BLAINJECTIONINJECTABLEPriority Review
Approved
Oct 2024
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
10
Data completeness
4/8 — Partial
Priority Review
VYLOY (zolbetuximab) by Astellas is claudin 18. Approved for claudin 18.2-directed cytolytic antibody [epc]. First approved in 2024.
Drug data last refreshed 13h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VYLOY (zolbetuximab) is a claudin 18.2-directed monoclonal antibody approved in October 2024 for treating claudin 18.2-positive cancers. It works by targeting and destroying cancer cells that express the claudin 18.2 protein on their surface. This represents a novel mechanism in oncology targeting a tumor-associated antigen present in gastric and gastroesophageal junction cancers.
Growth
Early-stage growth product with active market establishment; commercial teams are in launch and market development phases with opportunities for scaling.
Mechanism of Action
Claudin 18.2-directed Antibody Interactions
Pharmacologic Class:
Claudin 18.2-directed Cytolytic Antibody
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
Zolbetuximab With mFOLFOX6 or CAPOX in Claudin 18.2 Overexpressed Advanced or Metastatic Biliary Tract Cancers
Started Aug 2026
32 enrolled
Advanced Biliary Tract CancerMetastatic Biliary Tract Carcinoma
A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer
Started Sep 2025
12 enrolled
Metastatic Pancreatic Adenocarcinoma
A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer
Started May 2025
500 enrolled
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or CancerLocally Advanced Unresectable Gastric Adenocarcinoma or CancerMetastatic Gastric Adenocarcinoma or Cancer+1 more
A Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer.
Started Apr 2025
377 enrolled
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or CancerLocally Advanced Unresectable Gastric Adenocarcinoma or CancerMetastatic Gastric Adenocarcinoma or Cancer+1 more
A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects With Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
Started Oct 2019
12 enrolled
Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.