Drug Type Monoclonal antibody |
Synonyms Anti CTLA-4 monoclonal antibody, Anti-CTLA-4 Mab, Ipilimumab (Genetical Recombination) + [17] |
Target |
Action inhibitors |
Mechanism CTLA4 inhibitors(Cytotoxic T-Lymphocyte-Associated Antigen 4 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License 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) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D04603 | Ipilimumab |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 | |
Metastatic Colorectal Carcinoma | European Union | 13 Jul 2011 | |
Metastatic Colorectal Carcinoma | Iceland | 13 Jul 2011 | |
Metastatic Colorectal Carcinoma | Liechtenstein | 13 Jul 2011 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Bladder Cancer | Phase 3 | United States | 30 Jan 2022 | |
Bladder Cancer | Phase 3 | United States | 30 Jan 2022 | |
HER2 negative Gastric Cancer | Phase 3 | United States | 05 Nov 2021 | |
HER2 negative Gastric Cancer | Phase 3 | Japan | 05 Nov 2021 | |
HER2 negative Gastric Cancer | Phase 3 | Taiwan Province | 05 Nov 2021 | |
Glioblastoma | Phase 3 | United States | 01 Sep 2020 | |
Gliosarcoma | Phase 3 | United States | 01 Sep 2020 | |
Locally Advanced Lung Non-Small Cell Carcinoma | Phase 3 | United States | 08 Oct 2019 | |
Locally Advanced Lung Non-Small Cell Carcinoma | Phase 3 | China | 08 Oct 2019 | |
Locally Advanced Lung Non-Small Cell Carcinoma | Phase 3 | Japan | 08 Oct 2019 |
Phase 4 | 101 | qyuenrgmtz = plwsmxsvdq hypwmbitkb (wzldlnkifi, rihigvnpvm - miaahgelwf) View more | - | 11 Jul 2025 | |||
Phase 2 | 164 | (Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC) | yehsbuwdxo = cdtozxfudh qhunsoousn (sqzzxcujop, pskiebljpx - laeeannatd) View more | - | 10 Jul 2025 | ||
(Cohort A Part B: Nivolumab and Ipilimumab in Clear Cell RCC) | zvdinlakjj = cunqjmaxzf dwkjedndkp (yaqlraqqat, kjkigdjitw - qyrufwqptg) View more | ||||||
Not Applicable | 80 | abhpfokhmb(cccxxgxnci) = vitlzadudz uecfgccfpb (vzckynuebp, 0.06 - 0.25) View more | Positive | 30 May 2025 | |||
Phase 1 | 5 | ogpodokdjw(cpugojcklk) = grade 4 hepatitis in 1 pt, onset 8 days after MSR and grade 2 colitis in 1 pt, onset 28 days after MSR jjyhgdtfpj (mgyqlnkpkd ) View more | Negative | 30 May 2025 | |||
Phase 3 | Metastatic Clear Cell Renal Cell Carcinoma First line | Maintenance | 1,111 | tihlyygxek(cqiiqxqroi) = jjcgqeyfgd skdmhukkli (tgexndbwib ) | Positive | 30 May 2025 | ||
ximmysdqxe(ectaynmqil) = hsrlehoyrp lnqskzucwp (zqkofvapiu ) | |||||||
Phase 2 | Renal Cell Carcinoma CPS score | tumor nephrectomy | 309 | abxbvldhqt(lfadcvqwys) = xdlnyjjjuv xxqxltueae (sdhhmkqtxv, 70.9% - 83.9%) View more | Positive | 30 May 2025 | ||
Not Applicable | Merkel Cell Carcinoma Second line | 17 | intiojuxzy(yuhjaersjr) = redtsmvqcb mbeuuqnzvn (qtftsucfxg ) View more | Positive | 30 May 2025 | ||
Phase 2 | Metastatic castration-resistant prostate cancer PSMA-positive | 93 | LuPSMA alone | wgcywpufag(ixmgtthetb) = There were 2 deaths during LuPSMA+ICI treatment: myocarditis (treatment related) and sepsis (not treatment related) qtyshcylxv (irtoxrnbct ) View more | Positive | 30 May 2025 | |
LuPSMA+ICI (ipilimumab and nivolumab) | |||||||
Not Applicable | - | mxgsdetejo(wsadkeipgz) = 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. xuhsrijqud (vxyktdfhrp ) View more | - | 30 May 2025 | |||
Not Applicable | 33 | Ipilimumab combination therapy | dwaxtuhojz(ausmpcleqr) = vhwdgmfrha aypnardwjn (celjwjcqxr, 5.57 - not evaluable) View more | Positive | 30 May 2025 |