Nystatin
Nystaform, Nystatin, Nystop (nystatin) is a small molecule pharmaceutical. Nystatin was first approved as Nystaform on 1982-01-01. It is used to treat chronic mucocutaneous candidiasis, cutaneous candidiasis, mycoses, oral candidiasis, and vulvovaginal candidiasis in the USA.
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Commercial
Trade Name
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EMA
Nystatin, Nystop (discontinued: Candex, Mycostatin, Mykinac, Nilstat, Nysert, Nystatin, Nystex)
CombinationsNystatin triamcinolone (discontinued: Myco-triacet, Mycolog-ii, Mykacet, Mytrex f, Nystaform, Nystatin triamcinolone, Nystatin-triamcinolone)
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Abbreviated New Drug Application (ANDA)
Nystatin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CANDEX | Bayer | N-050233 DISCN | 1982-01-01 | 1 products |
| NILSTAT | Chartwell Pharmaceuticals | N-050299 DISCN | 1982-01-01 | 1 products, RLD |
| MYCOSTATIN | Delcor Asset | N-050619 DISCN | 1987-04-09 | 1 products |
| NILSTAT | Strides Pharma Global | N-050576 DISCN | 1983-12-22 | 1 products, RLD |
| NYSERT | Warner Chilcott | N-050478 DISCN | 1982-01-01 | 1 products |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| klayesta | ANDA | 2024-12-19 |
| mycostatin | ANDA | 2025-01-22 |
| nyamyc | ANDA | 2025-07-09 |
| nystatin | ANDA | 2025-07-03 |
| nystatin and triamcinolone | ANDA | 2011-05-10 |
| nystatin and triamcinolone acetonide | ANDA | 2025-07-07 |
| nystatin cream | ANDA | 2023-10-24 |
| nystatin topical powder | ANDA | 2023-08-10 |
| nystop | ANDA | 2025-04-02 |
| triple antibiotic | OTC monograph final | 2017-05-05 |
Indications
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Agency Specific
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ATC Codes
A: Alimentary tract and metabolism drugs
— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
— A07A: Intestinal antiinfectives
— A07AA: Antibiotics, intestinal
— A07AA02: Nystatin
D: Dermatologicals
— D01: Antifungals for dermatological use
— D01A: Antifungals for topical use
— D01AA: Antifungal antibiotics, topical
— D01AA01: Nystatin
G: Genito urinary system and sex hormones
— G01: Gynecological antiinfectives and antiseptics
— G01A: Antiinfectives and antiseptics, excl. combinations with corticosteroids
— G01AA: Antibiotics, gynecological
— G01AA01: Nystatin
— G01AA51: Nystatin, combinations
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Clinical
Clinical Trials
62 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stomatitis | D013280 | EFO_1001904 | K12.1 | 3 | 4 | 2 | 1 | 5 | 14 |
| Candidiasis | D002177 | — | B37 | — | 1 | 4 | 1 | 4 | 10 |
| Mucositis | D052016 | EFO_1001898 | — | 2 | 2 | 1 | 1 | 4 | 9 |
| Infections | D007239 | EFO_0000544 | — | 2 | — | 3 | 1 | 2 | 8 |
| Communicable diseases | D003141 | — | — | 1 | — | 2 | 1 | — | 4 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | 1 | 1 | 1 | 3 |
| Vaginitis | D014627 | EFO_0005757 | N76 | — | — | 2 | 1 | — | 3 |
| Birth weight | D001724 | EFO_0004344 | — | — | — | — | 3 | — | 3 |
| Critical illness | D016638 | — | — | — | — | 1 | 1 | — | 2 |
| Burns | D002056 | — | T30.0 | — | 1 | 1 | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | — | 1 | — | 4 | 7 |
| Oral candidiasis | D002180 | EFO_0007406 | B37.0 | — | 1 | 2 | — | 3 | 6 |
| Head and neck neoplasms | D006258 | — | — | 2 | 1 | 1 | — | 1 | 4 |
| Oral lichen planus | D017676 | — | — | 1 | 1 | 1 | — | 2 | 4 |
| Lichen planus | D008010 | — | L43 | 1 | 1 | 1 | — | 2 | 4 |
