DNA polymerase Inhibitors
4 drugsAbout DNA polymerase
DNA polymerase is a crucial enzyme involved in DNA replication and repair in all living organisms. It synthesizes new DNA strands using existing strands as templates, ensuring accurate duplication of genetic information. Its fundamental role makes it a significant target for drug development.
Currently, there is no genetic evidence directly linking DNA polymerase variations to specific diseases. However, its fundamental role in cell division and survival makes it a compelling target, particularly in rapidly dividing cells such as cancer cells.
Three FDA-approved drugs target DNA polymerase: VYXEOS, MULTRYS, and TRALEMENT. These drugs are all small molecules and are developed by AM REGENT and JAZZ PHARMS THERAP for oncology and other indications.
Top DNA polymerase Drugs
The competitive landscape is dominated by AM REGENT and JAZZ PHARMS THERAP.
High market concentration suggests potential entry barriers for new companies.
DNA polymerase Drug Modality Landscape
Modalities
Routes of Administration
DNA polymerase is druggable by small molecules, though no oral formulations are currently approved.
Exploring alternative modalities like antibodies or PROTACs may offer a competitive advantage.
DNA polymerase Clinical Trials 749 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on DNA polymerase. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 295 | 140 | 84 | 71 | 63% |
| Phase 2 | 335 | 125 | 67 | 143 | 65% |
| Phase 3 | 102 | 38 | 11 | 52 | 78% |
| Phase 4 | 17 | 11 | 2 | 4 | 85% |
Top Sponsors
By Modality
Top Conditions
Top Drugs
Phase 3 Readout Calendar Pro
4 Phase 3 trials testing approved DNA polymerase drugs across all sponsors.
Coverage: trials whose intervention is an approved drug targeting DNA polymerase. Pre-approval candidates with development codes (e.g. AZD0901, MK-7240) are not yet linked. Anchored on CT.gov primary completion date.
DNA polymerase Drug Approval Timeline (2017 - 2020)
The first drug was approved in 2017, and the most recent in 2020, spanning 4 years.
Recent approvals suggest continued interest, but a short timespan may indicate market saturation.
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Competitive Landscape
- • 3 companies competing
- • Market share by company
Full Drug Portfolio
- • All 4 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 4-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 269 (63 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 DNA polymerase. A trial counts if an approved drug acting on DNA polymerase 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.