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Last Updated: July 14, 2025

CLINICAL TRIALS PROFILE FOR KETOCONAZOLE


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505(b)(2) Clinical Trials for Ketoconazole

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.
OTC NCT03513393 ↗ Influence of Cola on the Absorption of the HCV Agent Velpatasvir in Combination With PPI Omeprazole. Completed Radboud University Phase 1 2018-08-01 Epclusa® is a pan-genotypic, once-daily tablet for the treatment of chronic hepatitis C virus (HCV) infection containing the NS5B- polymerase inhibitor sofosbuvir (SOF, nucleotide analogue) 400 mg and the NS5A inhibitor velpatasvir (VEL) 100 mg. Velpatasvir has pH dependent absorption. At higher pH the solubility of velpatasvir decreases. It has been shown that in subjects treated with proton pump inhibitors (PPIs) such as omeprazole, the absorption of velpatasvir is reduced by 26-56%, depending on the dose of omeprazole, concomitant food intake, and timing/sequence of velpatasvir vs. omeprazole intake. As a result, concomitant intake of PPIs with velpatasvir is not recommended. For a number of reasons, the prohibition of PPI use with velpatasvir is a clinically relevant problem. First, PPI use is highly frequent in the HCV-infected subject population with prevalences reported up to 40%. Second, PPIs are available as over-the-counter medications and thus can be used by subjects without informing their physician. Third, although HCV therapy is generally well tolerated, gastro-intestinal symptoms such as abdominal pain and nausea are frequently reported, which my lead to PPI use. One solution of this problem could be the use of other acid-reducing agents such as H2-receptor antagonists or antacids. In general, they have a less pronounced effect on intragastric pH, and are considered less effective than PPIs by many patients and physicians. A second solution would be the choice of another HCV agent or combination that is not dependent on low gastric pH for its absorption such as daclatasvir. Daclatasvir, however, is not a pan-genotypic HCV agent and may be less effective against GT 2 and 3 infections than velpatasvir. Second, not all subjects have access to daclatasvir, depending on health insurance company or region where they live. A third solution, and the focus of this COPA study, is to add a glass of the acidic beverage cola at the time of velpatasvir administration in subjects concurrently treated with PPIs. This intervention has been shown to be effective for a number of drugs from other therapeutic classes who all have in common a reduced solubility (and thus reduced absorption) at higher intragastric pH, namely erlotinib, itraconazole, ketoconazole. The advantages of this approach are: (1) only a temporary decrease in gastric pH at the time of cola intake; the rest of the day the PPI will have its therapeutic effect (2) cola is available worldwide (3) the administration of cola can be done irrespective to the timing of PPI use.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Ketoconazole

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000579 ↗ Acute Respiratory Distress Syndrome Clinical Network (ARDSNet) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1994-09-01 The purposes of this study are to assess rapidly innovative treatment methods in patients with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS and to create a network of interactive Critical Care Treatment Groups (CCTGs) to establish and maintain the required infrastructure to perform multiple therapeutic trials that may involve investigational drugs, approved agents not currently used for treatment of ARDS, or treatments currently used but whose efficacy has not been well documented.
NCT00000975 ↗ A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in Patients With AIDS Completed Janssen Pharmaceuticals Phase 2 1969-12-31 To evaluate the feasibility of itraconazole as (1) primary therapy in histoplasmosis and (2) maintenance therapy after completion of primary therapy. To evaluate the effect of therapy of CNS histoplasmosis. To determine if resistance to drug occurs in patients who fail therapy. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Although the clinical response to amphotericin B treatment in the AIDS patients is generally good, administration difficulties and toxicity detract from its usefulness. Oral treatment with ketoconazole overcomes these limitations of amphotericin B, but does not appear to be effective for primary treatment in patients with AIDS. Itraconazole is a triazole compound in which preclinical studies have demonstrated activity against Histoplasmosis capsulatum. Preclinical studies have also shown that itraconazole appears effective in the treatment of histoplasmosis. The frequency of adverse reactions to itraconazole has been low in several studies. Central nervous system (CNS) involvement occurs in up to 20 percent of patients with histoplasmosis, and appears to have a poor response to amphotericin B treatment. Itraconazole has been used successfully in a small number of patients with cryptococcal meningitis, supporting a study of its use in CNS histoplasmosis.
NCT00000975 ↗ A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in Patients With AIDS Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 To evaluate the feasibility of itraconazole as (1) primary therapy in histoplasmosis and (2) maintenance therapy after completion of primary therapy. To evaluate the effect of therapy of CNS histoplasmosis. To determine if resistance to drug occurs in patients who fail therapy. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Although the clinical response to amphotericin B treatment in the AIDS patients is generally good, administration difficulties and toxicity detract from its usefulness. Oral treatment with ketoconazole overcomes these limitations of amphotericin B, but does not appear to be effective for primary treatment in patients with AIDS. Itraconazole is a triazole compound in which preclinical studies have demonstrated activity against Histoplasmosis capsulatum. Preclinical studies have also shown that itraconazole appears effective in the treatment of histoplasmosis. The frequency of adverse reactions to itraconazole has been low in several studies. Central nervous system (CNS) involvement occurs in up to 20 percent of patients with histoplasmosis, and appears to have a poor response to amphotericin B treatment. Itraconazole has been used successfully in a small number of patients with cryptococcal meningitis, supporting a study of its use in CNS histoplasmosis.
NCT00000992 ↗ A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients With AIDS Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 To test the effectiveness of itraconazole in preventing the recurrence of disseminated histoplasmosis in AIDS patients. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Amphotericin B has been used to treat the infection. Although the response to this treatment is generally good, up to 90 percent of AIDS patients who have taken amphotericin B to treat their histoplasmosis infection will have a relapse (that is, they will get the disease again) within 12 months following treatment. Ketoconazole has been used to prevent relapse, but available information suggests that up to 50 percent of AIDS patients relapse even with ketoconazole treatment. A more effective therapy to prevent recurrence is needed. Itraconazole has been used successfully to treat disseminated histoplasmosis in non-AIDS patients and it is hoped that it may be more effective in preventing histoplasmosis relapse.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ketoconazole

