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Nanoliposomal Irinotecan
Nanoliposomal Irinotecan is a Small molecule drug developed by PharmaEngine. It is currently in Phase 2 development. Also known as: TAS-102, Irinotecan Liposome, Onivyde, PEP02.
Nanoliposomal Irinotecan is a small molecule inhibitor of DNA topoisomerase 1, classified as an INHIBITOR. It is being studied in clinical trials for various types of cancer, including Advanced Breast Cancer, Pancreatic Cancer, Colorectal Cancer Metastatic, Rectal Cancer, and Borderline Resectable Pancreatic Ductal Adenocarcinoma.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Nanoliposomal Irinotecan |
|---|---|
| Also known as | TAS-102, Irinotecan Liposome, Onivyde, PEP02, Camptosar |
| Sponsor | PharmaEngine |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
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)
- A Study of Suizenji in Patients With Unresectable Pancreatic Cancer (NA)
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:
- Nanoliposomal Irinotecan CI brief — competitive landscape report
- Nanoliposomal Irinotecan updates RSS · CI watch RSS
- PharmaEngine portfolio CI
Frequently asked questions about Nanoliposomal Irinotecan
What is Nanoliposomal Irinotecan?
Who makes Nanoliposomal Irinotecan?
Is Nanoliposomal Irinotecan also known as anything else?
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Related
- Manufacturer: PharmaEngine — full pipeline
- Also known as: TAS-102, Irinotecan Liposome, Onivyde, PEP02, Camptosar
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing