OncoSignal
Live from Open Targets Platform, fetched 2026-11-12 09:40 UTC. Every row links to its source record.

CLDN18 claudin 18

ENSG00000066405 · protein coding · Open Targets profile

Involved in alveolar fluid homeostasis via regulation of alveolar epithelial tight junction composition and therefore ion transport and solute permeability, potentially via downstream regulation of the actin cytoskeleton organization and beta-2-adrenergic signaling (By similarity). Required for lung alveolarization and maintenance of the paracellular alveolar epithelial barrier (By similarity). Acts to maintain epithelial progenitor cell proliferation and organ size, via regulation of YAP1 localization away from the nucleus and thereby restriction of YAP1 target gene transcription (By similarity). Acts as a negative regulator of RANKL-induced osteoclast differentiation, potentially via relocation of TJP2/ZO-2 away from the nucleus, subsequently involved in bone resorption in response to calcium deficiency (By similarity). Mediates the osteoprotective effects of estrogen, potentially via acting downstream of estrogen signaling independently of RANKL signaling pathways (By similarity). .

In 1 of 15 cancers, the evidence for CLDN18 comes mainly from inherited variants

Each row is a cancer, strongest overall evidence first. The two dots show how strong the inherited (germline) and tumour-mutation (somatic) evidence is; the line between them is the gap.

Inherited (germline) variantsMutations in tumours (somatic)
00.250.50.751gastric adenocarcinomagastric adenocarcinomagastroesophageal junction adenocarcinomagastroesophageal junction adenocarcinomagastric cancergastric cancergastric neoplasmgastric neoplasmneoplasm of esophagusneoplasm of esophagusesophageal canceresophageal cancerpancreatic neoplasmpancreatic neoplasmlung adenocarcinomalung adenocarcinomamalignant pancreatic neoplasmmalignant pancreatic neoplasmesophageal adenocarcinomaesophageal adenocarcinomapancreatic adenocarcinomapancreatic adenocarcinomahepatocellular carcinomahepatocellular carcinomalung carcinomalung carcinomaprostate carcinomaprostate carcinomaprostate carcinoma: germline 0.12small cell lung carcinomasmall cell lung carcinoma

Scores run from 0 (no evidence) to 1 (strongest). A missing dot at 0 means Open Targets holds no evidence of that kind. Source: Open Targets Platform, fetched live.

Tractability

Antibody
Advanced Clinical, UniProt loc med conf, UniProt SigP or TMHMM, GO CC med conf

gnomAD loss of function constraint: o/e 0.799340009689331 (upper bound 1.1614999771118164). Low values mean loss of function is poorly tolerated, a safety flag for inhibition.

Who runs trials of these drugs

Principal investigators and study chairs on 23 registry trials, updated in the last three years, of the most advanced drugs against CLDN18 (zolbetuximab), ranked by Phase 2+ trials. Live from ClinicalTrials.gov.

5 of 20 trials of drugs against CLDN18 have sites only in Europe

Registry trials of zolbetuximab updated in the last three years, counted by the country group of their listed sites. A trial with sites in several groups counts in each; 8 of 20 have all sites in one country.

Sites only in this groupSites here and elsewhere
United StatesUnited States: 2 trials with sites only hereUnited States: 7 trials with sites here and elsewhere9ChinaChina: 2 trials with sites only hereChina: 5 trials with sites here and elsewhere7EuropeEurope: 5 trials with sites only hereEurope: 7 trials with sites here and elsewhere12JapanJapan: 2 trials with sites only hereJapan: 6 trials with sites here and elsewhere8OtherOther: 1 trials with sites only hereOther: 8 trials with sites here and elsewhere9

Site counts are not patients per country, and trials registered only outside ClinicalTrials.gov are not covered. Where sites are is a fact about the record, not a judgement of its quality. Europe is the EU and EEA, the UK and Switzerland. 3 trials list no sites and are left out. Source: ClinicalTrials.gov, fetched live.

No terminated, withdrawn or suspended trials of CLDN18's drugs are registered

Paediatric incentives and obligations for CLDN18's drugs

For zolbetuximab: what EMA and FDA publish about paediatric plans, orphan status and pediatric approvals, and how many registered studies take children. Each line is a yes, no or not published fact from the record linked under it; none of it is a forecast.

  • FDA pediatric target list: no · CLDN18 is not on the list
    Rule: Target is on FDA's Pediatric Molecular Target List (relevant targets). Source: FDA Pediatric Molecular Target List (Listed as February 2026 on the FDA Pediatric Oncology page; the file served is 9.7.22_the_relevant_molecular_target_list.xlsx, whose Summary of Changes sheet is headed 'SEPTEMBER 2022 UPDATE' (footnote date 2022-09-01)), 2026-11-11
  • EU paediatric investigation plan: yes · EMEA-002695-PIP01-19 (zolbetuximab, Treatment of gastric cancer and gastro-oesophageal junction adenocarcinoma;Treatment of pancreatic cancer): W: decision granting a waiver in all age groups for all conditions or indications, 18 Mar 2020
    Rule: An EMA PIP decision (agreement, modification or waiver) lists the drug as its active substance, exact name. Source: EMA EMEA-002695-PIP01-19, 2026-11-11
  • EU orphan designation: yes · EU/3/10/803 positive 26 Nov 2010: Treatment of gastric cancer
    Rule: An EU orphan designation lists the drug as its active substance (exact name) or belongs to a medicine that does; withdrawn and expired designations are listed with their status. Source: EMA EU/3/10/803, 2026-11-11
  • Authorised in the EU: yes · Vyloy: authorised since 19 Sept 2024, orphan medicine
    Rule: An EMA medicine record lists the drug as its active substance or INN, exact name; national-only authorisations are not in this file. Source: EMA EPAR Vyloy, 2026-11-11
  • FDA orphan designation: not published · FDA's orphan designation database turns away automated requests, so this app does not read it; search it by hand at the link
    Rule: Would be: an FDA orphan designation names the drug. Source: FDA orphan designations search
  • FDA pediatric oncology approval: no · FDA's table lists no pediatric approval of zolbetuximab
    Rule: FDA's Pediatric Oncology Drug Approvals table names the drug. Source: FDA Pediatric Oncology Drug Approvals (content current as of 2026-03-03), 2026-11-12
  • Registered studies open to children: no · No interventional study of zolbetuximab includes patients under 18
    Rule: The registry's age group includes Child (birth to 17 years), which also counts studies that set no minimum age. Source: ClinicalTrials.gov search, 2026-11-12

Rare pediatric disease voucher. FDA, content current as of 29 Apr 2026: “As of February 3, 2026, enactment of the Consolidated Appropriations Act, 2026, the rare pediatric disease PRV program will sunset after September 30, 2029. FDA may not award any PRVs under this program after September 30, 2029.” Voucher sale prices are not shown here; they appear only as company-reported news. FDA: Rare Pediatric Disease Designation and Priority Review Voucher Programs

All 1 drugs and clinical candidates as a table

Each drug, stage and indication links to its Open Targets record, where the trials and approvals behind it are listed. Salt forms (for example a mesylate) are listed as Open Targets records them, as separate entries.

DrugTypeHighest stageIndicationsSource records
ZOLBETUXIMABAntibodyapprovalgastric cancer, neoplasm of esophagus, gastric neoplasm, neoplasm, gastroesophageal junction adenocarcinoma, gastric adenocarcinoma, esophageal cancer, pancreatic neoplasm, +3 moreOpen Targets · ChEMBL