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.

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.

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

Itraconazole Clinical Trials Update, Market Analysis, and Revenue Projection (2026-2035)

Last updated: July 25, 2026

Itraconazole is an established systemic antifungal with a maturing global generics market. Clinical activity is concentrated in drug-formulation optimization, pharmacokinetic (PK) refinement, and niche indications rather than broad Phase 3 registrational programs. Market outlook is driven by (1) loss of exclusivity dynamics for older brands in high-income markets, (2) continued demand for endemic mycoses and onychomycosis, (3) uptake of alternative azoles and newer agents in select indications, and (4) ongoing cost pressure from multi-source generic supply.

What is the current clinical trials landscape for itraconazole?

Clinical trials involving itraconazole generally cluster into three buckets: (a) generic bioequivalence and formulation changes, (b) PK and therapeutic drug monitoring (TDM) studies for interpatient variability, and (c) exploratory or supportive studies in specific fungal subtypes or special populations (HIV, oncology, transplant). Registrational, late-stage trials are less frequent because itraconazole is long on the market and many therapeutic claims are already supported.

Which itraconazole clinical trial phases are most common?

• Phase 1/PK studies: to characterize absorption, food effects, gastric pH dependence, and exposure-response for different formulations (capsules vs oral solution vs newer delivery approaches).
• Bioequivalence (BE) studies: for generic itraconazole products and switching from branded formulations.
• Phase 2/observational studies: for difficult-to-treat mycoses, often with limited enrollments or single-arm designs.
• Real-world evidence (RWE): dosing patterns, TDM use, and safety monitoring.

What endpoints dominate itraconazole trials?

• PK exposure metrics: Cmax, AUC, trough levels.
• Clinical response: mycologic cure, symptom resolution, radiographic improvement.
• Safety: hepatotoxicity signals, cardiac safety monitoring, drug-drug interaction tolerability.

PK/TDM remains the recurring clinical theme

Itraconazole exposure variability is a consistent trial and clinical management focus, especially when used with interacting medications or in populations with altered GI physiology. Trial designs increasingly incorporate TDM algorithms or standardized sampling windows to reduce between-subject variability.

What are the key market drivers and inhibitors for itraconazole through 2035?

Market drivers

• Persistent fungal burden: ongoing incidence of dermatophyte and yeast infections, plus continued treatment needs for endemic mycoses in endemic regions.
• Broad therapeutic positioning: itraconazole remains a standard systemic option for multiple fungal categories, supporting stable baseline demand.
• Generic availability expands access: low price elasticity supports volume growth in regions where affordability drives uptake.

Market inhibitors

• Competitive azole pressure: newer azoles and alternatives can shift share in some indications.
• Safety and tolerability constraints: itraconazole’s interaction profile and cardiac safety warnings reduce prescriber flexibility in specific cohorts.
• Formulation switching issues: differences between capsules and oral solution affect prescribing and therapeutic outcomes, which can limit interchangeability in clinical practice.

What is the size of the itraconazole market, and how does it split by geography and product type?

Itraconazole is widely sold as:

• Oral capsules (older standard formulation)
• Oral solution (historically used when absorption is a challenge)
• Generic multi-source tablets/capsules across most markets
• Brand remnants in select geographies where legacy products persist in distribution

Market structure is typically dominated by generics by volume and by near-generic price points. Specialty formulary dynamics matter more for hospital systemic use than for outpatient dermatology.

Geographic pattern (typical for long-established generic antifungals):

• Higher absolute volume in emerging markets due to access and higher unit consumption.
• Mature pricing and tighter margins in North America and Western Europe, where multi-source generics are established.

What is the competitive landscape for itraconazole, and how does it affect pricing?

Competition is primarily:

• Generic manufacturers supplying oral itraconazole across regulated markets.
• Alternative systemic azoles and other antifungal classes used in higher-acuity systemic fungal disease settings.

Pricing tends to trend toward:

• Low single-digit to high single-digit percent annual declines in mature markets as new entrants and BE-substitution expand supply.
• More stable pricing in constrained supply regions, but with frequent downward resets when additional approvals enter.

When do generic entry risks peak for itraconazole, and what does that mean for revenue?

Because itraconazole is long off patent for key older compositions in most jurisdictions, the “peak risk” framing depends on:

• Brand-specific remaining exclusivity windows in particular markets (often already expired for mainstream formulations).
• Formulation-based exclusivity for specific delivery improvements (rare for systemic itraconazole compared with niche antifungal innovations).
• Regulatory and manufacturing approvals that expand generic access.

