finasteride
Trade name: Proscar
Approved
Jun 19, 1992
Finasteride is a synthetic 4-azasteroid compound. This drug is a competitive and specific inhibitor of Type II 5a-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Two distinct isozymes are found in mice, rats, monkeys, and humans: Type I and II. Each of these isozymes is differentially expressed in tissues and developmental stages. In humans, Type I 5a-reductase is predominant in the sebaceous glands of most regions of skin, including scalp, and liver. Type I 5a-reductase is responsible for approximately one-third of circulating DHT. The Type II 5a-reductase isozyme is primarily found in prostate, seminal vesicles, epididymides, and hair follicles as well as liver, and is responsible for two-thirds of circulating DHT. Although finasteride is 100-fold more selective for type II 5a-reductase than for the type I isoenzyme, chronic treatment with this drug may have some effect on type I 5a-reductase. Finasteride is used 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, reduce the risk of the need for surgery including transurethral resection of the prostate. Also used for the stimulation of regrowth of hair in men with mild to moderate androgenetic alopecia (male pattern alopecia, hereditary alopecia, common male baldness). Finasteride is sold under the brand names Proscar and Propecia among others. — NCATS
Clinical trial activity
72 trials · 92 clinical orgs · 18 marketing orgs
Earliest trial started Dec 1, 1995 (NCT00021814)
Timeline
1990s
2000s
- Jan 1, 2002
Dr. Reddy's Laboratories — Earliest Phase 1 Sponsor(trial)
- Jun 19, 2006
Teva — Marketing Organization
- Jul 28, 2006
Dr. Reddy's Laboratories — Marketing Organization
- Dec 18, 2006
Mylan — Marketing Organization
- Dec 22, 2006
Gedeon Richter Ltd. — Marketing Organization
- Oct 30, 2007
Aurobindo Pharma — Marketing Organization
- Dec 28, 2009
Zydus Discovery DMCC — Marketing Organization
2010s
- Feb 23, 2010
Accord Research — Marketing Organization
- Jun 7, 2010
Hetero Labs Ltd — Marketing Organization
- Aug 16, 2011
Sun Pharmaceuticals — Marketing Organization
- Nov 5, 2013
Actavis — Marketing Organization
- Nov 5, 2013
Natco Pharma — Marketing Organization
- Nov 20, 2014
Cipla — Marketing Organization
- Jan 5, 2017
Alkem Labs Ltd — Marketing Organization
2020s
- Dec 9, 2021
Veru Inc. — NDA Secondary Org
- Dec 9, 2021
BLUE WATER BIOTECH — NDA Secondary Org
- Mar 19, 2025
Novitium Pharma — Marketing Organization
Indications
Approved for
Studied for
- Acne Vulgaris · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Central Nervous System Diseases · Phase 2
- Contraception · Phase 1
- Contraceptive Agents, Male · Phase 2
- Endocrine System Diseases · Phase 2
- Eunuchism · Phase 2
- Genital Diseases, Male · Phase 2
- Geriatrics · Phase 4
- Gonadal Disorders · Phase 2
- Healthy Volunteers · Phase 2
- Hematuria · Phase 2
- Hemospermia · Phase 2
- Hypogonadism · Phase 2
- Muscular Atrophy · Phase 2
- Nervous System Diseases · Phase 2
- Polycythemia · Phase 3
- Prostatic Intraepithelial Neoplasia · Phase 2/Phase 3
- Retinal Diseases · Phase 2
- Sarcopenia · Phase 2
- Sexual Dysfunction, Physiological · Phase 2
- Sleep Apnea Syndromes · Phase 4
- Spinal Cord Diseases · Phase 2
- Spinal Cord Injuries · Phase 2
- Transsexualism · Phase 4
- Trauma, Nervous System · Phase 2
- Urination Disorders · Phase 2
- Wounds and Injuries · Phase 2
Mechanism of action
- Steroid 5-alpha-reductase 2INHIBITOR
SRD5A2 inhibitor
Combination products
entadfi
with tadalafil
Approval history
- approvedPriority reviewJun 19, 1992
Chemistry & pharmacology
SMILES
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- Mol. weight
- 372.5441 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaFinasteride ↗
- NCATS57GNO57U7G ↗
- ChEMBLCHEMBL710 ↗
Also known as
- (5alpha,17beta)-(1,1-dimethylethyl)-3-oxo-4-azaandrost-1-ene-17-carboxamide
- (5alpha,17beta)-(1,1-dimethylethyl)-3-oxo-4-azaandrost-1-ene-17-carboxamide
- 5 ari
- aindeem
- cg 428
- da-4001
- finasterida
- finasterida
- finasteride
- finasteride
- finasteride
- finasteride
- finasteride
- finasteride
- finasteride
- finasteride
- finasteride
- finasteride
- finasteride
- finasteridum
- finasteridum
- finastid
- mk-906
- mk-906
- propecia
- propecia
- propecia
- proscar
- proscar
- proscar
- proscar
- prosteride
- prostide
- prostide
