Xtandi(enzalutamide)
Enzalutamide, Xtandi (enzalutamide) is a small molecule pharmaceutical. Enzalutamide was first approved as Xtandi on 2012-08-31. It is used to treat prostatic neoplasms in the USA. It has been approved in Europe to treat prostatic neoplasms. The pharmaceutical is active against androgen receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| urogenital diseases | D000091642 |
Trade Name
FDA
EMA
Xtandi (discontinued: Enzalutamide)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Enzalutamide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| XTANDI | Astellas Pharma | N-203415 RX | 2012-08-31 | 1 products, RLD, RS |
| XTANDI | Astellas Pharma | N-213674 RX | 2020-08-04 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| xtandi | New Drug Application | 2025-03-18 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| prostatic neoplasms | — | D011471 | C61 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ENZALUTAMIDE, XTANDI, ASTELLAS | |||
| 2026-11-17 | I-926 | ||
HCPCS
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Clinical
Clinical Trials
423 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 15 | 33 | 12 | 6 | 8 | 72 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 6 | 14 | 3 | 4 | 6 | 31 |
| Seizures | D012640 | — | G40.4 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 6 | 1 | — | — | 8 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | — | 3 | — | — | 4 |
| X-linked bulbo-spinal atrophy | D055534 | Orphanet_139557 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | — | 1 | 2 | — | — | — | 3 |
| Carcinoma | D002277 | — | C80.0 | 1 | 2 | — | — | — | 3 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | — | 2 |
| Triple negative breast neoplasms | D064726 | — | — | — | 2 | — | — | — | 2 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 1 | 1 | — | — | — | 2 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | 1 | — | — | — | 2 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | 1 | — | — | — | 1 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | — | — | — | 1 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | 1 | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | — | 5 |
| Drug interactions | D004347 | — | — | 2 | — | — | — | 1 | 3 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | — | — | 3 | 3 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Enzalutamide |
| INN | enzalutamide |
| Description | Enzalutamide is a benzamide obtained by formal condensation of the carboxy group of 4-{3-[4-cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl}-2-fluorobenzoic acid with methylamine. Used for the treatment of of metastatic castration-resistant prostate cancer. It has a role as an antineoplastic agent and an androgen antagonist. It is a member of benzamides, an imidazolidinone, a thiocarbonyl compound, a nitrile, a member of (trifluoromethyl)benzenes and a member of monofluorobenzenes. |
| Classification | Small molecule |
| Drug class | deuterated compounds; non-steroid antiandrogens |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CNC(=O)c1ccc(N2C(=S)N(c3ccc(C#N)c(C(F)(F)F)c3)C(=O)C2(C)C)cc1F |
Identifiers
| PDB | — |
| CAS-ID | 915087-33-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1082407 |
| ChEBI ID | 68534 |
| PubChem CID | 15951529 |
| DrugBank | DB08899 |
| UNII ID | 93T0T9GKNU (ChemIDplus, GSRS) |
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Safety
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Adverse Events
Top Adverse Reactions
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53,718 adverse events reported
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