5-alpha-reductase Inhibitors
3 drugsAbout 5-alpha-reductase
5-alpha-reductase is an enzyme that converts testosterone to dihydrotestosterone (DHT), a more potent androgen. DHT plays a key role in male characteristic development and maintenance. Overproduction of DHT can contribute to conditions addressed by current medications.
While there is no genetic evidence directly linking 5-alpha-reductase to specific diseases, its role in androgen metabolism makes it a therapeutic target. Inhibiting 5-alpha-reductase can reduce DHT levels, addressing related conditions.
Two drugs targeting 5-alpha-reductase are FDA-approved: JALYN and DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE. Both are small molecule drugs and are used in 'other' therapeutic areas.
Top 5-alpha-reductase Drugs
WAYLIS THERAP and Aurobindo Pharma are the companies with approved drugs targeting this enzyme.
The market is unconcentrated, suggesting relatively low barriers to entry for new competitors.
5-alpha-reductase Drug Modality Landscape
Modalities
Routes of Administration
5-alpha-reductase is amenable to small molecule drugs, with oral options available for convenient dosing.
Exploring alternative modalities like antibodies could provide a competitive advantage.
5-alpha-reductase Clinical Trials 146 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on 5-alpha-reductase. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 33 | 29 | 2 | 2 | 94% |
| Phase 2 | 38 | 18 | 10 | 10 | 64% |
| Phase 3 | 35 | 19 | 9 | 7 | 68% |
| Phase 4 | 40 | 27 | 7 | 6 | 79% |
Top Sponsors
By Modality
Top Conditions
Top Drugs
5-alpha-reductase Drug Approval Timeline (1992 - 2014)
The first drug was approved in 2010 (JALYN), and the most recent in 2014 (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE).
The approval timeline suggests a potential slowdown or saturation in this therapeutic area.
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Competitive Landscape
- • 3 companies competing
- • Market share by company
Full Drug Portfolio
- • All 3 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 3-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 100 (28 companies)
- • Completion rates by condition
Full summary • All drugs • Genetic evidence • Trials • Timeline
How We Count Trials
- Trials: phase 1-4 interventional trials on ClinicalTrials.gov that started in 2008 or later and test an FDA-approved drug acting on 5-alpha-reductase. A trial counts if an approved drug acting on 5-alpha-reductase is in any arm, including as a comparator, and a trial that tests two such drugs counts once. Trials that test only unapproved drugs are not counted. A trial listed as phase 1/2 counts as phase 1, and phase 2/3 as phase 2.
- Active: recruiting, not yet recruiting, enrolling by invitation, or active and no longer recruiting.
- Completion rate: of the trials that have ended, the share marked Completed rather than Terminated or Withdrawn. Completed means the trial ended as planned; it does not mean the drug worked. Suspended trials are not counted as ended.
- Stopped: terminated or withdrawn. Trials stop for many reasons, including slow enrolment and business decisions, not only safety or efficacy.
- Sponsors: the lead sponsor of each trial. Companies are the sponsors ClinicalTrials.gov classes as industry; the rest are universities, hospitals, cooperative groups, government bodies and individuals.