Claudin 18.2 Inhibitors
1 drugsAbout Claudin 18.2
Claudin 18.2 (CLDN18.2) is a protein crucial for forming tight junctions between cells in epithelial and endothelial tissues. It exhibits restricted expression in normal tissues, primarily in gastric mucosa. CLDN18.2 is frequently overexpressed in various cancers.
CLDN18.2 has emerged as a promising oncology target due to its overexpression in gastric, pancreatic, and lung cancers. Currently, there is no genetic evidence data available linking CLDN18.2 mutations to disease pathogenesis, but its overexpression in tumors provides a rationale for targeted drug development.
There is one FDA-approved drug, VYLOY (ASTELLAS), targeting CLDN18.2 for oncology indications. VYLOY, approved in 2024, is a biologic (other) modality. The focus on CLDN18.2 reflects a trend towards targeted agents that selectively attack tumor cells.
Top Claudin 18.2 Drugs
ASTELLAS is the only company with an approved drug targeting CLDN18.2.
Low competition indicates a potential first-mover advantage for new entrants.
Claudin 18.2 Drug Modality Landscape
Modalities
Routes of Administration
Only one approved drug targets Claudin 18.2, using biologic (other) modality.
The lack of modality diversity suggests an opportunity for novel therapeutic approaches.
Claudin 18.2 Clinical Trials 18 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on Claudin 18.2. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 4 | 1 | 0 | 3 | 100% |
| Phase 2 | 9 | 1 | 0 | 8 | 100% |
| Phase 3 | 4 | 0 | 0 | 4 | - |
| Phase 4 | 1 | 0 | 0 | 1 | - |
Top Sponsors
By Modality
Top Conditions
Top Drugs
Claudin 18.2 Drug Approval Timeline (2024 - 2024)
The first and most recent drug approval for CLDN18.2 was VYLOY in 2024.
Recent approval suggests growing interest, but also early stage of market saturation.
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: 11 (3 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 Claudin 18.2. A trial counts if an approved drug acting on Claudin 18.2 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.