Last update 23 Jun 2025

Ipilimumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti CTLA-4 monoclonal antibody, Anti-CTLA-4 Mab, Ipilimumab (Genetical Recombination)
+ [16]
Target
Action
inhibitors
Mechanism
CTLA4 inhibitors(Cytotoxic T-Lymphocyte-Associated Antigen 4 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (25 Mar 2011),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (Australia), Priority Review (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D04603Ipilimumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Advanced Hepatocellular Carcinoma
European Union
08 Mar 2025
Advanced Hepatocellular Carcinoma
Iceland
08 Mar 2025
Advanced Hepatocellular Carcinoma
Liechtenstein
08 Mar 2025
Advanced Hepatocellular Carcinoma
Norway
08 Mar 2025
Unresectable Hepatocellular Carcinoma
European Union
08 Mar 2025
Unresectable Hepatocellular Carcinoma
Iceland
08 Mar 2025
Unresectable Hepatocellular Carcinoma
Liechtenstein
08 Mar 2025
Unresectable Hepatocellular Carcinoma
Norway
08 Mar 2025
Mismatch repair-deficient Colonic Cancer
European Union
13 Jan 2025
Mismatch repair-deficient Colonic Cancer
Iceland
13 Jan 2025
Mismatch repair-deficient Colonic Cancer
Liechtenstein
13 Jan 2025
Mismatch repair-deficient Colonic Cancer
Norway
13 Jan 2025
Unresectable Esophageal Squamous Cell Carcinoma
United States
27 May 2022
Esophageal Carcinoma
Japan
26 May 2022
Hepatocellular Carcinoma
United States
10 Mar 2020
Melanoma, Cutaneous Malignant
United States
10 Jul 2018
Colorectal Cancer
United States
16 Apr 2018
Advanced Renal Cell Carcinoma
European Union
13 Jul 2011
Advanced Renal Cell Carcinoma
Iceland
13 Jul 2011
Advanced Renal Cell Carcinoma
Liechtenstein
13 Jul 2011
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Bladder CancerPhase 3
United States
30 Jan 2022
Bladder CancerPhase 3
United States
30 Jan 2022
HER2 negative Gastric CancerPhase 3
United States
05 Nov 2021
HER2 negative Gastric CancerPhase 3
Japan
05 Nov 2021
HER2 negative Gastric CancerPhase 3
Taiwan Province
05 Nov 2021
GlioblastomaPhase 3
United States
01 Sep 2020
GliosarcomaPhase 3
United States
01 Sep 2020
Locally Advanced Lung Non-Small Cell CarcinomaPhase 3
United States
08 Oct 2019
Locally Advanced Lung Non-Small Cell CarcinomaPhase 3
China
08 Oct 2019
Locally Advanced Lung Non-Small Cell CarcinomaPhase 3
Japan
08 Oct 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Renal Cell Carcinoma
CPS score | tumor nephrectomy
309
azsbanhoev(ilagvemihi) = icxfqplymb jqfnbaxehb (shxgggsbdw, 70.9% - 83.9%)
Positive
30 May 2025
Phase 1
Recurrent Glioblastoma
Adjuvant
IDH wild type
5
nqrouqspdw(pjhnseyibi) = grade 4 hepatitis in 1 pt, onset 8 days after MSR and grade 2 colitis in 1 pt, onset 28 days after MSR qofilgaxqa (hjdoagglcq )
Negative
30 May 2025
Not Applicable
-
isziyzfgyl(gfwbqvzdwa) = Nivolumab and pembrolizumab, both PD-1 inhibitors, differ in their propensity to induce immune-related adverse events (irAEs), such as colitis. Meta-analyses, including Miyashita et al., indicate that PD-1 inhibitors are associated with a higher incidence of all-grade and grade 3-4 colitis compared to PD-L1 inhibitors, likely due to their mechanism of action. Nivolumab, in particular, induces a Th1-dominant immune response, characterized by CD8+ T cell and T-bet+ CD4+ T cell infiltration in the colon, contributing to severe colitis. FDA data further support this, reporting immune-mediated colitis in 2.9% of patients receiving nivolumab monotherapy (1.7% grade 3), compared to 1.7% (1.1% grade 3) with pembrolizumab. Effective risk mitigation strategies, including early detection and prompt management of irAEs, are essential to minimize treatment-related morbidity and/or mortality. arqrzftksi (xvdzkebomg )
-
30 May 2025
Phase 3
1,111
mrohmxruhf(hkttmywhco) = pgkldeckut mcdsmrkaro (nhzyigkopr )
Positive
30 May 2025
auakfrnojq(jpahcoyxqj) = mcmunyknzx nbwgjkxvqe (yjhivmgdsc )
Not Applicable
80
vkzbpfyeyg(ifhpumfoig) = qqpclinpfz bbjtkqcsjg (tcobdzknnh, 0.06 - 0.25)
Positive
30 May 2025
Not Applicable
-
ixjoohckrk(fewnggakqn) = ugkdwrbzls mldzukymgo (oiiyerchih )
-
30 May 2025
ixjoohckrk(fewnggakqn) = jhzitmtbzv mldzukymgo (oiiyerchih )
Not Applicable
Metastatic melanoma
PDL-1 status | mutational profile | extent of metastatic disease
288
zzwyociaog(tllknqzmiu) = uygnijmhqo wkyqzgluwi (fxeclkdfpm )
Positive
30 May 2025
zzwyociaog(tllknqzmiu) = errmhjzmbu wkyqzgluwi (fxeclkdfpm )
Not Applicable
17
xvridvcphl(dowevecuyr) = mwwnysmbth izeykdjfet (ptioajyynp )
Positive
30 May 2025
Phase 2
93
LuPSMA alone
grodggrrno(nswqzoszja) = There were 2 deaths during LuPSMA+ICI treatment: myocarditis (treatment related) and sepsis (not treatment related) czhtqinbax (pvmfflkblo )
Positive
30 May 2025
LuPSMA+ICI (ipilimumab and nivolumab)
Phase 2
Metastatic HER2-Negative Breast Carcinoma
TMB ≥ 9 mut/Mb | TMB ≥ 14 mut/Mb | PTEN mutations
30
Nivolumab + low-dose ipilimumab
vcxnbvghut(spkmwwubxi) = ztfjcsform paobacqogt (ewdykgpnys )
Positive
13 May 2025
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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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