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Drug

Zolbetuximab

Approved · EMA
ClassClaudin-18 binding agentEmerging researchLate-stage development

Also known as Vyloy, Claudiximab, immunoglobulin G1, anti-(human Claudin-18.2) (human-mus musculus monoclonal IMAB362 heavy chain), disulfide with human-mus musculus monoclonal IMAB362 .kappa.-chain, dimer.

RxNorm2695869ChEMBLCHEMBL2109427ATCL01FX31UNIITF5MPQ8WGY
1
Research papers
12
Active clinical trials
Claudin-18
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 1 Open-label Study to Assess the Safety and Tolerability of Zolbetuximab (IMAB362) in Combination With Chemotherapy (mFOLFIRINOX) in Participants With CLDN18.2 Positive Metastatic Pancreatic Adenocarcinoma

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-Positive

Clinical trial2026-07-02Results expected Q3 2028 · ClinicalTrials.gov

Phase Ib/IIa Open-label Study, to Evaluate Safety, Tolerability, and Antitumor Activity of HCB101 in Combination With Multiple Agents in Subjects With Advanced Gastric or Gastro-esophageal (GEJ) Adenocarcinoma

Clinical trial2026-07-02Results expected Q4 2027 · ClinicalTrials.gov

A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)

Clinical trial2026-07-01Results expected Q3 2029 · ClinicalTrials.gov

A Phase 2 Study of Zolbetuximab (IMAB362) as Monotherapy and in Combination With Chemotherapy and/or Immunotherapy in Subjects With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and Locoregional Gastric or GEJ Adenocarcinoma Whose Are Claudin (CLDN) 18.2 Positive

Clinical trial2026-06-18Results expected Q4 2026 · ClinicalTrials.gov

A Phase 2, Open-Label, Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (IMAB362) in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

Clinical trial2026-06-04Results expected Q3 2026 · ClinicalTrials.gov

A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Clinical trial2026-05-04Results posted · ClinicalTrials.gov

A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Clinical trial2026-04-17Results posted · ClinicalTrials.gov

Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric or Gastroesophageal Adenocarcinoma (ROSETTE Trial): an Open-label, Single-center, Randomized Phase 2 Trial

Clinical trial2026-01-21Results expected Q4 2027 · ClinicalTrials.gov

Phase II RAINSPOT: a Multicentric Open Label Trial of Zolbetuximab-Paclitaxel-Ramucirumab in Second Line Setting for CLDN18.2 Positive Gastro-esophageal Adenocarcinoma

Clinical trial2025-12-22Results expected Q4 2029 · ClinicalTrials.gov

Approval: Vyloy (EMA)

Regulatory2024-09-19EMA

ILUSTRO: Phase II Multicohort Trial of Zolbetuximab in Patients with Advanced or Metastatic Claudin 18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma.

Research2023-10-01Clinical cancer research : an official journal of the American Association for Cancer Research

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Zolbetuximab
Aliases & brands
VyloyClaudiximabimmunoglobulin G1, anti-(human Claudin-18.2) (human-mus musculus monoclonal IMAB362 heavy chain), disulfide with human-mus musculus monoclonal IMAB362 .kappa.-chain, dimer
RxNorm CUI
2695869
ChEMBL ID
CHEMBL2109427
ATC codes
L01FX31
UNII
TF5MPQ8WGY
Primary mechanism
Claudin-18 binding agent
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Claudin-18
CLDN18 · P56856
BINDING AGENTClaudin-18 binding agent

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2024-09-19
Latest approval
2024-09-19
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2024-09-19Approval
Approval: Vyloy (EMA)
Indication: Vyloy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first line treatment of adult patients with locally advanced unresectable… Show full indication

Vyloy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first line treatment of adult patients with locally advanced unresectable or metastatic HER2 negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive (see section 4.2).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

16 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
16
registered trials across all phases
LATEST COMPLETION 2021
12
Active studies
7
Recruiting
5
Late-stage (III+)
4
Completed
PHASE DISTRIBUTIONn = 16
Phase 13Phase 1 / 22Phase 26Phase 34Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)

RecruitingPH IIIKey trialAstraZenecan=2,1302031

A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-Positive

RecruitingPH IIIAstellas Pharma Global Development, Inc.n=5002028

A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Active, not recruitingPH IIIAstellas Pharma Global Development, Inc.n=5652026

A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Active, not recruitingPH IIIAstellas Pharma Global Development, Inc.n=5072026

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1 Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects With Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma

CompletedPH IAstellas Pharma China, Inc.n=122021

A Phase 1 Open-label Study of IMAB362 in Japanese Subjects With Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma

CompletedN/AAstellas Pharma Incn=182020

A Randomized Phase II Multicenter, Open-Label Study Evaluating the Efficacy and Safety of IMAB362 in Combination With the EOX (Epirubicin, Oxaliplatin, Capecitabine) Regimen as First-Line Treatment of Patients With CLDN18.2-Positive Advanced Adenocarcinomas of the Stomach, the Esophagus or the Gastroesophageal Junction

CompletedPH IIAstellas Pharma Global Development, Inc.n=2522019

Clinical First-in-human Single-dose Escalation Study Evaluating the Safety and Tolerability of Claudiximab (iMAB-362) in Hospitalized Patients With Advanced Gastroesophageal Cancer. A Multi-center, Phase I, Open-label, i.v. Infusion Study

CompletedPH IGanymed Pharmaceuticals GmbHn=152010

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

ILUSTRO: Phase II Multicohort Trial of Zolbetuximab in Patients with Advanced or Metastatic Claudin 18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma.

Clinical cancer research : an official journal of the American Association for Cancer Research · 2023 · 65 cites
Recent papers

ILUSTRO: Phase II Multicohort Trial of Zolbetuximab in Patients with Advanced or Metastatic Claudin 18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma.

Clinical cancer research : an official journal of the American Association for Cancer Research · 2023 · 65 cites
Major research themes5
Adenocarcinoma1Antibodies, Monoclonal1Claudins1Esophageal Neoplasms1Stomach Neoplasms1
Journals, researchers & institutions
Top journals
  • Clinical cancer research : an official journal of the American Association for Cancer Research1
Leading researchers
  • Arozullah A1
  • Bai LY1
  • Bang YJ1
  • Fazio N1
  • Ilson DH1
  • Kim TY1
  • Klempner SJ1
  • Lee KW1
Leading institutions
free-text, unnormalised
  • China Medical University Hospital1
  • Clinical Sciences1
  • European Institute of Oncology1
  • Institut de Cancérologie et d'Hématologie1
  • Massachusetts General Hospital Cancer Center1
  • Memorial Sloan Kettering Cancer Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.