Drugs / zolbetuximab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Vyloy | — | 2024-09-19 | europa.eu ↗ |
Trials 18 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07680569 Background | Jun 2026 → Dec 2027 expected | gastroesophageal junction adenocarcinoma | Kaohsiung Medical University Chung-Ho Memorial Hospital | Not yet recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07431281 Comparator | Feb 2026 → Aug 2029 expected | esophageal cancer, gastric cancer, gastroesophageal junction adenocarcinoma | AstraZeneca | Recruiting | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2024-10-10 | Roche Global Development | Roche obtains CE certification for the first companion diagnostic to identify patients with gastric and gastroesophageal junction cancer eligible for targeted treatment with VYLOY roche.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zolbetuximab | “the first-in-class monoclonal antibody, zolbetuximab (formerly known as IMAB362), binds to CLDN18.2 and can induce immune-mediated lysis of CLDN18.2-positive cells.” PMID 31240302 ↗ Sep 201918“PURPOSE: Zolbetuximab (IMAB362) is engineered to induce antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity.” PMID 36607429 ↗ Jan 2023 “Targeted therapy: trastuzumab (HER2-positive) or zolbetuximab (Claudin 18.2-positive)” NCT07000253 ↗ |
| Known as | Claudiximab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00909025 ↗ |
| Known as | IMAB362 | “A Global, Multicenter, Open-label, Early Access Program for Zolbetuximab (IMAB362) Plus mFOLFOX6 or CAPOX in Patients With Claudin18.2-Positive, HER2-Negative, Locally Advanced...” NCT06048081 ↗2“the first-in-class monoclonal antibody, zolbetuximab (formerly known as IMAB362), binds to CLDN18.2 and can induce immune-mediated lysis of CLDN18.2-positive cells.” PMID 31240302 ↗ Sep 2019 “PURPOSE: Zolbetuximab (IMAB362) is engineered to induce antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity.” PMID 36607429 ↗ Jan 2023 |
| Known as | Vyloy | “Zolbetuximab (Vyloy) is a cancer medicine that is used to treat adults with gastric or gastro-esophageal junction adenocarcinoma” NCT06962137 ↗ |
| Known as | Zolbetuximab-clzb | ChEMBL registry synonym — accepted as the source's own label CHEMBL2109427 ↗ |
| Action | Deplete | “can induce immune-mediated lysis of CLDN18.2-positive cells” PMID 31240302 ↗ Sep 2019 |
| Modality | Monoclonal antibody | “first-in-class monoclonal antibody” PMID 31240302 ↗ Sep 2019 |
| Route | Intravenous | “received zolbetuximab intravenously” PMID 31240302 ↗ Sep 2019 |
| Target | CLDN18 | “binds to CLDN18.2” PMID 31240302 ↗ Sep 2019 |