Nilutamide
Nilandron, Nilutamide (nilutamide) is a small molecule pharmaceutical. Nilutamide was first approved as Nilandron on 1996-09-19. It is used to treat carcinoma and prostatic neoplasms in the USA. 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
Nilandron, Nilutamide (discontinued: Nilandron)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Nilutamide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NILANDRON | ADVANZ PHARMA | N-020169 RX | 1999-04-30 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nilandron | New Drug Application | 2024-12-05 |
| nilutamide | NDA authorized generic | 2021-12-10 |
Agency Specific
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
14 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 1 | 7 | 7 | — | 1 | 14 |
| Adenocarcinoma | D000230 | — | — | — | 2 | 1 | — | — | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| X-linked bulbo-spinal atrophy | D055534 | Orphanet_139557 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Nilutamide |
| INN | nilutamide |
| Description | Nilutamide is an imidazolidinone, a member of (trifluoromethyl)benzenes and a C-nitro compound. It has a role as an antineoplastic agent and an androgen antagonist. |
| Classification | Small molecule |
| Drug class | non-steroid antiandrogens |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC1(C)NC(=O)N(c2ccc([N+](=O)[O-])c(C(F)(F)F)c2)C1=O |
Identifiers
| PDB | — |
| CAS-ID | 63612-50-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1274 |
| ChEBI ID | 7573 |
| PubChem CID | 4493 |
| DrugBank | DB00665 |
| UNII ID | 51G6I8B902 (ChemIDplus, GSRS) |
Target
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Estimated US medical usage
Nilutamide
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PubMed Central
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Additional graphs summarizing 1,113 documents
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Safety
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Adverse Events
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94 adverse events reported
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