ONIVYDE

Peak

irinotecan hydrochloride

NDAINTRAVENOUSINJECTABLE, LIPOSOMALPriority Review
Approved
Oct 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
11

Mechanism of Action

1 inhibitor encapsulated in a lipid bilayer vesicle or liposome. Topoisomerase 1 relieves torsional strain in DNA by inducing single-strand breaks. Irinotecan and its active metabolite SN-38 bind reversibly to the topoisomerase 1-DNA complex and prevent re-ligation of the single-strand breaks,…

Clinical Trials (5)

NCT05383352Phase 1Completed

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
NCT04901702Phase 1/2Recruiting

Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma

Started Jun 2021
90 enrolled
Recurrent Solid TumorRecurrent Ewing SarcomaRecurrent Hepatoblastoma+19 more
NCT04825288Phase 1/2Active Not Recruiting

XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer

Started May 2021
76 enrolled
Pancreatic Cancer
NCT03088813Phase 3Completed

Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer

Started Apr 2018
491 enrolled
Small Cell Lung Cancer
NCT03245450Phase 1/2Completed

Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Children With Refractory or Recurrent Solid Tumors

Started Mar 2018
40 enrolled
Refractory or Recurrent Solid TumorsRhabdomyosarcomaNon-Rhabdomyosarcoma Soft Tissue Sarcoma+1 more

Loss of Exclusivity

LOE Date
Oct 15, 2036
129 months away
Patent Expiry
Oct 15, 2036
Exclusivity Expiry
Feb 13, 2031

Patent Records (5)

Patent #ExpiryTypeUse Code
8329213
Jan 6, 2027
SubstanceProduct
8147867
Aug 29, 2028
SubstanceProduct
11369597
Jun 12, 2033
U-1848
9717724
Jun 12, 2033
U-1848
10980795
Jun 12, 2033
U-1848