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Drug ReportsFinasteride
Finasteride
Finasteride, 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.
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Target
Variants
Financial
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Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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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
Finasteride, Propecia, Proscar (discontinued: Finasteride)
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
PROPECIAOrganonN-020788 RX1997-12-19
1 products, RLD, RS
PROSCAROrganonN-020180 RX1992-06-19
1 products, RLD, RS
Finasteride
+
Tadalafil
Tradename
Company
Number
Date
Products
ENTADFIOnconetixN-215423 DISCN2021-12-09
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
dexamethasone sodium phosphate 0.1% / finasteride 0.1% / minoxidil 5%unapproved drug other2019-05-08
dexamethasone sodium phosphate 0.1% / finasteride 0.1% / minoxidil 5% / tretinoin 0.025%unapproved drug other2019-05-08
entadfiNew Drug Application2023-01-12
finasterideANDA2024-10-17
finasteride 0.1% / minoxidil 5%unapproved drug other2019-05-08
finasteride 0.1% / minoxidil 7%unapproved drug other2019-04-24
finasteride 0.1% / minoxidil 7% / tretinoin 0.025%unapproved drug other2019-05-10
nr-11Export only2017-06-21
propeciaNew Drug Application2024-10-14
proscarNew Drug Application2024-10-14
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
85 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 hyperplasiaD011470EFO_0000284N4032751128
HyperplasiaD006965EFO_0000536—31751026
AlopeciaD000505HP_0002293L646471217
Alopecia areataD000506EFO_0004192L635361215
Prostatic neoplasmsD011471—C61—512310
Lower urinary tract symptomsD059411EFO_0008008————112
Sleep apnea syndromesD012891HP_0010535G47.3———1—1
ApneaD001049HP_0002104R06.81———1—1
HivD006678—————1—1
TranssexualismD014189—F64.0———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertrophyD006984EFO_0002460——11—35
PolycythemiaD011086EFO_0005804D75.1——1——1
NeoplasmsD009369—C80—11——1
Prostatic intraepithelial neoplasiaD019048—N42.31—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———101———11
Retinal diseasesD012164HP_0000479H35.923———3
Central serous chorioretinopathyD056833—H35.7123———3
HypogonadismD007006HP_0000044E23.012———3
Male contraceptive devicesD003275———1———1
Acne vulgarisD000152EFO_0003894L70—1———1
Wounds and injuriesD014947—T14.8—1———1
Spinal cord injuriesD013119EFO_1001919——1———1
Endocrine system diseasesD004700EFO_0001379E34.9—1———1
Gonadal disordersD006058———1———1
Show 14 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MalnutritionD044342EFO_0008572E40-E462————2
Photosensitivity disordersD010787HP_0000992L57.11————1
ContraceptionD003267——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AdenocarcinomaD000230——————11
DepressionD003863—F33.9————11
Depressive disorderD003866EFO_1002014F32.A————11
SuicideD013405——————11
Gastrointestinal neoplasmsD005770—C26.9————11
Urethral obstructionD014524——————11
Urologic diseasesD014570—N39.9————11
Prostatic diseasesD011469—N42.9————11
ProlapseD011391——————11
CystoceleD052858——————11
Show 4 more
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)Loading
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
PDB—
CAS-ID98319-26-7
RxCUI—
ChEMBL IDCHEMBL710
ChEBI ID5062
PubChem CID57363
DrugBankDB01216
UNII ID57GNO57U7G (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
AKR1D1
AKR1D1
Organism
Homo sapiens
Gene name
AKR1D1
Gene synonyms
SRD5B1
NCBI Gene ID
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
Mouse ortholog
Akr1d1 (208665)
aldo-keto reductase family 1 member D1 (Q8VCX1)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Entadfi – Veru
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Proscar – Organon
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Propecia – Organon
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Tabular view
Estimated US medical usage
Finasteride
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,626 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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14,412 adverse events reported
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