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 157 monoclonal antibody programs targeting Esophageal Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

156

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Esophageal CancerActive, not recruiting

AdenocarcinomaActive, not recruiting

Esophageal AdenocarcinomaActive, not recruiting

Pancreatic CancerRecruiting

Gastric CancerActive, not recruiting

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or CancerRecruiting

GC/GEJCNot yet recruiting

Esophageal CancerPhase 2

Active, not recruiting

AdenocarcinomaPhase 3

Active, not recruiting

Esophageal AdenocarcinomaPhase 3

Active, not recruiting

Pancreatic CancerPhase 3

Recruiting

Gastric CancerPhase 3

Active, not recruiting

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

Recruiting

GC/GEJCPreclinical

Not yet recruiting

Competition

Competitive Landscape

1063 competitors in Pancreatic Cancer

#DrugCompanyPhaseTrials

VYLOY

Astellas

Phase 3

2 2

Gemzar

GGynecologic Oncology Group

Byetta

1 4

MS Contin

Merck & Co.

Preclinical

1 5

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 6

ABI-007

Bristol-Myers Squibb

Preclinical

2 7

Chemotherapy Agents

Takeda

Preclinical

1 8

Secretin-Ferring

Ferring

Preclinical

1 9

Concurrent Lenvatinib

TTrans Tasman Radiation Oncology Group

Preclinical

2 10

Biguanides

Eli Lilly

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 1Active, not recruiting

Pancreatic Cancer

NCT06396091

Phase 2Active, not recruiting

Pancreatic Cancer

NCT03816163

Phase 3Active, not recruiting

Gastric Cancer

NCT03504397

Phase 3Active, not recruiting

Adenocarcinoma

NCT03653507

Q2 2027

Phase 2Active, not recruiting

Gastric Cancer

NCT03505320

Q4 2027

PreclinicalNot yet recruiting

GC/GEJC

NCT07680569

Clinical

Trials by Indication[1]

Gastric Cancer7 trials

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

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

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

Show 4 more trials

A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer

Active, not recruiting· Astellas logo

Astellas·Phase 2·NCT03505320·143 enrolled

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 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

Adenocarcinoma3 trials

A 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 (GLOW).

Active, not recruiting· Astellas logo

Astellas·Phase 3·NCT03653507·507 enrolled

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

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 Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer

Active, not recruiting· Astellas logo

Astellas·Phase 2·NCT03816163·393 enrolled

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer2 trials

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, 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

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

2 more indications

ESS1 trial

Early Access Program for Zolbetuximab

Available· Astellas logo

Astellas··NCT06048081

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

Sources

References

[1]
ClinicalTrials.gov — 17 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 (BLA 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

Q2 2027

Q4 2027

Trials by Indication[1]

Gastric Cancer7 trials

Adenocarcinoma3 trials

Pancreatic Cancer2 trials

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer2 trials

Esophageal Cancer1 trial

ESS1 trial

GC/GEJC1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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