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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Events Timeline
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YTD
1Y
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5Y
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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
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dexamethasone sodium phosphate 0.1% / finasteride 0.1% / minoxidil 5% | unapproved drug other | 2019-05-08 |
| dexamethasone sodium phosphate 0.1% / finasteride 0.1% / minoxidil 5% / tretinoin 0.025% | unapproved drug other | 2019-05-08 |
| entadfi | New Drug Application | 2023-01-12 |
| finasteride | ANDA | 2025-02-10 |
| finasteride 0.1% / minoxidil 5% | unapproved drug other | 2019-05-08 |
| finasteride 0.1% / minoxidil 7% | unapproved drug other | 2019-04-24 |
| finasteride 0.1% / minoxidil 7% / tretinoin 0.025% | unapproved drug other | 2019-05-10 |
| johnson foam pro | C200263 | 2024-11-21 |
| nr-11 | Export only | 2017-06-21 |
| propecia | New Drug Application | 2024-10-14 |
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Indications
FDA
EMA
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
86 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Finasteride |
| INN | finasteride |
| 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 class | steroids (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
| PDB | — |
| CAS-ID | 98319-26-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL710 |
| ChEBI ID | 5062 |
| PubChem CID | 57363 |
| DrugBank | DB01216 |
| UNII ID | 57GNO57U7G (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‚£
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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,840 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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15,654 adverse events reported
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