Nilutamide

Nilandron (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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Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
urogenital diseases	D000091642

Trade Name

FDA

EMA

Nilandron (generic drugs available since 2016-07-15)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Nilutamide

Tradename	Company	Number	Date	Products
NILANDRON	Concordia Laboratories	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	2020-01-22

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
carcinoma	—	D002277	C80.0
prostatic neoplasms	—	D011471	C61

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

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

— L02BB02: Nilutamide

HCPCS

No data

Clinical

Clinical Trials

813 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Tobacco use disorder	D014029		F17	46	52	23	32	87	226
Smoking cessation	D016540	EFO_0004319		29	29	19	47	69	185
Smoking	D012907	EFO_0003768	F17	15	14	12	27	55	116
Cigarette smoking	D000073865			11	17	3	7	25	58
Tobacco use cessation	D020340			2	4	4	10	11	28
Tobacco use	D064424		Z72.0	4	1	3	2	19	28
Tobacco smoking	D000073869			2	3	2	9	12	27
Vaping	D000072137			1	3	1	4	18	27
Schizophrenia	D012559	EFO_0000692	F20	5	5	—	8	7	24
Lung neoplasms	D008175		C34.90	2	—	4	1	9	16

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369		C80	—	1	1	—	5	7
Post-traumatic stress disorders	D013313	EFO_0001358	F43.1	1	1	1	—	1	3
Acute coronary syndrome	D054058	EFO_0005672		—	—	1	—	2	3
Covid-19	D000086382		U07.1	—	—	2	—	—	2
Disease	D004194	EFO_0000408	R69	—	—	2	—	—	2
Habits	D006184			—	1	1	—	—	1
Dyslipidemias	D050171	HP_0003119		—	—	1	—	—	1
Metabolic syndrome	D024821	EFO_0000195	E88.81	—	—	1	—	—	1
Tuberculosis	D014376	EFO_0000774	A15-A19	—	—	1	—	—	1
Severe acute respiratory syndrome-related coronavirus	D045473	NCBITaxon_227859		—	—	1	—	—	1

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—			7	1	—	—	5	12
Depression	D003863		F33.9	1	1	—	—	8	9
Breast neoplasms	D001943	EFO_0003869	C50	1	2	—	—	5	8
Cardiovascular diseases	D002318	EFO_0000319	I98	—	1	—	—	5	6
Depressive disorder	D003866	EFO_1002014	F32.A	2	1	—	—	—	3
Bipolar disorder	D001714	EFO_0000289	F30.9	—	1	—	—	2	3
Obesity	D009765	EFO_0001073	E66.9	—	1	—	—	2	3
Cognitive dysfunction	D060825		G31.84	1	2	—	—	—	2
Pregnancy	D011247	EFO_0002950	Z33.1	—	1	—	—	1	2
Postoperative nausea and vomiting	D020250	EFO_0004888		—	1	—	—	1	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Non-small-cell lung carcinoma	D002289			1	—	—	—	2	3
Squamous cell carcinoma of head and neck	D000077195			1	—	—	—	2	3
Harm reduction	D040261			3	—	—	—	—	3
Prostatic neoplasms	D011471		C61	1	—	—	—	1	2
Colorectal neoplasms	D015179			1	—	—	—	1	2
Cognition disorders	D003072			2	—	—	—	—	2
Anxiety disorders	D001008	EFO_0006788	F41.1	2	—	—	—	—	2
Aging	D000375	GO_0007568	R41.81	1	—	—	—	1	2
Nasopharyngeal neoplasms	D009303			1	—	—	—	—	1
Cannabis	D002188			1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Anesthesia	D000758			—	—	—	—	5	5
Anxiety	D001007	EFO_0005230	F41.1	—	—	—	—	4	4
Heart disease risk factors	D000082742			—	—	—	—	3	3
Suicide	D013405			—	—	—	—	3	3
Myocardial infarction	D009203	EFO_0000612	I21	—	—	—	—	2	2
Psychological distress	D000079225			—	—	—	—	2	2
Feeding behavior	D005247			—	—	—	—	2	2
Behavior	D001519	GO_0007610	STY/T053	—	—	—	—	2	2
Heart diseases	D006331	EFO_0003777	I51.9	—	—	—	—	2	2
Uterine cervical dysplasia	D002578	EFO_1000910	N87	—	—	—	—	1	1

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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	31805
ChEMBL ID	CHEMBL1274
ChEBI ID	7573
PubChem CID	4493
DrugBank	DB00665
UNII ID	51G6I8B902 (ChemIDplus, GSRS)

Target

Agency Approved

Organism

Homo sapiens

Gene name

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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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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19,783 adverse events reported

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Real-time Data on

Companies, Drugs, and Diseases

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MATERIALS

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