Stem definition | Drug id | CAS RN |
---|---|---|
non-steroid antiandrogens | 4628 | 915087-33-1 |
Dose | Unit | Route |
---|---|---|
0.16 | g | O |
None
Date | Agency | Company | Orphan |
---|---|---|---|
Aug. 31, 2012 | FDA | ASTELLAS | |
March 24, 2014 | PMDA | Astellas Pharma Inc |
None
None
Source | Code | Description |
---|---|---|
ATC | L02BB04 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ENDOCRINE THERAPY HORMONE ANTAGONISTS AND RELATED AGENTS Anti-androgens |
FDA MoA | N0000000243 | Androgen Receptor Antagonists |
FDA EPC | N0000175560 | Androgen Receptor Inhibitor |
FDA MoA | N0000185506 | Cytochrome P450 3A4 Inducers |
FDA MoA | N0000185507 | Cytochrome P450 2C9 Inducers |
FDA MoA | N0000185607 | Cytochrome P450 2C19 Inducers |
CHEBI has role | CHEBI:35497 | antiandrogen |
CHEBI has role | CHEBI:35610 | cytostatic |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Metastasis from malignant tumor of prostate | indication | 314994000 | |
Malignant tumor of prostate | indication | 399068003 | DOID:10283 |
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 12.88 | acidic |
None
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
40MG | XTANDI | ASTELLAS | N203415 | Aug. 31, 2012 | RX | CAPSULE | ORAL | July 13, 2021 | TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER |
40MG | XTANDI | ASTELLAS | N213674 | Aug. 4, 2020 | RX | TABLET | ORAL | July 13, 2021 | TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER |
80MG | XTANDI | ASTELLAS | N213674 | Aug. 4, 2020 | RX | TABLET | ORAL | July 13, 2021 | TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER |
40MG | XTANDI | ASTELLAS | N203415 | Aug. 31, 2012 | RX | CAPSULE | ORAL | Dec. 16, 2022 | TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC) |
40MG | XTANDI | ASTELLAS | N213674 | Aug. 4, 2020 | RX | TABLET | ORAL | Dec. 16, 2022 | TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC) |
80MG | XTANDI | ASTELLAS | N213674 | Aug. 4, 2020 | RX | TABLET | ORAL | Dec. 16, 2022 | TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC) |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Androgen receptor | Nuclear hormone receptor | ANTAGONIST | EC50 | 7.31 | CHEMBL | CHEMBL |
ID | Source |
---|---|
D10218 | KEGG_DRUG |
4031716 | VUID |
N0000185726 | NUI |
4031716 | VANDF |
C3496793 | UMLSCUI |
CHEBI:68534 | CHEBI |
CHEMBL1082407 | ChEMBL_ID |
DB08899 | DRUGBANK_ID |
C540278 | MESH_SUPPLEMENTAL_RECORD_UI |
15951529 | PUBCHEM_CID |
6812 | IUPHAR_LIGAND_ID |
9621 | INN_ID |
93T0T9GKNU | UNII |
1307298 | RXNORM |
192757 | MMSL |
28802 | MMSL |
d07900 | MMSL |
014630 | NDDF |
703125003 | SNOMEDCT_US |
703684000 | SNOMEDCT_US |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Xtandi | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0469-0125 | CAPSULE | 40 mg | ORAL | NDA | 28 sections |
Xtandi | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0469-0625 | TABLET | 40 mg | ORAL | NDA | 28 sections |
Xtandi | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0469-0725 | TABLET | 80 mg | ORAL | NDA | 28 sections |