Flutamide
Flutamide (flutamide) is a small molecule pharmaceutical. Flutamide was first approved as Eulexin on 1989-01-27. It is used to treat hirsutism and prostatic neoplasms in the USA. The pharmaceutical is active against androgen receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Flutamide (discontinued: Eulexin, Flutamide)
Drug Products
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EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Flutamide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| EULEXIN | Merck & Co | N-018554 DISCN | 1989-01-27 | 1 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| eulexin | ANDA | 2025-02-04 |
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Patent Expiration
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HCPCS
Code | Description |
|---|---|
| S0175 | Flutamide, oral, 125 mg |
Clinical
Clinical Trials
79 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 | 6 | 21 | 30 | 4 | 4 | 63 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | 2 | — | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | 2 | — | 2 |
| Retinal diseases | D012164 | — | H35.9 | — | — | — | 2 | — | 2 |
| Primary dysautonomias | D054969 | — | — | — | — | — | 2 | — | 2 |
| Premenstrual dysphoric disorder | D065446 | — | F32.81 | — | — | — | 1 | — | 1 |
| Premenstrual syndrome | D011293 | — | N94.3 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | — | — | 4 | 4 | — | 1 | 8 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | 1 | — | 1 | 2 |
| Recurrence | D012008 | — | — | — | 1 | 1 | — | — | 2 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | — | — | 1 |
| Anemia | D000740 | EFO_0004272 | D64.9 | — | — | 1 | — | — | 1 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | — | 1 | — | — | 1 |
| Hot flashes | D019584 | — | — | — | — | 1 | — | — | 1 |
| Congenital adrenal hyperplasia | D000312 | — | E25.0 | — | — | 1 | — | — | 1 |
| Neoplasms | D009369 | — | C80 | — | 1 | 1 | — | — | 1 |
| Prostatic intraepithelial neoplasia | D019048 | — | N42.31 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 2 | 1 | — | — | 3 | 6 |
| Hyperandrogenism | D017588 | — | — | — | 1 | — | — | 1 | 2 |
| Infertility | D007246 | EFO_0000545 | — | — | 1 | — | — | 1 | 2 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | — | 1 | — | — | 1 | 2 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | — | 1 | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 1 | — | — | — | 1 |
| Ovarian epithelial carcinoma | D000077216 | — | — | — | 1 | — | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | — | 1 | — | — | — | 1 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | — | 1 | — | — | — | 1 |
| Squamous cell carcinoma | D002294 | — | — | — | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | — | — | — | 1 | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | — | — | 1 | 1 |
| Overweight | D050177 | — | E66.3 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Flutamide |
| INN | flutamide |
| Description | Flutamide is a monocarboxylic acid amide and a member of (trifluoromethyl)benzenes. It has a role as an androgen antagonist and an antineoplastic agent. |
| Classification | Small molecule |
| Drug class | non-steroid antiandrogens |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)C(=O)Nc1ccc([N+](=O)[O-])c(C(F)(F)F)c1 |
Identifiers
| PDB | — |
| CAS-ID | 13311-84-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL806 |
| ChEBI ID | 5132 |
| PubChem CID | 3397 |
| DrugBank | DB00499 |
| UNII ID | 76W6J0943E (ChemIDplus, GSRS) |
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Estimated US medical usage
Flutamide
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Additional graphs summarizing 8,259 documents
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Safety
Black-box Warning
Black-box warning for: Eulexin
Adverse Events
Top Adverse Reactions
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1,078 adverse events reported
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