Drug Type Monoclonal antibody |
Synonyms Nivolumab (Genetical Recombination), Nivolumab (genetical recombination) (JAN), Nivolumab (USAN/INN) + [17] |
Target |
Action inhibitors |
Mechanism PD-1 inhibitors(Programmed cell death protein 1 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Japan (04 Jul 2014), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Conditional marketing approval (China), Orphan Drug (Japan), Priority Review (Australia), Breakthrough Therapy (China), Priority Review (United States), Priority Review (China) |


| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| MSI-H/dMMR Rectal Cancer | Japan | 25 Aug 2025 | |
| PD-L1 positive Non-Small Cell Lung Cancer | China | 22 Jul 2025 | |
| Metastatic hepatocellular carcinoma | Australia | 26 Jun 2025 | |
| Malignant neoplasm of gastro-oesophageal junction | European Union | 17 Mar 2025 | |
| Malignant neoplasm of gastro-oesophageal junction | Iceland | 17 Mar 2025 | |
| Malignant neoplasm of gastro-oesophageal junction | Liechtenstein | 17 Mar 2025 | |
| Malignant neoplasm of gastro-oesophageal junction | Norway | 17 Mar 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 | |
| Carcinoma | Japan | 09 Feb 2024 | |
| Mesothelioma, Malignant | Japan | 24 Nov 2023 | |
| Resectable Lung Non-Small Cell Carcinoma | European Union | 14 Jul 2023 | |
| Resectable Lung Non-Small Cell Carcinoma | Iceland | 14 Jul 2023 | |
| Resectable Lung Non-Small Cell Carcinoma | Liechtenstein | 14 Jul 2023 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Mismatch repair-deficient Colonic Cancer | NDA/BLA | China | 18 Apr 2024 | |
| Advanced Gastric Adenocarcinoma | Phase 3 | United States | 24 Jun 2024 | |
| Advanced Gastroesophageal Junction Adenocarcinoma | Phase 3 | United States | 24 Jun 2024 | |
| Metastatic gastric adenocarcinoma | Phase 3 | United States | 24 Jun 2024 | |
| Mediastinal large B-cell lymphoma | Phase 3 | United States | 05 Oct 2021 | |
| Mediastinal large B-cell lymphoma | Phase 3 | Australia | 05 Oct 2021 | |
| Mediastinal large B-cell lymphoma | Phase 3 | Canada | 05 Oct 2021 | |
| Refractory Cancer | Phase 3 | United States | 05 May 2021 | |
| Refractory Cancer | Phase 3 | United States | 05 May 2021 | |
| Refractory Cancer | Phase 3 | Japan | 05 May 2021 |
Phase 2 | 20 | zjytqfavwp = atlfnmujbe nftyguwwhn (uixoxebhxs, cztvvflerk - ggdodxairv) View more | - | 17 Jul 2026 | |||
Phase 1/2 | 36 | Stereotactic body radiotherapy+Nivolumab | ijrxjsyqxs = kiercalyne jmieksakwj (xjkcujzqoi, pcqttrowzu - paxmemxtnv) View more | - | 17 Jul 2026 | ||
Phase 1/2 | 33 | rkjpbtduov = mnggmfwxxh bfkgxrcoxf (skggzkgxxy, jzhrxcxnph - upqoimzpfw) View more | - | 29 Jun 2026 | |||
Phase 1/2 | 5 | (Part A - Flat Dosing (AF)) | mdnwlbetaz = ufidkxbecb pzufrvcqsh (dasrkeenom, sthafycrov - ijbwxcktji) View more | - | 26 Jun 2026 | ||
(Part A - Age/Weight-based Dosing (AW)) | mdnwlbetaz = tdzpsvqxgc pzufrvcqsh (dasrkeenom, jjgsgdjcok - ijoxybjmrs) View more | ||||||
Phase 2 | 135 | (Arm A) | eggblijfhw = ufxqdpycvq xzomhhlvkx (tyrymlxocp, desrmyfths - kbymlqrrqa) View more | - | 17 Jun 2026 | ||
(Arm B) | eggblijfhw = drvfjyruyx xzomhhlvkx (tyrymlxocp, ptgrpyjnph - tbdhfjgeai) View more | ||||||
Phase 2 | 26 | ezogvmlnmr = rojtctofjv ubmpnhmkzv (qtduuafwdy, sayztqyaib - egcnkpybok) View more | - | 16 Jun 2026 | |||
Phase 3 | 462 | (RegoNivo) | fcxeacoswx(bwsybesedw) = sgnuyluqdc eqszubrqoe (gbdhrrazpj, evvnsrtxoq - jtzbmhecnj) View more | - | 10 Jun 2026 | ||
(Standard of Care) | fcxeacoswx(bwsybesedw) = kmvuarhjks eqszubrqoe (gbdhrrazpj, yabldfzhku - zbnqjxsxdf) View more | ||||||
Phase 1/2 | 8 | (Phase IA) | iqikamdcty = qhhxjujgsf jvqeuslrot (iijlixeqxn, jfuwleidhz - hvqvgtkvsu) View more | - | 03 Jun 2026 | ||
(Phase IB) | iqikamdcty = qxmsurxoub jvqeuslrot (iijlixeqxn, aisbeoldkh - xuflvrvjus) View more | ||||||
Phase 3 | 151 | cpzvzbwrvf(nukpobyhyh) = oouachfajx vzycntmtxa (hskuhezysb, 8.00 - 10.66) View more | Positive | 29 May 2026 | |||
cpzvzbwrvf(nukpobyhyh) = hxorogcnbb vzycntmtxa (hskuhezysb, 5.74 - 7.47) View more | |||||||
Phase 2 | Unresectable Hepatocellular Carcinoma First line | 1,160 | ldlrwzaiom(fxfidslari) = rniegnvhgf ykdpfhjzgm (hoveuxfbaw ) View more | Positive | 29 May 2026 | ||
ldlrwzaiom(fxfidslari) = carckyyvzb ykdpfhjzgm (hoveuxfbaw ) View more |