Practical implication: revenue forecasts should be modeled as a generic-supplied commoditized product with incremental growth from volume and mix rather than expectation of premium pricing.

What patent estate issues matter for itraconazole today (formulations, methods of use)?

For an established molecule like itraconazole, the active IP question generally becomes:

• whether any formulation/process patents remain in force for certain marketed variants in specific jurisdictions, and
• whether any method-of-use claims exist that meaningfully restrict generic labeling or interchangeability.

In practice, most market risk is driven by regulatory and generic substitution rather than by blocking patent estates on core drug substance.

What is the regulatory status of itraconazole in the US (FDA pathways and Orange Book dynamics)?

Itraconazole is an approved systemic antifungal with generic availability. In the US, the market is dominated by ANDA approvals for oral products. Regulatory dynamics relevant to market entry:

• ANDA BE requirements for generic formulation approval.
• Labeling differences (e.g., which indications and dosing regimens are included).
• Product-specific formulation performance that drives real-world interchange decisions.

What is the biosimilar risk for itraconazole?

No biosimilar framework applies. Itraconazole is a small-molecule drug, so competitive substitution risk is via generics rather than biologics.

What formulation and delivery changes are in the pipeline for itraconazole?

Current activity tends to emphasize:

• Improving bioavailability consistency versus older capsules.
• Addressing absorption dependence (food and gastric pH).
• Streamlining dosing approaches to reduce exposure variability.

These efforts typically do not reset broad systemic exclusivity but can support line extensions and product differentiation within generics.

Clinical trial update: what is most likely to impact near-term adoption?

Near-term adoption will be influenced less by new Phase 3 efficacy data and more by:

• BE-supported generic product launches that increase pharmacy/hospital access.
• PK/TDM guidance refinements that improve clinician confidence in maintaining therapeutic levels.
• Updated safety monitoring protocols that shape prescribing behavior.

Market forecast and revenue projection for itraconazole (2026-2035)

Forecast structure

A practical commoditized-drug model uses:

1. Unit volume growth from fungal disease burden and generics penetration.
2. Net price decline from increased multi-source competition.
3. Mix changes between formulations and regions.
4. Substitution pressure from alternative antifungals in selected indications.

Projected global market direction (directional)

• 2026-2028: modest top-line stability to low growth by volume; pricing declines persist.
• 2029-2032: gradual deceleration as mature generics saturation strengthens; slight volume growth offsets price erosion.
• 2033-2035: low-growth environment driven mainly by emerging market volume and replacement of older product stock in formularies.

Revenue projection ranges (global, directional)

Because itraconazole is sold through numerous generic suppliers and pricing is highly sensitive to geography and tender dynamics, the correct approach is range-based. The expected pattern for a mature generic systemic antifungal is:

• Global market CAGR (2026-2030): low single digits
• Global market CAGR (2031-2035): further deceleration to near-flat to low single digits

Scenario analysis: what drives the upside/downside?

Upside scenarios

• Increased diagnostic rates and access in emerging markets.
• Greater reliance on azole-based regimens where newer alternatives are priced higher.
• Improved clinician uptake from updated PK guidance and better formulation performance.

Downside scenarios

• Faster substitution to other antifungals in systemic mycoses.
• Continued pricing pressure from large-scale generic supply.
• Restrictive formulary decisions due to safety and interaction concerns.

Key Takeaways

• Itraconazole’s clinical activity is largely PK/formulation and BE-driven, not new registrational efficacy expansion.
• Market growth is constrained by commoditization and pricing erosion but supported by persistent fungal demand and generics access.
• Revenue projections should assume low single-digit growth at best, with ongoing declines in net price and stabilization from volume.
• Competitive dynamics are dominated by multi-source generics and class competition from other antifungals, not by biosimilars or large remaining exclusivity blocks.

FAQs

1. Which itraconazole formulation (capsule vs oral solution) has the most favorable exposure profile in trials?
2. What PK sampling and TDM practices most commonly appear in itraconazole studies for systemic fungal infections?
3. How does itraconazole’s drug-drug interaction profile influence clinical trial inclusion/exclusion and real-world prescribing?
4. What generic launch pattern typically drives rapid price declines for established oral antifungals like itraconazole?
5. How do endemic mycoses treatment guidelines affect itraconazole volume demand in high-incidence regions?

References

No citations provided because no source documents were included in the prompt, and the response requires hard data (trial listings, FDA/Orange Book entries, and market figures) that cannot be produced accurately without external inputs.