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.

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
Belize	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

Nizoral Market Analysis and Financial Projection

Last updated: April 28, 2026

Nizoral (ketoconazole): Clinical-trial readout, market standing, and projection

What is Nizoral and what does the “clinical trials” picture look like?

Nizoral is the brand name for ketoconazole, an antifungal used for topical and oral therapy depending on jurisdiction and formulation. Public clinical activity is limited compared with earlier decades because oral ketoconazole faced major safety restrictions in multiple markets, and the therapeutic landscape shifted toward newer azoles and other antifungal classes.

Clinical-trials status (current public signal):

• Topical ketoconazole: Ongoing and historical studies concentrate on efficacy versus placebo/active comparators for common superficial fungal indications and on formulation/vehicle performance (bioavailability, skin penetration, tolerability).
• Oral ketoconazole: Clinical development has largely moved to niche regimens and dermatology/off-label contexts in countries where access exists, but broad, sponsor-led late-stage programs have been rare in the modern era.
• Core trial endpoint themes seen across ketoconazole studies: mycological cure (KOH microscopy/culture), clinical improvement scores, lesion clearance time, and safety monitoring for hepatic events (oral) or local irritation (topical).

Practical implication for “clinical trials update”:
With limited contemporary sponsor-led late-stage trials in the public domain, Nizoral’s near-term clinical footprint is dominated by incremental formulation evidence and post-market safety/tolerability evidence rather than Phase 3-style product-defining readouts.

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What is the market for Nizoral (ketoconazole) today?

Market structure:

• Ketoconazole is a mature antifungal with a long patent history that expired decades ago in most geographies.
• The brand’s market position is tied to formulation, channel access, and payer/formulary decisions, not to exclusivity-led differentiation.
• Topical products typically compete in the OTC and prescription-supervised segments through price and distribution.
• Oral ketoconazole is constrained by safety restrictions and prescriber use patterns, shifting volume to other oral azoles (for example fluconazole and itraconazole) in many markets.

Commercial reality:

• The ketoconazole market is crowded with generics, compressing margins and reducing sponsor incentives to run large new trials.
• Brand value survives where supply stability, clinical familiarity, and formulary placement favor established products, including Nizoral lines in certain countries.

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What drives demand for Nizoral by indication?

Demand drivers differ sharply by route.

Topical ketoconazole (Nizoral):

• Seborrheic dermatitis and related dandruff indications
• Superficial dermatophyte and yeast infections in creams and shampoos
• Periodic and episodic use patterns that create recurring treatment demand

Oral ketoconazole (where available):

• Less reliable demand due to liver safety constraints and clinical preference drift to other azoles
• Use concentrated in clinical settings that balance access, patient history, and alternative availability

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How strong is Nizoral versus alternatives?

Competitive set:

• Azoles: fluconazole, itraconazole, voriconazole, posaconazole (where indicated)
• Topical antifungals: terbinafine, butenafine, ciclopirox, etc.
• Non-azole classes: vary by indication and geography

Relative positioning:

• Ketoconazole remains competitive in topical superficial indications where efficacy is adequate and cost supports broad use.
• For systemic indications, ketoconazole typically loses share to other azoles when safety profiles and guideline alignment favor them.

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Clinical trial and regulatory dynamics that affect Nizoral volume

Key external constraints that shape the clinical and market trajectory:

1. Oral ketoconazole safety actions led to restricted prescribing and reduced population-level demand.
2. Generic penetration limits brand growth unless Nizoral is positioned via formulary access, supply reliability, or differentiated formulations (for example shampoos or specific concentrations).

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Market projection: base case, upside, and downside

This section projects a practical commercial range for Nizoral (ketoconazole brand) rather than the entire ketoconazole molecule market. The reason is straightforward: brand revenue depends on channel access and competitive substitution, not just underlying disease prevalence.

Base case (steady demand, slow brand erosion)

Assumptions:

• Topical volume grows modestly with maintenance therapy demand but faces generic price pressure.
• Oral sales remain flat or decline due to restricted use and persistent preference for alternative systemic azoles.

Projection profile (qualitative):

• Topical: low-to-mid single-digit growth rate in value is possible in markets where Nizoral retains formulary placement, but unit growth is constrained by generics.
• Oral: continued contraction in jurisdictions with strict limitations.

Upside case (channel retention plus formulation-led differentiation)

Assumptions:

• Nizoral retains or improves formulary standing for specific topical SKUs.
• Brand marketing and distribution keep the product “default” for certain physicians or pharmacies.
• Supply chain stability prevents substitution when patients switch due to availability.

Projection profile (qualitative):

• Value growth outpaces unit growth due to improved mix (higher-margin topical formats, pharmacy private label competition mitigated).

Downside case (renewed competitive price pressure and substitution)

Assumptions:

• Additional price erosion in key markets.
• Loss of formulary position in major accounts.
• Increased substitution to other branded alternatives or OTC options.

Projection profile (qualitative):

• Brand value declines even if total fungal disease incidence stays constant.

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Actionable takeaways for R&D and commercial teams

What should decision-makers do with this clinical and market reality?

• If the objective is growth: focus R&D on topical differentiation (vehicle, stability, patient-use adherence, and skin penetration) rather than systemic re-entry, given the modern constraint environment on oral ketoconazole.
• If the objective is portfolio defense: strengthen evidence packs around local tolerability and real-world adherence for seborrheic dermatitis and dandruff, where brand familiarity can still matter.
• If the objective is investment targeting: treat Nizoral as a mature, price-sensitive brand. Returns depend on distribution and formulary access, not novel mechanism exclusivity.

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Key Takeaways

• Nizoral (ketoconazole) has limited contemporary late-stage clinical-trial momentum; public activity is mainly formulation and post-market evidence.
• The market is mature and heavily generic, so brand performance tracks channel access and pricing power more than clinical novelty.
• Oral ketoconazole faces persistent demand headwinds from safety restrictions; topical remains the more stable business segment.
• Near-term projections are best framed as brand value stability with slow erosion unless topical SKU differentiation and formulary placement improve.

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FAQs

1) Is Nizoral still actively studied in clinical trials?

Yes, but most public clinical activity centers on topical indications and formulation-related evidence rather than broad, late-stage systemic development.

2) Why does oral ketoconazole underperform compared with other antifungals?

Safety-driven restrictions and guideline-aligned preference shift toward other systemic azoles reduce prescriber adoption.

3) What indications drive the most resilient Nizoral demand?

Seborrheic dermatitis/dandruff and other superficial fungal conditions where topical ketoconazole maintains clinical familiarity and usability.

4) What most impacts Nizoral revenue growth?

Formulary placement, distribution coverage, and relative pricing versus generics and OTC substitutes.

5) What R&D path is most aligned with Nizoral’s current market structure?

Topical product improvements that reduce irritation, improve adherence, and maintain consistent performance rather than new systemic claims.

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References

[1] FDA. Information for Healthcare Professionals: Oral Ketoconazole and the Risk of Hepatotoxicity (drug safety communications and related updates). U.S. Food and Drug Administration.
[2] EMA. Restrictions and safety-related updates on ketoconazole-containing medicines (European Medicines Agency communications). European Medicines Agency.
[3] WHO. Guidelines for the diagnosis and management of superficial fungal infections (background on antifungal use patterns). World Health Organization.