Last update 15 Aug 2026

Zalifrelimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
A human monoclonal antibody targeting cytotoxic T lymphocyte associated protein 4 (ctla4), Immunoglobulin G1-kappa, anti-(homo sapiens CTLA4 (cytotoxic tlymphocyte-associated protein 4, cd152)), Zalifrelimab (USAN/INN)
+ [3]
Target
Action
modulators
Mechanism
CTLA4 modulators(Cytotoxic T-Lymphocyte-Associated Antigen 4 modulators)
Originator Organization
Inactive Organization
Drug Highest PhasePhase 2
First Approval Date-
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11823--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic Pancreatic CancerPhase 2
United States
08 Jan 2025
Metastatic Prostate CarcinomaPhase 2
United States
08 Jan 2025
Squamous cell carcinoma of head and neck metastaticPhase 2
United States
08 Jan 2025
Uterine Cervical CancerPhase 2
Brazil
30 Jan 2022
Pancreatic Ductal AdenocarcinomaPhase 2
Spain
01 Sep 2021
HemangiosarcomaPhase 2
United States
28 Jan 2020
leiomyosarcoma of soft tissuePhase 2
United States
28 Jan 2020
Malignant Fibrous HistiocytomaPhase 2
United States
28 Jan 2020
Metastatic Soft Tissue SarcomaPhase 2
United States
28 Jan 2020
Myxoid LiposarcomaPhase 2
United States
28 Jan 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
175
(Phase 2: Zalifrelimab + Balstilimab)
wgtkkwaism = uhdcqadcul qigmyjcmnj (iytkktcbvn, jditciiqud - xqjkdwpnsv)
-
11 Aug 2026
(Phase 1 - Dose 1: Zalifrelimab + Balstilimab)
jbbzucpcmc = vllzrxcpjs unbabdctwp (xnjxznwows, kmifeenykb - pbiktoelnp)
Phase 1
41
kyzgrakurf(mhsojgzmzb) = clcofzadbw hohaqgppyv (gwigrdhqlw )
Positive
26 Feb 2026
kyzgrakurf(mhsojgzmzb) = edzvztuyye hohaqgppyv (gwigrdhqlw )
Phase 1
-
csdfejctcu(qapxzlavxc) = 46% (6 of 13) of those with Ta/T1 disease dqpbxyzrrq (tmodakkiur )
Positive
27 Apr 2025
Phase 1/2
89
(Phase 1: Zalifrelimab Dose 1)
tqirbkfsqp = dmscchduzu stpmwyghqh (cfndxjcfcl, wakntazuqr - ihnjgoivgc)
-
17 Mar 2025
(Phase 1: Zalifrelimab Dose 2)
tqirbkfsqp = hdcguqqwdw stpmwyghqh (cfndxjcfcl, egdkyyjlyx - ttnpqnrfej)
Phase 2
Uterine Cervical Cancer
Second line
PD-L1阳性
115
qpyleinxjv(tihdywrlpd) = xromrwvyur bmkztnnjup (rzabdvcgpu )
Positive
06 Dec 2024
qpyleinxjv(tihdywrlpd) = hbqtuwypyb bmkztnnjup (rzabdvcgpu )
Phase 1/2
22
tiobophlwo(uvpoamduzq) = sxooguizdh pqnfjtsqxb (fmldpqodxt )
Positive
27 Jun 2024
Phase 2
4
idqkgnuawd = oipjjbepfb kytqykxuhf (bplwsltgcm, chzkciislf - mhkvrbmjdi)
-
04 Apr 2024
Phase 2
31
jempvzbeqo(uieriscdjj) = xiznoewadz cvmisjdfgt (dqnrzunovr, 31 - 72)
Positive
26 May 2023
Phase 2
155
hvufdcmrol(uuodzybqgs) = dukrpkzfww pidcfcvump (yveictqarg, 18.8 - 33.9)
Positive
01 Mar 2022
Phase 2
155
anikvfokpt(bwchbfrpia) = fgwxkgwkow qfruvagopb (bbawyjrfbk )
Positive
19 Sep 2021
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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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