CLINICAL TRIALS PROFILE FOR FLUCONAZOLE

505(b)(2) Clinical Trials for FLUCONAZOLE

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.
New Indication	NCT04495608 ↗	Fluconazole in Hypercalciuric Patients With Increased 1,25(OH)2D Levels	Recruiting	Hospices Civils de Lyon	Phase 2	2021-01-13	Hypercalciuria is one of the most frequent metabolic disorders associated with nephrolithiasis and/or nephrocalcinosis leading to Chronic Kidney Disease (CKD) and bone complications in adults. Hypercalciuria can be secondary to increased intestinal absorption and/or increased renal distal tubular reabsorption of calcium due to increased active vitamin D, i.e. 1,25(OH)2D, levels. The management of hypercalciuria is challenging. Classic management based on hyperhydration and dietary advice has low impact on calciuria and therefore on CKD progression. Other strategies such as hydrochlorothiazide can be proposed, however with an uncertain medical benefit in view of side effects (hypokalemia, asthenia, potential cutaneous long-term side effects). Azoles are known to inhibit the 1α-hydroxylase and therefore decrease 1,25(OH)2D levels. These antifungal drugs are commonly used in neonates, infants and adults; pharmacokinetic data are well described. Recently, to improve azoles tolerance, fluconazole has been successfully reported to reduce calciuria in patients with CYP24A1 mutation (1 adult) or NPTIIc mutations (1 child), while maintaining a stable renal function. Based on these observations, the investigators hypothesize that fluconazole is effective to decrease and normalize calciuria in patients with hypercalciuria and increased 1,25(OH)2D levels. The primary objective is to demonstrate that fluconazole normalizes or decreases calciuria after 4 months of treatment in patients with hypercalciuria and increased 1,25(OH)2D levels. The secondary objectives aim to describe: - the effects of fluconazole on the evolution over time of the calcium/phosphate metabolism, - the evolution of renal function, - the cohort at Baseline and after 4 months of treatment period, - the safety of fluconazole, - the onset of potential mycological resistances, - and the treatment compliance. This is a prospective, interventional, national, randomized in 2 parallel groups (1:1), controlled versus placebo, double blind trial. This study will involve patients between 10 and 50 years of age suffering from nephrolithiasis and/or nephrocalcinosis with hypercalciuria (> 0.1 mmol/kg/d) and increased 1,25 (OH)2D levels (≥ 150 pmol/l) and 25-OH-D levels (≥50 nmol/L). FLUCOLITH study is a unique opportunity to develop a new indication of a well-known and not expensive drug (e.g. fluconazole) in rare renal diseases, the ultimate objective being the secondary prevention of CKD worsening in these patients. If the results of this proof-of-concept randomized controlled trial are positive, the investigators will propose an extension phase to evaluate the long term efficacy and safety of fluconazole on renal and bone parameters.
OTC	NCT05059145 ↗	A Clinical Trial for Chlorhexidine as Treatment for Vulvovaginal Candidiasis	Not yet recruiting	Karolinska Institutet	Phase 2	2021-10-01	The overall aim of this study is to investigate if vaginally applied 1% chlorhexidine gluconate (CHG) could be an alternative treatment to oral fluconazole (FLZ), both during an acute episode and as prophylaxis, against recurrent infections of vulvovaginal candidiasis (RVVC). RVVC is very common in fertile women. Up to six months of treatment with FLZ is recommended for RVVC. Over the last ten years, the use of FLZ has increased markedly in many countries. No major problems have been noted with resistance development, but there is concern that this will occur in the future and alternative treatments are requested. In recent years, it has emerged that flukonazol interacts with several different types of drugs that are common in the patient group; several antidepressants, pain relief at dysmenorrhea (NSAID) and oral contraceptives to name a few. In Sweden an over-the-counter vaginal cream consisting of 1% chlorhexidine gluconate (Hibitane®) is available with the indication antiseptic use in vaginal examinations, especially during childbirth. The product has been used for a long time in various gynecological and obstetric surgical procedures. Hibitane® is approved during pregnancy and the cream is usually well tolerated. Our research group has previously done an in vitro study in which we analyzed the effect of FLZ and CHG's ability to kill fungal cells and to break down existing biofilm or prevent new biofilm formation. The biofilm formation is an important stage for the fungal cells to attach to surfaces such as skin and mucosa and is considered a first step in the development of an infection. In the biofilm, the fungus can hide from the immune system and also to some extent for various treatments aimed against the fungus. The results of the study showed that CHG was better than FLZ both at killing the fungal cells and preventing new biofilm from forming and dissolving already established "old" biofilm. This effect is absolutely crucial for successful treatment with antimycotics. These encouraging results form the basis of the planned study. If CHG is at least as effective as FLZ with little impact on vaginal lactobacillus, with high tolerability and without cytotoxic effect on epithelial cells, the results of the study might lead to major benefits to the patients with reduced risk of systemic side effects such as drug interactions, development of drug resistance and reduced drug costs.

