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Last Updated: May 17, 2025

CLINICAL TRIALS PROFILE FOR FUNGIZONE


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All Clinical Trials for Fungizone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002019 ↗ Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome Completed Liposome N/A 1969-12-31 To evaluate the safety, tolerance and efficacy of three different dosage regimens of Amphotericin B Lipid Complex (ABLC) compared to Fungizone (Amphotericin B) in patients with AIDS and cryptococcal meningitis.
NCT00750737 ↗ Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC) Completed Enzon Pharmaceuticals, Inc. Phase 3 2008-06-01 The objective of this study is to compare the safety and efficacy of ABLC versus oral Posaconazole in the prevention of invasive fungal infections in high risk patients with hematologic malignancies or hematopoietic stem cell transplant. Primary objective is to demonstrate the low toxicity rate and low rate of invasive fungal infections associated with ABLC or Posaconazole prophylaxis. Secondary objective will be to compare the cost effectiveness of these two prophylactic regimens.
NCT00750737 ↗ Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC) Completed M.D. Anderson Cancer Center Phase 3 2008-06-01 The objective of this study is to compare the safety and efficacy of ABLC versus oral Posaconazole in the prevention of invasive fungal infections in high risk patients with hematologic malignancies or hematopoietic stem cell transplant. Primary objective is to demonstrate the low toxicity rate and low rate of invasive fungal infections associated with ABLC or Posaconazole prophylaxis. Secondary objective will be to compare the cost effectiveness of these two prophylactic regimens.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Fungizone

Condition Name

Condition Name for Fungizone
Intervention Trials
Visceral Leishmaniasis 2
HIV Infections 2
Breast Cancer 1
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Condition MeSH

Condition MeSH for Fungizone
Intervention Trials
Meningitis, Cryptococcal 2
Meningitis 2
HIV Infections 2
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Clinical Trial Locations for Fungizone

Trials by Country

Trials by Country for Fungizone
Location Trials
United States 17
Brazil 7
Kenya 2
Ukraine 2
Canada 2
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Trials by US State

Trials by US State for Fungizone
Location Trials
California 3
Texas 2
New Jersey 2
Virginia 1
North Carolina 1
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Clinical Trial Progress for Fungizone

Clinical Trial Phase

Clinical Trial Phase for Fungizone
Clinical Trial Phase Trials
Phase 4 3
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Fungizone
Clinical Trial Phase Trials
Completed 6
Terminated 3
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Clinical Trial Sponsors for Fungizone

Sponsor Name

Sponsor Name for Fungizone
Sponsor Trials
Ministry of Health, Brazil 2
University of Brasilia 2
M.D. Anderson Cancer Center 1
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Sponsor Type

Sponsor Type for Fungizone
Sponsor Trials
Other 10
Industry 4
NIH 1
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Clinical Trials, Market Analysis, and Projections for Antifungal Drugs: A Focus on Fosravuconazole and the Broader Market

Introduction to Antifungal Drugs and Clinical Trials

The field of antifungal drugs has seen significant advancements in recent years, driven by the increasing incidence of fungal infections globally. This article will delve into the latest clinical trials, particularly focusing on fosravuconazole, a new antifungal treatment, and provide a comprehensive market analysis and projection for the antifungal drugs market.

Clinical Trials: Fosravuconazole for Mycetoma

Background and Trial Design

Mycetoma, a chronic and disabling fungal disease, has long lacked effective treatments. The Drugs for Neglected Diseases initiative (DNDi), in collaboration with the Mycetoma Research Center (MRC) in Sudan, Erasmus MC in the Netherlands, and Eisai Co., Ltd., conducted the world’s first double-blind, randomized clinical trial to evaluate the efficacy of fosravuconazole against mycetoma[1].

Trial Results

The Phase II clinical trial compared fosravuconazole with itraconazole, the current standard of care. The results showed that both drugs had similar efficacy rates, with fosravuconazole achieving efficacy rates of 65% and 85% in the 300-milligram and 200-milligram arms, respectively. Itraconazole had an efficacy rate of 80%, which was higher than expected based on historical data. Although the difference in efficacy rates was not statistically significant, fosravuconazole offers significant advantages in terms of patient adherence and convenience due to its lower pill burden[1].

Patient Adherence and Convenience

Fosravuconazole requires only two pills to be taken once a week, compared to four tablets per day for itraconazole. This reduction in pill burden from 120 tablets per month to just eight tablets per month is expected to improve patient adherence significantly[1].

Market Analysis of Antifungal Drugs

Global Market Size and Growth

The global antifungal drugs market is projected to grow substantially over the coming years. By 2025, the market is expected to reach USD 18 billion, and by 2034, it is anticipated to be worth around USD 24.51 billion, growing at a CAGR of 3.49% from 2025 to 2034[5].

