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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
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
No data
Clinical
Clinical Trials
416 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
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 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | 1 | — | 2 | — | 3 | 6 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | 2 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | — | 1 | 3 | — | — | — | 4 |
| 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 |
Show 4 more
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
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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) |
Target
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 15,419 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
53,718 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use