zolbetuximab
Trade name: Vyloy
mAbapprovedOrphan Drug FDAFast Track FDA
Approved
Oct 18, 2024
Zolbetuximab, sold under the brand name Vyloy, is a monoclonal antibody used for the treatment of gastric cancer. It is a claudin 18.2-directed cytolytic antibody against isoform 2 of Claudin-18. Zolbetuximab was developed by Ganymed Pharmaceuticals. Astellas Pharma acquired the rights to zolbetuximab in December 2016, when it acquired Ganymed Pharmaceuticals. — Wikipedia
Clinical trial activity
11 trials · 4 clinical orgs · 2 marketing orgs
Phase 1
3
Phase 2
8
Phase 3
3
Phase 4
0
Earliest trial started Jun 21, 2018 (NCT03504397)
Timeline
2010s
2020s
- Oct 18, 2024
Leo Pharma — Earliest FDA Approval
- Oct 18, 2024
Astellas — Marketing Organization
- Oct 18, 2024
Leo Pharma — NDA Organization
Indications
Approved for
Mechanism of action
- Claudin-18INHIBITOR
CLDN18 inhibitor
Approval history
- approvedPriority reviewFast trackOct 18, 2024
Chemistry & pharmacology
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaZolbetuximab ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06962137 | Phase 2 | Oct 1, 2025 | Katholieke Universiteit Leuven |
| NCT06901531 | Phase 3 | May 22, 2025 | Astellas |
| NCT06881017 | Phase 2 | May 1, 2025 | China Medical University |
| NCT06732856 | Phase 1/Phase 2 (Phase 2) | Mar 1, 2025 | University of Ulsan |
| NCT06396091 | Phase 1 | Jul 22, 2024 | Astellas |
| NCT04086758 | Phase 1 | Sep 30, 2019 | Astellas |
| NCT03816163 | Phase 2 | Mar 15, 2019 | Astellas |
| NCT03653507 | Phase 3 | Oct 31, 2018 | Astellas |
| NCT03505320 | Phase 2 | Jun 29, 2018 | Astellas |
| NCT03504397 | Phase 3 | Jun 21, 2018 | Astellas |
| NCT06048081 | N/A | — | Astellas |
Showing 11 of 11 trials
Page 1 / 1
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Astellas | For profit | 8 | 8 | 4 | 2018 |
| China Medical University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Katholieke Universiteit Leuven | Academic/Hospital | 1 | 1 | 1 | 2025 |
| University of Ulsan | Academic/Hospital | 1 | 1 | 1 | 2025 |
4 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Astellas | For profit | MKTG | Oct 18, 2024 |
| Leo Pharma | For profit | NDA | Oct 18, 2024 |