Drugs / IRINOTECAN

Trials 13

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT07030283 Dec 2025 → Jul 2028 expected pancreatic ductal adenocarcinoma University of Colorado, Denver Recruiting No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT07595172 Apr 2026 → Aug 2028 expected pancreatic ductal adenocarcinoma West China Hospital Recruiting No outcome recorded
Phase 27 trials
Phase 2 NCT06192680 Apr 2024 → Nov 2025 overdue colorectal cancer Harbin Medical University Not yet recruiting No outcome recorded
Phase 2 NCT06184698 Jan 2024 → Feb 2026 overdue colorectal cancer Hebei Medical University Fourth Hospital Recruiting No outcome recorded
Phase 2 NCT06467565 Dec 2023 → Dec 2024 pancreatic ductal adenocarcinoma The First Affiliated Hospital with Nanjing Medical University Unknown No outcome recorded
Phase 2 NCT05859750 May 2023 → Jun 2025 overdue malignant pancreatic neoplasm Akeso Recruiting No outcome recorded
Phase 2 NCT04233866 Aug 2020 → Mar 2026 overdue pancreatic adenocarcinoma ECOG-ACRIN Cancer Research Group Active not recruiting No outcome recorded
Phase 2 NCT03736720 Jun 2019 → Oct 2022 pancreatic endocrine carcinoma Roswell Park Cancer Institute Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT03764553 May 2019 → Jul 2025 overdue esophageal cancer Academic Medical Center - University of Amsterdam Active not recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT07585279 May 2026 → Feb 2031 expected colorectal cancer Hebei Medical University Fourth Hospital Not yet recruiting No outcome recorded
Phase 32 trials
Phase 3 NCT06571461 Sep 2024 → Jan 2028 expected malignant pancreatic neoplasm CSPC Ouyi Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT06501664 Aug 2024 → Nov 2026 expected esophageal squamous cell carcinoma Rui-hua Xu, MD, PhD Not yet recruiting No outcome recorded
Phase not applicable1 trial
— NCT07474103 Nov 2025 → Mar 2028 expected rectum adenocarcinoma Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting No outcome recorded
Comparator or background therapy6 trials
Phase 1 NCT05382559 Background Jun 2022 → Dec 2028 expected cancer Astellas Pharma Inc Recruiting No outcome recorded
Phase 1 NCT03883919 Background Jul 2019 → Mar 2021 malignant pancreatic neoplasm Washington University School of Medicine Completed No outcome recorded
Phase 2 NCT07622771 Background Jun 2026 → Jun 2028 expected rectal cancer Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 2 NCT07099794 Background Aug 2025 → Feb 2029 expected biliary tract cancer Cancer Institute and Hospital, Chinese Academy of Medical Sciences Not yet recruiting No outcome recorded
Phase 3 NCT07409272 Background Feb 2026 → Aug 2029 expected pancreatic adenocarcinoma Astellas Pharma Global Development, Inc. Recruiting No outcome recorded

Press releases naming this drug 41 releases

DateIssuerRelease
2025-12-12 CSPC ZhongQi Pharmaceutical Technology Co., Ltd. VOLUNTARY ANNOUNCEMENT - NEW INDICATION FOR DUOENYI (IRINOTECAN HYDROCHLORIDE LIPOSOME INJECTION) OBTAINS MARKETING APPROVAL irasia.com ↗
2025-11-17 PharmaEngine ONIVYDE® with oxaliplatin, fluorouracil and leucovorin will be included in Taiwan NHI for first-line treatment of metastatic pancreatic adenocarcinoma pharmaengine.com ↗
2025-05-31 Ipsen Late-breaking analysis demonstrates characteristics associated with long-term overall survival with Onivyde® regimen in metastatic pancreatic adenocarcinoma ipsen.com ↗
2025-05-15 CSPC ZhongQi Pharmaceutical Technology Co., Ltd. VOLUNTARY ANNOUNCEMENT - EXCLUSIVE LICENSE AGREEMENT WITH CIPLA USA, INC. FOR IRINOTECAN LIPOSOME INJECTION irasia.com ↗
2024-05-27 Starpharma Pty Ltd Positive final DEP irinotecan Phase 2 clinical trial results starpharma.com ↗
2024-03-24 PharmaEngine ONIVYDE® obtains positive opinion from EMA's CHMP for new regimen in First-line Treatment of Metastatic PDAC pharmaengine.com ↗
2024-03-18 PharmaEngine ONIVYDE® obtains TFDA Approval for the new regimen in First-line Treatment of Metastatic PDAC pharmaengine.com ↗
2024-02-14 PharmaEngine ONIVYDE® obtains U.S. FDA approval of its supplemental new drug application pharmaengine.com ↗
2024-02-13 Ipsen Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA ipsen.com ↗
2023-12-18 CSPC ZhongQi Pharmaceutical Technology Co., Ltd. VOLUNTARY ANNOUNCEMENT - SUBMISSION OF NEW DRUG APPLICATION FOR IRINOTECAN LIPOSOME INJECTION TO U.S. FDA irasia.com ↗
2023-10-16 Starpharma Pty Ltd DEP irinotecan IO/PARP combination data presented at AACR starpharma.com ↗
2023-10-15 Starpharma Pty Ltd DEP irinotecan clinical data presented at AACR meeting starpharma.com ↗

