Ornithine Decarboxylase Inhibitors
1 drugsAbout Ornithine Decarboxylase
Ornithine Decarboxylase (ODC) catalyzes the first step in polyamine synthesis, which are essential for cell growth and apoptosis. Its role in cellular proliferation has made it a potential drug target.
ODC is a potential therapeutic target due to its involvement in cell growth, though no genetic evidence currently links it to specific diseases.
One FDA-approved drug, Iwilfin, targets ODC. It is a small molecule approved in 2023, developed by USWM, for an indication in the 'other' therapeutic area category.
Top Ornithine Decarboxylase Drugs
USWM is the only company with an approved drug targeting ODC.
Low competition suggests an opportunity for new entrants, but also highlights potential target risk.
Ornithine Decarboxylase Drug Modality Landscape
Modalities
Routes of Administration
Only one approved drug targets Ornithine Decarboxylase, using small molecule modality.
The lack of diverse modalities represents a whitespace opportunity for novel therapeutic approaches.
Ornithine Decarboxylase Clinical Trials 9 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on Ornithine Decarboxylase. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 1 | 0 | 0 | 1 | - |
| Phase 2 | 7 | 4 | 0 | 3 | 100% |
| Phase 3 | 1 | 1 | 0 | 0 | 100% |
Top Sponsors
By Modality
Top Conditions
Top Drugs
Ornithine Decarboxylase Drug Approval Timeline (2023 - 2023)
The first and only drug targeting ODC was approved in 2023.
Recent approval suggests renewed interest, but also early stage of market maturity.
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Deep insights for drug target analysis
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: 9 (1 company)
- • 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 Ornithine Decarboxylase. A trial counts if an approved drug acting on Ornithine Decarboxylase 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.