Topoisomerase II Inhibitors
7 drugsAbout Topoisomerase II
Topoisomerase II is an enzyme essential for DNA replication, transcription, and chromosome segregation. It relieves torsional stress by cutting and re-ligating DNA strands during these processes. Inhibiting Topoisomerase II disrupts DNA metabolism, leading to cell death, particularly in rapidly dividing cancer cells.
Topoisomerase II is a viable drug target with seven approved drugs, though there is currently no genetic evidence directly linking it to specific diseases. Inhibitors of this enzyme are clinically relevant, especially in oncology, making it an important target for addressing critical medical needs.
The seven FDA-approved drugs targeting Topoisomerase II are all small molecules, including DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), DOXIL (LIPOSOMAL), and ELLENCE. These drugs are developed by six companies, including Pfizer, Baxter, and EPIC PHARMA LLC, primarily for oncology indications.
Top Topoisomerase II Drugs
Six companies have approved drugs targeting Topoisomerase II, including EPIC PHARMA LLC and Pfizer.
The competitive landscape is moderately concentrated, suggesting potential entry barriers for new players.
| Drug | Company | Approved | Indications |
|---|---|---|---|
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | ALEMBIC | 2013 | 10 |
| EPIRUBICIN HYDROCHLORIDE | Pfizer | 2006 | 1 |
| IDAMYCIN PFS | Pfizer | 1997 | 1 |
| VYXEOS | JAZZ PHARMS THERAP | 2017 | 1 |
Topoisomerase II Drug Modality Landscape
Modalities
Routes of Administration
Topoisomerase II is druggable by small molecules, though no oral formulations are currently approved.
The modality landscape suggests an opportunity to explore alternative modalities like antibodies or PROTACs.
Topoisomerase II Clinical Trials 1,779 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on Topoisomerase II. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 609 | 274 | 154 | 177 | 64% |
| Phase 2 | 840 | 283 | 151 | 402 | 65% |
| Phase 3 | 311 | 116 | 36 | 158 | 76% |
| Phase 4 | 19 | 9 | 1 | 9 | 90% |
Top Sponsors
By Modality
Top Conditions
Top Drugs
Phase 3 Readout Calendar Pro
8 Phase 3 trials testing approved Topoisomerase II drugs across all sponsors.
Coverage: trials whose intervention is an approved drug targeting Topoisomerase II. Pre-approval candidates with development codes (e.g. AZD0901, MK-7240) are not yet linked. Anchored on CT.gov primary completion date.
Topoisomerase II Drug Approval Timeline (1995 - 2026)
The first drug targeting Topoisomerase II was approved in 1995, with the most recent approval in 2026.
The approval timeline indicates sustained interest in this target, but potential saturation warrants careful market analysis.
Pro Intelligence Preview
Deep insights for drug target analysis
Competitive Landscape
- • 5 companies competing
- • Market share by company
Full Drug Portfolio
- • All 7 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 7-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 564 (160 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 Topoisomerase II. A trial counts if an approved drug acting on Topoisomerase II 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.