Histone deacetylase Inhibitors
1 drugsAbout Histone deacetylase
Histone deacetylases (HDACs) are enzymes that regulate gene expression by removing acetyl groups from histone proteins, influencing chromatin structure and gene silencing.
HDACs are therapeutic targets because modulating gene expression can treat diseases; however, there is currently no genetic evidence linking HDACs to specific diseases.
There is one FDA-approved drug, DUVYZAT, a small molecule targeting HDACs for rare disease, developed by ITALFARMACO SPA and approved in 2024.
Top Histone deacetylase Drugs
ITALFARMACO SPA is the only company with an approved HDAC-targeting drug.
Low competition represents an opportunity, but also highlights potential challenges in the therapeutic area.
Histone deacetylase Drug Modality Landscape
Modalities
Routes of Administration
Only one approved drug targets Histone deacetylase, using small molecule modality.
Explore alternative modalities like PROTACs or antibodies to differentiate from existing therapies and potentially improve efficacy.
Histone deacetylase Clinical Trials 14 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on Histone deacetylase. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 5 | 5 | 0 | 0 | 100% |
| Phase 2 | 6 | 2 | 1 | 3 | 67% |
| Phase 3 | 3 | 1 | 0 | 2 | 100% |
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Histone deacetylase Drug Approval Timeline (2024 - 2024)
The first and most recent drug approval for HDACs was DUVYZAT in 2024.
Recent approval indicates renewed interest, but limited history suggests potential for market growth or saturation.
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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: 1 (1 company)
- • 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 Histone deacetylase. A trial counts if an approved drug acting on Histone deacetylase 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.