FSHR Inhibitors
2 drugsAbout FSHR
The follicle-stimulating hormone receptor (FSHR) is a G protein-coupled receptor crucial for reproductive physiology. As the primary receptor for follicle-stimulating hormone (FSH), it is essential for gonadal development and function in both females and males.
FSHR's established physiological importance makes it a significant target for drug development. Currently, there is no genetic evidence data available linking FSHR to specific diseases.
Two drugs targeting FSHR have been approved: GONAL-F RFF and GONAL-F RFF REDI-JECT, both biologics. These drugs, developed by EMD SERONO, are used in specific therapeutic areas.
Top FSHR Drugs
EMD SERONO is the only company with approved drugs targeting FSHR.
The lack of competitors suggests high barriers to entry or an underserved market.
FSHR Drug Modality Landscape
Modalities
Routes of Administration
FSHR requires biologic approaches (enzyme), likely due to its structure or location.
Explore small molecule or alternative modalities to differentiate from existing FSHR-targeting therapies.
FSHR Clinical Trials 50 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on FSHR. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 9 | 7 | 2 | 0 | 78% |
| Phase 2 | 8 | 6 | 0 | 2 | 100% |
| Phase 3 | 20 | 19 | 0 | 1 | 100% |
| Phase 4 | 13 | 8 | 1 | 4 | 89% |
Top Sponsors
By Modality
Top Conditions
Top Drugs
FSHR Drug Approval Timeline (2004 - 2004)
The first FSHR-targeting drug was approved in 2004, with the most recent approval also in 2004.
The stagnant approval timeline indicates a mature market with limited recent innovation.
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Competitive Landscape
- • 1 companies competing
- • Market share by company
Full Drug Portfolio
- • All 2 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 2-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 27 (11 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 FSHR. A trial counts if an approved drug acting on FSHR 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.