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 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
PROSCAR finasteride 5mg tablet, blister pack | 43667 | Medicine | A | 10/26/1993 | |
FINNACAR finasteride 5 mg tablet blister pack | 143402 | Medicine | A | 12/17/2008 | |
FINASTA finasteride1 mg film-coated tablet blister pack | 330148 | Medicine | A | 5/4/2020 | |
APO-FINASTERIDE 1 finasteride 1 mg film-coated tablet blister pack | 155233 | Medicine | A | 3/26/2010 | |
PHARMACOR FINASTERIDE 1 finasteride 1 mg film-coated tablet blister pack | 155234 | Medicine | A | 3/26/2010 | |
FINASTERIDE VIATRIS 5 finasteride 5 mg film-coated tablet blister pack | 330152 | Medicine | A | 5/4/2020 | |
APO-FINASTERIDE 5 finasteride 5 mg film-coated tablet blister pack | 155238 | Medicine | A | 3/26/2010 | |
PHARMACOR FINASTERIDE 5 finasteride 5 mg film-coated tablet blister pack | 155235 | Medicine | A | 3/26/2010 | |
PROPECIA Finasteride 1.0mg tablet blister pack | 62084 | Medicine | A | 6/26/1998 | |
FINASTERIDE VIATRIS 1 finasteride 1 mg film-coated tablet blister pack | 330151 | Medicine | A | 5/4/2020 |
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