Drugs / Irinotecan Sucrosofate
Irinotecan Sucrosofate
also known as
nal-IRI · MM-398 · PEP02 · liposomal irinotecan · Irinotecan liposome · Irinotecan Sucrosofate Liposome Injection · Liposome Irinotecan · liposome-encapsulated irinotecan hydrochloride · +1 more
Other / unclassified targets TOP1 via inhibition
Trials 20 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT02631733 | May 2017 → Nov 2019 | cancer | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT02640365 | Nov 2015 → Dec 2016 | — | GERCOR - Multidisciplinary Oncology Cooperative Group | Completed | No outcome recorded |
| Phase 1 | NCT02013336 | Dec 2013 → Dec 2023 | Ewing sarcoma, neuroblastoma, osteosarcoma, rhabdomyosarcoma | South Plains Oncology Consortium | Unknown | No outcome recorded |
| Phase 1 | NCT01770353 | Nov 2012 → Oct 2018 | hormone receptor-positive breast cancer, metastatic malignant neoplasm in the brain, triple-negative breast carcinoma | Ipsen | Completed | No outcome recorded |
| Phase 1 | NCT00940758 | Jun 2009 → May 2012 | colorectal cancer | PharmaEngine | Completed | No outcome recorded |
| Phase 1 | NCT02884128 | Jan 2006 → Aug 2008 | neoplasm | PharmaEngine | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT04662112 | Jun 2021 → Oct 2023 | pancreatic ductal adenocarcinoma | Asan Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT02785068 | Jul 2016 → May 2018 | colorectal cancer | Merrimack Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT06662006 | Mar 2024 → Dec 2027 expected | malignant pancreatic neoplasm | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | No outcome recorded |
| Phase 2 | NCT04753216 | Mar → Aug 2021 | fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma | Northwestern University | Completed | No outcome recorded |
| Phase 2 | NCT04150640 | Jul 2020 → Dec 2027 expected | esophageal adenocarcinoma, gastric adenocarcinoma | University of Wisconsin, Madison | Recruiting | No outcome recorded |
| Phase 2 | NCT03986294 | Dec 2019 → Jan 2022 | malignant pancreatic neoplasm | Academic Medical Center - University of Amsterdam | Unknown | No outcome recorded |
| Phase 2 | NCT04009876 | May 2019 → Oct 2022 | rectal cancer | HM Hospitales | Completed | No outcome recorded |
| Phase 2 | NCT03043547 | Oct 2017 → Dec 2021 | cholangiocarcinoma, gallbladder carcinoma | AIO-Studien-gGmbH | Completed | No outcome recorded |
| Phase 2 | NCT01375816 | May 2011 → Jun 2014 | colorectal cancer | GERCOR - Multidisciplinary Oncology Cooperative Group | Terminated | No outcome recorded |
| Phase 2 | NCT00813163 | Jan 2009 → Dec 2010 | malignant pancreatic neoplasm | PharmaEngine | Completed | No outcome recorded |
| Phase 2 | NCT00813072 | Nov 2007 → Jul 2010 | gastric neoplasm, neoplasm of esophagus | PharmaEngine | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07689539 | Sep 2026 → Jul 2028 expected | malignant pancreatic neoplasm | Jiangxi Kvvit Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT01494506 | Nov 2011 → Feb 2014 | malignant pancreatic neoplasm | Merrimack Pharmaceuticals | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06494514 | Apr 2024 → Apr 2027 expected | pancreatic exocrine neoplasm | Du Juan | Recruiting | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07033689 Background | Jan → Dec 2026 expected | pancreatic ductal adenocarcinoma | SONIRE Therapeutics Inc. | Recruiting | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT02231723 Background | Aug 2014 → Jun 2020 | pancreatic adenocarcinoma | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04731467 Background | Mar 2021 → Sep 2024 | colorectal adenocarcinoma, malignant pancreatic neoplasm, melanoma, non-small cell lung carcinoma +2 | Famewave Ltd. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07028424 Background | Jul 2025 → Jul 2029 expected | pancreatic ductal adenocarcinoma | GERCOR - Multidisciplinary Oncology Cooperative Group | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06669078 Background | Oct 2024 → Oct 2027 expected | pancreatic exocrine neoplasm | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Not yet recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06998940 Background | May 2026 → Dec 2029 expected | pancreatic adenocarcinoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-11-30 | Ipsen | Ipsen receives FDA Fast Track designation for investigational irinotecan liposome injection (ONIVYDE®) as a second-line monotherapy treatment for small cell lung cancer (SCLC) ipsen.com ↗ |
