RNA polymerase Inhibitors
5 drugsAbout RNA polymerase
RNA polymerase synthesizes RNA from DNA, a process essential for all living organisms. As a critical enzyme, it transcribes genetic information, making it a fundamental component of cellular function and a key target for therapeutic intervention.
RNA polymerase is a validated drug target, evidenced by five FDA-approved drugs despite the absence of direct genetic links to specific diseases. These drugs inhibit RNA polymerase activity, demonstrating the enzyme's vulnerability and therapeutic potential.
The RNA polymerase drug landscape includes five small molecule drugs, such as RIFADIN and TALICIA, developed by companies like Sanofi and AM REGENT. These drugs are used across infectious disease and other therapeutic areas.
Top RNA polymerase Drugs
Four companies have approved drugs targeting RNA polymerase, including AM REGENT and Sanofi.
The presence of multiple players indicates moderate competition, but also established market access pathways.
| Drug | Company | Approved | Indications |
|---|---|---|---|
| RIMACTANE | TP ANDA HOLDINGS | 1971 | 1 |
| TRALEMENT | AM REGENT | 2020 | - |
RNA polymerase Drug Modality Landscape
Modalities
Routes of Administration
RNA polymerase is amenable to small molecule drugs, with oral options available for convenient dosing.
Exploring alternative modalities like oligonucleotides could provide a competitive advantage.
RNA polymerase Clinical Trials 677 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on RNA polymerase. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 282 | 251 | 13 | 18 | 95% |
| Phase 2 | 82 | 47 | 10 | 25 | 82% |
| Phase 3 | 107 | 66 | 13 | 28 | 84% |
| Phase 4 | 206 | 135 | 24 | 47 | 85% |
Top Sponsors
By Modality
Top Conditions
RNA polymerase Drug Approval Timeline (1971 - 2020)
The first drug was approved in 1971 (RIFADIN), with the most recent approval in 2020 (TRALEMENT).
The 50-year span suggests a mature field, but recent approval indicates continued innovation potential.
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Competitive Landscape
- • 4 companies competing
- • Market share by company
Full Drug Portfolio
- • All 5 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 5-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 388 (135 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 RNA polymerase. A trial counts if an approved drug acting on RNA 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.