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Vyloy (ZOLBETUXIMAB)
Vyloy works by binding to Claudin 18.2 on cancer cells, triggering their destruction.
Vyloy (zolbetuximab) is a Claudin 18.2-directed Cytolytic Antibody developed by Astellas, targeting a specific protein on cancer cells. It is a monoclonal antibody that works by binding to Claudin 18.2, leading to the destruction of cancer cells. Vyloy has been approved by the FDA for the treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. The commercial status of Vyloy is patented, and it is currently owned by Astellas. Key safety considerations include the potential for severe side effects, such as infusion reactions and gastrointestinal toxicity.
At a glance
| Generic name | ZOLBETUXIMAB |
|---|---|
| Sponsor | Astellas |
| Drug class | Claudin 18.2-directed Cytolytic Antibody [EPC] |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2024 |
| Annual revenue | 100 |
Mechanism of action
Zolbetuximab-clzb is a claudin 18.2 (CLDN18.2)-directed cytolytic antibody that depletes CLDN18.2-positive cells via antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Zolbetuximab-clzb in combination with chemotherapy had increased antitumor activity in CLDN18.2-expressing mouse tumor models compared to zolbetuximab-clzb or chemotherapy alone.
Approved indications
- locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma
- locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma
Common side effects
- Nausea
- Vomiting
- Decreased appetite
- Diarrhea
- Peripheral sensory neuropathy
- Abdominal pain
- Constipation
- Decreased weight
- Hypersensitivity reactions
- Pyrexia
- Decreased neutrophil count
- Decreased leucocyte count
Key clinical trials
- A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer (PHASE2)
- A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer (PHASE3)
- A Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer.
- Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2 (PHASE3)
- Real-WorlD ZolbetUximab in Patients With HER-2 Negative and CLaudin 18.2 PosItive MetastatiC AdEnocarcinoma
- A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer. (PHASE3)
- 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). (PHASE3)
- Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric Cancer (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Vyloy CI brief — competitive landscape report
- Vyloy updates RSS · CI watch RSS
- Astellas portfolio CI