Nystatin
Barstatin, Candex, Korostatin, Myco-triacet, Mycolog-ii, Mycostatin, Mykinac, Mytrex F, Nilstat, Nysert, Nystaform, Nystex (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
Therapeutic Areas
Therapeutic Area | MeSH |
---|---|
infections | D007239 |
stomatognathic diseases | D009057 |
urogenital diseases | D000091642 |
skin and connective tissue diseases | D017437 |
signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Clioquinol
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Nystatin
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
NYSTAFORM | Bayer | N-050235 DISCN | 1982-01-01 | 1 products |
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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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Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
mycostatin | ANDA | 2023-01-05 |
nystatin | ANDA | 2023-06-07 |
nystop | ANDA | 2022-02-09 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
chronic mucocutaneous candidiasis | Orphanet_1334 | D002178 | B37.2 |
cutaneous candidiasis | — | D002179 | — |
mycoses | — | D009181 | B35-B49 |
oral candidiasis | EFO_0007406 | D002180 | B37.0 |
vulvovaginal candidiasis | EFO_0007543 | D002181 | B37.3 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
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
HCPCS
No data
Clinical
Clinical Trials
106 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Endometriosis | D004715 | EFO_0001065 | N80 | — | 3 | 9 | 1 | 2 | 15 |
Healthy volunteers/patients | — | 14 | — | — | 1 | — | 15 | ||
Leiomyoma | D007889 | HP_0000131 | D25 | — | 2 | 7 | 1 | — | 10 |
Menorrhagia | D008595 | N92.0 | — | — | 6 | 2 | 1 | 9 | |
Contraception | D003267 | — | 1 | 3 | 2 | — | 6 | ||
Menopause | D008593 | EFO_0003922 | N95 | 2 | — | 1 | 2 | 1 | 6 |
Pelvic pain | D017699 | — | — | 2 | 2 | 1 | 5 | ||
Metrorrhagia | D008796 | HP_0100608 | N92.1 | — | — | 1 | 3 | — | 4 |
Dysmenorrhea | D004412 | HP_0100607 | N94.6 | — | — | 3 | 1 | — | 4 |
Hiv | D006678 | O98.7 | — | — | — | 1 | 1 | 2 |
Show 8 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | 1 | — | 1 | — | 1 | 3 |
Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | — | 1 | — | — | 2 |
Contraception behavior | D003268 | — | — | 1 | — | 1 | 2 | ||
Lymphoma | D008223 | C85.9 | — | 1 | 1 | — | — | 1 | |
Fertility preservation | D059247 | — | 1 | 1 | — | — | 1 | ||
Ovulation | D010060 | — | — | 1 | — | — | 1 | ||
Postmenopause | D017698 | — | — | 1 | — | — | 1 | ||
Hot flashes | D019584 | — | — | 1 | — | — | 1 | ||
Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | — | — | 1 |
Dyspareunia | D004414 | HP_0030016 | N94.1 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Endometrial hyperplasia | D004714 | N85.0 | — | 2 | — | — | 1 | 3 | |
Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | 1 | — | — | 1 | 2 |
Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | — | 1 |
Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | — | — | — | 1 | |
Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | 1 | — | — | — | 1 |
Hyperandrogenism | D017588 | — | 1 | — | — | — | 1 | ||
Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | 1 | — | — | — | 1 | |
Chronic progressive multiple sclerosis | D020528 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Neoplasms | D009369 | C80 | 2 | — | — | — | — | 2 | |
Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 2 | — | — | — | — | 2 |
Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 | ||
Biological availability | D001682 | 1 | — | — | — | — | 1 | ||
Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | 1 | — | — | — | — | 1 |
Psoriasis | D011565 | EFO_0000676 | L40 | 1 | — | — | — | — | 1 |
Inflammatory bowel diseases | D015212 | EFO_0003767 | 1 | — | — | — | — | 1 | |
Infections | D007239 | EFO_0000544 | 1 | — | — | — | — | 1 | |
Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | — | — | — | — | 1 |
Hepatitis c | D006526 | B19.2 | 1 | — | — | — | — | 1 |
Show 2 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | — | — | 1 | 1 |
Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | — | — | — | 1 | 1 |
Headache | D006261 | HP_0002315 | R51 | — | — | — | — | 1 | 1 |
Appetitive behavior | D001070 | — | — | — | — | 1 | 1 | ||
Pregnancy rate | D018873 | — | — | — | — | 1 | 1 | ||
Pregnancy complications | D011248 | — | — | — | — | 1 | 1 | ||
High-risk pregnancy | D018566 | — | — | — | — | 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 brandname 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) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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14,034 adverse events reported
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