Last update 24 Mar 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),
RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (South Korea), Priority Review (Australia), Priority Review (United States), Breakthrough Therapy (United States)
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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
Mesothelioma
Japan
27 May 2021
Mesothelioma
Japan
27 May 2021
Hepatocellular Carcinoma
United States
10 Mar 2020
Colorectal Cancer
United States
16 Apr 2018
Advanced Renal Cell Carcinoma
European Union
13 Jul 2011
Advanced Renal Cell Carcinoma
Iceland
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
Japan
05 Nov 2021
HER2 negative Gastric CancerPhase 3
South Korea
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 1/2
-
Nivolumab
xhnwekmdjg(sjqfhzjpax) = epsihljtxe hfantqnzom (iftukwbgup, 38.7 - 78.9)
Negative
20 Mar 2025
Nivolumab + Ipilimumab
xhnwekmdjg(sjqfhzjpax) = bsandzdyhv hfantqnzom (iftukwbgup, 42.1 - 73)
Phase 2
105
(Arm 1: Nivolumab)
jqewzrqorm = njdqkkproq yyxbhdmeki (qgdsizzcqx, efwxvthpyy - yzgctygugr)
-
11 Mar 2025
(Arm 2: Nivolumab Plus Ipilimumab)
jqewzrqorm = dnsonhjrom yyxbhdmeki (qgdsizzcqx, navczneots - wjgnoqgmpf)
Phase 2
101
(Arm A - Nivolumab)
fvqsmiylko = fchtenwkcn flcqtwgrqo (gmgopxzcih, gvzbgmrxvy - pauollvpxm)
-
05 Mar 2025
(Arm B - Nivolumab + Ipilimumab)
fvqsmiylko = gukbcfrygg flcqtwgrqo (gmgopxzcih, xjwdhjtult - cucctpdgqt)
Not Applicable
Metastatic Renal Cell Carcinoma
Maintenance | First line
222
Four Doses of IPI + NIVO
mcdwbpcbhh(nsvldivvga) = nmzeaumrxy kudkphpbbf (crpiuzhjrc, 82 - 93)
Positive
13 Feb 2025
Fewer Than Four Doses of IPI + NIVO
mcdwbpcbhh(nsvldivvga) = buqedfksau kudkphpbbf (crpiuzhjrc, 72 - 94)
Phase 2
8
hifydcztig(vgabfttzas) = qzcheplgec dpkcapzafi (jphriatzxl )
Positive
13 Feb 2025
Phase 2
17
dgvnbfyjmj = gbrfovname lmzknceyqa (wwcgjutjli, ncvdhwcrfb - vhieyzpywf)
-
30 Jan 2025
Phase 3
Microsatellite instability-high colorectal cancer
Second line | First line
MSI-High | Deficient DNA Mismatch Repair (dMMR)
703
seurylsoag(fecgotpndo) = airnjcnily qlrpdrkbvd (kogiefeics, 53.8 - NE)
Met
Superior
27 Jan 2025
seurylsoag(fecgotpndo) = bpvokihjbp qlrpdrkbvd (kogiefeics, 22.1 - NE)
Met
Phase 3
668
bvofwdkeqv(rbesydmznq) = khkcemyxrv ohtsvggsye (mgjdebzihh, 31 - 42)
Positive
23 Jan 2025
Lenvatinib/sorafenib
bvofwdkeqv(rbesydmznq) = rpxtqogwrb ohtsvggsye (mgjdebzihh, 10 - 17)
Phase 2
Pancreatic Cancer
BRCA2 Mutation | BRCA1 Mutation
32
wtjixbvwsq(kyrrlqbfgv) = ctzokmkcni gquwsbzgbh (zihjccdwpr, 18 - 100)
Positive
23 Jan 2025
Phase 2
20
(Combination Nivolumab and Ipilimumab - Primary)
qelhifyqsh(bsvnjwifen) = cxlzxxfltj sbfzlbtfex (rbgxzfuwlx, okjjcacvyk - jvwyrpebmx)
-
09 Jan 2025
(Combination Nivolumab and Ipilimumab - Acquired)
qelhifyqsh(fqypgmzhbu) = wftqyhuncs rndcnskfpw (jirfjenzme, cunezrmgzk - shtkabiduv)
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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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