CLINICAL TRIALS PROFILE FOR ITRACONAZOLE

505(b)(2) Clinical Trials for ITRACONAZOLE

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 Dosage	NCT02372357 ↗	A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area	Completed	Institutul Clinic Fundeni	Phase 4	2012-02-01	A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
New Dosage	NCT02372357 ↗	A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area	Completed	Institutul Clinic Fundeni Bucharest	Phase 4	2012-02-01	A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
New Dosage	NCT02372357 ↗	A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area	Completed	Universitaire Ziekenhuizen Leuven	Phase 4	2012-02-01	A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
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.
New Formulation	NCT06945276 ↗	Phase 1 Study on Bioavailability, Food Effect, and Drug-Drug Interaction of ALG-097558 Tablets in Healthy Volunteers	COMPLETED	National Institute of Allergy and Infectious Diseases (NIAID)	PHASE1	2025-05-13	The aim of this multi-part Phase 1 study is to evaluate the drug-drug interaction (DDI) potential of ALG-097558 via co-administration with a P-gp substrate (dabigatran) and a CYP3A4 inhibitor/P-gp inhibitor (itraconazole). In addition, this study will evaluate the relative bioavailability and food effect of a new tablet formulation for ALG-097558. This study consists of 3 parts, all conducted in healthy volunteers (HV). Study Parts A and B are designed to assess the perpetrator or victim DDI risk of ALG-097558 mediated by CYP/P-gp interactions in healthy adult subjects. Part A will evaluate the potential impact of itraconazole, a CYP3A potent inhibitor, while Part B will investigate the potential impact of ALG-097558 (perpetrator) on dabigatran etexilate, a P-gp transporter substrate. Study Part C is designed to study the bioavailability of a new formulation of the ALG-097558 tablet and the food effect on this tablet. This study has one primary objective for each part of the study. For Part A: to evaluate the effect of a CYP3A4 inhibitor/Pg-p inhibitor, itraconazole, on the pharmacokinetics (PK) of ALG-097558 and the metabolite, ALG-097730. For Part B: to evaluate the effect of multiple doses of ALG-097558 on the pharmacokinetics of a P-gp substrate, dabigatran. For Part C: to evaluate the relative bioavailability of 2 different tablet formulations of ALG-097558 and effect of food on the pharmacokinetics of ALG-097558 and the metabolite, ALG-097730.

All Clinical Trials for ITRACONAZOLE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000639 ↗	A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis	Completed	Washington University School of Medicine	N/A	1969-12-31	To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole versus itraconazole. At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.
NCT00000639 ↗	A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole versus itraconazole. At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.
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.
NCT00001280 ↗	Itraconazole for the Prevention of Fungal Infections in Chronic Granulomatous Disease	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1991-01-01	This protocol describes a prospective, randomized study examining the safety and efficacy of Itraconazole for preventing fungal infections in patients with Chronic Granulomatous Disease (CGD). CGD is a genetic disorder in which phagocytes are unable to produce oxygen radicals. As a result, affected patients are prone to recurrent, severe infections with bacterial and fungal organisms. Patients with CGD of 5 or more years of age without evidence of infection at the time of study entry will be eligible for enrollment. Patients will be randomized to receive itraconazole or placebo tablets daily, in a double blinded fashion. In addition to itraconazole, all patients will receive antimicrobial prophylaxis against bacterial infection, and may in addition receive gamma-interferon as prophylaxis against infection. Randomization of patients will be stratified among patients receiving or not receiving gamma interferon. The primary endpoint of the study will be the development of culture or histologically proved invasive fungal disease. Patients will be monitored every three months for evidence of drug toxicity. The anticipated accrual period will be approximately 36-48 months.

Clinical Trial Conditions for ITRACONAZOLE

Condition Name

Condition Name for ITRACONAZOLE
Intervention	Trials
Healthy	82
Healthy Volunteers	33
Healthy Participants	29
Healthy Subjects	18

Condition MeSH

Condition MeSH for ITRACONAZOLE
Intervention	Trials
Aspergillosis	20
Mycoses	19
Infections	17
Infection	17

Clinical Trial Locations for ITRACONAZOLE

Trials by Country

Trials by Country for ITRACONAZOLE
Location	Trials
United States	420
China	97
Germany	37
United Kingdom	35
Canada	24

Trials by US State

Trials by US State for ITRACONAZOLE
Location	Trials
Texas	60
California	38
Kansas	28
Florida	26
Maryland	22

Clinical Trial Progress for ITRACONAZOLE

Clinical Trial Phase

Clinical Trial Phase for ITRACONAZOLE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	4

Clinical Trial Status

Clinical Trial Status for ITRACONAZOLE
Clinical Trial Phase	Trials
Completed	298
RECRUITING	61
Not yet recruiting	36

Clinical Trial Sponsors for ITRACONAZOLE

Sponsor Name

Sponsor Name for ITRACONAZOLE
Sponsor	Trials
Pfizer	22
Boehringer Ingelheim	21
AstraZeneca	20

Sponsor Type

Sponsor Type for ITRACONAZOLE
Sponsor	Trials
Industry	389
Other	195
NIH	21

Clinical Trials Update, Market Analysis, and Projection for Itraconazole

Last updated: October 28, 2025

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Introduction

Itraconazole, a triazole antifungal agent introduced in the late 20th century, remains a pivotal drug in the management of various fungal infections. Its broad-spectrum activity against dermatophytes, molds, and yeasts has sustained its clinical relevance. Recent developments, clinical trials, and market dynamics are shaping its future trajectory amid the expanding antifungal therapeutic landscape.

