Zolbetuximab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Chimeric (mouse/human) |
| Target | CLDN18.2 |
| Clinical data | |
| Trade names | Vyloy |
| Other names | IMAB362, claudiximab, zolbetuximab-clzb |
| AHFS/Drugs.com | Vyloy |
| License data |
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| Routes of administration | Intravenous infusion |
| ATC code | |
| Legal status | |
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Zolbetuximab, sold under the brand name Vyloy, is a monoclonal antibody used for the treatment of gastric cancer.[4] It is a claudin 18.2-directed cytolytic antibody against isoform 2 of Claudin-18.[4] Zolbetuximab was developed by Ganymed Pharmaceuticals.[7] Astellas Pharma acquired the rights to zolbetuximab in December 2016, when it acquired Ganymed Pharmaceuticals.[8]
Zolbetuximab was approved for medical use in Japan in March 2024,[9] in the European Union in September 2024,[5] and in the United States in October 2024.[10][11] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[12]
- ^ https://www.tga.gov.au/resources/prescription-medicines-registrations/vyloy-astellas-pharma-australia-pty-ltd
- ^ "Vyloy product information". Health Canada. 13 December 2024. Retrieved 27 December 2024.
- ^ "Summary Basis of Decision for Vyloy". Drug and Health Products Portal. 19 February 2024. Retrieved 10 July 2025.
- ^ a b c "Vyloy- zolbetuximab injection, powder, for suspension". DailyMed. 18 October 2024. Retrieved 31 October 2024.
- ^ a b Cite error: The named reference
Vyloy EPARwas invoked but never defined (see the help page). - ^ Cite error: The named reference
Vyloy PIwas invoked but never defined (see the help page). - ^ "Our mission - Ganymed Pharmaceuticals GmbH - Ganymed Pharmaceuticals GmbH". www.ganymed-pharmaceuticals.de. Archived from the original on 20 December 2013. Retrieved 20 December 2013.
- ^ "Astellas Completes Acquisition of Ganymed Pharmaceuticals". Astellas Pharma. Archived from the original on 5 August 2020. Retrieved 20 January 2023.
- ^ "Astellas' Vyloy (zolbetuximab) Approved in Japan for Treatment of Gastric Cancer" (Press release). Astellas Pharma. 26 March 2024. Archived from the original on 19 April 2024. Retrieved 19 April 2024 – via PR Newswire.
- ^ "FDA Roundup: October 18, 2024". U.S. Food and Drug Administration (FDA) (Press release). 18 October 2024. Archived from the original on 21 October 2024. Retrieved 19 October 2024. This article incorporates text from this source, which is in the public domain.
- ^ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). Archived from the original on 19 April 2024. Retrieved 28 October 2024.
- ^ New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.