Key Drivers of Market Growth

  • Increasing Incidence of Fungal Infections: The rising prevalence of fungal infections such as candidiasis and aspergillosis is a major driver of market growth.
  • Advancements in Innovative Products: Developments in new antifungal agents, such as fosravuconazole and oral lipid nanocrystal amphotericin B, are fueling market expansion.
  • Growing Awareness and Healthcare Infrastructure: Increased awareness among patients and healthcare professionals, along with improvements in healthcare infrastructure, particularly in regions like Asia-Pacific, are contributing to market growth[2][5].

Regional Market Dynamics

  • North America: This region holds the largest market share due to higher awareness levels and a large target population. The market size in North America was USD 7.30 billion in 2024 and is expected to grow at a CAGR of 3.49% during the forecast period[5].
  • Asia-Pacific: This region is projected to register the fastest growth due to improving healthcare facilities and rising government initiatives to create awareness about infectious diseases[2][5].

Drug Classes and Indications

  • Azoles, Echinocandins, Polyenes, and Allyamines: These are the primary drug classes in the antifungal market. Echinocandins are anticipated to exhibit lucrative growth due to their cell wall-specific fungicidal properties and broad-spectrum activity against Aspergillus and Candida species[2].
  • Candidiasis, Aspergillosis, and Dermatophytosis: Candidiasis is expected to witness the fastest CAGR due to increasing drug resistance of Candida species to azoles. Dermatophytosis, particularly in children, and aspergillosis are also significant segments driving market growth[2][5].

Market Projections and Trends

Future Outlook

The antifungal drugs market is poised for significant growth driven by the increasing incidence of fungal infections and advancements in treatment options. Here are some key trends and projections:

  • Oral Antifungal Drugs: The oral dosage form segment dominated the market in 2024, driven by initiatives to increase awareness and the bioavailability of oral antifungal drugs. However, oral drugs also come with higher risks compared to other forms[5].
  • Systemic and Superficial Infections: The market for systemic antifungal infections, such as candidiasis and aspergillosis, is expected to grow due to the rising number of immunocompromised patients and hospital-acquired infections[5].

Challenges and Opportunities

  • Resistance and Toxicity: One of the major challenges is the increasing resistance of fungal pathogens to existing antifungal agents. New formulations like oral lipid nanocrystal amphotericin B, which show less toxicity and similar efficacy to traditional IV formulations, offer promising solutions[4].
  • Clinical Trials and R&D: The global clinical trials market, valued at $48.2 billion in 2023, is expected to reach $73.2 billion by 2028. This growth is driven by increasing pharmaceutical R&D investments and a burgeoning pipeline of drug candidates, including antifungal agents[3].

Key Takeaways

  • Fosravuconazole Efficacy: Fosravuconazole has shown promising results in treating mycetoma, offering better patient adherence and convenience compared to itraconazole.
  • Market Growth: The global antifungal drugs market is expected to reach USD 24.51 billion by 2034, driven by increasing fungal infections and advancements in treatment options.
  • Regional Dynamics: North America currently dominates the market, but Asia-Pacific is expected to show the fastest growth due to improving healthcare infrastructure and awareness.
  • Drug Classes and Indications: Echinocandins and azoles are key drug classes, with candidiasis and aspergillosis being significant indications driving market growth.

FAQs

What is fosravuconazole, and how does it compare to itraconazole in treating mycetoma?

Fosravuconazole is a new oral antifungal treatment that has shown similar efficacy to itraconazole in treating mycetoma. However, it offers a significant advantage in terms of patient adherence and convenience due to its lower pill burden.

What are the key drivers of the global antifungal drugs market?

The key drivers include the increasing incidence of fungal infections, advancements in innovative products, and growing awareness and healthcare infrastructure.

Which region is expected to show the fastest growth in the antifungal drugs market?

Asia-Pacific is projected to register the fastest growth due to improving healthcare facilities and rising government initiatives to create awareness about infectious diseases.

What are the primary drug classes in the antifungal market?

The primary drug classes include azoles, echinocandins, polyenes, and allyamines, with echinocandins exhibiting lucrative growth due to their broad-spectrum activity.

What are the challenges faced by the antifungal drugs market?

One of the major challenges is the increasing resistance of fungal pathogens to existing antifungal agents, along with the toxicity associated with some treatments.

Sources

  1. DNDi Press Release: "World's first clinical trial for devastating fungal disease mycetoma shows efficacy of new promising treatment."
  2. Business Wire: "Global Antifungal Drugs Market 2018-2025: Size, Share & Trends Analysis."
  3. MarketsandMarkets: "Clinical Trials Market Size, Share, Trends and Revenue Forecast."
  4. PubMed: "Oral Lipid Nanocrystal Amphotericin B for Cryptococcal Meningitis."
  5. Precedence Research: "Antifungal Drugs Market Size to Reach USD 24.51 Bn by 2034."
Last updated: 2025-01-02

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