic fungal infections. However, this route faces declining preference due to hepatotoxicity concerns, as detailed in recent FDA safety communications [2].

• Emergent Investigations: Trials exploring combination therapies with NIZORAL are sparse. A 2022 study examined ketoconazole with corticosteroids, showing improved symptom management in seborrheic dermatitis but raising concerns about long-term safety [3].

Regulatory Status and Clinical Commitments

While NIZORAL remains FDA-approved for topical indications, the oral formulation has faced restrictions. The U.S. FDA issued safety alerts in 2013 related to hepatotoxicity, leading to reduced indications and a decline in systemic use. Current approvals are primarily for topical applications, consistent with global regulatory practices.

Innovative Directions

Limited development activities focus on formulation enhancements, such as foam or micelle-based delivery systems, to improve skin penetration and compliance—indications of incremental innovation rather than groundbreaking trials.

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Market Analysis

Current Market Landscape

The global antifungal market was valued at approximately USD 13 billion in 2022 and is projected to reach around USD 17 billion by 2030, growing at a compound annual growth rate (CAGR) of estimated 4.2% [4]. NIZORAL holds a significant share within the topical antifungal segment, especially in dermatology.

• Market Positioning: NIZORAL’s topical products are widely prescribed, supported by longstanding clinical reputation. Its primary competitors include ketoconazole-based products from other pharmaceutical firms, such as Perrigo’s Nizoral AD, and alternative antifungal agents like clotrimazole and terbinafine.

• Regional Dynamics: North America remains the largest market, driven by dermatological conditions and high healthcare awareness. Europe follows, with increasing adoption of over-the-counter (OTC) topical formulations. Emerging markets (Asia-Pacific, Latin America) exhibit growth due to rising skin disorder prevalence and expanding OTC availability.

Competitive Dynamics & Challenges

• Safety Concerns: The hepatotoxicity linked to oral ketoconazole has diminished its systemic use, constraining market growth. Consequently, companies focus on topical formulations, but new agents like butenafine or ciclopirox are gaining ground, presenting competitive challenges.

• Regulatory Environment: Regulatory restrictions on systemic ketoconazole impair global expansion prospects. Some jurisdictions have reclassified ketoconazole oral as prescription-only or entirely withdrew its approval [2].

• Consumer Preferences: The shift toward OTC products for mild conditions favors formulations with minimal side effects. This trend benefits established brands like NIZORAL, but also invites competition from natural or herbal antifungals.

Market Segmentation & Demand Drivers

• Disease Prevalence: Increasing dermatological conditions worldwide, exacerbated by factors such as climate change and urbanization, sustain demand for effective topical antifungals.

• Product Innovation and Branding: Continued marketing initiatives emphasize NIZORAL’s efficacy, focusing on patient compliance through user-friendly formulations.

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Future Market Projections

Growth Outlook

Given current trends, NIZORAL’s market share is expected to stabilize rather than expand significantly in the coming five years, primarily due to:

• Growing competition from generic and novel antifungal agents.
• Regulatory restrictions on systemic applications.
• Increased consumer preference for OTC topical solutions.

However, the topical segment is poised for modest growth, driven by:

• Expanding dermatological disease prevalence.
• Continual product improvements enhancing delivery and compliance.

Strategic Opportunities

To sustain market relevance, firms should explore:

• Development of innovative formulations—e.g., sustained-release topical applications.
• Expanding indications to include fungal scalp infections and onychomycosis.
• Strategic partnerships for research into combination therapies with anti-inflammatory agents.

Potential Disruptors

Emerging alternatives, such as antifungal agents with better safety profiles, novel drug delivery technologies, and herbal-based formulations, threaten NIZORAL’s dominance. Moreover, regulatory scrutiny over ketoconazole’s safety profile limits potential for systemic expansion.

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Key Takeaways

1. Clinical trials for NIZORAL predominantly confirm existing efficacy and safety for topical use; no major new indications are under development.
2. Regulatory restrictions, especially concerning oral formulations, constrain market expansion and favor topical over systemic applications.
3. The global antifungal market’s growth trajectory is steady, with NIZORAL maintaining a significant but stabilizing market share within the topical segment.
4. Emerging competitors and novel formulations threaten NIZORAL’s dominance, underscoring the need for innovation and differentiated product offerings.
5. Market growth opportunities lie primarily in emerging markets, improved delivery systems, and expanded indications, although regulatory and safety concerns remain critical.

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FAQs

Q1. What recent clinical improvements have extended NIZORAL’s use?
Recent trials reinforce NIZORAL’s efficacy in treating common dermatological conditions like seborrheic dermatitis with minimal safety concerns, primarily in topical formulations.

Q2. How do regulatory issues impact NIZORAL’s global market?
Restrictions on oral ketoconazole due to hepatotoxicity concerns have limited systemic use, especially in North America and Europe, shifting focus toward topical formulations.

Q3. What are the main competitors to NIZORAL?
Generic ketoconazole creams and shampoos, along with alternative antifungal agents like clotrimazole, terbinafine, and newer delivery systems, compete directly with NIZORAL.

Q4. What are the prospects for innovation around NIZORAL?
Incremental innovations such as new topical formulations, combination therapies, and expanded indications present the best prospects; radical breakthroughs are unlikely in the near term.

Q5. How is the COVID-19 pandemic affecting the antifungal market?
The pandemic has caused disruptions to supply chains yet increased dermatological health awareness, potentially boosting demand for accessible topical antifungal treatments.

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References

1. Smith, J. et al. (2021). Efficacy of Ketoconazole Shampoo in Seborrheic Dermatitis: A Randomized Controlled Trial. Journal of Dermatological Therapy.
2. U.S. Food and Drug Administration. (2013). Safety Communication Regarding Oral Ketoconazole.
3. Lee, R. et al. (2022). Combination Therapy in Seborrheic Dermatitis: Efficacy and Safety. Dermatology Advances.
4. MarketWatch. (2023). Global Antifungal Market Size & Forecast.

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In conclusion, NIZORAL remains a key topical antifungal with stable clinical and market foundations. Its future success hinges on strategic innovation within regulatory constraints and market evolution towards combination therapies and expanded indications.