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.

Clinical Trial Conditions for ITRACONAZOLE

Condition Name

Condition Name for ITRACONAZOLE
Intervention	Trials
Healthy	83
Healthy Volunteers	34
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	422
China	100
Germany	38
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	3
PHASE3	3
PHASE2	4

Clinical Trial Status

Clinical Trial Status for ITRACONAZOLE
Clinical Trial Phase	Trials
Completed	298
Recruiting	63
Not yet recruiting	36

Clinical Trial Sponsors for ITRACONAZOLE

Sponsor Name

Sponsor Name for ITRACONAZOLE
Sponsor	Trials
Pfizer	23
Boehringer Ingelheim	22
AstraZeneca	20

Sponsor Type

Sponsor Type for ITRACONAZOLE
Sponsor	Trials
Industry	395
Other	200
NIH	21

Last updated: April 25, 2026

Itraconazole Clinical Trials Update and Market Projection (2026–2035)

Itraconazole is an older, off-patent systemic antifungal used for endemic mycoses, onychomycosis, and selected serious fungal infections. Market traction continues largely from (1) established hospital and outpatient formularies, (2) chronic treatment paradigms in endemic regions, and (3) lifecycle differentiation (e.g., additional oral formulations and therapeutic positioning), rather than new molecular IP. No credible, platform-level “late-stage pipeline” for itraconazole as a molecule is evident in publicly indexed trial registries at a scale that would materially reset global demand in the 5- to 10-year window.

What is the current clinical trial landscape for itraconazole?

Public registries show itraconazole studies concentrated in three buckets: (i) comparative effectiveness or regimen optimization for existing indications, (ii) combination therapy protocols (including drug–drug interaction and dose management in special populations), and (iii) safety/tolerability or therapeutic drug monitoring workflows. Across these categories, the trial pattern is typically incremental and does not indicate a near-term mechanism-changing new product.

Observed trial types (high-level)

• Comparative studies of itraconazole regimens for endemic mycoses and cutaneous fungal disease.
• Studies evaluating pharmacokinetics, absorption variability, and therapeutic drug monitoring, particularly for oral dosing.
• Combination protocols and interaction-focused studies in co-morbid populations.

Practical implication

• Trial activity supports clinician confidence and regimen standardization rather than signaling a new regulatory endpoint likely to expand global labeled use materially.

Key public-source anchor

• Itraconazole is consistently listed in clinical use guidelines and monographs as an oral/systemic triazole antifungal, including for endemic mycoses and dermatologic fungal infections (e.g., onychomycosis). (See key sources at end.)

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How big is the itraconazole market and what drives demand?

The itraconazole market is mature and value is shaped by unit volumes, generic penetration, pricing pressure, and treatment duration in chronic mycoses.

Demand drivers

1. Endemic mycoses burden
   • Itraconazole is used for several endemic fungal infections where oral long-course therapy is standard in many settings.
2. Onychomycosis
   • Oral itraconazole remains a recognized option in dermatology; even with switching toward topical agents and newer pathways in some geographies, itraconazole maintains a large base.
3. Institutional uptake
   • Formularies and infectious disease pathways keep itraconazole in circulation even when off-patent.
4. Administration and formulation management
   • Clinician and patient handling of oral absorption and drug interactions reduces variability and supports continued use.

Countervailing pressures

• Generic price compression
• Competition from other systemic antifungals
  • Clinically relevant alternatives (e.g., fluconazole for selected indications; voriconazole/posaconazole for others) can reduce share depending on indication and guideline updates.
• Safety and tolerability management
  • Black-box related safety concerns and monitoring requirements can deter some outpatient adoption.

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Where does competitive pressure come from?

Competition is strongest at the segment level rather than as a “class” replacement.

Key competitor groups by use case

• Endemic mycoses
  • Other triazoles and amphotericin-class options based on local guidelines and disease severity.
• Onychomycosis
  • Topicals and other systemic azoles depending on country reimbursement and clinical practice.
• Hospital systemic fungal infections
  • Newer triazoles with broader hospital use in high-acuity settings can displace itraconazole when clinicians prefer them for their spectrum and pharmacology.

Net effect

• Itraconazole retains share where it is already embedded, but growth rates tend to lag behind any segment where newer agents enter or where local epidemiology shifts.

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What regulatory and clinical constraints shape adoption?

Itraconazole dosing strategy is constrained by absorption variability, food and acid interaction, and patient-specific monitoring.

Clinical-use constraints reflected in practice

• Oral absorption is sensitive to gastric conditions; formulation choice can change exposure profiles.
• Drug–drug interaction risk is managed through medication review and selection of co-therapies.
• Monitoring is used in patients with risk factors for hepatotoxicity or cardiac events, aligning with established labeling and monographs. (See sources below.)

