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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Korlym, Mifeprex (generic drugs available since 2019-04-11)
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 |
|---|---|---|---|---|
| KORLYM | Corcept Therapeutics | N-202107 RX | 2012-02-17 | 1 products, RLD, RS |
| MIFEPREX | Danco Laboratories | N-020687 RX | 2000-09-28 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| korlym | New Drug Application | 2024-04-12 |
| mifepristone | New Drug Application | 2024-05-29 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Mifepristone, Korlym, Corcept Therap | |||
| 10231983 | 2038-08-22 | U-1643 | |
| 10314850 | 2038-08-22 | U-1643 | |
| 10780097 | 2038-08-22 | U-1643 | |
| 10195214 | 2037-06-19 | U-1643 | |
| 10842800 | 2037-06-19 | U-1643 | |
| 10151763 | 2037-01-18 | U-1643 | |
| 9829495 | 2036-08-15 | U-1643 | |
| 10006924 | 2036-08-12 | U-1643 | |
| 10495650 | 2036-08-12 | U-1643 | |
| 9943526 | 2036-04-20 | U-1643 | |
| 10166242 | 2036-04-20 | U-1643 | |
| 10166243 | 2036-04-20 | U-1643 | |
| 10660904 | 2036-04-20 | U-1643 | |
| 10500216 | 2033-03-05 | U-1643 | |
| 10842801 | 2032-11-15 | U-1643 | |
| 8921348 | 2028-08-27 | U-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
212 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Induced abortion | D000028 | — | — | — | 1 | 5 | 9 | 24 | 39 |
| Spontaneous abortion | D000022 | EFO_1001255 | O00.1 | — | — | 3 | 2 | 5 | 10 |
| Leiomyoma | D007889 | HP_0000131 | D25 | 1 | 5 | 4 | 1 | 1 | 9 |
| Cushing syndrome | D003480 | EFO_0003099 | E24 | — | 1 | 3 | 2 | 2 | 8 |
| Myofibroma | D047708 | — | — | 1 | 5 | 3 | 1 | 1 | 8 |
| Incomplete abortion | D000027 | EFO_1001799 | — | — | — | 1 | 1 | 5 | 7 |
| Syndrome | D013577 | — | — | — | 1 | 3 | 1 | 2 | 7 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | 1 | 2 | — | 2 | 1 | 6 |
| Traumatic stress disorders | D040921 | — | — | 1 | 2 | — | 2 | 1 | 6 |
| Fetal death | D005313 | HP_0003826 | — | — | — | 1 | 3 | 2 | 6 |
Show 20 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | 3 | 8 | — | 2 | 12 |
| Depression | D003863 | — | F33.9 | 1 | 2 | 7 | — | 2 | 11 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 4 | 3 | 1 | — | 2 | 10 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 2 | 7 | — | 1 | 9 |
| Psychotic disorders | D011618 | — | F20.81 | — | 1 | 8 | — | — | 8 |
| Pituitary acth hypersecretion | D047748 | EFO_1001110 | E24.0 | — | 1 | 4 | — | 2 | 7 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | — | 7 | — | — | 7 |
| Male breast neoplasms | D018567 | — | — | 2 | — | 1 | — | — | 3 |
| Adenomyosis | D062788 | EFO_1001757 | N80.0 | 1 | 1 | 1 | — | — | 2 |
| Acth-secreting pituitary adenoma | D049913 | — | — | — | — | 2 | — | — | 2 |
Show 5 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Triple negative breast neoplasms | D064726 | — | — | 1 | 2 | — | — | 1 | 4 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 2 | 4 | — | — | — | 4 |
| Prostatic neoplasms | D011471 | — | C61 | 2 | 2 | — | — | — | 3 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | 1 | — | — | — | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 2 | — | — | — | 2 |
| Weight gain | D015430 | HP_0004324 | — | 1 | 1 | — | — | — | 2 |
| Alcohol drinking | D000428 | EFO_0004329 | — | 1 | 2 | — | — | — | 2 |
| Fallopian tube neoplasms | D005185 | — | — | 1 | 1 | — | — | — | 2 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 2 | — | — | — | 2 |
| Premature cardiac complexes | D005117 | — | I49.40 | — | 1 | — | — | — | 1 |
Show 25 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | — | 5 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 2 | — | — | — | — | 2 |
| Recurrence | D012008 | — | — | 1 | — | — | — | 1 | 2 |
| Persian gulf syndrome | D018923 | EFO_0007430 | — | 1 | — | — | — | — | 1 |
| Occupational diseases | D009784 | — | — | 1 | — | — | — | — | 1 |
| Sarcoma | D012509 | — | — | 1 | — | — | — | — | 1 |
| Transitional cell carcinoma | D002295 | — | — | 1 | — | — | — | — | 1 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | — | 1 |
| Tobacco use disorder | D014029 | — | F17 | 1 | — | — | — | — | 1 |
| Carcinoma in situ | D002278 | — | D09.9 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pathologic dilatation | D004108 | — | — | — | — | — | — | 2 | 2 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | — | — | — | — | 1 | 1 |
| Thrombosis | D013927 | — | — | — | — | — | — | 1 | 1 |
| Venous thrombosis | D020246 | HP_0004936 | I82.40 | — | — | — | — | 1 | 1 |
| Embolism | D004617 | — | — | — | — | — | — | 1 | 1 |
| Thromboembolism | D013923 | HP_0001907 | — | — | — | — | — | 1 | 1 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | — | — | — | 1 | 1 |
| Hemostatic disorders | D020141 | — | — | — | — | — | — | 1 | 1 |
| Obstetric labor complications | D007744 | — | — | — | — | — | — | 1 | 1 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | — | — | 1 | 1 |
Show 7 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Mifepristone |
| INN | mifepristone |
| 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 class | steriodal compounds acting on progesterone receptors (excluding-gest- compounds); progesterone receptor antagonists |
| Image (chem structure or protein) |  |
| 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-ID | 84371-65-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1276308 |
| ChEBI ID | 50692 |
| PubChem CID | 55245 |
| DrugBank | DB00834 |
| UNII ID | 320T6RNW1F (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)
Variants
No data
Financial
No data
Trends
PubMed Central
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Additional graphs summarizing 12,654 documents
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Safety
Black-box Warning
Black-box warning for: Korlym, Mifepristone
Adverse Events
Top Adverse Reactions
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7,271 adverse events reported
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