VYLOY

(Zolbetuximab)

Phase 3Monoclonal antibody

VYLOY is a monoclonal antibody that works as a Claudin 18.2 Inhibitor.[2] It is being investigated across 7 indications, with its most advanced program in Phase 3.[1]

VYLOY is one of 138 monoclonal antibody programs targeting Gastric Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

137

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Gastric CancerActive, not recruiting

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or CancerActive, not recruiting

GC/GEJCNot yet recruiting

Advanced Biliary Tract CancerNot yet recruiting

Gastroesophageal AdenocarcinomaRecruiting

Pancreatic CancerActive, not recruiting

Esophageal CancerRecruiting

Gastric CancerPhase 3

Active, not recruiting

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or CancerPhase 3

Active, not recruiting

GC/GEJCPreclinical

Not yet recruiting

Advanced Biliary Tract CancerPhase 2

Not yet recruiting

Gastroesophageal AdenocarcinomaPhase 2

Recruiting

Pancreatic CancerPhase 3

Active, not recruiting

Esophageal CancerPhase 2

Recruiting

Competition

Competitive Landscape

335 competitors in Pancreatic Cancer

#DrugCompanyPhaseTrials

VYLOY

Astellas

Phase 3

2 2

Medrol

Pfizer

Preclinical

1 3

Byetta

AstraZeneca

Preclinical

1 4

Ayvakit Sprinkle

MMemorial Sloan Kettering Cancer Center

Preclinical

1 5

Xylocaine

MMEDRx USA, Inc.

Preclinical

1 6

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

1 8

Active Comparator

Moderna

Preclinical

1 9

Sulfonylureas

Eli Lilly

Preclinical

1 10

Hyperpolarized 13c Pyruvate

UUniversity of Maryland, Baltimore

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 3Active, not recruiting

Gastric Cancer

NCT03504397

Phase 3Active, not recruiting

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer

NCT03653507

Q4 2027

PreclinicalNot yet recruiting

GC/GEJC

NCT07680569

Phase 1/2Recruiting

Gastric Cancer

NCT06732856

Q2 2028

Phase 2Active, not recruiting

Gastric Cancer

NCT03505320

Q3 2028

Phase 3Recruiting

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer

NCT06901531

Clinical

Trials by Indication[1]

Gastric Cancer7 trials

A Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locally Advanced Gastric Cancer

Recruiting·—·Phase 1/2·NCT06732856·57 enrolled

Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer

Completed· Astellas logo

Astellas·Phase 2·NCT01630083·252 enrolled

A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.

Active, not recruiting· Astellas logo

Astellas·Phase 3·NCT03504397·565 enrolled

Show 4 more trials

Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric Cancer

Recruiting·SShanghai Zhongshan Hospital·Phase 2·NCT06468280·84 enrolled

Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping

Not yet recruiting·—·Phase 2·NCT06881017·140 enrolled

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)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT07431281·2,130 enrolled

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

Active, not recruiting· Astellas logo

Astellas·Phase 2·NCT03505320·143 enrolled

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer3 trials

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

Recruiting· Astellas logo

Astellas·Phase 3·NCT06901531·500 enrolled

Post-marketing Observational Study of VYLOY (Zolbetuximab) Injection 100 mg, 300 mg for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in South Korea

Recruiting· Astellas logo

Astellas··NCT06902545·377 enrolled

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 recruiting· Astellas logo

Astellas·Phase 3·NCT03653507·507 enrolled

Pancreatic Cancer2 trials

A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer

Active, not recruiting· Astellas logo

Astellas·Phase 1·NCT06396091·12 enrolled

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

Active, not recruiting· Astellas logo

Astellas·Phase 2·NCT03816163·393 enrolled

Adenocarcinoma2 trials

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

Completed· Astellas logo

Astellas·N/A·NCT03528629·18 enrolled

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

Completed· Astellas logo

Astellas·Phase 1·NCT04086758·12 enrolled

Esophageal Cancer1 trial

Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer

Recruiting·UUniversitaire Ziekenhuizen KU Leuven·Phase 2·NCT06962137·100 enrolled

4 more indications

ESS1 trial

Early Access Program for Zolbetuximab

Available· Astellas logo

Astellas··NCT06048081

Advanced Biliary Tract Cancer1 trial

A Single Arm Phase II Trial of Zolbetuximab in Combination With mFOLFOX6 or CAPOX Chemotherapy in Claudin 18.2 Overexpressed Advanced or Metastatic Biliary Tract Cancers

Not yet recruiting·MMidhun Malla·Phase 2·NCT07723534·32 enrolled

Gastroesophageal Adenocarcinoma1 trial

AACR Adaptive Biomarker-Driven Organ Preservation Trial In Gastroesophageal Adenocarcinomas (AACR-ADOPT-GEA)

Recruiting·AAmerican Association for Cancer Research·Phase 2·NCT07290985·242 enrolled

GC/GEJC1 trial

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

Not yet recruiting·KKaohsiung Medical University Chung-Ho Memorial Hospital·Preclinical·NCT07680569·40 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 18, 2024

VYLOY

BLA BLA761365

Oct 18, 2024

VYLOY

NDA BLA761365

Jun 6, 2025

VYLOY

NDA BLA761365

Sources

References

[1]
ClinicalTrials.gov — 19 trial records for Zolbetuximab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Zolbetuximab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Zolbetuximab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA BLA761365). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Astellas company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Claudin 18.2 Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Astellas

VYLOY

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2027

Q2 2028

Q3 2028

Trials by Indication[1]

Gastric Cancer7 trials

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer3 trials

Pancreatic Cancer2 trials

Adenocarcinoma2 trials

Esophageal Cancer1 trial

ESS1 trial

Advanced Biliary Tract Cancer1 trial

Gastroesophageal Adenocarcinoma1 trial

GC/GEJC1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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