Cardiolipin Inhibitors
1 drugsAbout Cardiolipin
Cardiolipin is a phospholipid in the inner mitochondrial membrane, crucial for mitochondrial structure, energy production, and apoptosis. It is a dimeric phospholipid that plays a key role in maintaining mitochondrial function.
Cardiolipin is emerging as a drug target, with one FDA-approved drug suggesting therapeutic relevance. Currently, there is no genetic evidence linking cardiolipin to specific diseases, highlighting the need for further research.
FORZINITY is the only FDA-approved drug targeting cardiolipin, developed by STEALTH BIOTHERAPS. It is a small molecule approved in 2025, representing the sole entry in this therapeutic area.
Top Cardiolipin Drugs
STEALTH BIOTHERAPS is the only company with an approved drug targeting cardiolipin.
Low competition suggests a first-mover advantage but also higher market entry risk.
Cardiolipin Drug Modality Landscape
Modalities
Routes of Administration
Only one approved drug targets Cardiolipin, using small molecule modality.
The modality landscape presents a whitespace opportunity for alternative modalities.
Cardiolipin Clinical Trials 11 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on Cardiolipin. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 2 | 2 | 0 | 0 | 100% |
| Phase 2 | 6 | 5 | 1 | 0 | 83% |
| Phase 3 | 2 | 1 | 0 | 1 | 100% |
| Phase 4 | 1 | 0 | 0 | 1 | - |
Top Sponsors
By Modality
Top Conditions
Top Drugs
Cardiolipin Drug Approval Timeline (2025 - 2025)
The first and only drug, FORZINITY, was approved in 2025.
Recent approval indicates a nascent market with potential for growth.
Pro Intelligence Preview
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: 2 (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 Cardiolipin. A trial counts if an approved drug acting on Cardiolipin 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.