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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
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)

PK Comparison of GL2701 With Finasteride and Tamsulosin in Combination

Phase 1
Completed
Conditions
Benign Prostatic Hyperplasia (BPH)
Interventions
First Posted Date
2013-04-11
Last Posted Date
2013-04-11
Lead Sponsor
Korea University Anam Hospital
Target Recruit Count
26
Registration Number
NCT01829893
Locations
🇰🇷

Clinical trial center of Anam Hospital, Seoul, Korea, Republic of

Advanced Benefits of Alpha-blocker Monotherapy on Lower Urinary Tracts Symptoms(LUTS) Patients

Phase 4
Conditions
Benign Prostate Hyperplasia
Interventions
First Posted Date
2012-11-29
Last Posted Date
2014-05-14
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
545
Registration Number
NCT01736033
Locations
🇰🇷

Chungbuk National University Hospital, Cheongju, Chungbuk, Korea, Republic of

🇰🇷

Eulji General Hospital, Seoul, Korea, Republic of

🇰🇷

Hallym University Sacred Heart Hospital, Anyang, Gyeoggi, Korea, Republic of

and more 8 locations

Finasteride for Chronic Central Serous Chorioretinopathy

Phase 2
Terminated
Conditions
Retinal Disease
Interventions
Drug: Placebo
First Posted Date
2012-04-25
Last Posted Date
2014-12-04
Lead Sponsor
National Eye Institute (NEI)
Target Recruit Count
6
Registration Number
NCT01585441
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2)

Phase 3
Terminated
Conditions
Benign Prostatic Hyperplasia
Interventions
Drug: Tamsulosin-matching placebo
Drug: Finasteride-matching placebo
First Posted Date
2012-02-16
Last Posted Date
2018-08-29
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
1
Registration Number
NCT01534351

Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer

Not Applicable
Active, not recruiting
Conditions
Prostate Cancer
Interventions
First Posted Date
2011-04-27
Last Posted Date
2024-05-24
Lead Sponsor
University of Chicago
Target Recruit Count
74
Registration Number
NCT01342367
Locations
🇺🇸

University of Chicago, Chicago, Illinois, United States

3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer

Phase 4
Completed
Conditions
Prostate Cancer
Interventions
Drug: Placebo
First Posted Date
2011-02-15
Last Posted Date
2017-10-06
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Target Recruit Count
383
Registration Number
NCT01296672
Locations
🇺🇸

The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center, San Antonio, Texas, United States

Bioequivalence Study of Finasteride 5 mg Tablet Formulations Under Fasting Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-12-21
Last Posted Date
2010-12-21
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
26
Registration Number
NCT01264289
Locations
🇺🇸

Novum Pharmaceutical Research Services, Las Vegas,, Nevada, United States

Bioequivalence Study of Two Finasteride 5 mg Tablet Formulations Under Non-Fasting Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-12-21
Last Posted Date
2010-12-21
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
26
Registration Number
NCT01264302
Locations
🇺🇸

Novum Pharmaceutical Research Services, Las Vegas,, Nevada, United States

Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia

Phase 3
Completed
Conditions
Androgenetic Alopecia
Interventions
First Posted Date
2010-11-01
Last Posted Date
2018-08-10
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
917
Registration Number
NCT01231607
Locations
🇹🇭

GSK Investigational Site, Rajthevee Bangkok, Thailand

Extension Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy

Phase 1
Completed
Conditions
Retinal Disease
Interventions
First Posted Date
2010-10-25
Last Posted Date
2024-01-30
Lead Sponsor
National Eye Institute (NEI)
Target Recruit Count
3
Registration Number
NCT01227993
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

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