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Finasteride
Entadfi, Propecia, Proscar (finasteride) is a small molecule pharmaceutical. Finasteride was first approved as Proscar on 1992-06-19. It is used to treat alopecia, hirsutism, prostatic hyperplasia, and prostatic neoplasms in the USA. The pharmaceutical is active against 3-oxo-5-alpha-steroid 4-dehydrogenase 2. In addition, it is known to target aldo-keto reductase family 1 member D1.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Propecia, Proscar (generic drugs available since 2006-07-28)
Combinations
Entadfi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Finasteride
Tradename
Company
Number
Date
Products
PROSCAROrganonN-020180 RX1992-06-19
1 products, RLD, RS
PROPECIAOrganonN-020788 RX1997-12-19
1 products, RLD, RS
Finasteride
+
Tadalafil
Tradename
Company
Number
Date
Products
ENTADFIVeruN-215423 RX2021-12-09
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
entadfiNew Drug Application2021-12-12
finasterideANDA2023-06-19
propeciaNew Drug Application2021-10-12
proscarNew Drug Application2021-07-21
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
alopeciaHP_0002293D000505L64
hirsutismHP_0001007D006628L68.0
prostatic hyperplasiaEFO_0000284D011470N40
prostatic neoplasms—D011471C61
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
D: Dermatologicals
— D11: Other dermatological preparations in atc
— D11A: Other dermatological preparations in atc
— D11AX: Other dermatological preparations in atc
— D11AX10: Finasteride
G: Genito urinary system and sex hormones
— G04: Urologicals
— G04C: Drugs used in benign prostatic hypertrophy
— G04CA: Alpha-adrenoreceptor antagonists, benign prostatic hypertrophy
— G04CA51: Alfuzosin and finasteride
— G04CB: Testosterone-5-alpha reductase inhibitors for benign prostatic hypertrophy
— G04CB01: Finasteride
HCPCS
Code
Description
S0138
Finasteride, 5 mg
Clinical
Clinical Trials
11 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Otitis externaD010032EFO_0009560H60——2——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urinary tract infectionsD014552EFO_0003103N39.012———3
Helicobacter infectionsD016481EFO_100096111———2
DyspepsiaD004415EFO_0008533K30—1———1
Gram-negative bacterial infectionsD016905—1———1
PyelonephritisD011704EFO_1001141N10-N16—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—2————2
Otitis mediaD010033EFO_0004992H66.91————1
PharmacokineticsD0105991————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFINASTERIDE
INNfinasteride
Description
Finasteride is an aza-steroid that is a synthetic drug for the treatment of benign prostatic hyperplasia. It has a role as an androgen antagonist, an EC 1.3.1.22 [3-oxo-5alpha-steroid 4-dehydrogenase (NADP(+))] inhibitor and an antihyperplasia drug. It is an aza-steroid, a 3-oxo steroid and a delta-lactam. It derives from a hydride of a 5alpha-androstane.
Classification
Small molecule
Drug classsteroids (androgens, anabolics); testosterone reductase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(C)(C)NC(=O)[C@H]1CC[C@H]2[C@@H]3CC[C@H]4NC(=O)C=C[C@]4(C)[C@H]3CC[C@]12C
Identifiers
PDB3G1R
CAS-ID98319-26-7
RxCUI25025
ChEMBL IDCHEMBL710
ChEBI ID5062
PubChem CID57363
DrugBankDB01216
UNII ID57GNO57U7G (ChemIDplus, GSRS)
Target
Agency Approved
SRD5A2
SRD5A2
Organism
Homo sapiens
Gene name
SRD5A2
Gene synonyms
NCBI Gene ID
6716
Protein name
3-oxo-5-alpha-steroid 4-dehydrogenase 2
Protein synonyms
5 alpha-SR2, S5AR 2, SR type 2, Steroid 5-alpha-reductase 2, steroid-5-alpha-reductase, alpha polypeptide 2 (3-oxo-5 alpha-steroid delta 4-dehydrogenase alpha 2), Type II 5-alpha reductase
Uniprot ID
P31213
Mouse ortholog
Srd5a2 (94224)
3-oxo-5-alpha-steroid 4-dehydrogenase 2 (Q99N99)
Alternate
AKR1D1
AKR1D1
Organism
Homo sapiens
Gene name
AKR1D1
Gene synonyms
SRD5B1
NCBI Gene ID
6718
Protein name
aldo-keto reductase family 1 member D1
Protein synonyms
3-oxo-5-beta-steroid 4-dehydrogenase, Delta(4)-3-ketosteroid 5-beta-reductase, Delta(4)-3-oxosteroid 5-beta-reductase, steroid-5-beta-reductase, beta polypeptide 1 (3-oxo-5 beta-steroid delta 4-dehydrogenase beta 1)
Uniprot ID
P51857
Mouse ortholog
Akr1d1 (208665)
aldo-keto reductase family 1 member D1 (Q8VCX1)
Variants
Clinical Variant
No data
Financial
Propecia - Organon
$
€
£
₣
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Entadfi - VERU INC.
$
€
£
₣
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Proscar - Organon
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,670 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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