Condition Name

Condition Name for Ketoconazole
Intervention Trials
Healthy 34
Prostate Cancer 24
Healthy Volunteers 8
Cancer 7
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Condition MeSH

Condition MeSH for Ketoconazole
Intervention Trials
Prostatic Neoplasms 35
Tinea 8
Infections 6
Tinea Pedis 6
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Clinical Trial Locations for Ketoconazole

Trials by Country

Trials by Country for Ketoconazole
Location Trials
United States 397
Australia 15
China 14
United Kingdom 13
Netherlands 13
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Trials by US State

Trials by US State for Ketoconazole
Location Trials
Texas 33
California 28
New York 24
Florida 17
Pennsylvania 17
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Clinical Trial Progress for Ketoconazole

Clinical Trial Phase

Clinical Trial Phase for Ketoconazole
Clinical Trial Phase Trials
Phase 4 22
Phase 3 25
Phase 2/Phase 3 11
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Clinical Trial Status

Clinical Trial Status for Ketoconazole
Clinical Trial Phase Trials
Completed 170
Terminated 23
Unknown status 18
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Clinical Trial Sponsors for Ketoconazole

Sponsor Name

Sponsor Name for Ketoconazole
Sponsor Trials
National Cancer Institute (NCI) 21
GlaxoSmithKline 20
AstraZeneca 8
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Sponsor Type

Sponsor Type for Ketoconazole
Sponsor Trials
Other 175
Industry 153
NIH 32
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Ketoconazole: Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction to Ketoconazole

Ketoconazole is an antifungal medication that has been widely used for treating various fungal infections. Originally approved for its antifungal properties, ketoconazole is now being explored for its potential in treating other conditions, including certain types of cancer.

Clinical Trials Update

Repurposing Ketoconazole for Brain Tumors

One of the most promising areas of research involves the repurposing of ketoconazole for the treatment of high-grade gliomas, such as glioblastoma multiforme and astrocytoma. A clinical study is underway to determine if ketoconazole can effectively penetrate brain tumors and inhibit tumor cell proliferation. This study is significant because ketoconazole and another antifungal agent, posaconazole, have shown efficacy in reducing tumor cell growth in in-vitro and animal models by inhibiting hexokinase 2 (HK2) activity[1].

Pharmacokinetics and Pharmacodynamics

The trial aims to assess the pharmacokinetics of ketoconazole in brain and tumor tissue, as well as its pharmacodynamic effects, such as the inhibition of glycolysis and subsequent tumor cell death. Given that posaconazole has a more predictable half-life and fewer off-target effects, the study will focus exclusively on posaconazole after initial assessments[1].

Other Clinical Studies

Another clinical study involves investigating the effects of ketoconazole on the pharmacokinetics of NKTR-118 in healthy volunteers. This open-label, crossover study is designed to assess drug-drug interactions and bioavailability, providing valuable insights into how ketoconazole interacts with other medications[4].

