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Last Updated: January 17, 2025

CLINICAL TRIALS PROFILE FOR MYCOSTATIN


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All Clinical Trials for Mycostatin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00942526 ↗ Oral Anti-Infective Agent for Esophageal Anastomotic Leakage Unknown status National Taiwan University Hospital Phase 2 2009-06-01 Anastomotic leakage is still to be a major cause of considerable morbidity and mortality after esophagectomy and gastric pull up for esophageal carcinoma. Risk factor analyses of anastomotic leakage, including blood supply, graft tension, and comorbidity, have been performed, but few studies have produced strategies that have improved operative results. This study will be performed to identify prognostic variables that might be used to develop a strategy for optimizing outcomes after esophagogastrectomy.
NCT01495039 ↗ Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients Completed Policlinico Hospital Phase 4 2008-11-01 Purpose. Oral chemoprophylaxis has been advocated to reduce the incidence of Candida colonization and infection. However, Candida prophylaxis in intensive care unit (ICU) is still a matter of debate. Methods. Randomized, single-center trial studying single drug (nystatin) versus control in surgical ICU patients. Multiple-site testing for fungi were performed in each patient at ICU admission (T0) and subsequently every 3 days (T3, T6, T9…). The primary evaluation criterion was the time course of colonization index (CI) during ICU stay.
NCT02166450 ↗ Effects of Denture-Related Stomatitis on Blood Pressure in Denture Wearers Unknown status Jagiellonian University 2011-10-01 The aim of this study is to evaluate the influence of presence of oral fungal infection, which leads to denture-related stomatitis, on blood pressure, endothelial function and immune cell phenotype in patients wearing dentures.
NCT03390374 ↗ Oral Nystatin Prophylaxis to Prevent Systemic Fungal Infection in Very Low Birth Weight Preterm Infants Completed Dr Cipto Mangunkusumo General Hospital Phase 4 2010-10-01 This study determines the effectiveness of oral nystatin as prophylaxis in order to prevent systemic fungal infection in very low birth weight preterm neonates. 47 participants received oral nystatin and 48 participants received sterile water as part of oral hygiene.
NCT03862079 ↗ Fecal Transplant +/- Gut Decontamination in Preventing Acute Graft Versus Host Disease in Patients Given Broad-Spectrum Antibiotics Withdrawn National Cancer Institute (NCI) Phase 2 2020-06-01 This phase II trial studies how well a fecal microbiota transplant with or without total gut decontamination works in preventing graft versus host disease in patients exposed to broad-spectrum antibiotics. Fecal microbiota transplantation is the administration by enema of fecal matter (stool) that includes helpful bacteria from a normal, healthy donor. Total gut decontamination uses antibiotics to remove/reduce the amount of bacteria in the digestive system. It is not yet known if a fecal microbiota transplant with or without total gut decontamination works better in preventing graft versus host disease compared to standard immunosuppressive therapies (therapies that lower the normal function of the immune system).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Mycostatin

Condition Name

Condition Name for Mycostatin
Intervention Trials
Denture Stomatitis 1
Fungal Infections Systemic 1
Fungal Prophylaxis 1
Graft-versus-host Disease Prevention 1
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Condition MeSH

Condition MeSH for Mycostatin
Intervention Trials
Mycoses 1
Critical Illness 1
Infections 1
Candidiasis 1
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Clinical Trial Locations for Mycostatin

Trials by Country

Trials by Country for Mycostatin
Location Trials
United States 2
Italy 1
Taiwan 1
Poland 1
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Trials by US State

Trials by US State for Mycostatin
Location Trials
New York 1
Texas 1
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Clinical Trial Progress for Mycostatin

Clinical Trial Phase

Clinical Trial Phase for Mycostatin
Clinical Trial Phase Trials
Phase 4 2
Phase 2 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Mycostatin
Clinical Trial Phase Trials
Unknown status 2
Completed 2
Withdrawn 1
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Clinical Trial Sponsors for Mycostatin

Sponsor Name

Sponsor Name for Mycostatin
Sponsor Trials
National Taiwan University Hospital 1
Policlinico Hospital 1
Jagiellonian University 1
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Sponsor Type

Sponsor Type for Mycostatin
Sponsor Trials
Other 6
NIH 1
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Mycostatin (Nystatin): Clinical Trials, Market Analysis, and Projections

Overview of Mycostatin (Nystatin)

Mycostatin, commonly known by its active ingredient nystatin, is an antifungal medication used to treat various fungal infections, particularly those caused by Candida species. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials

Current Status and Phases

Nystatin has been extensively studied in various clinical trials across different phases. Here are some key points:

  • Phase 0 to Phase 4 Trials: Nystatin has undergone multiple clinical trials, with several studies in each phase. As of the latest data, there are 1 Phase 0, 6 Phase 1, 8 Phase 2, 13 Phase 3, and 8 Phase 4 trials[4].
  • Indications: These trials cover a range of indications, including the treatment and prophylaxis of oral candidiasis, intestinal candidiasis, anal candidiasis, and cutaneous candidiasis[4].

