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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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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
Trade Name
FDA
EMA
Nubeqa
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Darolutamide
Tradename
Company
Number
Date
Products
NUBEQABayerN-212099 RX2019-07-30
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
nubeqaNew Drug Application2021-01-07
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
DAROLUTAMIDE, NUBEQA, BAYER HEALTHCARE
2025-08-05I-900
2024-07-30NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Darolutamide, Nubeqa, Bayer Healthcare
111680582038-02-27DS, DP
100105302036-01-28DP
103838532036-01-28DP
108355152036-01-28DPU-2605
89752542033-03-25DS, DPU-2605
96570032030-10-27DS, DPU-2605
107110132030-10-27DS, DP
110467132030-10-27DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L02: Endocrine therapy antineoplastic and immunomodulating agents
— L02B: Hormone antagonists and related agents
— L02BB: Anti-androgen hormone antagonists and related agents
— L02BB06: Darolutamide
HCPCS
No data
Clinical
Clinical Trials
59 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Castration-resistant prostatic neoplasmsD0641293611110
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471C619187—233
NeoplasmsD009369C80121——3
AdenocarcinomaD0002301—1——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C5021———2
Male breast neoplasmsD01856711———2
Salivary gland neoplasmsD012468EFO_0003826D11—2———2
Non-small-cell lung carcinomaD00228911———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD0105992————2
Healthy volunteers/patients—2————2
Myelodysplastic syndromesD009190D461————1
Myeloid leukemia acuteD015470C92.01————1
Hematologic neoplasmsD0193371————1
Pancreatic neoplasmsD010190EFO_0003860C251————1
Non-hodgkin lymphomaD008228C85.91————1
Primary myelofibrosisD055728D47.41————1
Multiple myelomaD009101C90.01————1
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.01————1
Show 13 more
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDAROLUTAMIDE
INNdarolutamide
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 classnon-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-ID1297538-32-9
RxCUI—
ChEMBL IDCHEMBL4297185
ChEBI ID—
PubChem CID67171867
DrugBankDB12941
UNII IDX05U0N2RCO (ChemIDplus, GSRS)
Target
Agency Approved
AR
AR
Organism
Homo sapiens
Gene name
AR
Gene synonyms
DHTR, NR3C4
NCBI Gene ID
367
Protein name
androgen receptor
Protein synonyms
Dihydrotestosterone receptor, Nuclear receptor subfamily 3 group C member 4
Uniprot ID
Q9UD95
Mouse ortholog
Ar (11835)
androgen receptor (P19091)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 875 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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38,277 adverse events reported
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