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Drug ReportsMifepristone
Mifepristone
Korlym, Mifeprex, Mifepristone (mifepristone) is a small molecule pharmaceutical. Mifepristone was first approved as Mifeprex on 2000-09-28. It is used to treat brain neoplasms, ectopic pregnancy, hyperglycemia, and meningeal neoplasms in the USA. The pharmaceutical is active against glucocorticoid receptor and progesterone receptor. In addition, it is known to target androgen receptor and nuclear receptor subfamily 1 group I member 2.
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1M
3M
6M
YTD
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2Y
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FDA approval date
EMA approval date
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Study first post date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
nervous system diseasesD009422
urogenital diseasesD000091642
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Korlym, Mifeprex, Mifepristone
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Mifepristone
Tradename
Company
Number
Date
Products
KORLYMCorcept TherapeuticsN-202107 RX2012-02-17
1 products, RLD, RS
MIFEPREXDanco LaboratoriesN-020687 RX2000-09-28
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
korlymNew Drug Application2025-01-21
mifeprexNew Drug Application2025-03-12
mifepristoneNew Drug Application2025-01-28
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Mifepristone, Korlym, Corcept Therap
102319832038-08-22U-1643
103148502038-08-22U-1643
107800972038-08-22U-1643
101952142037-06-19U-1643
108428002037-06-19U-1643
101517632037-01-18U-1643
98294952036-08-15U-1643
100069242036-08-12U-1643
104956502036-08-12U-1643
99435262036-04-20U-1643
101662422036-04-20U-1643
101662432036-04-20U-1643
106609042036-04-20U-1643
105002162033-03-05U-1643
108428012032-11-15U-1643
89213482028-08-27U-1643
ATC Codes
G: Genito urinary system and sex hormones
— G03: Sex hormones and modulators of the genital system
— G03X: Other sex hormones and modulators of the genital system in atc
— G03XB: Progesterone receptor modulators, sex hormones and modulators of the genital system
— G03XB01: Mifepristone
— G03XB51: Mifepristone, combinations
HCPCS
Code
Description
S0190
Mifepristone, oral, 200 mg
Clinical
Clinical Trials
214 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cushing syndromeD003480EFO_0003099E24——3126
Adrenocortical hyperfunctionD000308EFO_1000797————112
Type 2 diabetes mellitusD003924EFO_0001360E11———1—1
Diabetes mellitusD003920EFO_0000400E08-E13———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Major depressive disorderD003865EFO_0003761F22—16——7
Depressive disorderD003866EFO_1002014F32.A—16——7
Pituitary acth hypersecretionD047748EFO_1001110E24.0——4—26
Psychotic disordersD011618—F20.81——6——6
DepressionD003863—F33.9——6——6
Mental disordersD001523EFO_0000677F91.9——6——6
SyndromeD013577————3—25
Acth-secreting pituitary adenomaD049913————2——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C5011———2
Non-small-cell lung carcinomaD002289——11———2
Weight gainD015430——11———2
Alzheimer diseaseD000544EFO_0000249F03—1———1
Body weightD001835EFO_0004338——1———1
Adrenal insufficiencyD000309———1———1
Wounds and injuriesD014947—T14.8—1———1
Lung neoplasmsD008175—C34.90—1———1
Post-traumatic stress disordersD013313EFO_0001358F43.1—1———1
Traumatic stress disordersD040921———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———5————5
Prostatic neoplasmsD011471—C611————1
Triple negative breast neoplasmsD064726——1————1
SarcomaD012509——1————1
Transitional cell carcinomaD002295——1————1
Ovarian epithelial carcinomaD000077216——1————1
Drug interactionsD004347——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMifepristone
INNmifepristone
Description
Mifepristone is a 3-oxo-Delta(4) steroid, an acetylenic compound and a tertiary amino compound. It has a role as an abortifacient, a contraceptive drug, a synthetic oral contraceptive and a hormone antagonist. It derives from a hydride of an estrane.
Classification
Small molecule
Drug classsteriodal compounds acting on progesterone receptors (excluding-gest- compounds); progesterone receptor antagonists
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC#C[C@]1(O)CC[C@H]2[C@@H]3CCC4=CC(=O)CCC4=C3[C@@H](c3ccc(N(C)C)cc3)C[C@@]21C
Identifiers
PDB—
CAS-ID84371-65-3
RxCUI—
ChEMBL IDCHEMBL1276308
ChEBI ID50692
PubChem CID55245
DrugBankDB00834
UNII ID320T6RNW1F (ChemIDplus, GSRS)
Target
Agency Approved
NR3C1
NR3C1
PGR
PGR
Organism
Homo sapiens
Gene name
NR3C1
Gene synonyms
GRL
NCBI Gene ID
Protein name
glucocorticoid receptor
Protein synonyms
Nuclear receptor subfamily 3 group C member 1, nuclear receptor subfamily 3 group C member 1 variant hGR-B(54), nuclear receptor subfamily 3 group C member 1 variant hGR-B(77), nuclear receptor subfamily 3 group C member 1 variant hGR-B(93), nuclear receptor subfamily 3, group C, member 1 (glucocorticoid receptor)
Uniprot ID
Mouse ortholog
Nr3c1 (14815)
glucocorticoid receptor (Q61629)
Alternate
AR
AR
NR1I2
NR1I2
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)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 13,147 documents
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Safety
Black-box Warning
Black-box warning for: Korlym, Mifeprex, Mifepristone
Adverse Events
Top Adverse Reactions
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7,436 adverse events reported
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