Nubeqa(darolutamide)
Nubeqa (darolutamide) is a small molecule pharmaceutical. Darolutamide was first approved as Nubeqa on 2019-07-30. It has been approved in Europe to treat castration-resistant 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
Nubeqa
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nubeqa | New Drug Application | 2026-03-04 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DAROLUTAMIDE, NUBEQA, BAYER HEALTHCARE | |||
| 2025-08-05 | I-900 | ||
| 2024-07-30 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
145 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 | 24 | 45 | 22 | 3 | 21 | 108 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 11 | 12 | 6 | 1 | 5 | 32 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 3 | 1 | — | 1 | 2 | 7 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | — | 4 | 3 | 2 | — | 1 | 9 |
| Neoplasms | D009369 | — | C80 | 4 | 3 | 1 | — | 2 | 8 |
| Lymphatic metastasis | D008207 | EFO_1001364 | — | — | — | 1 | — | — | 1 |
| Directly observed therapy | D023801 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 2 | — | — | — | 4 |
| Salivary gland neoplasms | D012468 | EFO_0003826 | D11 | — | 3 | — | — | — | 3 |
| Male breast neoplasms | D018567 | — | — | 1 | 1 | — | — | — | 2 |
| X-linked bulbo-spinal atrophy | D055534 | Orphanet_139557 | — | 1 | 2 | — | — | — | 2 |
| Male urogenital diseases | D052801 | — | — | 2 | 1 | — | — | — | 2 |
| Prostatic diseases | D011469 | — | N42.9 | 2 | 1 | — | — | — | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | 1 | — | — | — | 1 |
| Male genital diseases | D005832 | EFO_0009555 | N50.9 | 1 | 1 | — | — | — | 1 |
| Triple negative breast neoplasms | D064726 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | — | 2 |
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Urogenital neoplasms | D014565 | EFO_0003863 | D07 | 1 | — | — | — | 1 | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | — | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 1 | — | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | — | — | — | — | 1 |
| Primary myelofibrosis | D055728 | — | D47.4 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Radiosurgery | D016634 | — | — | — | — | — | — | 1 | 1 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | — | — | 1 | 1 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | — | — | — | — | 1 | 1 |
| Transitional cell carcinoma | D002295 | — | — | — | — | — | — | 1 | 1 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | — | — | — | 1 | 1 |
| Fatigue | D005221 | — | R53.83 | — | — | — | — | 1 | 1 |
| Depression | D003863 | — | F33.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Darolutamide |
| INN | darolutamide |
| Description | Darolutamide, sold under the brand name Nubeqa, is an antiandrogen medication which is used in the treatment of non-metastatic castration-resistant prostate cancer in men. It is specifically approved to treat non-metastatic castration-resistant prostate cancer (nmCRPC) in conjunction with surgical or medical castration. The medication is taken by mouth twice per day with food.
|
| Classification | Small molecule |
| Drug class | non-steroid antiandrogens |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(O)c1cc(C(=O)N[C@@H](C)Cn2ccc(-c3ccc(C#N)c(Cl)c3)n2)n[nH]1 |
Identifiers
| PDB | — |
| CAS-ID | 1297538-32-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297185 |
| ChEBI ID | — |
| PubChem CID | 67171867 |
| DrugBank | DB12941 |
| UNII ID | X05U0N2RCO (ChemIDplus, GSRS) |
Target
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Trends
PubMed Central
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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3,240 adverse events reported
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