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Last Updated: February 15, 2025

CLINICAL TRIALS PROFILE FOR DIFLUCAN


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All Clinical Trials for Diflucan

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00075803 ↗ Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101) Completed Blood and Marrow Transplant Clinical Trials Network Phase 3 2003-11-01 The study is designed as a Phase III, randomized, double-blind, multicenter, prospective, comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients. Recipients will be stratified by center and donor type (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm in a 1:1 ratio.
NCT00075803 ↗ Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101) Completed National Cancer Institute (NCI) Phase 3 2003-11-01 The study is designed as a Phase III, randomized, double-blind, multicenter, prospective, comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients. Recipients will be stratified by center and donor type (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm in a 1:1 ratio.
NCT00075803 ↗ Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 2003-11-01 The study is designed as a Phase III, randomized, double-blind, multicenter, prospective, comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients. Recipients will be stratified by center and donor type (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm in a 1:1 ratio.
NCT00075803 ↗ Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101) Completed National Marrow Donor Program Phase 3 2003-11-01 The study is designed as a Phase III, randomized, double-blind, multicenter, prospective, comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients. Recipients will be stratified by center and donor type (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm in a 1:1 ratio.
NCT00075803 ↗ Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101) Completed Medical College of Wisconsin Phase 3 2003-11-01 The study is designed as a Phase III, randomized, double-blind, multicenter, prospective, comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients. Recipients will be stratified by center and donor type (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm in a 1:1 ratio.
NCT00166166 ↗ Endothelial Hyperpolarization in Humans Terminated National Heart, Lung, and Blood Institute (NHLBI) Phase 2 2002-07-01 The purpose of this study is to elucidate the role Endothelium-Derived Hyperpolarizing Factor (EDHF) plays in dilating blood vessels and whether it differs between healthy people and those with high cholesterol. A second purpose of the study is to determine the identity of EDHF.
NCT00166166 ↗ Endothelial Hyperpolarization in Humans Terminated Emory University Phase 2 2002-07-01 The purpose of this study is to elucidate the role Endothelium-Derived Hyperpolarizing Factor (EDHF) plays in dilating blood vessels and whether it differs between healthy people and those with high cholesterol. A second purpose of the study is to determine the identity of EDHF.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Diflucan

Condition Name

Condition Name for Diflucan
Intervention Trials
Candidiasis 5
Fungal Infection 4
Candidemia 3
Healthy 3
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Condition MeSH

Condition MeSH for Diflucan
Intervention Trials
Candidiasis 14
Mycoses 9
Infections 5
Infection 5
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Clinical Trial Locations for Diflucan

Trials by Country

Trials by Country for Diflucan
Location Trials
United States 157
Canada 14
Brazil 5
Italy 4
Spain 4
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Trials by US State

Trials by US State for Diflucan
Location Trials
California 9
Florida 8
Texas 8
Pennsylvania 8
North Carolina 8
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Clinical Trial Progress for Diflucan

Clinical Trial Phase

Clinical Trial Phase for Diflucan
Clinical Trial Phase Trials
Phase 4 7
Phase 3 11
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Diflucan
Clinical Trial Phase Trials
Completed 27
Not yet recruiting 4
Unknown status 3
[disabled in preview] 6
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Clinical Trial Sponsors for Diflucan

Sponsor Name

Sponsor Name for Diflucan
Sponsor Trials
Pfizer 4
Astellas Pharma Inc 3
National Cancer Institute (NCI) 3
[disabled in preview] 8
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Sponsor Type

Sponsor Type for Diflucan
Sponsor Trials
Other 45
Industry 25
NIH 10
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DIFLUCAN: Clinical Trials, Market Analysis, and Projections

Introduction

DIFLUCAN, the brand name for the antifungal drug fluconazole, is widely used for the treatment and prevention of various fungal infections. This article provides an update on the clinical trials, market analysis, and projections for DIFLUCAN.

Clinical Trials and Efficacy

Treatment of Cryptococcal Meningitis

In a multicenter study, DIFLUCAN (200 mg/day) was compared to amphotericin B (0.3 mg/kg/day) for the treatment of cryptococcal meningitis in patients with AIDS. The study revealed that mortality rates were similar between the two treatment groups, with 40% for DIFLUCAN and 33% for amphotericin B. However, pretreatment factors such as abnormal mental status, high cerebrospinal fluid cryptococcal antigen titer, and low cerebrospinal fluid white blood cell count predicted higher mortality rates[4].

Vaginal Candidiasis

Clinical trials have shown that DIFLUCAN is effective in treating vaginal candidiasis. A study where patients were administered a single 150 mg DIFLUCAN tablet orally resulted in an 80% clinical cure rate, 67% mycologic eradication, and 59% therapeutic cure for patients with acute vaginitis. For patients with recurrent vaginitis, the clinical cure rate was 57%, mycologic eradication was 47%, and therapeutic cure was 40%[4].

