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Drug ReportsGriseofulvin
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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Financial
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Fulvicin p/g, Fulvicin-u/f, Gris-peg, Griseofulvin, Griseofulvin, ultramicrosize, Griseofulvin,ultramicrosize (discontinued: Grifulvin, Grisactin, Grisactin ultra)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Griseofulvin
+
ultramicrosize
Tradename
Company
Number
Date
Products
GRIS-PEGBausch Health CompaniesN-050475 RX1982-01-01
2 products, RLD
Griseofulvin
+
microcrystalline
Tradename
Company
Number
Date
Products
GRIFULVIN VJohnson & JohnsonN-050448 DISCN1982-01-01
1 products, RLD
GRISACTINWyethN-050051 DISCN1982-01-01
2 products
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Labels
FDA
EMA
Brand Name
Status
Last Update
gris-pegNew Drug Application2010-06-01
griseofulviin (microsize)ANDA2012-09-26
griseofulvinANDA2024-10-28
griseofulvin microsizeANDA2024-10-28
ultramicrosize griseofulvinANDA2023-10-05
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
D: Dermatologicals
— D01: Antifungals for dermatological use
— D01A: Antifungals for topical use
— D01AA: Antifungal antibiotics, topical
— D01AA08: Griseofulvin
— D01B: Antifungals for systemic use
— D01BA: Antifungals for systemic use
— D01BA01: Griseofulvin
HCPCS
No data
Clinical
Clinical Trials
7 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TineaD014005EFO_0007510B35.9——2—13
Tinea capitisD014006—B35.0——2—13
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
MalnutritionD044342EFO_0008572E40-E461————1
Diabetes mellitusD003920HP_0000819E08-E131————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGriseofulvin
INNgriseofulvin
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—
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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-ID126-07-8
RxCUI—
ChEMBL IDCHEMBL562
ChEBI ID27779
PubChem CID441140
DrugBankDB00400
UNII ID32HRV3E3D5 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Griseofulvin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,508 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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240 adverse events reported
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