Griseofulvin
Fulvicin P/g, Fulvicin-u/f, Grifulvin, Gris-peg, Grisactin, Griseofulvin, Microsize, Ultragris, Ultramicrosize (griseofulvin) is a small molecule pharmaceutical. Griseofulvin was first approved as Grifulvin v on 1982-01-01. It is used to treat tinea capitis and tinea pedis in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Gris-peg (generic drugs available since 1982-01-01, discontinued: Grifulvin, Grisactin, Grisactin ultra, Ultragris)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Griseofulvin
+
microcrystalline
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| GRIFULVIN V | Johnson & Johnson | N-050448 DISCN | 1982-01-01 | 1 products, RLD |
| GRISACTIN | Wyeth | N-050051 DISCN | 1982-01-01 | 2 products |
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Griseofulvin
+
ultramicrosize
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| GRIS-PEG | Bausch Health Companies | N-050475 RX | 1982-01-01 | 2 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| gris-peg | New Drug Application | 2010-06-01 |
| griseofulviin (microsize) | ANDA | 2012-09-26 |
| griseofulvin | ANDA | 2023-12-27 |
| griseofulvin microsize | ANDA | 2023-09-08 |
| ultramicrosize griseofulvin | ANDA | 2023-10-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| tinea pedis | EFO_0007512 | D014008 | B35.3 |
| tinea capitis | — | D014006 | B35.0 |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
7 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tinea | D014005 | EFO_0007510 | B35.9 | — | — | 2 | — | 1 | 3 |
| Tinea capitis | D014006 | — | B35.0 | — | — | 2 | — | 1 | 3 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | — | — | — | — | 1 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 1 | — | — | — | — | 1 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Griseofulvin |
| INN | griseofulvin |
| Description | Griseofulvin is an oxaspiro compound produced by Penicillium griseofulvum. It is used by mouth as an antifungal drug for infections involving the scalp, hair, nails and skin that do not respond to topical treatment. It has a role as an antibacterial agent and a Penicillium metabolite. It is an organochlorine compound, a member of 1-benzofurans, an oxaspiro compound, an antibiotic antifungal drug and a benzofuran antifungal drug. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COC1=CC(=O)C[C@@H](C)[C@]12Oc1c(Cl)c(OC)cc(OC)c1C2=O |
Identifiers
| PDB | — |
| CAS-ID | 126-07-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL562 |
| ChEBI ID | 27779 |
| PubChem CID | 441140 |
| DrugBank | DB00400 |
| UNII ID | 32HRV3E3D5 (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Estimated US medical usage
Griseofulvin
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,474 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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240 adverse events reported
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