- prostide
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06944145 | Phase 2 | Nov 30, 2025 | Harvard University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| NCT06826001 | Phase 2 | Feb 28, 2025 | Sheikh Zayed Medical College |
| NCT07076706 | Phase 2 | Dec 5, 2024 | Government of China, Peking University |
| NCT06590779 | N/A | Nov 2, 2024 | Cosmetique Active International, University of Nice Sophia Antipolis, University of Paris |
| NCT05990400 | Phase 2/Phase 3 (Phase 3) | May 1, 2023 | University of Indonesia |
| NCT05611593 | Phase 1 | Oct 20, 2022 | Follicle Pharma Ltd |
| NCT04594018 | Phase 3 | Oct 31, 2021 | EMS S/A |
| NCT04945226 | Phase 1/Phase 2 (Phase 2) | Aug 30, 2021 | Inventage Lab., Inc. |
| NCT04288427 | N/A | Apr 30, 2020 | Harvard University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| NCT04848181 | Early Phase 1 (Phase 1) | Jul 1, 2019 | Benha University |
| NCT02248701 | Phase 2 | Jan 16, 2017 | Department of Veteran Affairs, University of Florida |
| NCT02919735 | Phase 2 | Oct 1, 2016 | ViraCyte |
| NCT02483195 | Phase 4 | Aug 1, 2016 | University of Florida |
| NCT02605629 | N/A | Jul 13, 2016 | Legacy Healthcare Services, Sungkyunkwan University |
| NCT03004469 | Phase 3 | Jul 1, 2016 | Polichem S.A. |
| NCT02824380 | Phase 1 | Jul 1, 2016 | Dong-A Pharmaceutical |
| NCT02791243 | Phase 1 | May 9, 2016 | Polichem S.A., Princeton Consumer Research Inc. |
| NCT02548117 | Phase 3 | Feb 1, 2016 | Baylor University |
| NCT02986412 | N/A | Jan 15, 2016 | Legacy Healthcare Services, Sungkyunkwan University |
| NCT02703220 | Phase 4 | Jul 3, 2015 | Department of Veteran Affairs |
Organizations
Research & Development (92)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Merck | For profit | 8 | 3 | 2 | 1998 |
| Dr. Reddy's Laboratories | For profit | 4 | 4 | 1 | 2002 |
| GlaxoSmithKline | For profit | 4 | 4 | 3 | 2003 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Government | 4 | 2 | 3 | 1995 |
| Novum Pharmaceutical Research Services | For profit | 4 | 0 | 1 | 2002 |
| Department of Veteran Affairs | Government | 3 | 3 | 2 | 2007 |
| National Cancer Institute (NCI) | Government | 3 | 2 | 2 | 1998 |
| National Eye Institute (NEI) | Government | 3 | 3 | 1 | 2009 |
| National Institutes of Health (NIH) | Government | 3 | 0 | 3 | 2008 |
| Sungkyunkwan University | Academic/Hospital | 3 | 3 | 2 | 2011 |
| Actavis | For profit | 2 | 2 | 1 | 2004 |
| Baylor University | Academic/Hospital | 2 | 1 | 1 | 1995 |
| Dong-A Pharmaceutical | For profit | 2 | 2 | 2 | 2014 |
| Harvard University | Academic/Hospital | 2 | 2 | 2 | 2020 |
| Kendle International Inc. | For profit | 2 | 0 | 1 | 2004 |
| Legacy Healthcare Services | Academic/Hospital | 2 | 0 | 1 | 2016 |
| MDS Pharma | For profit | 2 | 0 | 1 | 2002 |
| Mylan | For profit | 2 | 2 | 1 | 2004 |
| Polichem S.A. | For profit | 2 | 2 | 2 | 2016 |
| SFBC Anapharm | For profit | 2 | 0 | 1 | 2004 |
Marketing (26)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Accord Research | For profit | MKTG | Feb 23, 2010 |
| Actavis | For profit | MKTG | Nov 5, 2013 |
| Actavis | For profit | SYN | Mar 28, 2007 |
| Alkem Labs Ltd | For profit | MKTG | Jan 5, 2017 |
| Aurobindo Pharma | For profit | MKTG | Oct 30, 2007 |
| Aurobindo Pharma | For profit | SYN | Nov 5, 2013 |
| BLUE WATER BIOTECH | For profit | NDA2 | Dec 9, 2021 |
| Cipla | For profit | MKTG | Nov 20, 2014 |
| Dr. Reddy's Laboratories | For profit | MKTG | Jul 28, 2006 |
| Dr. Reddy's Laboratories | For profit | SYN | Feb 28, 2007 |
| Gedeon Richter Ltd. | For profit | MKTG | Dec 22, 2006 |
| Hetero Labs Ltd | For profit | MKTG | Jun 7, 2010 |
| Merck | For profit | NDA | Jun 19, 1992 |
| Mylan | For profit | MKTG | Dec 18, 2006 |
| Mylan | For profit | SYN | Nov 5, 2013 |
| Natco Pharma | For profit | MKTG | Nov 5, 2013 |
| Novitium Pharma | For profit | MKTG | Mar 19, 2025 |
| Organon | For profit | MKTG | Jun 19, 1992 |
| Organon | For profit | NDA2 | Jun 19, 1992 |
| Sun Pharmaceuticals | For profit | MKTG | Aug 16, 2011 |
| Sun Pharmaceuticals | For profit | SYN | Aug 16, 2011 |
| Teva | For profit | SYN | Dec 15, 2006 |
| Teva | For profit | MKTG | Jun 19, 2006 |
| Veru Inc. | For profit | NDA2 | Dec 9, 2021 |
| Zydus Discovery DMCC | For profit | MKTG | Dec 28, 2009 |
| Zydus Discovery DMCC | For profit | SYN | Mar 15, 2024 |