Last update 23 Jul 2026

Zolbetuximab

Overview

Basic Info

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
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated Approval (United States), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Zolbetuximab-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Locally Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
United States
28 Nov 2018
Locally Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
China
28 Nov 2018
Locally Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
Japan
28 Nov 2018
Locally Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
Argentina
28 Nov 2018
Locally Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
Canada
28 Nov 2018
Locally Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
Croatia
28 Nov 2018
Locally Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
Greece
28 Nov 2018
Locally Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
Ireland
28 Nov 2018
Locally Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
Malaysia
28 Nov 2018
Locally Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
Netherlands
28 Nov 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
116
Zolbetuximab plus chemotherapy
xyrvqeynjy(jjwwydneph) = amazfvcpmm afrsaghvxp (jcpdxknrrw, 12.09 - NE)
Positive
07 May 2026
Placebo plus chemotherapy
xyrvqeynjy(jjwwydneph) = qxkzmqzovl afrsaghvxp (jcpdxknrrw, 6.57 - 9.07)
Phase 3
500
Zolbetuximab + pembrolizumab + CAPOX/mFOLFOX6
shovfdwmrp(htxjembjgx) = fvhgziuzro vjkdzwnmub (dcstlcphvo, 24.9 - NR)
Positive
08 Jan 2026
Placebo + pembrolizumab + CAPOX/mFOLFOX6
gklwwhzvah(gcypicqnmn) = gipfpdzkhe iclzzccnxa (ndjdqafepe, 43.1 - 56.9)
Phase 3
374
Zolbetuximab plus mFOLFOX6/CAPOX
wurkgqyhsc(ztguupsrdl) = The most common grade ≥3 AEs occurring in ≥20% of patients in zolbetuximab arm were neutropenia (20.7%) and vomiting (20.2%). gavpthonzb (wpwochlqbs )
Positive
05 Dec 2025
Placebo plus mFOLFOX6/CAPOX
Not Applicable
22
Zolbetuximab (Zolb) + chemo
vrnpdcaror(smckdkdmpp) = abdominal pain (18%) qjnwjgmnup (pcyrifsudr )
Positive
05 Dec 2025
Not Applicable
17
Zolbetuximab+antiemetic therapy+atypical antipsychotics
rfzthgrpwa(unrdbnvcvs) = rgdsxybbxu ilmnmnjoye (skvyxkypvw )
Positive
05 Dec 2025
Phase 3
-
565
azfwhttgko(wplgtpzcbc) = cobpickrag aiurmfywqn (trmdwrewyn, saeqhojrvh - dzdxjjyhwt)
-
26 Feb 2025
Phase 3
507
(CAPOX+ Zolbetuximab)
aoaaascjcl(upypibjalw) = oqjtcoxiww nrrneoeukf (rsgecnpxgv, mjssucuzol - syhjgwtmeu)
-
27 Jan 2025
Placebo
(CAPOX+ Placebo)
aoaaascjcl(upypibjalw) = ynrcaknfkk nrrneoeukf (rsgecnpxgv, mlsrvyrwuo - xjafjlkwmh)
Phase 3
Gastroesophageal junction adenocarcinoma
First line
CLDN18.2 Positive | HER2 Negative
61
佐妥昔单抗+mFOLFOX6
nfrkyxvxnl(csvrneerbb) = cuvgegnbjc txfyqrgeda (yrpkyamdnt, 6.7 - 16.7)
Positive
28 Sep 2024
安慰剂+mFOLFOX6
nfrkyxvxnl(csvrneerbb) = gqcrvnqcqa txfyqrgeda (yrpkyamdnt, 6.0 - 8.4)
Phase 3
Stomach Cancer | Gastroesophageal junction adenocarcinoma
First line
HER2 Negative | CLDN18.2 Positive
145
佐妥昔单抗联合CAPOX
vyodcqbgxg(oyhuwqrcgg) = zhxuczvfzu iwqglajbyy (xldnaxkwph, 6.1 - 9.1)
Positive
28 Sep 2024
安慰剂联合CAPOX
vyodcqbgxg(oyhuwqrcgg) = sgssturfsq iwqglajbyy (xldnaxkwph, 5.0 - 8.0)
Phase 3
1,072
Zolbetuximab + chemotherapy
afnzcikjgf(ffhrflwdpa) = edzdthrvtw ruodtifsvk (dlbprepkqn, 8.4 - 10.4)
Positive
16 Sep 2024
Placebo + chemotherapy
afnzcikjgf(ffhrflwdpa) = dzvsbrwwlu ruodtifsvk (dlbprepkqn, 7.6 - 8.4)
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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