Evidence & citations 25 cited values

Every value below carries the sentence it was read from. 20 sources stand behind the page.

FieldValueCited text
Known as IRINOTECAN ChEMBL registry synonym — accepted as the source's own label CHEMBL481 ↗
Known as Biotecan ChEMBL registry synonym — accepted as the source's own label CHEMBL481 ↗
Known as Campto ChEMBL registry synonym — accepted as the source's own label CHEMBL481 ↗
Known as Camptosar ChEMBL registry synonym — accepted as the source's own label CHEMBL481 ↗
Known as CPT-11 ChEMBL registry synonym — accepted as the source's own label CHEMBL481 ↗
Known as DQ-2805 ChEMBL registry synonym — accepted as the source's own label CHEMBL481 ↗
Known as Irinophore c ChEMBL registry synonym — accepted as the source's own label CHEMBL481 ↗
Known as Irinotecan anhydrous free-base ChEMBL registry synonym — accepted as the source's own label CHEMBL481 ↗
Known as IRINOTECAN HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL481 ↗
Known as Irinotecan hydrochloride anhydrous ChEMBL registry synonym — accepted as the source's own label CHEMBL481 ↗
Known as Irinotecan hydrochloride component of xeliri ChEMBL registry synonym — accepted as the source's own label CHEMBL481 ↗
Known as IRINOTECAN HYDROCHLORIDE HYDRATE ChEMBL registry synonym — accepted as the source's own label CHEMBL481 ↗
Known as Irinotecan hydrochloride trihydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL481 ↗
Known as Irinotecan monohydrochloride trihydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL481 ↗
Known as Liposomal Irinotecan “NALIRIFOX (liposomal irinotecan 50 mg/m2, oxaliplatin 60 mg/m2, leucovorin 400 mg/m2, and fluorouracil 2400 mg/m2, administered sequentially as a continuous intravenous...” PMID 37708904 ↗ Sep 2023
18

“It's a combination of drugs that are already approved to treat pancreatic cancer: Liposomal irinotecan (Nal-IRI or Onivyde®), 5 fluorouracil (5-FU)/leucovorin, and Oxaliplatin.” NCT07030283 ↗

“NALIRIFOX: Oxaliplatin 85 mg/m2, D1; Liposomal irinotecan 60 mg/m2, D1; LV 200 mg/m2; 5-FU 2400 mg/m2, Infusion for 48 hours” NCT07622771 ↗

NCT03883919 ↗

NCT07409272 ↗

NCT06192680 ↗

NCT03764553 ↗

NCT07099794 ↗

NCT03736720 ↗

NCT06501664 ↗

NCT07585279 ↗

Show 8 more sources

Known as Nal-IRI “It's a combination of drugs that are already approved to treat pancreatic cancer: Liposomal irinotecan (Nal-IRI or Onivyde®), 5 fluorouracil (5-FU)/leucovorin, and Oxaliplatin.” NCT07030283 ↗
Known as NSC-728073 ChEMBL registry synonym — accepted as the source's own label CHEMBL481 ↗
Known as NSC-759878 ChEMBL registry synonym — accepted as the source's own label CHEMBL481 ↗
Known as Onivyde “It's a combination of drugs that are already approved to treat pancreatic cancer: Liposomal irinotecan (Nal-IRI or Onivyde®), 5 fluorouracil (5-FU)/leucovorin, and Oxaliplatin.” NCT07030283 ↗
Known as Onivyde pegylated liposomal (previously known as onivyde) ChEMBL registry synonym — accepted as the source's own label CHEMBL481 ↗
Known as U-101,440E ChEMBL registry synonym — accepted as the source's own label CHEMBL481 ↗
Action Inhibit “DNA topoisomerase I inhibitor” CHEMBL481 ↗
Modality Small molecule — CHEMBL481 ↗
Route Intravenous “Given IV” NCT03736720 ↗
Target TOP1 “DNA topoisomerase I inhibitor” CHEMBL481 ↗