| Denture stomatitis | D013282 | EFO_1000893 | K12.1 | — | 2 | 1 | — | 1 | 4 |
| Bacterial vaginosis | D016585 | EFO_0003932 | — | 1 | — | 2 | — | — | 3 |
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | 1 | 2 | — | — | 2 |
| Bacteremia | D016470 | EFO_0003033 | R78.81 | — | 1 | 2 | — | — | 2 |
| Graft vs host disease | D006086 | — | D89.81 | — | 1 | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 1 | — | — | — | 1 |
| Kidney transplantation | D016030 | — | — | 1 | 1 | — | — | — | 1 |
| Wounds and injuries | D014947 | — | T14.8 | 1 | 1 | — | — | — | 1 |
| Cross infection | D003428 | — | — | — | 1 | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | — | 1 | — | — | — | 1 |
| Anastomotic leak | D057868 | — | — | — | 1 | — | — | — | 1 |
| Hiv seropositivity | D006679 | — | — | — | 1 | — | — | — | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | 1 | — | — | — | 1 |
| Non-muscle invasive bladder neoplasms | D000093284 | — | — | 1 | 1 | — | — | — | 1 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | 1 | — | — | — | 1 |
Show 1 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 2 | — | — | — | 2 | 4 |
| Recurrence | D012008 | — | — | 1 | — | — | — | — | 1 |
| Aphthous stomatitis | D013281 | EFO_0003938 | K12.0 | 1 | — | — | — | — | 1 |
| Otomycosis | D059249 | — | — | 1 | — | — | — | — | 1 |
| Dental caries | D003731 | EFO_0003819 | K02 | 1 | — | — | — | — | 1 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | 1 | — | — | — | — | 1 |
| Geographic atrophy | D057092 | — | — | 1 | — | — | — | — | 1 |
| Atrophy | D001284 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Immunologic deficiency syndromes | D007153 | — | D84.9 | — | — | — | — | 2 | 2 |
| Death | D003643 | PATO_0001422 | — | — | — | — | — | 1 | 1 |
| Conization | D019092 | — | — | — | — | — | — | 1 | 1 |
| Low-level light therapy | D028022 | — | — | — | — | — | — | 1 | 1 |
| Periodontal diseases | D010510 | — | K05.6 | — | — | — | — | 1 | 1 |
| Neoplasms | D009369 | — | C80 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Nystatin |
| INN | nystatin |
| Description | Nystatin, sold under the brand name Mycostatin among others, is an antifungal medication. It is used to treat Candida infections of the skin including diaper rash, thrush, esophageal candidiasis, and vaginal yeast infections. It may also be used to prevent candidiasis in those who are at high risk. Nystatin may be used by mouth, in the vagina, or applied to the skin.
|
| Classification | Small molecule |
| Drug class | enzyme inhibitors: antihyperlipidemics (HMG-CoA inhibitors) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@@H]1OC(=O)C[C@H](O)C[C@H](O)C[C@H](O)CC[C@@H](O)[C@H](O)C[C@]2(O)C[C@H](O)[C@@H](C(=O)O)[C@H](C[C@@H](O[C@@H]3O[C@H](C)[C@@H](O)[C@H](N)[C@@H]3O)/C=C/C=C/C=C/C=C/CC/C=C/C=C/[C@H](C)[C@@H](O)[C@H]1C)O2 |
Identifiers
| PDB | — |
| CAS-ID | 1400-61-9 |
| RxCUI | 7597 |
| ChEMBL ID | CHEMBL450895 |
| ChEBI ID | — |
| PubChem CID | 14960 |
| DrugBank | DB00646 |
| UNII ID | BDF1O1C72E (ChemIDplus, GSRS) |
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Nystatin
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Diphenhydramine
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Nystatin
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Nystatin
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Triamcinolone
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Safety
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2,778 adverse events reported
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