Friday, July 10, 2026

Drug profile · INN

irinotecan hydrochloride trihydrate

irinotecan hydrochloride trihydrate (ONIVYDE PEGYLATED LIPOSOMAL (PREVIOUSLY ONIVYDE)) is a dna topoisomerase i inhibitor.

EMA: approved Antineoplastic and immunomodulating agents (L01) L01CE02
Patents linked 0
Pipeline programs 4
News articles 0
Drug details — irinotecan hydrochloride trihydrate
Class
Antineoplastic and immunomodulating agents (L01)
Route
Patents
0
Programs
4
Data quality
0.83

Quick answer

irinotecan hydrochloride trihydrate (ONIVYDE PEGYLATED LIPOSOMAL (PREVIOUSLY ONIVYDE)) is a dna topoisomerase i inhibitor.

Key facts

INN irinotecan hydrochloride trihydrate
Brand ONIVYDE PEGYLATED LIPOSOMAL (PREVIOUSLY ONIVYDE)
Mechanism DNA topoisomerase I inhibitor
Target DNA topoisomerase 1
Therapeutic class Antineoplastic and immunomodulating agents (L01)
ATC code L01CE02

Mechanism of action

DNA topoisomerase I inhibitor

Primary target: DNA topoisomerase 1

Approval history

Authority Status Date
EMA approved

Pipeline programs

  1. 20210081 Phase 3 · Amgen · Colorectal Cancer (CRC)
  2. CA2660003 Phase 3 · Bristol-Myers Squibb Australia · Untreated, Unresectable or Metastatic Colorectal Cancer
  3. GEMCAD-1802 Phase 2 · Disc Medicine · Colorectal cancer and metastatic disease limited to the live
  4. ​​D798VC00001​ Phase 2 · AstraZeneca · ​​Colorectal cancer​

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is irinotecan hydrochloride trihydrate?

irinotecan hydrochloride trihydrate (ONIVYDE PEGYLATED LIPOSOMAL (PREVIOUSLY ONIVYDE)) is a dna topoisomerase i inhibitor.

What is the brand name for irinotecan hydrochloride trihydrate?

ONIVYDE PEGYLATED LIPOSOMAL (PREVIOUSLY ONIVYDE) is a marketed brand name for irinotecan hydrochloride trihydrate. Check FDA Drugs@FDA for the current US label holder and prescribing information.