Tinostamustine is under clinical development by Mundipharma EDO and currently in Phase I for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia). According to GlobalData, Phase I drugs for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia) have a 71% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Tinostamustine’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.

Tinostamustine overview

Tinostamustine (NL-101) is under development for the treatment of hematological malignancies and solid tumors including glioblastoma multiforme (GBM), sarcomas, breast cancer, triple negative breast cancer, endometrial cancer, soft tissue sarcoma (STS) or non-KIT gastrointestinal stromal tumors (GIST), small cell lung cancer, acute myelocytic leukemia, multiple myeloma, Hodgkin lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, peripheral T-cell lymphomas and epithelial ovarian cancer, primary peritoneal cancer, relapsed and refractory cutaneous T-cell lymphoma,T-cell prolymphocytic leukemia and fallopian tube cancer. The therapeutic candidate is administered by intravenous and parenteral route. NL-101 is a hybrid fusion molecule in which the side chain of bendamustine was replaced with the hydroxamic acid of HDACi vorinostat (SAHA). It has a bendamustine back-bone and a histone deacetylase (HDAC) pharmacophore. The drug candidate targets DNA and histone deacetylase. It is developed based on dual functional cytotoxic targeted therapy (DCTT) technology.

It was under development for relapsed/refractory multiple myeloma.

For a complete picture of Tinostamustine’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.