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Irinotecan sucrosofate - Ipsen

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Drug Profile

Irinotecan sucrosofate - Ipsen

Alternative Names: BAX-2398; Irinotecan liposome injection - Merrimack; Liposomal irinotecan - Ipsen/Servier; MM-398; nal-IRI; Nano-irinotecan; Nanoliposomal irinotecan - Merrimack/PharmaEngine; Nanoliposomal irinotecan injection - Merrimack/PharmaEngine; Onivyde; pegylated liposomal irinotecan hydrochloride trihydrate; PEP-02; S-095013; SHP-673

Latest Information Update: 17 Sep 2024

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At a glance

  • Originator Academic Medical Center; HERMES BioSciences
  • Developer Academic Medical Center; AIO Studien gGmbH; Bristol-Myers Squibb; Emory University; Federation Francophone de Cancerologie Digestive; Ipsen; Medica Scientia Innovation Research; Merrimack Pharmaceuticals; National Cancer Institute (USA); PharmaEngine; Rhode Island Hospital; Servier; Shire; Taiho Pharmaceutical; University of California at San Francisco; University of Florida; University of Michigan
  • Class Alkaloids; Antineoplastics; Camptothecins; Carboxylic acids; Esters; Indolizines; Piperidines; Pyrans; Quinolines; Small molecules
  • Mechanism of Action DNA topoisomerase I inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Pancreatic cancer
  • New Molecular Entity No

Highest Development Phases

  • Marketed Pancreatic cancer
  • Phase III Small cell lung cancer
  • Phase II Adenocarcinoma; Biliary cancer; Cholangiocarcinoma; Colorectal cancer; Fallopian tube cancer; Gallbladder cancer; Gastric cancer; HER2 negative breast cancer; Oesophageal cancer; Ovarian cancer; Peritoneal cancer
  • Phase I/II Gastrointestinal cancer; Glioblastoma
  • Phase I Solid tumours
  • No development reported Glioma

Most Recent Events

  • 17 Sep 2024 AIO-Studien-gGmbH in collaboration with Servier completes a phase II NIFE trial in Adenocarcinoma (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in Germany (IV), prior to September 2024 (NCT03044587) (EudraCT2016‐002467‐34)
  • 31 May 2024 Efficacy data from the phase III NAPOLI-3 trial in Pancreatic cancer presented at the 60th Annual Meeting of the American Society of Clinical Oncology (ASCO-2024)
  • 13 Feb 2024 Registered for Pancreatic cancer (Combination therapy, First-line therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in USA (IV)

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