Efficacy and Safety

Clinical trials have consistently shown that nystatin is effective against a wide variety of yeasts and yeast-like fungi, including Candida albicans. The drug acts by binding to sterols in the cell membrane of susceptible species, leading to a change in membrane permeability and the subsequent leakage of intracellular components[1].

Resistance and Cross-Resistance

While nystatin generally does not lead to resistance during therapy, some species of Candida (e.g., C. tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) can develop resistance. However, this resistance is lost when the antibiotic is removed, and these species also become cross-resistant to amphotericin B[1].

Market Analysis

Global Market Size and Growth

The global nystatin market is part of the broader antifungal drugs market, which was valued at USD 17.39 billion in 2024 and is expected to grow to USD 24.51 billion by 2034, with a Compound Annual Growth Rate (CAGR) of 3.49% from 2025 to 2034[2].

Regional Segmentation

  • North America: Currently the dominant region due to its well-established healthcare system and high awareness of fungal infections[3].
  • Asia-Pacific: Expected to grow at the fastest rate due to improving healthcare access and a higher prevalence of diabetes, which increases the risk of fungal diseases[3].

Market Drivers

  • Increasing Fungal Infections: The rise in chronic conditions such as diabetes, cancer, and HIV/AIDS has led to an increase in fungal infections, driving the demand for antifungal treatments like nystatin[4].
  • Advancements in Diagnostics and Healthcare Infrastructure: Improved diagnostics and healthcare infrastructure support early detection and treatment of fungal infections, further boosting the market[4].
  • Antibiotic Resistance: The growing issue of antibiotic resistance has shifted focus towards antifungal treatments, contributing to the market's growth[4].

Market Restraints and Challenges

  • Competition from Other Antifungal Drugs: The market is competitive, with other classes like Azoles, Polyenes, and Echinocandins also vying for market share. For example, the Azoles segment is expected to reach $10.7 billion by 2030, growing at a CAGR of 4.5%[2].
  • Regulatory Hurdles: Strict regulatory requirements and the need for continuous innovation can pose challenges for manufacturers[2].

Market Projections

Financial Performance

The financial performance of the nystatin market is closely tied to the broader antifungal drugs market. Here are some key projections:

  • Market Size: The global antifungal drugs market is expected to reach USD 24.51 billion by 2034[2].
  • Growth Rate: The nystatin market is expected to grow at a notable CAGR from 2024 to 2031, although the exact rate is not specified[3].

Regional Growth

  • North America: Will continue to be a significant market due to its established healthcare infrastructure and high awareness of fungal infections.
  • Asia-Pacific: Expected to grow rapidly due to increasing healthcare access and a higher prevalence of diabetes and other chronic conditions that predispose individuals to fungal infections[3].

Product Development and Innovation

The market for nystatin is also driven by innovations in product formulations, such as extended-release tablets, orally disintegrating tablets, and standard tablets. These advancements aim to improve patient compliance and treatment outcomes[5].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the nystatin market. While there were initial disruptions in supply chains and manufacturing, the increased focus on healthcare and the rise in fungal infections among immunocompromised patients ultimately drove demand for antifungal treatments like nystatin[3].

Key Takeaways

  • Growing Demand: The nystatin market is driven by increasing fungal infections and advancements in healthcare.
  • Regional Growth: North America leads the market, but the Asia-Pacific region is expected to grow the fastest.
  • Competitive Market: The market is competitive with several key players and other antifungal drug classes.
  • Financial Projections: The broader antifungal market is projected to grow significantly, indicating a positive financial trajectory for nystatin.

FAQs

1. What is the current market size of the global nystatin market?

The exact current market size of the global nystatin market is not specified, but it is part of a larger antifungal market valued at $17.39 billion in 2024[2].

2. What is the projected growth rate of the nystatin market?

The nystatin market is expected to grow at a notable CAGR from 2024 to 2031, though the exact rate is not provided[3].

3. Which regions are leading the nystatin market?

North America currently leads the market, but the Asia-Pacific region is expected to grow at the fastest rate due to improving healthcare access and a higher prevalence of diabetes[3].

4. What are the main drivers of the nystatin market?

The main drivers include increasing fungal infections, advancements in diagnostics and healthcare infrastructure, and the growing issue of antibiotic resistance[4].

5. Who are the key players in the nystatin market?

While specific key players are not listed here, the market is competitive with several major pharmaceutical companies involved in the production and distribution of nystatin and other antifungal drugs[2].

Sources

  1. RxList: Mycostatin (Nystatin): Side Effects, Uses, Dosage[1].
  2. Precedence Research: Antifungal Drugs Market Size to Reach USD 24.51 Bn by 2034[2].
  3. DrugPatentWatch: Nystatin - Generic Drug Details[3].
  4. DrugBank: Nystatin: Uses, Interactions, Mechanism of Action[4].
  5. 360 Research Reports: Nystatin Tablets Market Size & Share 2025-2030[5].

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