All Clinical Trials for FLUCONAZOLE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000627 ↗	Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome	Completed	Pfizer	N/A	1969-12-31	To evaluate the use of fluconazole as (1) induction therapy in histoplasmosis, (2) maintenance therapy to prevent relapse of histoplasmosis. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Fluconazole is a triazole antifungal agent that has been used successfully in the treatment of experimental histoplasmosis in animals, but has not been completely evaluated in patients for this use. It has been approved by the Food and Drug Administration for certain other fungal infections. Nevertheless, physicians are prescribing it to their patients with histoplasmosis. This is a pilot study to examine the role of fluconazole for treating histoplasmosis in AIDS patients.
NCT00000627 ↗	Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate the use of fluconazole as (1) induction therapy in histoplasmosis, (2) maintenance therapy to prevent relapse of histoplasmosis. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Fluconazole is a triazole antifungal agent that has been used successfully in the treatment of experimental histoplasmosis in animals, but has not been completely evaluated in patients for this use. It has been approved by the Food and Drug Administration for certain other fungal infections. Nevertheless, physicians are prescribing it to their patients with histoplasmosis. This is a pilot study to examine the role of fluconazole for treating histoplasmosis in AIDS patients.
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.
NCT00000676 ↗	Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)	Completed	Pfizer	Phase 3	1969-12-31	To study the effectiveness, safety, and tolerance of fluconazole versus clotrimazole troches (lozenges) as prophylaxis (preventive treatment) against fungal infections in patients enrolled in ACTG 081 (a study of prophylaxis against pneumocystosis, toxoplasmosis, and serious bacterial infection). Primarily, to compare the rates of invasive infections by C. neoformans, endemic mycoses, and Candida. To compare the mortality rates due to fungal infections between two antifungal prophylactic treatments. Secondarily, to assess the effect of prophylaxis on the incidence of severe fungal infections, defined as invasive infections and esophageal candidiasis and less severe mucocutaneous infection. Serious fungal infections are significant complicating and life-threatening occurrences in patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly, esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses, and coccidioidomycosis also cause significant illness and death in AIDS patients. Once established, fungal infections in AIDS patients generally require continuous suppressive therapy because attempts at curing these infections are usually unsuccessful. Fluconazole has a number of characteristics that would make it a logical candidate to examine as a prophylactic agent in patients with advanced HIV infection. Animal studies have shown it to be prophylactic in models of candidiasis, cryptococcosis, histoplasmosis, and coccidioidomycosis. Initial experience in patients with active cryptococcal meningitis appears favorable, and studies of oropharyngeal candidiasis show it to be effective.

Clinical Trial Conditions for FLUCONAZOLE

Condition Name

Condition Name for FLUCONAZOLE
Intervention	Trials
HIV Infections	42
Candidiasis	21
Mycoses	19
Meningitis, Cryptococcal	16

Condition MeSH

Condition MeSH for FLUCONAZOLE
Intervention	Trials
Candidiasis	77
HIV Infections	45
Mycoses	45
Infections	31

Clinical Trial Locations for FLUCONAZOLE

Trials by Country

Trials by Country for FLUCONAZOLE
Location	Trials
United States	771
China	36
Canada	28
Spain	20
Belgium	15

Trials by US State

Trials by US State for FLUCONAZOLE
Location	Trials
California	57
Texas	55
Florida	46
New York	46
Pennsylvania	40

Clinical Trial Progress for FLUCONAZOLE

Clinical Trial Phase

Clinical Trial Phase for FLUCONAZOLE
Clinical Trial Phase	Trials
PHASE4	6
PHASE3	4
PHASE2	4

Clinical Trial Status

Clinical Trial Status for FLUCONAZOLE
Clinical Trial Phase	Trials
Completed	189
Recruiting	28
Unknown status	21

Clinical Trial Sponsors for FLUCONAZOLE

Sponsor Name

Sponsor Name for FLUCONAZOLE
Sponsor	Trials
Pfizer	40
National Institute of Allergy and Infectious Diseases (NIAID)	25
Merck Sharp & Dohme Corp.	7

Sponsor Type

Sponsor Type for FLUCONAZOLE
Sponsor	Trials
Other	231
Industry	168
NIH	46

Fluconazole Clinical Trials Update, Market Analysis, and Projection

Last updated: April 26, 2026

What is fluconazole and where is it used today?

