zolbetuximab History and Updates

53 events · 2012 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

2
FDA Approvals
0
Label Revisions
51
Trial Milestones
0
Pivotal Publications
zolbetuximab — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications20122013201420152016201720182019202020212022202320242025202620272028202920302031Trial: NCT07431281 2026-02-03 → 2029-08-16 (primary completion)Trial: NCT06962137 2025-12-11 → 2029-12-31 (primary completion)Trial: NCT06396091 2025-09-24 → 2026-07-31 (primary completion)Trial: NCT06901531 2025-05-22 → 2028-09-30 (primary completion)Trial: NCT06881017 2025-05-01 → 2029-08-01 (primary completion)Trial: NCT06732856 2025-04-04 → 2027-12-31 (primary completion)Trial: NCT06902545 2025-04-03 → 2030-07-31 (primary completion)Trial: NCT06468280 2024-11-08 → 2027-12-31 (primary completion)Trial: NCT04086758 2019-10-18 → 2021-01-22 (primary completion)Trial: NCT03816163 2019-03-15 → 2026-08-31 (primary completion)Trial: NCT03653507 2018-11-28 → 2022-10-25 (primary completion)Trial: NCT03505320 2018-06-29 → 2026-12-31 (primary completion)Trial: NCT03504397 2018-06-21 → 2022-09-09 (primary completion)Trial: NCT03528629 2018-06-08 → 2020-06-09 (primary completion)Trial: NCT01630083 2012-07-19 → 2019-01-31 (primary completion)FDA approval — 2024-10-18 FDA approved Vyloy (zolbetuximab) (BLA 761365) Sponsor: ASTELLAS. Class: Type 1 - New Molecular Entity.FDA approval (supplemental) — 2025-06-06 FDA approved supplemental application for Vyloy (zolbetuximab) — Efficacy (BLA 761365 S-3) Sponsor: ASTELLAS. Class: Efficacy.Results posted — 2025-01-27 Trial results posted: NCT03653507 A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-pResults posted — 2025-02-26 Trial results posted: NCT03504397 A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.today (2026-07-17)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-07-17Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for zolbetuximab since 2012, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (3)

2025
2022

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06468280
Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-
Primary completion· ClinicalTrials.gov
Phase 1/Phase 2 primary completion: NCT07680569
Phase Ib/IIa Open-label Study, to Evaluate Safety, Tolerability, and Antitumor Activity of HCB101 in Combination With Multiple Agents in Sub
Primary completion· ClinicalTrials.gov
Phase 1/Phase 2 primary completion: NCT06732856
A Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locally Advanced Gastric C
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06881017
Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07431281
Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gast
Primary completion· ClinicalTrials.gov
Primary completion: NCT06902545
A Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer.

Past events

2026
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07431281
Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gast
2025
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06962137
Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06901531
A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06881017
Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping
Trial started· ClinicalTrials.gov
Phase 1/Phase 2 trial started: NCT06732856
A Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locally Advanced Gastric C
Trial started· ClinicalTrials.gov
Trial started: NCT06902545
A Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer.
Results posted· ClinicalTrials.gov
Trial results posted: NCT03504397
A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.
Results posted· ClinicalTrials.gov
Trial results posted: NCT03653507
A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-p
2024
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06468280
Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-
2023
2022
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT03653507
A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-p
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT03504397
A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.
2021
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT04086758
A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects With Locally Advanced Unresectable or Metastatic Gastric or Gastro-eso
2020
Primary completion· ClinicalTrials.gov
NA primary completion: NCT03528629
A Study of IMAB362 in Japanese Subjects With Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
2019
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT04086758
A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects With Locally Advanced Unresectable or Metastatic Gastric or Gastro-eso
2018
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT03653507
A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-p
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT03504397
A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.
Trial started· ClinicalTrials.gov
NA trial started: NCT03528629
A Study of IMAB362 in Japanese Subjects With Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
2012
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT01630083
Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.