MedPath

Finasteride

Generic Name
Finasteride
Brand Names
Entadfi, Propecia, Proscar
Drug Type
Small Molecule
Chemical Formula
C23H36N2O2
CAS Number
98319-26-7
Unique Ingredient Identifier
57GNO57U7G

Overview

Finasteride is a synthetic 4-azasteroid compound and specific inhibitor of steroid Type II 5α-reductase, which is an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). It works in a similar fashion as dutasteride, which is another 5-alpha-reductase inhibitor, by exerting antiandrogenic effects. Finasteride is an orally active drug that was first approved by the FDA in 1992 for the treatment of benign prostatic hyperplasia to improve symptoms and reduce the risk for acute urinary retention or the need for surgical procedures. In 1998, it was approved by the FDA to treat male pattern hair loss. Finasteride is commonly marketed under the brand names Propecia and Proscar to be used aloneo or in combination with doxazosin, an alpha-blocker. Both benign prostatic hyperplasia and androgenic alopecia are androgen-dependent disorders that are characterized by in situ high levels of DHT. In the treatment of benign prostate hyperplasia, alpha-blockers such as tamsulosin and terazosin are also used. Compared to alpha-blockers that focus on providing the rapid relief of symptoms, 5α-reductase inhibitors aim to target the underlying disease by blocking the effects of the primary androgen involved in benign prostate hyperplasia and androgenic alopecia, thus reducing the risk for secondary complications while providing symptom control.

Background

Finasteride is a synthetic 4-azasteroid compound and specific inhibitor of steroid Type II 5α-reductase, which is an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). It works in a similar fashion as dutasteride, which is another 5-alpha-reductase inhibitor, by exerting antiandrogenic effects. Finasteride is an orally active drug that was first approved by the FDA in 1992 for the treatment of benign prostatic hyperplasia to improve symptoms and reduce the risk for acute urinary retention or the need for surgical procedures. In 1998, it was approved by the FDA to treat male pattern hair loss. Finasteride is commonly marketed under the brand names Propecia and Proscar to be used aloneo or in combination with doxazosin, an alpha-blocker. Both benign prostatic hyperplasia and androgenic alopecia are androgen-dependent disorders that are characterized by in situ high levels of DHT. In the treatment of benign prostate hyperplasia, alpha-blockers such as tamsulosin and terazosin are also used. Compared to alpha-blockers that focus on providing the rapid relief of symptoms, 5α-reductase inhibitors aim to target the underlying disease by blocking the effects of the primary androgen involved in benign prostate hyperplasia and androgenic alopecia, thus reducing the risk for secondary complications while providing symptom control.

Indication

Finasteride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. A combination product with tadalafil is also used for the symptomatic treatment of BPH for up to 26 weeks. Finasteride is also indicated for the treatment of male pattern hair loss (androgenetic alopecia, hereditary alopecia, or common male baldness) in male patients.

Associated Conditions

  • Androgenetic Alopecia (AGA)
  • Benign Prostatic Hyperplasia (BPH)
  • Idiopathic Hirsutism
  • Symptomatic benign prostatic hyperplasia (BPH)

FDA Approved Products

Finasteride
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:5 mg in 1 1
Approved: 2021/11/18
NDC:71335-1530
Finasteride
Manufacturer:A-S Medication Solutions
Route:ORAL
Strength:5 mg in 1 1
Approved: 2017/07/29
NDC:50090-1936
Finasteride
Manufacturer:Direct_Rx
Route:ORAL
Strength:5 mg in 1 1
Approved: 2024/03/11
NDC:72189-542
Finasteride
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:1 mg in 1 1
Approved: 2021/11/11
NDC:71335-1304
DEXAMETHASONE SODIUM PHOSPHATE 0.1% / FINASTERIDE 0.1% / MINOXIDIL 5%
Manufacturer:Sincerus Florida, LLC
Route:TOPICAL
Strength:0.1 g in 100 g
Approved: 2019/05/08
NDC:72934-4069

Singapore Approved Products

FINAINTAS 5 FILM COATED TABLET 5 MG
Manufacturer:Intas Pharmaceuticals Limited
Form:TABLET, FILM COATED
Strength:5 mg
Online:Yes
Approved: 2022/06/29
Approval:SIN16529P
FINAPECIA 1 FILM COATED TABLET 1 MG
Manufacturer:Intas Pharmaceuticals Limited
Form:TABLET, FILM COATED
Strength:1 mg
Online:Yes
Approved: 2022/06/29
Approval:SIN16530P
FINASTERIDE TABLETS USP 1mg (FINAS 1)
Manufacturer:Intas Pharmaceuticals Limited.
Form:TABLET
Strength:1mg
Online:Yes
Approved: 2010/09/28
Approval:SIN13869P
STERCIA FILM-COATED TABLET 1MG
Manufacturer:MEGA LIFESCIENCES PUBLIC COMPANY LIMITED
Form:TABLET, FILM COATED
Strength:1.00mg
Online:Yes
Approved: 2015/10/08
Approval:SIN14865P
FINAGEN 5 FILM-COATED TABLET 5 MG
Manufacturer:Aurobindo Pharma Limited (Unit III)
Form:TABLET, FILM COATED
Strength:5.00 mg
Online:Yes
Approved: 2013/10/30
Approval:SIN14423P

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