Histamine H3 receptor Inhibitors
1 drugsAbout Histamine H3 receptor
The Histamine H3 receptor (H3R) is a G protein-coupled receptor that binds histamine, primarily functioning as a presynaptic autoreceptor and heteroreceptor in the central nervous system. It regulates the release of histamine and other neurotransmitters like dopamine and serotonin. This regulatory role makes H3R a drug target for neurological and psychiatric conditions.
Currently, there is no genetic evidence available linking the Histamine H3 receptor to specific diseases. However, the H3 receptor's influence on neurotransmitter release suggests potential applications in areas such as sleep disorders and cognitive enhancement.
There is one FDA-approved drug, WAKIX (pitolisant), targeting H3R; it was first approved in 2019. WAKIX is a small molecule and is marketed by HARMONY.
Top Histamine H3 receptor Drugs
HARMONY is the only company with an approved drug targeting H3R.
The market is not competitive, but HARMONY's dominance creates a high barrier to entry.
Histamine H3 receptor Drug Modality Landscape
Modalities
Routes of Administration
Only one approved drug targets Histamine H3 receptor, using small molecule modality.
Explore opportunities for novel modalities like antibodies or biologics to differentiate from existing therapies.
Histamine H3 receptor Clinical Trials 10 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on Histamine H3 receptor. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 4 | 2 | 2 | 0 | 50% |
| Phase 2 | 1 | 0 | 0 | 1 | - |
| Phase 3 | 5 | 4 | 0 | 1 | 100% |
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Histamine H3 receptor Drug Approval Timeline (2019 - 2019)
WAKIX was the first and most recent drug approved in 2019.
The approval timeline indicates a nascent market; further clinical validation may drive future approvals.
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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: 5 (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 Histamine H3 receptor. A trial counts if an approved drug acting on Histamine H3 receptor 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.