Irinotecan hydrochloride is under clinical development by Ipsen and currently in the Phase I, Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Irinotecan hydrochloride’s likelihood of approval (LoA) and phase transition for Small-Cell Lung Cancer took place on 29 Nov 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Irinotecan hydrochloride Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Irinotecan hydrochloride overview

Irinotecan Hydrochloride (Onivyde) is a semisynthetic derivative of camptothecin, a cytotoxic, quinoline-based alkaloid extracted from the Asian tree Camptotheca acuminata. It is formulated as suspension pegylated liposomal injection for intravenous route of administration. Onivyde is indicated in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.

It is under development for the treatment of extra-pulmonary neuroendocrine carcinoma, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, esophagogastric cancer, high grade glioma includes gliosarcoma, anaplastic astrocytoma, pancreatic ductal adenocarcinoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma, metastatic triple negative breast cancer, gastric cancer, metastatic adenocarcinoma of the pancreas, small-cell lung cancer, esophageal squamous cell carcinoma, refractory and relapsed pediatric solid tumors including Ewing sarcoma, rhabdomyosarcoma, neuroblastoma, osteosarcoma, cholangio and gallbladder carcinoma, refractory gastroesophageal junction carcinomas, metastatic gastroenteropancreatic poorly differentiated neuroendocrine carcinoma. The drug candidate is a nanoliposomal formulation of irinotecan based on liposome loading and intraliposomal stabilization technology known as Lipotrap technology. It was under development for metastatic colorectal cancer and glioblastoma multiforme.

Ipsen overview

Ipsen is a global specialty biopharmaceutical company engaged in the manufacturing and distribution of drugs for the treatment of cancer, rare diseases and neurological diseases, including specialty pharmaceutical products. The company develops and commercializes novel medicines for cancer, neuroscience and rare diseases and also offers products to treat gastrointestinal disorders, neurodegenerative pathologies and rheumatic diseases. Ipsen sells its drugs through a network of distributors and directly to hospitals in a few countries. The company operates its research and development facilities in Paris-Saclay, France; Oxford, the UK; and Cambridge, the US. The company offers products in Europe, North America, Asia and rest of the world. Ipsen is headquartered in Paris, France.

Quick View Irinotecan hydrochloride LOA Data

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Irinotecan hydrochloride
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.