Oropharyngeal Candidiasis in Pediatric Patients

An open-label, comparative study in immunocompromised pediatric patients showed that DIFLUCAN (2 to 3 mg/kg/day) had higher clinical and mycological response rates compared to oral nystatin. Clinical cure was reported in 86% of fluconazole-treated patients versus 46% for nystatin-treated patients, and mycological eradication was achieved in 76% of fluconazole-treated patients versus 11% for nystatin-treated patients[4].

Drug Interactions

DIFLUCAN interacts with several other medications, which can affect its efficacy and safety.

Oral Contraceptives

DIFLUCAN can increase the levels of levonorgestrel and ethinyl estradiol when co-administered with oral contraceptives. This results in a mean percentage increase of 25% for levonorgestrel and 38% for ethinyl estradiol compared to placebo[1].

Hydrochlorothiazide

Concomitant administration of DIFLUCAN and hydrochlorothiazide leads to a significant increase in fluconazole AUC and Cmax due to reduced renal clearance of fluconazole[1].

Rifampin

Co-administration with rifampin decreases fluconazole AUC and increases its apparent oral clearance, leading to a shorter half-life of fluconazole[1].

Warfarin

DIFLUCAN can increase the prothrombin time response when administered with warfarin, indicating a potential for increased anticoagulant effect[1].

Phenytoin

DIFLUCAN significantly increases the AUC of phenytoin, which can lead to increased levels of phenytoin in the body[1].

Market Analysis

Global Market Size and Growth

The global fluconazole market is expected to witness significant growth from 2020 to 2025. The market size was anticipated to grow from USD 17.39 billion in 2024 to USD 18 billion in 2025 and is projected to reach USD 24.51 billion by 2034, with a CAGR of 3.49% from 2025 to 2034[5].

Regional Market

The North America market is the largest for antifungal drugs, including DIFLUCAN, with a market size of USD 7.30 billion in 2024. The Asia-Pacific region is expected to be the fastest-growing market during the forecast period[5].

Market Drivers

The rising prevalence of fungal infections such as candidiasis and aspergillosis is a key driver for the growth of the antifungal drugs market. Additionally, developments in innovative products and increasing awareness about fungal diseases are expected to fuel market growth further[5].

Impact of COVID-19

The COVID-19 pandemic has had a significant impact on the global economy and the pharmaceutical industry. The demand and supply chain of antifungal drugs, including DIFLUCAN, have seen fluctuations. However, the overall impact on the revenue matrix has been manageable, and the market is expected to recover and grow as predicted[2].

Optimal Dosing Strategies

Cryptococcosis Treatment

Current fluconazole doses may be inadequate for treating cryptococcosis due to the increasing prevalence of fluconazole-nonsusceptible Cryptococcus. Studies suggest that higher doses and a rational dosing strategy based on minimum inhibitory concentration (MIC) and area under the curve (AUC) relative to MIC are necessary for effective treatment[3].

Key Takeaways

  • Clinical Efficacy: DIFLUCAN is effective in treating various fungal infections, including cryptococcal meningitis, vaginal candidiasis, and oropharyngeal candidiasis.
  • Drug Interactions: DIFLUCAN interacts with several medications, necessitating careful monitoring and dose adjustments.
  • Market Growth: The global fluconazole market is expected to grow significantly from 2020 to 2025, driven by increasing fungal infections and innovative product developments.
  • Regional Markets: North America is the largest market, while the Asia-Pacific region is expected to be the fastest-growing.
  • Optimal Dosing: Higher doses and rational dosing strategies may be necessary for effective treatment of cryptococcosis.

FAQs

What are the common uses of DIFLUCAN?

DIFLUCAN is commonly used to treat fungal infections such as cryptococcal meningitis, vaginal candidiasis, and oropharyngeal candidiasis.

How does DIFLUCAN interact with other medications?

DIFLUCAN can interact with oral contraceptives, hydrochlorothiazide, rifampin, warfarin, and phenytoin, affecting its efficacy and safety.

What is the projected market size of the global fluconazole market by 2034?

The global fluconazole market is projected to reach USD 24.51 billion by 2034, growing at a CAGR of 3.49% from 2025 to 2034.

How has the COVID-19 pandemic impacted the antifungal drugs market?

The COVID-19 pandemic has caused fluctuations in demand and supply chains but is expected to have a manageable impact on the overall revenue matrix.

What are the concerns regarding the current dosing of DIFLUCAN for cryptococcosis?

Current doses of DIFLUCAN may be inadequate due to the increasing prevalence of fluconazole-nonsusceptible Cryptococcus, necessitating higher doses and rational dosing strategies.

Sources

  1. Diflucan: Package Insert / Prescribing Information - Drugs.com
  2. Fluconazole Market Globally Expected to Drive Growth through 2025 - OpenPR
  3. Minimum Inhibitory Concentration Distribution of Fluconazole - Oxford Academic
  4. DIFLUCAN ® TABLET, SUSPENSION Clinical Studies - Pfizer Medical Information
  5. Antifungal Drugs Market Size to Reach USD 24.51 Bn by 2034 - Precedence Research

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