Sclerostin Inhibitors
1 drugsAbout Sclerostin
Sclerostin, encoded by the *SOST* gene, is a secreted glycoprotein produced by osteocytes. It inhibits the Wnt signaling pathway by binding to LRP5/6 receptors on osteoblasts, suppressing bone formation.
Sclerostin is a therapeutic target for conditions with reduced bone mass. Currently, there is no genetic evidence data available linking sclerostin to specific diseases.
EVENITY (romosozumab) is the only approved drug targeting sclerostin, developed by Amgen for osteoporosis. It is a biologic (other) modality, placing sclerostin-targeted therapies in the 'other' therapeutic area category.
Top Sclerostin Drugs
Amgen is the only company with an approved drug targeting sclerostin.
The market is highly concentrated, indicating potential entry barriers or a first-mover advantage for Amgen.
Sclerostin Drug Modality Landscape
Modalities
Routes of Administration
Only one approved drug targets Sclerostin, using biologic (other) modality.
The lack of modality diversity suggests an opportunity to develop small molecule or alternative biologic approaches.
Sclerostin Clinical Trials 41 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on Sclerostin. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 8 | 5 | 0 | 3 | 100% |
| Phase 2 | 9 | 6 | 1 | 2 | 86% |
| Phase 3 | 10 | 8 | 0 | 2 | 100% |
| Phase 4 | 14 | 3 | 0 | 11 | 100% |
Top Sponsors
By Modality
Top Conditions
Top Drugs
Sclerostin Drug Approval Timeline (2019 - 2019)
The first and only drug, EVENITY, was approved in 2019.
The recent approval and lack of subsequent approvals suggest a potentially unsaturated market with room for new entrants.
Pro Intelligence Preview
Deep insights for drug target analysis
Competitive Landscape
- • 1 companies competing
- • Market share by company
Full Drug Portfolio
- • All 1 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 1-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 17 (3 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 Sclerostin. A trial counts if an approved drug acting on Sclerostin 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.