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.

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)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/04/25
Phase 2
Not yet recruiting
2025/02/13
Phase 2
Not yet recruiting
2024/09/19
Phase 2
Completed
2023/08/14
Phase 2
Recruiting
2022/11/10
Phase 1
Recruiting
2021/06/30
Phase 1
Completed
2021/04/19
Early Phase 1
Completed
2020/10/20
Phase 3
Recruiting
EMS
2020/02/28
Not Applicable
Recruiting
2019/07/25
Phase 3
Completed
GemVax & Kael

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Direct_Rx
72189-542
ORAL
5 mg in 1 1
3/11/2024
Sun Pharmaceutical Industries, Inc.
47335-715
ORAL
5 mg in 1 1
10/20/2022
Ascend Laboratories, LLC
67877-288
ORAL
5 mg in 1 1
11/11/2022
Bryant Ranch Prepack
71335-1304
ORAL
1 mg in 1 1
11/11/2021
A-S Medication Solutions
50090-6941
ORAL
5 mg in 1 1
9/21/2021
Proficient Rx LP
71205-767
ORAL
5 mg in 1 1
2/1/2023
American Health Packaging
60687-428
ORAL
5 mg in 1 1
4/26/2023
Physicians Total Care, Inc.
54868-4120
ORAL
1 mg in 1 1
6/11/2013
Bryant Ranch Prepack
71335-1634
ORAL
5 mg in 1 1
12/2/2016
Rising Health, LLC
57237-061
ORAL
1 mg in 1 1
8/24/2022

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
FINAINTAS 5 FILM COATED TABLET 5 MG
SIN16529P
TABLET, FILM COATED
5 mg
6/29/2022
FINAPECIA 1 FILM COATED TABLET 1 MG
SIN16530P
TABLET, FILM COATED
1 mg
6/29/2022
FINASTERIDE TABLETS USP 1mg (FINAS 1)
SIN13869P
TABLET
1mg
9/28/2010
STERCIA FILM-COATED TABLET 1MG
SIN14865P
TABLET, FILM COATED
1.00mg
10/8/2015
FINAGEN 5 FILM-COATED TABLET 5 MG
SIN14423P
TABLET, FILM COATED
5.00 mg
10/30/2013
FINAREX FILM-COATED TABLET 5MG
SIN15733P
TABLET, FILM COATED
5mg
7/4/2019
PROSCAR TABLET 5 mg
SIN07513P
TABLET, FILM COATED
5 mg
10/4/1993
PROPECIA TABLET 1 mg
SIN09921P
TABLET, FILM COATED
1 mg
7/31/1998
Finasteride Mevon 5mg tablet
SIN13681P
TABLET, FILM COATED
5mg
8/3/2009
BINFIN 1 FINASTERIDE TABLET 1MG
SIN15104P
TABLET, FILM COATED
1.000 mg
10/19/2016

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Finasteride Dispersible Tablets
国药准字H20050261
化学药品
片剂
2/11/2020
Finasteride Tablets
国药准字H20247238
化学药品
片剂
10/9/2024
Finasteride Tablets
国药准字H20253091
化学药品
片剂
1/8/2025
Finasteride Tablets
国药准字H20253092
化学药品
片剂
1/8/2025
Finasteride Tablets
国药准字H20040078
化学药品
片剂
7/16/2022
Finasteride Tablets
国药准字H20061299
化学药品
片剂
1/5/2022
Finasteride Tablets
国药准字H20060300
化学药品
片剂
8/16/2020
Finasteride Tablets
国药准字H20070163
化学药品
片剂
12/24/2021
Finasteride Tablets
国药准字HJ20230069
化学药品
片剂
6/7/2023
Finasteride Tablets
国药准字H20030951
化学药品
片剂
1/8/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
FINCAR TAB 5MG
N/A
N/A
N/A
2/23/2004

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