Market Analysis

Global Market Size and Growth

The global ketoconazole market is expected to grow at a compound annual growth rate (CAGR) of around 3.1% during the forecast period from 2024 to 2030. This growth is driven by increasing demand for skincare and antifungal drugs, particularly in the Asia-Pacific region[2][5].

Product Segmentation

The ketoconazole market is segmented into oral, topical, and shampoo forms. The oral segment is anticipated to hold a significant share due to its high efficacy against fungal and non-fungal infections, as well as its ease of consumption and storage[2][5].

Application Segmentation

The antifungal segment dominates the market, driven by the surge in compromised immune systems and the adaptation of harmful pathogens to warmer temperatures. Advances in technology, changing lifestyles, and an increasing urban population also contribute to this segment's growth[2][5].

Regional Analysis

The Asia-Pacific region is expected to grow with the highest CAGR during the forecast period, driven by the growing number of ketoconazole manufacturing companies and increased demand for skincare products in this region[2][5].

Market Projections

Future Trends and Opportunities

The global antifungal drugs market, which includes ketoconazole, is projected to reach USD 85.54 billion by 2030, growing at a CAGR of 3.6%. The azoles segment, which includes ketoconazole, is expected to continue its significant growth due to its effectiveness in treating various fungal infections[3].

Key Players and Strategies

Major players in the ketoconazole market, such as Mylan Inc., Johnson & Johnson, and Teva Pharmaceutical Industries Ltd., are focusing on expanding their product portfolios and business through strategic investments and product launches. For instance, the FDA approval of Recorlev (levoketoconazole) for the treatment of endogenous hypercortisolemia in adult patients highlights the ongoing innovation in this market[2][5].

Regulatory Framework and Safety Profile

Ketoconazole and its derivatives, such as posaconazole, have well-established safety profiles. These drugs are FDA-approved and have been used for years, providing a solid foundation for their repurposing in new therapeutic areas. The regulatory framework supports the continued development and approval of these drugs for various applications[1][2].

Consumer Behavior and Market Attractiveness

Consumer demand for effective and safe antifungal treatments is driving the market growth. The ease of use, efficacy, and safety of ketoconazole products make them highly attractive to consumers. Market attractiveness is further enhanced by the increasing urban population and changing lifestyles that contribute to the rise in fungal infections[2][5].

Key Takeaways

  • Clinical Trials: Ketoconazole is being repurposed for treating high-grade gliomas, with studies focusing on its pharmacokinetics and pharmacodynamics.
  • Market Growth: The global ketoconazole market is expected to grow at a CAGR of around 3.1% from 2024 to 2030.
  • Product Segmentation: The oral segment is expected to dominate due to its ease of consumption and high efficacy.
  • Regional Analysis: The Asia-Pacific region is projected to grow with the highest CAGR.
  • Future Trends: The antifungal segment will continue to dominate, driven by increasing demand and technological advances.

FAQs

What is the primary focus of the current clinical trials involving ketoconazole?

The primary focus is on determining if ketoconazole can effectively penetrate brain tumors and inhibit tumor cell proliferation, particularly in high-grade gliomas.

Which segment is expected to dominate the ketoconazole market?

The oral segment is anticipated to hold a significant share due to its high efficacy and ease of consumption.

What is driving the growth of the ketoconazole market in the Asia-Pacific region?

The growth is driven by the increasing number of ketoconazole manufacturing companies and the rising demand for skincare products in this region.

What is the projected size of the global antifungal drugs market by 2030?

The global antifungal drugs market is projected to reach USD 85.54 billion by 2030.

Which companies are key players in the ketoconazole market?

Major players include Mylan Inc., Johnson & Johnson, and Teva Pharmaceutical Industries Ltd.

Sources

  1. CenterWatch, "Neuro-pharmacological Properties of Repurposed Ketoconazole in High-Grade Gliomas," May 7, 2024.
  2. UnivDatos, "Ketoconazole Market: Share, Size, Trends, Growth & Forecast to 2030."
  3. Emergen Research, "Antifungal Drugs Market Size Worth USD 85.54 Billion in 2030," July 5, 2022.
  4. AstraZeneca Clinical Trials, "Study in healthy volunteers to investigate the effects of Ketoconazole on the Pharmacokinetics of NKTR-118."
  5. Cognitive Market Research, "Ketoconazole Market Report 2024 (Global Edition)," October 21, 2022.

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