Cytochrome P450 2D6 Inhibitors
2 drugsAbout Cytochrome P450 2D6
Cytochrome P450 2D6 (CYP2D6) is an enzyme in the cytochrome P450 superfamily, responsible for metabolizing various compounds, including many drugs. Its activity significantly impacts drug response, influencing efficacy and adverse effect risks due to variations in the CYP2D6 gene.
CYP2D6 is a vital target in drug development, particularly within the central nervous system (CNS) therapeutic area, despite the lack of direct genetic evidence linking CYP2D6 variations to specific diseases. Understanding CYP2D6's influence is paramount for optimizing drug dosages and personalizing treatment strategies.
CYP2D6 is targeted by one FDA-approved drug, AUVELITY, a small molecule developed by AXSOME for CNS indications. AUVELITY was first approved in 2022, representing the sole approved drug targeting CYP2D6 to date.
Top Cytochrome P450 2D6 Drugs
The competitive landscape is highly concentrated, with AXSOME being the only company with an approved drug.
High market concentration suggests potential entry barriers and the need for differentiated strategies to compete effectively.
Cytochrome P450 2D6 Drug Modality Landscape
Modalities
Routes of Administration
Cytochrome P450 2D6 is amenable to small molecule drugs, with oral options available for convenient dosing.
The lack of diverse modalities indicates a whitespace opportunity for novel therapeutic approaches like antibodies or biologics.
Cytochrome P450 2D6 Clinical Trials 144 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on Cytochrome P450 2D6. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 57 | 47 | 3 | 7 | 94% |
| Phase 2 | 30 | 25 | 3 | 2 | 89% |
| Phase 3 | 20 | 12 | 3 | 5 | 80% |
| Phase 4 | 37 | 23 | 11 | 3 | 68% |
Top Sponsors
By Modality
Cytochrome P450 2D6 Drug Approval Timeline (2010 - 2022)
The approval timeline shows that the first and most recent drug, AUVELITY, was approved in 2022.
Recent approval suggests renewed interest in CYP2D6, but saturation may occur quickly without novel approaches.
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Competitive Landscape
- • 2 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: 94 (33 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 Cytochrome P450 2D6. A trial counts if an approved drug acting on Cytochrome P450 2D6 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.