NDAINTRAVENOUSINJECTABLE, LIPOSOMALPriority Review
Approved
Oct 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
18
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ONIVYDE is a liposomal formulation of irinotecan hydrochloride, a topoisomerase I inhibitor approved in 2015 for multiple solid tumors including colorectal, pancreatic, breast, and lung cancers. It works by binding to topoisomerase I-DNA complexes to prevent DNA religation, causing double-strand breaks during DNA synthesis that mammalian cells cannot efficiently repair. The drug is administered intravenously and has peak lifecycle status with 10.5 years of patent exclusivity remaining.
$1MPart D
Peak10.4 years to LOEPeak lifecycle status with modest Part D spending ($1M, 98 claims in 2023) suggests a niche oncology asset with stable but limited commercial scale.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (18)
A Real-world Study of Liposomal Irinotecan (Onivyde)-Based Therapy in Patients With Locally Advanced/Metastatic Pancreatic Cancer in China
Started Jul 2025
40 enrolled
Advanced Pancreatic Cancer
A Multi-center, Single-arm, Prospective Non-interventional Study to Investigate the Safety Profiles and Effectiveness of Liposomal Irinotecan (ONIVYDE®) in Combination with 5-fluorouracil (5-FU) and Leucovorin (LV) in Chinese Patients with Metastatic Pancreatic Cancer As Approval Condition (SEOPAC)
Started Nov 2024
120 enrolled
Metastatic Pancreatic Cancer
Clinical Study of Irinotecan Hydrochloride Liposome Combined With Capecitabine for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma
Started Jun 2024
20 enrolled
Biliary Tract Carcinoma
Treatment of Irinotecan Hydrochloride Liposome Injection II in China: a Real World Study of Pancreatic Cancer Patients
Started Apr 2024
3,000 enrolled
Pancreatic Cancer
A Study to Compare Onivyde Manufactured at Two Different Production Sites in Adult Participants With Advanced Cancer in the Pancreas
Started May 2022
177 enrolled
Metastatic Pancreatic Adenocarcinoma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.