Mitoxantrone hydrochloride is under clinical development by CSPC Pharmaceutical Group and currently in Phase III for Natural Killer Cell Lymphomas. According to GlobalData, Phase III drugs for Natural Killer Cell Lymphomas have a 50% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Mitoxantrone 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.

Mitoxantrone hydrochloride overview

Mitoxantrone hydrochloride is a anthracenedione antibiotic with antineoplastic activity. It is formulated as liposomal solution for intravenous route of administration. Mitoxantrone Hydrochloride is indicated for the treatment of relapsed or refractory peripheral T-cell lymphoma.

Mitoxantrone hydrochloride is under development for the treatment of recurrent/metastatic head and neck squamous cell carcinoma, relapsed or refractory multiple myeloma, HER-2 negative and positive advanced breast cancer, advanced solid tumor, advanced or metastatic urothelial cancer, diffuse large B-cell lymphoma, peripheral T-cell lymphoma, soft tissue sarcoma, bone sarcoma, angioimmunoblastic T-cell lymphoma, large anaplastic T-cell lymphoma, epithelial ovarian cancer, nasopharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, fallopian tube carcinoma, acute myeloid leukemia (AML), advanced pancreatic cancer, primary peritoneal cancer, anaplastic large T-cell lymphoma, advanced hepatocellular carcinoma, metastatic breast cancer, natural killer cell lymphoma, T-cell lymphomas, peripheral T cell lymphoma, small cell lung cancer and peripheral T/NK cell non-Hodgkin lymphomas, gastric cancer, gastroesophageal junction cancer, colorectal cancer, lymphoma-associated hemophagocytic syndrome, lymphoblastic lymphoma, Burkitt's lymphoma, neuroblastoma. The drug is a liposomal formulation and administered by parenteral route and intravenous route of administration as an infusion. The drug acts by targeting type II topoisomerase. It was under development for cutaneous T-cell lymphoma, mantle cell lymphoma, anaplastic large-cell lymphoma, follicular lymphoma and small lymphocytic lymphoma.

It was also under development for the treatment of relapsing multiple sclerosis (RMS).

CSPC Pharmaceutical Group overview

CSPC Pharmaceutical Group (CSPC) is a pharmaceutical company, which provides innovative, common 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 childhood acute lymphoblastic 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 Mitoxantrone hydrochloride’s drug-specific PTSR and LoA scores, buy the report here.


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.