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Drug ReportsCyproterone
Cyproterone acetate
Cyproterone acetate is a small molecule pharmaceutical. It is currently being investigated in clinical studies. The pharmaceutical is active against androgen receptor.
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FDA approval date
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Therapeutic Areas
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name
Status
Last Update
dianeal low calcium peritoneal dialysis solution with dextrose dianeal pd-2 peritoneal dialysis solution with dextroseNew Drug Application2013-06-30
dianeal low calcium with dextroseunapproved drug for use in drug shortage2024-11-07
dianeal low calcium with dextrose dianeal pd-2 with dextroseunapproved drug for use in drug shortage2024-11-07
dianeal pd-2 peritoneal dialysis solution with dextroseNew Drug Application2010-06-07
dianeal pd-2 with dextroseunapproved drug for use in drug shortage2025-01-03
emme diane pure protection tinted antioxidant sunscreenC2002632025-01-16
emme diane tinted mineral sunscreenC2002632025-01-16
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
G: Genito urinary system and sex hormones
G03: Sex hormones and modulators of the genital system
G03H: Antiandrogen sex hormones and modulators of the genital system
G03HA: Antiandrogens, plain
G03HA01: Cyproterone
G03HB: Antiandrogens and estrogens
G03HB01: Cyproterone and estrogen
HCPCS
No data
Clinical
Clinical Trials
61 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Polycystic ovary syndromeD011085EFO_0000660E28.21217717
SyndromeD0135771216514
HyperandrogenismD017588314
Gender dysphoriaD000068116F64134
Acne vulgarisD000152EFO_0003894L701124
OverweightD050177E66.322
DysmenorrheaD004412N94.6112
Menstruation disturbancesD008599N91.522
TranssexualismD014189F64.022
ObesityD009765EFO_0001073E66.911
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471C6115410
EndometriosisD004715EFO_0001065N80122
HyperplasiaD006965EFO_00005361112
Hot flashesD019584112
PerimenopauseD047648111
Diabetic nephropathiesD003928EFO_000040111
Kidney diseasesD007674EFO_0003086N0811
AdenocarcinomaD00023011
PedophiliaD010378F65.411
Endometrial neoplasmsD016889EFO_0004230111
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Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic hyperplasiaD011470EFO_0000284N4011
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AlopeciaD000505L6422
Seborrheic dermatitisD012628L2122
HirsutismD006628L68.022
MeningiomaD008579EFO_0003098D32.922
GingivitisD005891K05.1022
Drug interactionsD00434711
InfertilityD007246EFO_000054511
Insulin resistanceD007333EFO_0002614E88.81911
Chronic painD05935011
Pelvic painD01769911
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCyproterone acetate
INNcyproterone
Description
Cyproterone acetate is a steroid ester resulting from the formal condensation of the carboxy group of acetic acid with the 17-hydroxy group of cyproterone. It is an antiandrogenic drug which has recently been recognized to promote the occurrence and growth of intracranial meningiomas. It has a role as an androgen antagonist, a progestin and a geroprotector. It is a 20-oxo steroid, a 3-oxo-Delta(4) steroid, a chlorinated steroid, a steroid ester and an acetate ester. It is functionally related to a cyproterone.
Classification
Small molecule
Drug classantiandrogens
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(=O)O[C@]1(C(C)=O)CC[C@H]2[C@@H]3C=C(Cl)C4=CC(=O)[C@@H]5C[C@@H]5[C@]4(C)[C@H]3CC[C@@]21C
Identifiers
PDB
CAS-ID427-51-0
RxCUI
ChEMBL IDCHEMBL139835
ChEBI ID50743
PubChem CID9880
DrugBankDB04839
UNII IDE61Q31EK2F (ChemIDplus, GSRS)
Target
Agency Approved
AR
AR
Organism
Homo sapiens
Gene name
AR
Gene synonyms
DHTR, NR3C4
NCBI Gene ID
Protein name
androgen receptor
Protein synonyms
Dihydrotestosterone receptor, Nuclear receptor subfamily 3 group C member 4
Uniprot ID
Mouse ortholog
Ar (11835)
androgen receptor (P19091)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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147,341 adverse events reported
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