Tinostamustine is under clinical development by Northlake International and currently in the Phase I and Phase II 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 Tinostamustine’s likelihood of approval (LoA) and phase transition for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia) took place on 11 Mar 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 11 Mar 2022 increased Tinostamustine’s LoA and PTSR for Diffuse Large B-Cell Lymphoma.

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

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.

Quick View Tinostamustine LOA Data

Report Segments
  • Innovator
Drug Name
  • Tinostamustine
Administration Pathway
  • Intravenous
  • Parenteral
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Phase II

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.