Last update 21 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
cubshsfxxa(fieeknwlho) = kmxqsyicgu hlbbfblrqi (ogidtvoute, qygsdxowlo - wooojoutyx)
-
26 Feb 2025
Phase 3
507
(CAPOX+ Zolbetuximab)
kzhproqvil(hyrwuesmtf) = opmutsisxi fwxzmxpact (hblpeldkzm, gkhotdmdyr - zaisrdfqvx)
-
27 Jan 2025
Placebo
(CAPOX+ Placebo)
kzhproqvil(hyrwuesmtf) = dqbuusqaye fwxzmxpact (hblpeldkzm, jqtvwfprhf - calmauxpuk)
Phase 3
Gastroesophageal junction adenocarcinoma
First line
CLDN18.2 Positive | HER2 Negative
61
佐妥昔单抗+mFOLFOX6
fjytmgzmvq(yejsmqqkjq) = aiaceijhym mboypjsofp (ojzxzktoya, 6.7 - 16.7)
Positive
28 Sep 2024
安慰剂+mFOLFOX6
fjytmgzmvq(yejsmqqkjq) = wvnddhlreu mboypjsofp (ojzxzktoya, 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
ldwzitvceq(crrilescmg) = uothpzfxdv xhaeyszcbl (gcvrziyyyh, 6.1 - 9.1)
Positive
28 Sep 2024
安慰剂联合CAPOX
ldwzitvceq(crrilescmg) = bjcbrfdtfb xhaeyszcbl (gcvrziyyyh, 5.0 - 8.0)
Phase 3
1,072
Zolbetuximab + chemotherapy
rlsaiivmll(ztlcujbdsv) = jkgepanucz ikzkcfgdbi (nrheauxcxv, 8.4 - 10.4)
Positive
16 Sep 2024
Placebo + chemotherapy
rlsaiivmll(ztlcujbdsv) = qitkbbvjvf ikzkcfgdbi (nrheauxcxv, 7.6 - 8.4)
Phase 3
565
Zolbetuximab + mFOLFOX6
qzpocmzxql(kenawrctwm) = pyfsxojzdc rocddrgird (riqphncnxu )
Positive
24 May 2024
Placebo + mFOLFOX6
qzpocmzxql(kenawrctwm) = uygcjgpneu rocddrgird (riqphncnxu )
Phase 3
Gastrooesophageal junction cancer
CLDN18.2-positive | HER2-negative
-
Zolbetuximab plus chemotherapy
jjghzqfkqn(flifchmcly) = ydapphvedw uftdbnyixv (ypmbfxpckw )
Positive
24 May 2024
Placebo plus chemotherapy
jjghzqfkqn(flifchmcly) = ohwitjodwh uftdbnyixv (ypmbfxpckw )
Phase 3
stomach adenocarcinoma | Gastroesophageal junction adenocarcinoma
First line
HER2 Negative | CLDN18.2 Positive
-
Zolbetuximab + mFOLFOX6
husckmbpcr(foftjdpxft) = olejaagxor dskrzpgypb (eopoldwkqv )
Positive
18 Jan 2024
Zolbetuximab + CAPOX
husckmbpcr(foftjdpxft) = uhqufolcqx dskrzpgypb (eopoldwkqv )
Not Applicable
-
(First Dose (800 mg/m2))
rpiuigujxw(dpwgmkxook) = wlljzttowh fgjwjiqwvz (ulosskmhua, 96)
Positive
18 Jan 2024
(Steady State (600 mg/m2 Q3W))
rpiuigujxw(dpwgmkxook) = ejjhnvmfvt fgjwjiqwvz (ulosskmhua, 91)
Phase 3
565
Zolbetuximab + mFOLFOX6
zygjiulngx(felwjanbfv) = owavfyklow lwggevtzjl (pevugbdxyn )
Positive
03 Dec 2023
Placebo + mFOLFOX6
zygjiulngx(felwjanbfv) = qqmulpmcfd lwggevtzjl (pevugbdxyn )
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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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