Fluconazole is an oral and injectable antifungal drug used to prevent and treat a range of fungal infections. Its commercial use is dominated by:

• Vulvovaginal candidiasis
• Oropharyngeal and esophageal candidiasis
• Systemic fungal infections (including some off-label and guideline-supported indications depending on pathogen and patient population)
• Prophylaxis in immunocompromised patients

Current market structure is generic-driven in most regions. Commercial pricing, volume, and gross margins are therefore heavily impacted by patent expiry status, local tender dynamics, and government reimbursement.

What does the clinical trials landscape look like right now?

Fluconazole is an established small-molecule product. Most active clinical activity is concentrated in three buckets:

1. Comparative studies of existing regimens (fluconazole vs other azoles or step-down strategies)
2. New formulations or dosing strategies (bioavailability, pediatric dosing refinements, simplified schedules)
3. In vitro and observational expansions that translate into pragmatic clinical endpoints (time-to-therapy response, microbiological outcomes), often led by academic centers

A practical marker for “current trials intensity” in fluconazole is whether sponsors run interventional registration-grade trials versus post-marketing comparative/observational studies. In mature antifungals, interventional registration trials are less common than in new chemical entities because evidence is already in place.

Key clinical implication for R&D planning: new fluconazole programs typically need a credible differentiated claim: formulation advantage, a specific clinical subpopulation, or a specific resistance/rapid diagnostics strategy. Without that, the patent and competitive economics are weak.

What is the near-term clinical pipeline signal from major registries?

Public registries typically show:

• Numerous studies with fluconazole comparators
• Repeat involvement in candidiasis and prophylaxis settings
• Limited number of trials whose primary goal is to expand into entirely new indications

Because fluconazole is widely generic, many trials are small, sponsor-poor, or academically driven. That reduces the likelihood of high-value label expansion and increases the probability that trials support local prescribing guidelines rather than global label breadth.

How does fluconazole’s patent status affect clinical and commercial incentives?

Fluconazole’s origin IP is long expired, and the market is dominated by generic manufacturers. This creates a stable but low-differentiation environment:

• Brand premium is limited to remnants where generics face supply, tender, or reimbursement friction.
• Clinical trial spend is constrained by weak ability to secure exclusivity.
• Competitive strategy shifts to manufacturing scale, supply reliability, and portfolio breadth (combos and adjacent azoles).

What is the market size and what drives demand?

Fluconazole demand is driven by:

• Incidence and recurrence of vulvaginal candidiasis
• Hospital and immunocompromised use (oncology, transplant, HIV care)
• Growth in healthcare access, especially where prophylaxis practices are adopted or reimbursed
• Ongoing need for antifungals as antimicrobial stewardship and invasive care rise

However, market value growth is constrained by generic competition. The market can grow in volume, but pricing often follows tender and buyer-driven rates.

Market framing

For a mature, generic antifungal like fluconazole, business projections usually split into:

• Volume growth (patient numbers, healthcare utilization, prophylaxis uptake)
• Price erosion (generic price competition, manufacturing oversupply, regional reimbursement caps)
• Mix effects (oral vs IV, packet size, tender brand vs store brands)

What is the competitive landscape?

Competition is primarily among generic manufacturers. Brand differentiation is limited. Buyers prioritize:

• Supply continuity
• Regulatory compliance
• Cost per treated episode
• Formulation availability (tablets, capsules, oral suspensions, IV where applicable)

In practical terms, the fluconazole market behaves like a commoditized procurement category:

• Large tender cycles
• Frequent switching to lowest-cost equivalent products
• Limited differentiation unless a manufacturer controls a specific supply route or has distinct packaging and distribution advantages

What regions have the strongest demand dynamics?

Demand is strongest where candidiasis incidence is high and healthcare utilization supports both outpatient and inpatient antifungal prescribing.

High-level regional drivers:

• North America and Europe: stable volumes, strong guideline use, price pressure from generics
• Asia-Pacific: volume-led growth potential tied to population and healthcare expansion, with pricing volatility by country
• Latin America and Middle East & Africa: procurement and reimbursement swings affect realized pricing; volume resilience often outperforms price growth

How should investors and R&D leaders project fluconazole revenue?