| 2020-07-01 | Ipsen | Ipsen presents Phase I/II clinical data evaluating liposomal irinotecan (Onivyde®) as an investigational first-line combination treatment for metastatic pancreatic cancer at the ESMO World Congress on Gastrointestinal Cancer ipsen.com ↗ |
| 2020-06-17 | Ipsen | Ipsen receives FDA Fast Track designation for liposomal irinotecan (ONIVYDE®) as a first-line combination treatment for metastatic pancreatic cancer ipsen.com ↗ |
| 2019-09-08 | Ipsen | Ipsen and Servier announce initial Phase II/III clinical data evaluating investigational liposomal irinotecan (ONIVYDE®) as a second-line treatment for small cell lung cancer (SCLC) at the IASLC 2019 World Conference on Lung Cancer ipsen.com ↗ |
| 2019-07-05 | Ipsen | Ipsen and Servier announce initial Phase 1/2 clinical data evaluating liposomal irinotecan (ONIVYDE®) as an investigational first-line treatment for metastatic pancreatic cancer at ESMO 21st World Congress on Gastrointestinal Cancer ipsen.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 30 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Irinotecan Sucrosofate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04753216 ↗ |
| Known as | Irinotecan liposome | “nal-IRI \[Irinotecan liposome\] (80 mg/m2 as a 1.5 hour infusion)” NCT03043547 ↗ |
| Known as | Irinotecan Sucrosofate Liposome Injection | “MM-398 (Irinotecan Sucrosofate Liposome Injection)” NCT02013336 ↗ |
| Known as | liposomal irinotecan | “This study aimed to determine the optimal second-line treatment strategy in patients with metastatic pancreatic cancer, hypothesizing that liposomal irinotecan (nal-IRI)...” PMID 41921365 ↗ Mar 20263“Liposomal irinotecan (nal-IRI) is the novel agent enhancing the drug delivery of irinotecan and approved for the management of gemcitabine-progressed metastatic pancreatic...” NCT04662112 ↗ “liposomal irinotecan (nal-IRI) plus 5-fluorouracil (5-FU)/leucovorin (LV) (nal-IRI/5-FU/LV) combined with benmelstobart and anlotinib ± SBRT” NCT06662006 ↗ “nal-IRI \[Liposomal Irinotecan\]” NCT04009876 ↗ |
| Known as | Liposome Irinotecan | “PEP02 (Liposome Irinotecan)” NCT00940758 ↗ |
| Known as | liposome-encapsulated irinotecan hydrochloride | “RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated irinotecan hydrochloride PEP02, irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in...” NCT01375816 ↗ |
| Known as | MM-398 | “A randomized phase II study of PEP02 (MM-398), irinotecan or docetaxel as a second-line therapy in patients with locally advanced or metastatic gastric or gastro-oesophageal...” PMID 23406728 ↗ Feb 20137“A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer.” PMID 23880820 ↗ Jul 2013 “PEP02 (also known as MM-398, nal-IRI) is a novel nanoparticle formulation of irinotecan encapsulated in liposomes.” PMID 27871319 ↗ Nov 2016 |
| Known as | nal-IRI | “PEP02 (also known as MM-398, nal-IRI) is a novel nanoparticle formulation of irinotecan encapsulated in liposomes.” PMID 27871319 ↗ Nov 201614“NASOX regimen contains nal-IRI, which has recently been proven effective in pancreatic cancer.” NCT04662112 ↗ “Nal-IRI+Oxaliplatin+5- FU, these drugs are given on d1, d15, 28 days as one cycle.” NCT06669078 ↗ “MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels” NCT01770353 ↗ “Investigator's Choice of Chemotherapy: nal-IRI + 5-FU/LV, AG, or S-1” NCT07689539 ↗ |
| Known as | Nanoliposomal Irinotecan | “MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels” NCT01770353 ↗ |
| Known as | PEP02 | “A randomized phase II study of PEP02 (MM-398), irinotecan or docetaxel as a second-line therapy in patients with locally advanced or metastatic gastric or gastro-oesophageal...” PMID 23406728 ↗ Feb 20135“MM-398 (also known as PEP02) is nanoliposomal encapsulated irinotecan” NCT02640365 ↗ |
| Action | Inhibit | “Irinotecan liposome may help block the formation of growths that may become cancer.” NCT04753216 ↗1“DNA topoisomerase I inhibitor” CHEMBL5314381 ↗ |
| Modality | Other / unclassified | “MM-398 (also known as PEP02) is nanoliposomal encapsulated irinotecan” NCT02640365 ↗ |
| Route | Intravenous | “Intravenous injection of PEP02 120 mg m(-2) was given every 3 weeks.” PMID 23880820 ↗ Jul 2013 |
| Target | TOP1 | “DNA topoisomerase I inhibitor” CHEMBL5314381 ↗ |