Nystatin

Summary

Nystatin (CHEMBL5465559) is an approved unknown (ATC D01AA01); indicated across 22 conditions including candidiasis and hiv infectious disease.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Unknown
• ATC class: D01AA01 (+3 more)
• Indications: 22 conditions
• Clinical trials: 30

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL5465559
Name	Nystatin
Type	Unknown
Max phase	4
ATC	D01AA01, G01AA01, A07AA02, G01AA51

Also known as: Barstatin 100, Candex, Infestat, Korostatin, L-nystatin, Mikostatin, Multilind, Mycostatin, Mykinac, Nilstat, Nistatina, NSC-150817

Targets

Targets

Broader ChEMBL bioactivity targets: 2 (assay-derived). Sample: Prostaglandin G/H synthase 1, Bile salt export pump.

Bioactivity

ChEMBL activities: 4 potent at pChembl ≥ 5 of 5 total. Top 100 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
PTGS1	5.79	AC50	1630	nM	CHEMBL_ACT_25204945
PTGS1	5.48	AC50	3280	nM	CHEMBL_ACT_25204944
PTGS1	5.37	AC50	4310	nM	CHEMBL_ACT_25205878
PTGS1	5.14	AC50	7200	nM	CHEMBL_ACT_25205877

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

1 approved indication. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
candidiasis	4	MONDO:0002026	MONDO:0002026

18 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
HIV infectious disease	3	MONDO:0005109	EFO:0000180
myelodysplastic syndrome	3	MONDO:0018881	EFO:0000198
leukemia	3	MONDO:0005059	EFO:0000565
plasma cell myeloma	3	MONDO:0009693	EFO:0001378
bacterial vaginosis	3	MONDO:0005316	EFO:0003932
oral candidiasis	3	MONDO:0005886	EFO:0007406
stomatitis	3	MONDO:0004842	EFO:0009688
myeloproliferative neoplasm	3	MONDO:0020076	EFO:0002428
nicotine dependence	3	MONDO:0008575	EFO:0003768
lymphoma	3	MONDO:0005062	EFO:0000574
bacterial infectious disease with sepsis	2	MONDO:0005229	EFO:0003033
pneumonia	2	MONDO:0005249	EFO:0003106
burn	2	MONDO:0043519	EFO:0009516
denture stomatitis	2	MONDO:0006723	EFO:1000893
graft versus host disease	2	MONDO:0013730	MONDO:0013730
kidney disorder	1	MONDO:0005240	EFO:0003086
dental caries	1	MONDO:0005276	EFO:0003819
age-related macular degeneration	1	MONDO:0005150	EFO:0001365

3 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 30.

Phase distribution

Phase	Trials
PHASE4	8
Not specified	6
PHASE3	5
PHASE1	5
PHASE2	4
PHASE2/PHASE3	1
PHASE1/PHASE2	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00629122	PHASE4	COMPLETED	Pharmacokinetics of Sublingual Versus Oral Tacrolimus in Patients Awaiting Kidney Transplantation
NCT01411748	PHASE4	UNKNOWN	Comparison of Saccharomyces Boulardii and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants
NCT01495039	PHASE4	COMPLETED	Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients
NCT01531192	PHASE4	COMPLETED	Comparison of Lactobacillus Reuteri and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants
NCT02444481	PHASE4	COMPLETED	Open Study of the Efficacy of the Local Treatment With Polygynax of Bacterial and/or Mycotic Vaginitis
NCT02642900	PHASE4	COMPLETED	Photodynamic Therapy Against Candida Spp. in Complete Denture Wearers
NCT02662374	PHASE4	UNKNOWN	Oral Hygiene Regimen in Patients on HCT
NCT03390374	PHASE4	COMPLETED	Oral Nystatin Prophylaxis to Prevent Systemic Fungal Infection in Very Low Birth Weight Preterm Infants
NCT00001812	PHASE3	COMPLETED	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
NCT00002742	PHASE3	COMPLETED	Antifungal Therapy for Fever and Neutropenia in Patients Receiving Treatment for Hematologic Cancer
NCT00128323	PHASE3	COMPLETED	A Comparison of Gentian Violet (GV) Mouth Washes, Nystatin, and Ketoconazole Tabs in Treating Oropharyngeal Candidiasis
NCT00674999	PHASE2/PHASE3	WITHDRAWN	Use of Amnion on Partial Thickness Burns
NCT01427738	PHASE3	COMPLETED	Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis
NCT04837664	PHASE3	UNKNOWN	Curcumin; Rose Bengal; Denture Stomatitis
NCT00078559	PHASE1/PHASE2	COMPLETED	Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults
NCT00942526	PHASE2	UNKNOWN	Oral Anti-Infective Agent for Esophageal Anastomotic Leakage
NCT01198223	PHASE2	COMPLETED	Effect of Aqueous Extract of Garlic and Nystatin Mouthwash in Denture Stomatitis
NCT03862079	PHASE2	WITHDRAWN	Fecal Transplant +/- Gut Decontamination in Preventing Acute Graft Versus Host Disease in Patients Given Broad-Spectrum Antibiotics
NCT04532060	PHASE2	COMPLETED	Clinical Trial Evaluating Chlorine e6 Derivative-mediated Antimicrobial Photodynamic Therapy as a Treatment for Denture Stomatitis
NCT03178149	PHASE1	RECRUITING	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
NCT06616168	PHASE1	ACTIVE_NOT_RECRUITING	Urogenital Infections in Women of Reproductive Age and the Activity of 4-Thiazolidinone Derivatives Against Pathogens
NCT00002097	PHASE1	COMPLETED	A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.
NCT00002313	PHASE1	COMPLETED	A Study of Nystatin in HIV-Infected Patients
NCT04550546	PHASE1	COMPLETED	Effects of Nystatin Suspension Oral Application on Oral Microbial Community
NCT00001998	Not specified	COMPLETED	Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)
NCT00002057	Not specified	COMPLETED	Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
NCT00002112	Not specified	COMPLETED	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
NCT00002293	Not specified	COMPLETED	A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients With AIDS or AIDS-Related Syndromes
NCT01743690	Not specified	COMPLETED	The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus
NCT02166450	Not specified	UNKNOWN	Effects of Denture-Related Stomatitis on Blood Pressure in Denture Wearers

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).