A realistic projection model for fluconazole uses:

1. Total treated episodes (candidiasis + prophylaxis + systemic candidiasis)
2. Average net price after generic discounting and tender outcomes
3. Share shifts between oral vs IV, and among generic suppliers
4. Regulatory actions (quality recalls, tender bans, pharmacovigilance restrictions)

Given commoditization, the base case is usually:

• Low single-digit CAGR by value globally (driven more by volume and mix than by price)
• Higher volume CAGR than value CAGR
• Regional divergence depending on procurement and reimbursement cycles

What are the key risks to forecast accuracy?

Forecasting fluconazole is primarily about pricing and procurement variability, not clinical breakthrough risk.

Top forecast risks:

• Wholesale price compression during periods of oversupply
• Tender renegotiations and contracting model changes
• Antifungal guideline updates that reduce fluconazole use in certain patient profiles
• Safety or manufacturing quality events that temporarily disrupt supply

What are the most relevant opportunities despite commoditization?

Opportunities exist where differentiation can be defended without needing new patents:

• Formulation improvements that reduce dosing friction (oral suspension, pediatric-friendly presentations, stability)
• IV-to-oral step-down protocols that reduce inpatient cost
• Evidence in specific subpopulations where payers care about failure rates and hospital length of stay
• Combination and adjunct strategies (within regulatory and payer frameworks)

Is there a viable path for new clinical development with fluconazole?

New fluconazole clinical value typically comes from:

• Narrow endpoint claims such as time-to-clinical response, microbiological eradication, and tolerability in defined cohorts
• Pragmatic trials in routine practice that strengthen reimbursement justification
• Pharmacokinetic and dosing refinement for pediatric or special populations

Absent those, commercial incentives remain limited because exclusivity is hard to secure.

Market projection summary

Base case outlook (structure, not brand-specific)

• Value growth: low-to-mid single digit CAGR where procurement is stable; can be lower where price erosion intensifies
• Volume growth: moderate, supported by candidiasis burden and prophylaxis usage
• Supply dynamics: continue to be a dominant driver of realized revenues

Projection mechanics (what to model)

Variable	What moves it	Typical direction in generics
Net selling price	tender, reimbursement, import competition	Down or flat
Treated episodes	patient incidence, healthcare utilization	Up
Mix	oral vs IV, pack size, adherence support	Mixed
Supplier share	manufacturing reliability, regulatory status	Rotates based on supply

Where does fluconazole sit versus other antifungals?

Compared with newer antifungals (some with novel mechanisms or branded differentiation), fluconazole usually loses on:

• Pricing power
• Differentiated clinical positioning
• Exclusivity-led margins

But it often wins on:

• Broad prescriber familiarity
• Coverage in formularies due to low acquisition costs
• Strong performance in guideline-supported candidiasis settings

Key Takeaways

• Fluconazole is a mature, generic-dominated antifungal where clinical development is most often comparative, formulation, or dosing-focused, not label-expanding.
• The market is driven by treated episode volumes (vulvovaginal and candidiasis, prophylaxis) while value growth is constrained by persistent generic price compression.
• Forecasting should weight procurement and tender dynamics more than clinical uncertainty.
• Near-term R&D opportunities concentrate on product presentation and dosing strategies and on pragmatic outcomes that matter for reimbursement and clinical protocols.

FAQs

1) What indications account for most fluconazole demand?

Candidiasis indications, including vulvovaginal candidiasis and oropharyngeal/esophageal candidiasis, plus prophylaxis use in immunocompromised settings, typically drive bulk demand.

2) Why does fluconazole usually not sustain high revenue growth?

Because it is widely generic, pricing follows procurement and tender outcomes, compressing margins and limiting value CAGR even when volumes rise.

3) What kind of clinical trials are most likely to appear for fluconazole?

Trials commonly compare regimens, evaluate dosing schedules, or test formulations and step-down strategies rather than pursuing major new mechanisms.

4) What most affects fluconazole market forecasting?

Net price and supply chain stability (tenders, reimbursement rules, generic competition) usually outweigh clinical pipeline variability.

5) Where can differentiation still pay off?

Formulation and regimen innovations that improve adherence, reduce inpatient cost via oral step-down, or demonstrate pragmatic outcomes in specific cohorts can create defensible positioning even without new exclusivity.

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References (APA)

[1] US Food and Drug Administration. (n.d.). Drug development and drug trials. https://www.fda.gov/drugs
[2] European Medicines Agency. (n.d.). Human medicines: clinical trials. https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials
[3] ClinicalTrials.gov. (n.d.). Fluconazole studies and results. https://clinicaltrials.gov/
[4] World Health Organization. (n.d.). Antifungal medicines and treatment guidance resources. https://www.who.int/health-topics/antifungal-medicines