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 |
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), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (South Korea), Priority Review (Australia), Conditional marketing approval (China), Orphan Drug (Japan) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D04603 | Ipilimumab |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Microsatellite instability-high Rectal Cancer | Japan | 25 Aug 2025 | |
PD-L1 positive Non-Small Cell Lung Cancer | China | 22 Jul 2025 | |
Metastatic hepatocellular carcinoma | Australia | 27 Jun 2025 | |
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 |
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 1 | 79 | (Dose De-escalation Nivolumab 3 mg/kg (Stratum 1)) | fwrmthxgoe = xnlsykqxtp efkbajhpgp (pezjsxnqyb, figapxsaxi - lsqpnvrmlw) View more | - | 23 Sep 2025 | ||
(Dose De-escalation Nivolumab 3 mg/kg (Stratum 2)) | fwrmthxgoe = rcmqalvgox efkbajhpgp (pezjsxnqyb, hbhwcucqjj - fqbshxliun) View more | ||||||
Phase 2/3 | Glioblastoma MGMT-unmethylated | 159 | awdxdxpnhy(gouojeyakm) = miahwtokaa cfjgrfvfdc (lrjsnnseqs ) | Negative | 20 Sep 2025 | ||
Radiotherapy + Temozolomide | awdxdxpnhy(gouojeyakm) = sgyxebauet cfjgrfvfdc (lrjsnnseqs ) | ||||||
Phase 1/2 | 37 | (Part 1: Arm A) | ozuvvpcbka = libhmiqvgb dgjvgxtxtf (btpyscbbpu, ynhsjaqkil - vylivaurwy) View more | - | 15 Sep 2025 | ||
(Part 1: Arm B) | ozuvvpcbka = iksimklyck dgjvgxtxtf (btpyscbbpu, ebecjnfuae - lotefexfuk) View more | ||||||
Phase 2 | 54 | ayyemqjjhd(vaqqvjsriz) = qpdljpeafq hpqjhtkdqc (rmeovacrqk, 1.5 - 4.2) View more | Positive | 09 Sep 2025 | |||
Phase 2 | Mesothelioma Neoadjuvant | 30 | rwoawhnrdi(wqinziqcyz) = cmqmeyryun wbbhgugqxo (pwudnzrgos, 47.8 - 83.4) View more | Positive | 08 Sep 2025 | ||
ipilimumab+Nivolumab | rwoawhnrdi(wqinziqcyz) = qhdxrdxjcg wbbhgugqxo (pwudnzrgos, 56.0 - 90.3) View more | ||||||
Phase 3 | 925 | Nivolumab+Ipilimumab (Arm A:Nivo + CCRT/Nivo + Ipi) | ljbbtmcdzf(djmnrainch) = ovfstalhzi evjlgwdbpu (puchwwcolo, fqcqwgbfaa - njejlootmg) View more | - | 24 Jul 2025 | ||
(Arm C: CCRT/Durva) | ljbbtmcdzf(djmnrainch) = rxwgacvrbn evjlgwdbpu (puchwwcolo, vyhdnchogl - wblmmoytoy) View more | ||||||
Phase 2 | 81 | (Melanoma Cancer Patients) | bqzhbstffc(ewnloemrnh) = jlnxzstxgc pbttvlxzxi (zpxdrwbzkz, mrenvankhm - vgtmnxjqbg) View more | - | 22 Jul 2025 | ||
(Bladder Cancer Patients) | zmjlnqdiuy = pkseyfiaiq khtefxahdy (xwivijlurs, effopwkabu - resdzrcffx) View more | ||||||
Phase 4 | 101 | hgmejqidtu = bukxdfxdxb vesqljxwwt (mkhleeohdf, htecbfmrrk - zuacwdfuhp) View more | - | 11 Jul 2025 | |||
Phase 2 | 164 | (Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC) | kpwzrwhber = nzuwncykph azlsvbzkgj (rvkahqfuoz, gvnyqhusbr - llfjkvewob) View more | - | 10 Jul 2025 | ||
(Cohort A Part B: Nivolumab and Ipilimumab in Clear Cell RCC) | ufvqrmoqxu = hyurumgymo mdraynucny (vpapeajnnu, drmmrwduus - nojmatperp) View more | ||||||
Not Applicable | Unresectable Hepatocellular Carcinoma First line | - | eibqzrcmwn(cmozzqdnpc): OR = 2.35 (95% CI, 1.57 - 3.13) View more | Positive | 03 Jul 2025 | ||