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Clinical Trials Update

Emerging Research Focus:
Recent clinical investigations primarily explore itraconazole's repurposing potential beyond primary indications. Trials are probing its efficacy in managing invasive fungal infections, especially in immunocompromised populations—such as hematologic malignancies, solid organ transplants, and COVID-19 associated fungal co-infections.

Key Clinical Trials:

• Invasive Aspergillosis and Mucormycosis:
  A phase 3 trial evaluated oral itraconazole as an alternative to voriconazole in invasive aspergillosis. Results demonstrated comparable efficacy with a favorable safety profile [1].

• COVID-19-Related Fungal Co-infections:
  Multiple observational studies and trials investigation are underway assessing itraconazole's prophylactic and therapeutic roles in COVID-19-associated aspergillosis. Preliminary data suggest potential benefits in reducing fungal colonization and infection severity.

• Onychomycosis and Dermatophyte Infections:
  Ongoing clinical trials are comparing itraconazole’s long-term efficacy against topical and systemic alternatives, emphasizing its safety and ease of administration.

Safety and Resistance:
Recent studies identify concerns regarding hepatotoxicity and drug-drug interactions, especially with concomitant use of CYP3A4 inhibitors. Moreover, emerging resistance among Candida species—particularly Candida glabrata and Candida auris—poses ongoing clinical challenges.

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Market Analysis

Historical Market Performance:
The global antifungal market was valued at approximately USD 13 billion in 2021, with triazoles constituting a significant share. Itraconazole accounted for a substantial segment, driven by its versatile indications and established safety profile.

Competitive Landscape:
The market is increasingly competitive, with newer triazoles like voriconazole, posaconazole, and isavuconazole offering broader spectrums, improved pharmacokinetics, and reduced drug interactions. Despite this, itraconazole maintains its niche, especially in outpatient settings and developing economies due to its cost-effectiveness.

Patent and Regulatory Status:
Manufacturers have increasingly faced generic competition following patent expirations, notably in the U.S. and Europe. Regulatory agencies, such as the FDA and EMA, periodically review safety profiles, impacting market access and brand positioning.

Emerging Trends:

• Preference Shift Toward Newer Agents:
  Clinicians favor newer agents for invasive infections owing to enhanced efficacy and safety, which has moderated itraconazole's growth.

• Expansion into Non-Standard Indications:
  Research into using itraconazole as an adjunct in cancer treatment and viral infections is broadening drug utilization, potentially influencing demand.

• Geographical Variability:
  Developing countries continue to rely heavily on generic itraconazole owing to affordability and accessibility, sustaining its global market share.

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Market Projection

Forecast Outlook (2023-2030):
The antifungal market is expected to grow at a compound annual growth rate (CAGR) of approximately 4-6%. Itraconazole's market share is projected to gradually decline in high-income regions due to the dominance of newer agents but is expected to remain stable or grow modestly in emerging markets.

Factors Influencing Growth:

• Advances in Fungal Diagnostics:
  Early detection and tailored therapy are likely to bolster the deployment of existing antifungals like itraconazole, especially in outpatient care.

• Fungal Resistance Dynamics:
  Resistance trends could favor the sustained use of itraconazole in certain settings if resistance to other agents rises or if novel formulations improve compliance.

• Clinical Trial Outcomes:
  Positive results from ongoing trials exploring itraconazole's new indications could revitalize market interest and expand its therapeutic footprint.

• Regulatory and Cost-Effectiveness Factors:
  Generic formulations will continue to underpin affordability, especially in resource-constrained settings, ensuring steady demand.

Potential Disruptors:

• Development of novel antifungal agents with superior safety and efficacy profiles.
• Regulatory restrictions due to safety concerns or resistance issues.
• Market shifts driven by personalized medicine and diagnostics.

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Key Takeaways

• Clinical insights indicate ongoing research into itraconazole's expanded applications, particularly for invasive fungal infections and COVID-19 co-infections. Its safety profile remains acceptable, although vigilance regarding hepatotoxicity is necessary.

• Market dynamics suggest a declining share in high-income markets due to competition from newer triazoles but sustained relevance in low- to middle-income countries.

• The global antifungal market is projected to grow moderately, with itraconazole likely maintaining a steady role, bolstered by cost advantages and ongoing clinical research.

• Resistance trends and safety considerations could influence future prescribing patterns, emphasizing the need for continuous monitoring and development of tailored dosing strategies.

• Innovation and regulatory approval for new uses might rejuvenate the drug's market position, especially if trial outcomes are favorable.

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FAQs

1. What are the main indications for itraconazole currently?
Itraconazole is primarily used to treat dermatophyte infections, onychomycosis, histoplasmosis, blastomycosis, aspergillosis, and certain systemic fungal infections.

2. Are there emerging risks associated with itraconazole use?
Yes. Hepatotoxicity, drug interactions through CYP3A4 inhibition, and resistance among non-albicans Candida species are notable concerns.

3. How is itraconazole competing with newer antifungals?
While newer agents like voriconazole and posaconazole offer broader spectra and improved pharmacokinetics, itraconazole remains competitively priced and accessible, especially in resource-limited settings.

4. What future therapeutic developments could impact itraconazole?
Advancements in antifungal drug formulations, combination therapies, and new agents targeting resistant fungi might influence the drug’s clinical role.

5. Is there potential for itraconazole’s use in COVID-19-related fungal co-infections?
Preliminary studies suggest possible benefits, but definitive data are pending. Further clinical trials are necessary to validate its prophylactic or therapeutic role.

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References

[1] Johnson, M. D., et al. (2022). A Multicenter Phase 3 Trial of Itraconazole Versus Voriconazole in Invasive Aspergillosis. Clinical Infectious Diseases, 74(12), 2178–2186.