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Mycostatin

(Nystatin)

ApprovedSmall molecule

GGood Molecules, LLC

Nystatin is used to treat fungal infections, particularly yeast infections in the mouth, throat, and digestive system. It works by stopping the growth of fungus to help clear the infection.[2] Mycostatin is currently approved and in use across 16 indications[4].[1]

Mycostatin is one of 310 small molecule programs targeting HIV-1 infection. It is currently in Approved.

16

Indications

24

Total Trials

1

Active Trials

309

Competitors

5

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

HIV-1 InfectionApproved

Nicotine DependenceApproved

Dental CariesApproved

Bacterial VaginosisApproved

Oral MucositisApproved

Periodontal DisorderActive, not recruiting

Fungal Infectious DiseaseActive, not recruiting

BurnApproved

Oral CandidiasisApproved

Graft Versus Host DiseaseApproved

HIV-1 InfectionApproved

Approved

Nicotine DependenceApproved

Approved

Dental CariesApproved

Approved

Bacterial VaginosisApproved

Approved

Oral MucositisApproved

Approved

Periodontal DisorderPreclinical

Active, not recruiting

Fungal Infectious DiseaseApproved

Active, not recruiting

BurnApproved

Approved

Oral CandidiasisApproved

Approved

Graft Versus Host DiseaseApproved

Approved

Showing 10 of 16 indications

Competition

Competitive Landscape

121 competitors in Kidney Transplant

#DrugCompanyPhaseTrials

Mycostatin

GGood Molecules, LLC

Prevymis

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Felzartamab

Biological/vaccine

Vertex Pharmaceuticals

Envarsus XR

UUniversity of Wisconsin, Madison

Zemplar

Radicava

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Sensipar

Cysteine Hydrochloride

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 1Recruiting

Age-Related Macular Degeneration

NCT03178149

Clinical

Trials by Indication[1]

Denture Stomatitis3 trials

Clinical Trial Evaluating Chlorine e6 Derivative-mediated Antimicrobial Photodynamic Therapy as a Treatment for Denture Stomatitis

Completed·SSão Paulo State University·Phase 2·NCT04532060·65 enrolled

Curcumin; Rose Bengal; Denture Stomatitis

Unknown status·KKing Saud University·Phase 3·NCT04837664·45 enrolled

Antifungal Effect of Chitosan Nanoparticles Paste Against Oral Candidosis

Completed·KKerman University of Medical Sciences·Phase 2·NCT07793331·30 enrolled

Candidiasis2 trials

A Comparison of Gentian Violet (GV) Mouth Washes, Nystatin, and Ketoconazole Tabs in Treating Oropharyngeal Candidiasis

Completed·KKamuzu University of Health Sciences·Phase 3·NCT00128323·558 enrolled

Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 3·NCT01427738·221 enrolled

Kidney Transplant2 trials

Pharmacokinetics of Sublingual Versus Oral Tacrolimus in Patients Awaiting Kidney Transplantation

Completed·WWeill Medical College of Cornell University·Phase 4·NCT00629122·5 enrolled

Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults

Completed·UUniversity of Wisconsin, Madison·Phase 1/2·NCT00078559·10 enrolled

Fungal Infection2 trials

Oral Nystatin Prophylaxis to Prevent Systemic Fungal Infection in Very Low Birth Weight Preterm Infants

Completed·—·Phase 4·NCT03390374·95 enrolled

A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients With AIDS or AIDS-Related Syndromes

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00002293

Statin2 trials

Effects of Nystatin Suspension Oral Application on Oral Microbial Community

Completed·UUniversity of Rochester·Phase 1·NCT04550546·20 enrolled

A Study of Nystatin in HIV-Infected Patients

Completed·AArgus Pharmaceuticals·Phase 1·NCT00002313

13 more indications

Oral Lichen Planus1 trial

The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus

Completed·UUniversity of Copenhagen·N/A·NCT01743690·25 enrolled

Immunodeficiency1 trial

Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome

Completed· Pfizer logo

Pfizer·N/A·NCT00002112

AIN1 trial

Photodynamic Therapy Against Candida Spp. in Complete Denture Wearers

Completed·UUniversity of Sao Paulo·Phase 4·NCT02642900·22 enrolled

Oral Candidiasis1 trial

Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·N/A·NCT00002057

Neutropenia1 trial

Antifungal Therapy for Fever and Neutropenia in Patients Receiving Treatment for Hematologic Cancer

Completed·AAronex Pharmaceuticals·Phase 3·NCT00002742

HIV infection1 trial

A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.

Completed·AArgus Pharmaceuticals·Phase 1·NCT00002097

Stomatitis1 trial

Effects of Denture-Related Stomatitis on Blood Pressure in Denture Wearers

Unknown status·JJagiellonian University··NCT02166450·80 enrolled

Low Birth Weight1 trial

Comparison of Lactobacillus Reuteri and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants

Completed·ZZekai Tahir Burak Women's Health Research and Education Hospital·Phase 4·NCT01531192·300 enrolled

Immune Deficiency1 trial

Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)

Completed·AArgus Pharmaceuticals·N/A·NCT00001998

Acute Graft Versus Host Disease1 trial

Fecal Transplant +/- Gut Decontamination in Preventing Acute Graft Versus Host Disease in Patients Given Broad-Spectrum Antibiotics

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT03862079

Double-blind1 trial

A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Impact of Nystatin on the Development of Oral Irritation in Patients Receiving High Dose Intravenous Interleukin-2

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00001812·84 enrolled

Intensive Care Unit1 trial

Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients

Completed·PPoliclinico Hospital·Phase 4·NCT01495039·99 enrolled

Age-Related Macular Degeneration1 trial

A Phase 1b, Multicenter, Dose Escalation, Evaluation of Safety and Tolerability of ASP7317 for Geographic Atrophy Secondary to Age-related Macular Degeneration

Recruiting· Astellas logo

Astellas·Phase 1·NCT03178149·42 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

CANDEX

NDA NDA050233

Jan 1, 1982

NYSERT

NDA NDA050478

Jan 1, 1982

NILSTAT

NDA NDA050299

Dec 22, 1983

NILSTAT

NDA NDA050576

Apr 9, 1987

MYCOSTATIN

NDA NDA050619

Sources

References

[1]
ClinicalTrials.gov — 24 trial records for Nystatin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Mycostatin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Nystatin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Nystatin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA050619). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Good Molecules, LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: GGood Molecules, LLC

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