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Irinotecan Liposomal
Irinotecan Liposomal is a Topoisomerase I inhibitor Small molecule drug developed by The First Affiliated Hospital of Zhengzhou University. It is currently in Phase 3 development for Metastatic colorectal cancer, Metastatic pancreatic cancer, Ovarian cancer. Also known as: 5-FU, Calcium folinate, Oxaliplatin, Karelizumab.
Irinotecan liposomal is a topoisomerase I inhibitor encapsulated in liposomes that prevents DNA religation during replication, leading to cell death.
Irinotecan liposomal is a topoisomerase I inhibitor encapsulated in liposomes that prevents DNA religation during replication, leading to cell death. Used for Metastatic colorectal cancer, Metastatic pancreatic cancer, Ovarian cancer.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Irinotecan Liposomal |
|---|---|
| Also known as | 5-FU, Calcium folinate, Oxaliplatin, Karelizumab, Onivyde® |
| Sponsor | The First Affiliated Hospital of Zhengzhou University |
| Drug class | Topoisomerase I inhibitor |
| Target | Topoisomerase I |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Irinotecan inhibits topoisomerase I, an enzyme essential for DNA unwinding and replication. By stabilizing the cleavage complex between topoisomerase I and DNA, the drug prevents religation of DNA strands, causing double-strand breaks and apoptosis in rapidly dividing cancer cells. The liposomal formulation enhances drug delivery to tumors while potentially reducing systemic toxicity.
Approved indications
- Metastatic colorectal cancer
- Metastatic pancreatic cancer
- Ovarian cancer
Common side effects
- Neutropenia
- Diarrhea
- Nausea and vomiting
- Anemia
- Fatigue
- Abdominal pain
Key clinical trials
- Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations (PHASE3)
- Oxaliplatin Combined With Irinotecan Liposome Injection II Through Hepatic Artery Infusion (HAIC) Followed by 5-FU/LV (HAIC) or Tegorgor Oral Combination Therapy for Hepatic Metastasis of Pancreatic Cancer (PHASE2)
- A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer (PHASE3)
- Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread (PHASE2)
- Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma (PHASE1, PHASE2)
- Monthly Alternating NALIRIFOX and GnP in the First-Line Setting for Metastatic Pancreatic Ductal Adenocarcinoma (PHASE2)
- SCRT-NALIRIXELOX+Sintilimab as TNT for High-Risk LARC (NA)
- Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Irinotecan Liposomal CI brief — competitive landscape report
- Irinotecan Liposomal updates RSS · CI watch RSS
- The First Affiliated Hospital of Zhengzhou University portfolio CI
Frequently asked questions about Irinotecan Liposomal
What is Irinotecan Liposomal?
How does Irinotecan Liposomal work?
What is Irinotecan Liposomal used for?
Who makes Irinotecan Liposomal?
Is Irinotecan Liposomal also known as anything else?
What drug class is Irinotecan Liposomal in?
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What are the side effects of Irinotecan Liposomal?
What does Irinotecan Liposomal target?
Related
- Drug class: All Topoisomerase I inhibitor drugs
- Target: All drugs targeting Topoisomerase I
- Manufacturer: The First Affiliated Hospital of Zhengzhou University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic colorectal cancer
- Indication: Drugs for Metastatic pancreatic cancer
- Indication: Drugs for Ovarian cancer
- Also known as: 5-FU, Calcium folinate, Oxaliplatin, Karelizumab, Onivyde®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing