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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Trade Name
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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)
Drug Products
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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 | 2023-12-27 |
| mycostatin | ANDA | 2023-01-05 |
| nyamyc | ANDA | 2024-06-18 |
| nystatin | ANDA | 2024-11-06 |
| nystatin and triamcinolone | ANDA | 2011-05-10 |
| nystatin and triamcinolone acetonide | ANDA | 2024-11-06 |
| nystatin cream | ANDA | 2023-10-24 |
| nystatin oral suspension | ANDA | 2022-02-21 |
| nystatin topical powder | ANDA | 2023-08-10 |
| nystop | ANDA | 2024-03-22 |
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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
59 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 | 2 | 3 | 2 | 1 | 4 | 12 |
| Candidiasis | D002177 | — | B37 | — | 1 | 4 | 1 | 4 | 10 |
| Infections | D007239 | EFO_0000544 | — | 2 | — | 3 | 1 | 2 | 8 |
| Mucositis | D052016 | EFO_1001898 | — | 1 | 1 | 1 | 1 | 3 | 7 |
| Communicable diseases | D003141 | — | — | 1 | — | 2 | 1 | — | 4 |
| Sepsis | D018805 | HP_0100806 | 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 |
| 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 |
| Head and neck neoplasms | D006258 | — | — | 1 | — | 1 | — | 1 | 3 |
| 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 |
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 | HP_0011107 | 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 | HP_0002721 | 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 |
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.
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| 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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Nystatin
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Triamcinolone
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Safety
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2,402 adverse events reported
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