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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 20 indications[4].[1]

Mycostatin is one of 458 small molecule programs targeting HIV infection. It is currently in Approved.

20

Indications

23

Total Trials

1

Active Trials

457

Competitors

5

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

HIV InfectionActive, not recruiting

NeutropeniaActive, not recruiting

Nicotine DependenceApproved

Denture StomatitisActive, not recruiting

Oral Lichen PlanusActive, not recruiting

HIV-1 InfectionApproved

Bacterial VaginosisApproved

CandidiasisActive, not recruiting

Dental CariesApproved

Kidney TransplantActive, not recruiting

HIV InfectionPhase 1

Active, not recruiting

NeutropeniaPhase 3

Active, not recruiting

Nicotine DependenceApproved

Approved

Denture StomatitisPhase 3

Active, not recruiting

Oral Lichen PlanusPreclinical

Active, not recruiting

HIV-1 InfectionApproved

Approved

Bacterial VaginosisApproved

Approved

CandidiasisPhase 3

Active, not recruiting

Dental CariesApproved

Approved

Kidney TransplantApproved

Active, not recruiting

Showing 10 of 20 indications

Competition

Competitive Landscape

476 competitors in Kidney Transplant

#DrugCompanyPhaseTrials

Mycostatin

GGood Molecules, LLC

Nulojix

Bristol-Myers Squibb

Simulect

Medrol

Zinbryta

Cysteine Hydrochloride

Sensipar

Epogen

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

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Jardiance

Boehringer Ingelheim

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

Clinical

Trials by Indication[1]

Denture Stomatitis2 trials

Curcumin; Rose Bengal; Denture Stomatitis

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

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

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

Kidney Transplant2 trials

Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults

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

Pharmacokinetics of Sublingual Versus Oral Tacrolimus in Patients Awaiting Kidney Transplantation

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

Fungal Infection2 trials

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

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

Completed·—·Phase 4·NCT03390374·95 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

13 more indications

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

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

Stomatitis1 trial

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

Unknown status·JJagiellonian University··NCT02166450·80 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

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

Age-Related Macular Degeneration1 trial

A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration

Recruiting· Astellas logo

Astellas·Phase 1·NCT03178149·42 enrolled

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

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

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

Intensive Care Unit1 trial

Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients

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

AIN1 trial

Photodynamic Therapy Against Candida Spp. in Complete Denture Wearers

Completed·UUniversity of Sao Paulo·Phase 4·NCT02642900·22 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 — 23 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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