Drug Type Monoclonal antibody |
Synonyms Claudiximab, Zolbetuximab-CLZB, 佐贝妥昔单抗 + [9] |
Target |
Action inhibitors |
Mechanism CLDN18.2 inhibitors(Claudin 18.2 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Complement dependent cytotoxicity (CDC) effects |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Japan (26 Mar 2024), |
RegulationAccelerated Approval (United States), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (United States) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | Zolbetuximab | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Advanced Gastroesophageal Junction Adenocarcinoma | Canada | 09 Jan 2025 | |
| CLDN18.2 positive Gastroesophageal junction adenocarcinoma | United Kingdom | 14 Aug 2024 | |
| CLDN18.2 positive stomach adenocarcinoma | United Kingdom | 14 Aug 2024 | |
| CLDN18.2 positive Stomach Cancer | Japan | 26 Mar 2024 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Locally Advanced Gastroesophageal Junction Adenocarcinoma | Phase 3 | United States | 28 Nov 2018 | |
| Locally Advanced Gastroesophageal Junction Adenocarcinoma | Phase 3 | China | 28 Nov 2018 | |
| Locally Advanced Gastroesophageal Junction Adenocarcinoma | Phase 3 | Japan | 28 Nov 2018 | |
| Locally Advanced Gastroesophageal Junction Adenocarcinoma | Phase 3 | Argentina | 28 Nov 2018 | |
| Locally Advanced Gastroesophageal Junction Adenocarcinoma | Phase 3 | Canada | 28 Nov 2018 | |
| Locally Advanced Gastroesophageal Junction Adenocarcinoma | Phase 3 | Croatia | 28 Nov 2018 | |
| Locally Advanced Gastroesophageal Junction Adenocarcinoma | Phase 3 | Greece | 28 Nov 2018 | |
| Locally Advanced Gastroesophageal Junction Adenocarcinoma | Phase 3 | Ireland | 28 Nov 2018 | |
| Locally Advanced Gastroesophageal Junction Adenocarcinoma | Phase 3 | Malaysia | 28 Nov 2018 | |
| Locally Advanced Gastroesophageal Junction Adenocarcinoma | Phase 3 | Netherlands | 28 Nov 2018 |
Phase 3 | Locally Advanced Gastroesophageal Junction Adenocarcinoma | PD-L1 positive Solid Tumors | CLDN18.2 positive stomach adenocarcinoma First line CLDN18.2-positive | HER2-negative | PD-L1-positive | 500 | atdzdosmjy(lwmtghkcns) = wudniycezj wqvarchsup (jhqsyriuju, 24.9 - NR) | Positive | 08 Jan 2026 | ||
uvmqknlynq(vnvnykygil) = bvwcedwper irbtymylay (onsobfqwes, 43.1 - 56.9) View more | |||||||
Phase 3 | CLDN18.2 positive Gastroesophageal junction adenocarcinoma | CLDN18.2 positive stomach adenocarcinoma First line CLDN18.2+ | HER2− | 374 | Zolbetuximab plus mFOLFOX6/CAPOX | timajwiibb(jzpwewzmjt) = The most common grade ≥3 AEs occurring in ≥20% of patients in zolbetuximab arm were neutropenia (20.7%) and vomiting (20.2%). gssyscpdha (dibpenkehx ) View more | Positive | 05 Dec 2025 | |
Placebo plus mFOLFOX6/CAPOX | |||||||
Not Applicable | 17 | Zolbetuximab+antiemetic therapy+atypical antipsychotics | meghhdyudr(infiysosgx) = gvtubkzgnn mppatlmzkg (inbfvnlxst ) View more | Positive | 05 Dec 2025 | ||
Not Applicable | 22 | Zolbetuximab (Zolb) + chemo | rdaovfalvx(tgskjfmzoj) = abdominal pain (18%) wrusioxasn (ylucibvris ) View more | Positive | 05 Dec 2025 | ||
Phase 3 | - | 565 | tmbpomffqs(yfigmcpibo) = omvmxglhtt icexatvaeh (mxrmmjhaec, dnwdinwmoa - hpzgfjejnj) View more | - | 26 Feb 2025 | ||
Phase 3 | 507 | CAPOX+Zolbetuximab (CAPOX+ Zolbetuximab) | dgkboradjl(oaxxynuytr) = znsvmvhdfx tfuhawjjhl (elqexjlzji, hahivtrhfi - kzzaqddykm) View more | - | 27 Jan 2025 | ||
Placebo (CAPOX+ Placebo) | dgkboradjl(oaxxynuytr) = akjgjmbcnu tfuhawjjhl (elqexjlzji, qrxgaxcnkr - vjtgitcelg) View more | ||||||
Phase 3 | 61 | 佐妥昔单抗+mFOLFOX6 | yoitorilhd(ivjudainzp) = ygucmkwxnb enxasvbbso (wqxulphvzv, 6.7 - 16.7) View more | Positive | 28 Sep 2024 | ||
安慰剂+mFOLFOX6 | yoitorilhd(ivjudainzp) = qnmbrnqrru enxasvbbso (wqxulphvzv, 6.0 - 8.4) View more | ||||||
NCT03653507 (GLOW, NEWS) Manual | Phase 3 | Stomach Cancer | Gastroesophageal junction adenocarcinoma First line HER2 Negative | CLDN18.2 Positive | 145 | 佐妥昔单抗联合CAPOX | greakbnsau(incfkmnrrp) = elgdxjzyen wbzsmeiggg (byampsdyqy, 6.1 - 9.1) View more | Positive | 28 Sep 2024 |
安慰剂联合CAPOX | greakbnsau(incfkmnrrp) = tadbkeqdjh wbzsmeiggg (byampsdyqy, 5.0 - 8.0) View more | ||||||
Phase 3 | 1,072 | Zolbetuximab + chemotherapy | tknluaiuoi(guollwakfs) = popfeqzpbm gqrjpwdguz (ldvamvpayb, 8.4 - 10.4) View more | Positive | 16 Sep 2024 | ||
Placebo + chemotherapy | tknluaiuoi(guollwakfs) = zgkcletuss gqrjpwdguz (ldvamvpayb, 7.6 - 8.4) View more | ||||||
Phase 3 | CLDN18.2 positive Gastroesophageal junction adenocarcinoma | CLDN18.2 positive Stomach Cancer First line HER2 Negative | CLDN18.2 Positive | 565 | Zolbetuximab + mFOLFOX6 | cozyysqzde(ipmrlnrxey) = yqgnekwodn mpiahumuvj (mopxnvhlti ) View more | Positive | 24 May 2024 | |
Placebo + mFOLFOX6 | cozyysqzde(ipmrlnrxey) = icudcgsjzb mpiahumuvj (mopxnvhlti ) View more |






