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Griseofulvin
Grifulvin, Gris-peg, Grisactin, Ultragris (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
Therapeutic Area
MeSH
infectionsD007239
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
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 VJohnson & JohnsonN-050448 DISCN1982-01-01
1 products, RLD
GRISACTINWyethN-050051 DISCN1982-01-01
2 products
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Griseofulvin
+
ultramicrosize
Tradename
Company
Number
Date
Products
GRIS-PEGBausch Health CompaniesN-050475 RX1982-01-01
2 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
gris-pegNew Drug Application2010-06-01
griseofulvin microsizeANDA2022-12-20
ultramicrosize griseofulvinANDA2023-04-19
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
tinea capitis—D014006B35.0
tinea pedisEFO_0007512D014008B35.3
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
6 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
Tinea capitisD014006B35.0——1—12
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
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—
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-ID126-07-8
RxCUI5021
ChEMBL IDCHEMBL562
ChEBI ID27779
PubChem CID441140
DrugBankDB00400
UNII ID32HRV3E3D5 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,946 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,804 adverse events reported
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