Irinotecan hydrochloride is under clinical development by CSPC Pharmaceutical Group and currently in Phase I for Metastatic Colorectal Cancer. According to GlobalData, Phase I drugs for Metastatic Colorectal Cancer have an 84% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Irinotecan hydrochloride’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Irinotecan hydrochloride overview

Irinotecan Hydrochloride (Doenyi) is a semisynthetic derivative of camptothecin, a cytotoxic, quinoline-based alkaloid extracted from the Asian tree camptotheca acuminata. It is formulated as solution for intravenous route of administration. Irinotecan hydrochloride is indicated for the treatment of patients with metastatic pancreatic cancer after disease progression following gemcitabine-based therapy.

Irinotecan hydrochloride is under development for the treatment of small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), head and neck squamous cell carcinoma,  oral cancer, oropharyngeal cancer, larynx cancer, hypopharyngeal cancer, nasopharyngeal cancer, pancreatic cancer, HER2 negative breast cancer, metastatic colorectal cancer, Ewing sarcoma and metastatic adenocarcinoma of the pancreas. The drug candidate is formulated as a liposome administered by the intravenous drip route. The drug candidate acts by targeting topoisomerase I.

The drug candidate was also under the development of metastatic biliary tract cancer (intra-or extrahepatic cholangiocarcinoma) and gallbladder cancer.

CSPC Pharmaceutical Group overview

CSPC Pharmaceutical Group (CSPC) is a pharmaceutical company, which provides innovative, generic and bulk drugs. The company manufactures, research and markets medicines and pharmaceutical related products. CSPC product portfolio includes capsules, tablets, injections, caffeine and antibiotics such as acarbose, penicillin sodium, cefazolin sodium and meropenem. The company offers its products for various diseases including ovarian cancer, breast cancer, hypertension and leukemia. Its drugs focus on major therapeutic areas such as neurology, diabetes, cardio-cerebrovascular, oncology and anti-infective. The company operates in the Americas, Europe and Asia. CSPC Pharma is headquartered in Shijiazhuang, Hebei, China.

For a complete picture of Irinotecan hydrochloride’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 16 July 2024

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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.