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.
NCT00006371 ↗	A Phase II Trial of Early Medical Adrenalectomy for "D0.5" Prostate Cancer	Terminated	H. Lee Moffitt Cancer Center and Research Institute	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
Cancer	2
Sleep Restriction	2

Condition MeSH

Condition MeSH for Nizoral
Intervention	Trials
Prostatic Neoplasms	11
Tinea Pedis	5
Tinea	5
Carcinoma	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
Biolab Sanus Farmaceutica	3
M.D. Anderson Cancer Center	3

Sponsor Type

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

Nizoral (Ketoconazole): Clinical Trials, Market Analysis, and Projections

Introduction

Nizoral, known generically as ketoconazole, is an antifungal medication that has been used for various fungal infections. However, its usage has been limited due to significant safety concerns. Here, we will delve into the current clinical trials, market analysis, and future projections for ketoconazole.

Clinical Trials and Safety Concerns

FDA Safety Announcements

The U.S. Food and Drug Administration (FDA) has issued several safety announcements regarding the use of Nizoral oral tablets. Due to the risk of severe liver injuries, adrenal gland problems, and harmful drug interactions, the FDA has limited the use of Nizoral oral tablets. These tablets should only be used for the treatment of certain life-threatening mycoses when alternative antifungal therapies are not available or tolerated[1].

Hepatotoxicity

Ketoconazole has been associated with serious hepatic injury, which can be fatal. Studies have shown that the risk of acute liver injury is higher with ketoconazole compared to other azole antifungal drugs. For instance, a study in the U.K. General Practice Research Database indicated a risk of acute liver injury of approximately 1 in 500 patients[1].

Current Clinical Trials

There are ongoing and completed clinical trials investigating the effects of ketoconazole on various aspects, such as drug interactions. For example, a Phase 1 study by AstraZeneca aimed to assess the effects of ketoconazole on the pharmacokinetics of NKTR-118 in healthy subjects. This open-label, crossover study evaluated the bioavailability and potential drug-drug interactions involving ketoconazole[4].

Market Analysis

Market Size and Growth

The global antifungal drugs market, which includes ketoconazole, is expected to grow significantly. In 2021, the global antifungal drugs market size was USD 13.81 billion, and it is projected to register a revenue CAGR of 3.6% during the forecast period. The azoles segment, which includes ketoconazole, accounted for the largest market share in 2020 and is expected to continue growing[3].

Product Segments

The ketoconazole market is segmented into oral, topical, and shampoo forms. The ketoconazole oral segment is expected to hold a significant share due to its high efficacy against fungal and non-fungal infections. The ketoconazole shampoo segment has also seen significant growth, with ANI Pharmaceuticals recently launching a generic version of Nizoral shampoo, which has annual sales of approximately USD 69.2 million in the U.S.[2][5].

Regional Market

North America accounted for the largest market share in 2020 and is expected to grow at a significant CAGR during the forecast period. This growth is driven by the rising prevalence of fungal infections, new treatment options, and increasing government initiatives to raise awareness about fungal infections[3].

Key Players

Major companies operating in the ketoconazole market include Mylan Inc., Almirall, S.A, Johnson & Johnson Services, Inc., Taro Pharmaceutical Industries Ltd., and Teva Pharmaceutical Industries Ltd. These companies are continuously expanding their product portfolios and investing in research and development to address patient needs[5].

Projections and Future Outlook

Market Growth

The ketoconazole market is expected to grow at a CAGR of around 3.1% during the forecast period, driven by rising demand for skincare drugs, increasing product launches, and research and development activities. The Asia-Pacific region is expected to grow with the highest CAGR due to the growing number of ketoconazole manufacturing companies and increased demand for skincare products[5].

New Developments

Recent developments, such as the FDA approval of Recorlev (levoketoconazole) for the treatment of endogenous hypercortisolemia, indicate a continued interest in ketoconazole and its derivatives. These advancements suggest potential new therapeutic applications for ketoconazole, which could further expand its market presence[5].

Competitive Landscape

The launch of generic versions, such as ANI Pharmaceuticals' ketoconazole shampoo, positions companies to capture significant market share. However, the competitive landscape, especially in the generic drug market, will be influenced by factors such as manufacturing efficiency, distribution strategies, and pricing competitiveness[2].

Key Takeaways

• Limited Use: Nizoral oral tablets are limited to treating certain life-threatening mycoses due to safety concerns.
• Hepatotoxicity: Ketoconazole is associated with a higher risk of serious liver injury compared to other antifungal drugs.
• Market Growth: The global antifungal drugs market, including ketoconazole, is expected to grow at a CAGR of 3.6%.
• Product Segments: Ketoconazole oral and shampoo segments are significant, with the oral segment expected to grow due to its efficacy.
• Regional Market: North America and the Asia-Pacific region are key markets, driven by rising prevalence and new treatment options.
• New Developments: Recent FDA approvals and product launches indicate continued interest and potential new therapeutic applications.

FAQs

What are the primary safety concerns associated with Nizoral (ketoconazole) oral tablets?

The primary safety concerns include severe liver injuries, adrenal gland problems, and harmful drug interactions.

Why has the FDA limited the use of Nizoral oral tablets?

The FDA has limited the use due to the risk of severe liver injuries, adrenal gland problems, and harmful drug interactions, making it a last-line treatment for certain fungal infections.

What is the projected growth rate of the global antifungal drugs market?

The global antifungal drugs market is expected to register a revenue CAGR of 3.6% during the forecast period.

Which segment of the ketoconazole market is expected to grow significantly?

The ketoconazole oral segment is expected to hold a significant share due to its high efficacy against fungal and non-fungal infections.

What is the annual sales figure for ketoconazole shampoo in the U.S.?

The annual sales for ketoconazole shampoo in the U.S. are approximately USD 69.2 million.

Which regions are expected to drive the growth of the ketoconazole market?

North America and the Asia-Pacific region are expected to drive the growth, with the latter growing at the highest CAGR.

Sources

1. FDA Drug Safety Communication: FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems. FDA Website
2. ANI Pharmaceuticals: ANI Pharmaceuticals Announces the FDA Approval and Launch of Ketoconazole Shampoo, 2%. Stock Titan
3. Emergen Research: Antifungal Drugs Market Size Worth USD 85.54 Billion in 2030. BioSpace
4. AstraZeneca Clinical Trials: Study in healthy volunteers to investigate the effects of Ketoconazole on the Pharmacokinetics of NKTR-118. AstraZeneca Clinical Trials
5. UnivDatos: Ketoconazole Market: Share, Size, Trends, Growth & Forecast to 2030. UnivDatos