Prescription medicine
Zolbetuximab Brand names: Vyloy
Zolbetuximab (Vyloy) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the zolbetuximab FDA label on DailyMed (effective August 11, 2026); every zolbetuximab label on DailyMed.
Highlights of the record
FDA label of August 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVYLOY, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)‑negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test [see Dosage and Administration ( 2.1
Forms and strengths
- 20 mg/ml
Injection (powder) for suspension.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,293 through July 30, 2026
What is zolbetuximab used for?
From the label: indications and usageVYLOY, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)‑negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test [see Dosage and Administration ( 2.1 ) and Clinical Studies ( 14 )]. […]
FDA pharmacologic class: Claudin 18.2-directed Cytolytic Antibody.
Source: FDA drug label (VYLOY), Astellas Pharma US, Inc., effective August 11, 2026 (SPL set e7695a21-abb6-47ac-93f8-0ece5a9c4409), via openFDA; the full label on DailyMed
Is there a generic for zolbetuximab (Vyloy)?
No generic zolbetuximab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for zolbetuximab?
The FDA Adverse Event Reporting System holds 1,293 reports that list zolbetuximab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 160 are coded as a death and 438 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Zolbetuximab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other