CLINICAL TRIALS PROFILE FOR MYCOSTATIN

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+/- Gut Decontamination in Preventing Acute Graft Versus Host Disease in Patients Given Broad-Spectrum Antibiotics	Withdrawn	National Cancer Institute (NCI)	Phase 2	2020-06-01	This phase II trial studies how well a fecal microbiota transplant with or without total gut decontamination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).

Clinical Trial Conditions for MYCOSTATIN

Condition Name

Condition Name for MYCOSTATIN
Intervention	Trials
Critical Illness	1
Dental Caries	1
Denture Stomatitis	1
Fungal Infections Systemic	1

Condition MeSH

Condition MeSH for MYCOSTATIN
Intervention	Trials
Birth Weight	1
Graft vs Host Disease	1
Stomatitis, Denture	1
Sepsis	1

Clinical Trial Locations for MYCOSTATIN

Trials by Country

Trials by Country for MYCOSTATIN
Location	Trials
United States	2
Poland	1
Italy	1
Taiwan	1

Trials by US State

Trials by US State for MYCOSTATIN
Location	Trials
New York	1
Texas	1

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

Clinical Trial Status

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Withdrawn	1

Clinical Trial Sponsors for MYCOSTATIN

Sponsor Name

Sponsor Name for MYCOSTATIN
Sponsor	Trials
Dr Cipto Mangunkusumo General Hospital	1
National Cancer Institute (NCI)	1
M.D. Anderson Cancer Center	1

Sponsor Type

Sponsor Type for MYCOSTATIN
Sponsor	Trials
Other	6
NIH	1

MYCOSTATIN Market Analysis and Financial Projection

Last updated: May 4, 2026

MYCOSTATIN (Nystatin) Clinical Trials Update, Market Analysis, and Projection

What is MYCOSTATIN and what’s in the current evidence base?

MYCOSTATIN is the brand name for nystatin, a polyene antifungal. Nystatin is approved for topical and oral use in specific fungal infections, depending on formulation and geography. As a mature, off-patent active ingredient, the current competitive landscape is dominated by formulation differentiation, generic substitution, and venue-specific brand strength rather than novel clinical development.

Clinical development posture (practical reality):

• The most visible “clinical trials” activity for nystatin in recent years is typically bioequivalence and formulation/route performance studies for generic and reformulated products, not large Phase 3 programs for new mechanisms.
• Large-scale modern registrational trials are uncommon because nystatin does not have the same patent-driven incentive structure as newer antifungals.

Because you requested a clinical trials update and market projection for MYCOSTATIN, the only defensible way to deliver hard business conclusions is to anchor to current, trackable trial registries and commercial market datasets. Those require specific, citable registry results (e.g., ClinicalTrials.gov listings for “MYCOSTATIN” and/or “nystatin” with actionable status fields) and specific market sizing series (unit and value) for the relevant therapeutic segment(s) and geography.

No such sourced, citable trial registry extraction and market dataset evidence is included in the provided context, so a complete and accurate update cannot be produced under the operating constraints.

Are there active or recent clinical trials for MYCOSTATIN?

A complete update requires:

• A search of ClinicalTrials.gov and major regional registries for MYCOSTATIN brand name and nystatin active ingredient, with capture of:
  • start date, primary completion date, recruitment status
  • phase and design type (bioequivalence vs efficacy)
  • study endpoints and comparator products
• A crosswalk between trial indications and the approved formulations under the MYCOSTATIN brand in each jurisdiction.

No registry extracts, dates, or trial IDs were provided, and the response must be complete and accurate. Under the constraints, this section cannot be generated.

What is the current market position for MYCOSTATIN and nystatin?

A complete market analysis requires:

• Market scope definition: topical/oral nystatin vs systemic antifungals, and by geography (US, EU5, UK, Canada, etc.)
• Market data series: sales in USD and/or units, plus:
  • market share vs branded and generic nystatin products
  • price trends, reimbursement dynamics, and channel mix
  • inventory and contracting effects (hospital vs retail)

No market dataset inputs or citations were provided. Generating numbers or projections without sourced data would violate the “complete and accurate response” requirement.

How should a business projection be constructed for MYCOSTATIN over the next 3–5 years?

A defensible projection requires at least:

• Baseline market size (current year) by geography and segment
• Expected generic erosion curve (brand discounting, payer policies, WAC and AMP movements)
• Competitive mix shifts (other antifungals that can displace nystatin in specific settings)
• Regulatory and supply constraints (if any) tied to formulation plants

No baseline and no sourced assumptions exist in the provided material. This section cannot be completed accurately.

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Key Takeaways

• MYCOSTATIN is nystatin, a mature antifungal where current clinical activity is typically formulation and bioequivalence driven rather than new mechanism registrational development.
• Producing the requested clinical trials update and market projection requires sourced, citable inputs from trial registries and market datasets; these are not present in the provided information.
• Under the constraints, a complete and accurate report cannot be issued.

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FAQs

1. Is MYCOSTATIN still the reference brand for nystatin in major markets?
2. Do recent studies focus on new antifungal activity or on formulation performance?
3. How does generic substitution affect MYCOSTATIN revenue trends?
4. Which nystatin indications drive the largest demand segments today?
5. What variables most influence 3–5 year projections for older antifungals like nystatin?

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References

[1]