These constraints limit “universal switching,” which stabilizes demand for established users but slows rapid share gains in new care settings.

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What is the market projection for itraconazole (2026–2035)?

A forward projection for a mature, largely generic commodity antifungal is best expressed as a range with scenario boundaries tied to epidemiology, substitution rates, and pricing.

Projection approach (scenario model)

• Base case: low single-digit value growth driven by volume elasticity in endemic mycoses and incremental price recovery in certain regions, offset by ongoing generic price erosion.
• Downside case: stronger substitution to newer azoles in hospital protocols and sustained pricing pressure in retail channels.
• Upside case: greater guideline adherence to oral itraconazole in endemic mycoses and improved dosing management supporting broader outpatient use.

Indicative global market outlook (value growth)

Because itraconazole is off-patent in most markets, projections are best expressed by growth rate bands rather than a single-point dollar forecast.

Horizon	Base case annual market growth (value)	Downside	Upside
2026–2028	1%–3%	-1%–1%	3%–5%
2029–2031	1%–3%	0%–2%	2%–4%
2032–2035	0%–2%	-1%–1%	2%–3%

Interpretation

• The market grows slowly in value terms, with occasional regional uplift tied to endemic disease cycles and procurement patterns.
• If newer triazoles capture additional hospital share, itraconazole’s growth stays near zero in mature markets.

Indicative segment contribution

• Onychomycosis (retail/derm channels): stable-to-slow growth; sensitive to pricing and branded-to-generic transitions.
• Endemic mycoses (hospital and specialty channels): steadier demand with treatment duration supporting volumes.
• Systemic fungal infections (hospital): displacement risk limits long-term upside unless protocols favor itraconazole.

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What is the investment and R&D implication for stakeholders?

For generics and branded lifecycle players

• Growth is primarily achieved through formulation differentiation, distribution execution, and procurement contracting rather than new IP.
• Dossier strategy should emphasize bioavailability consistency and interaction management documentation.

For companies considering new development

• Competitive advantage is most feasible via:
  • improved oral exposure profiles,
  • optimized dosing regimens with clear clinical endpoint leverage,
  • or niche indications where evidence gaps exist.
• Trials will likely focus on endpoints aligned to existing labeled uses to reduce regulatory friction and shorten timelines.

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What do clinical guideline sources say about itraconazole positioning?

Guidelines and monographs consistently position itraconazole as:

• an oral triazole for systemic fungal infections,
• a standard option in endemic mycoses treatment algorithms,
• and a therapy for onychomycosis with specific dosing regimens.

This guideline stability is a key reason demand remains durable despite generic competition. (See citations.)

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Key Takeaways

• Itraconazole clinical trials activity is largely incremental (comparisons, dosing optimization, and monitoring/interaction work), not a pipeline reset for new molecular demand.
• Demand is supported by endemic mycoses and onychomycosis, with hospital systemic antifungal protocols providing both stability and displacement risk.
• Global market growth is modest: base-case value growth bands of roughly 1%–3% annually through 2028, trending toward 0%–2% from 2032 onward.
• Competitive advantage is likely formulation and execution driven, not IP driven.

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FAQs

1. Is itraconazole still actively studied in clinical trials?
   Yes, but most activity centers on regimen optimization, pharmacokinetics, safety monitoring, and comparative protocols rather than new mechanism or late-stage label expansions at a global scale.

2. What indications drive itraconazole volume most consistently?
   Endemic mycoses and onychomycosis are the most persistent volume contributors, with hospital systemic antifungal use supporting demand in higher-acuity pathways.

3. What are the main risks to itraconazole market growth?
   Ongoing generic price compression and substitution toward other systemic antifungals in hospital protocols.

4. What formulation factors matter for itraconazole adoption?
   Oral absorption variability and drug–drug interaction management are central to how clinicians select and monitor therapy.

5. What is the most realistic market expectation for 2026–2035?
   Slow value growth with regional variability, anchored by treatment duration in endemic disease and stable use in dermatology, tempered by substitution and pricing pressure.

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References

[1] World Health Organization. Model List of Essential Medicines (itraconazole entries). World Health Organization.
[2] European Medicines Agency (EMA). Itraconazole product information and related assessment documents. European Medicines Agency.
[3] Drugs@FDA. Itraconazole (Sporanox and generic products) prescribing information and labeling. U.S. Food and Drug Administration.
[4] National Library of Medicine (NLM). PubMed: itraconazole clinical studies and regimen reviews. PubMed.
[5] ClinicalTrials.gov. Itraconazole clinical trials registry entries (trial types: comparative, PK/PD, and monitoring-related studies). U.S. National Library of Medicine.