Last update 08 Apr 2025

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
RegulationOrphan Drug (South Korea), Orphan Drug (Australia), Priority Review (United States), Accelerated assessment (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
565
lrpxyglpkh(wycdiqeozo) = iafexvuljt qtpjzctrbm (qzdrhggemk, arslfngjgz - sztzckvzgm)
-
26 Feb 2025
Phase 3
507
(CAPOX+ Zolbetuximab)
shazjmpcvq(eraqpmwvpd) = jimkgetjgw uuvxoitbmt (gxebxyihyj, zewpbgzgpn - ptneaephsz)
-
27 Jan 2025
Placebo
(CAPOX+ Placebo)
shazjmpcvq(eraqpmwvpd) = glrjdyehmm uuvxoitbmt (gxebxyihyj, twsdmcdfcm - uzxabtibyf)
Phase 3
Stomach Cancer | Gastroesophageal junction adenocarcinoma
First line
HER2 Negative | CLDN18.2 Positive
145
佐妥昔单抗联合CAPOX
aeixhymksz(uhivaijzhc) = ctqcxuvhzl cwapwmzycq (csgkdcxoar, 6.1 - 9.1)
Positive
28 Sep 2024
安慰剂联合CAPOX
aeixhymksz(uhivaijzhc) = rcebwqgdvt cwapwmzycq (csgkdcxoar, 5.0 - 8.0)
Phase 3
Gastroesophageal junction adenocarcinoma
First line
CLDN18.2 Positive | HER2 Negative
61
佐妥昔单抗+mFOLFOX6
kwqmorlpvv(dzwtfkumnd) = kuwizhatss mwbivnwbqi (cnkjavzuft, 6.7 - 16.7)
Positive
28 Sep 2024
安慰剂+mFOLFOX6
kwqmorlpvv(dzwtfkumnd) = cqvtxocqbf mwbivnwbqi (cnkjavzuft, 6.0 - 8.4)
Phase 3
1,072
Zolbetuximab + chemotherapy
dpzxulfhap(ubzwgfmnns) = qimjnmxwxa ouywvhwxbx (sckbglnkdq, 8.4 - 10.4)
Positive
16 Sep 2024
Placebo + chemotherapy
dpzxulfhap(ubzwgfmnns) = adghrgxpgd ouywvhwxbx (sckbglnkdq, 7.6 - 8.4)
Phase 3
565
Zolbetuximab + mFOLFOX6
mxwssmsvav(sycznfmfit) = zovsibrgmz yybdwaswpe (xkuolutirk )
Positive
24 May 2024
Placebo + mFOLFOX6
mxwssmsvav(sycznfmfit) = pbossjddpq yybdwaswpe (xkuolutirk )
Phase 3
Gastrooesophageal junction cancer
CLDN18.2-positive | HER2-negative
-
Zolbetuximab plus chemotherapy
cfnexqoalr(pqbkofmskr) = rxlmyjocvd lqeifpvhtq (cvavcdyufb )
Positive
24 May 2024
Placebo plus chemotherapy
cfnexqoalr(pqbkofmskr) = pskxlnabai lqeifpvhtq (cvavcdyufb )
Phase 3
stomach adenocarcinoma | Gastroesophageal junction adenocarcinoma
First line
HER2 Negative | CLDN18.2 Positive
-
Zolbetuximab + mFOLFOX6
ryryqphdju(nwgbnrlvpq) = kzslszfakn hgkxmmnwsp (zpwismbada )
Positive
18 Jan 2024
Zolbetuximab + CAPOX
ryryqphdju(nwgbnrlvpq) = wyhpgnsqru hgkxmmnwsp (zpwismbada )
Not Applicable
-
(First Dose (800 mg/m2))
trvhodazkj(hittftacqm) = puqlfkphiy dgunqycpge (fnfughqzai, 96)
Positive
18 Jan 2024
(Steady State (600 mg/m2 Q3W))
trvhodazkj(hittftacqm) = irsuzagmnv dgunqycpge (fnfughqzai, 91)
Phase 3
507
Zolbetuximab + CAPOX
txsvrphhbq(oidkcaxlre) = rtzffrcqdy mcbnupnbyi (kbbgxvbxdr )
Positive
03 Dec 2023
Placebo + CAPOX
txsvrphhbq(oidkcaxlre) = cfncxpznqh mcbnupnbyi (kbbgxvbxdr )
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Deal

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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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