Overview
Zolbetuximab is under investigation in clinical trial NCT01630083 (Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer).
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/08 | Phase 2 | Not yet recruiting | |||
2025/03/30 | Phase 3 | Recruiting | |||
2025/03/30 | N/A | Recruiting | |||
2025/03/18 | Phase 2 | Not yet recruiting | |||
2024/12/13 | Phase 1 | Recruiting | |||
2024/05/02 | Phase 1 | Recruiting | |||
2023/09/21 | N/A | AVAILABLE | |||
2019/09/12 | Phase 1 | Completed | |||
2019/01/25 | Phase 2 | Active, not recruiting | |||
2018/08/31 | Phase 3 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/19/2024 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| VYLOY™ POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL | SIN17197P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100mg/vial | 3/6/2025 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Zolbetuximab for Injection | 国药准字SJ20240050 | 生物制品 | 注射剂 | 12/25/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| VYLOY zolbetuximab 100 mg vial powder for concentrate for solution for infusion | 428330 | Medicine | A | 3/17/2025 |
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