BLAINJECTIONINJECTABLEPriority Review
Approved
Oct 2024
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
9
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 Yesterday · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VYLOY (zolbetuximab) is a claudin 18.2-directed monoclonal antibody approved in October 2024 for gastric and gastroesophageal junction adenocarcinomas. It represents a novel immunotherapy targeting a tumor-associated surface antigen, enabling cytolytic killing of cancer cells expressing claudin 18.2. This represents a new mechanism of action in gastric cancer treatment.
Growth
As a newly approved oncology biologic in growth phase, VYLOY will require significant commercial investment and field team expansion to establish market presence against established competitors.
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 (9)
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
A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer
Started Mar 2019
393 enrolled
Pancreatic CancerMetastatic Pancreatic CancerMetastatic Pancreatic 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.