Belinostat is under clinical development by Acrotech Biopharma 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 Belinostat’s likelihood of approval (LoA) and phase transition for Solid Tumor took place on 27 Jun 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

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

Belinostat overview

Belinostat (Beleodaq) is a antineoplastic drug, belongs to oncology class. It is formulated as a lyophilized powder for solution for intravenous route of administration. Beleodaq is indicated for the treatment of relapsed or refractory peripheral T-cell lymphoma.

It is under development for the treatment of unresectable and metastatic conventional chondrosarcoma, metastatic triple-negative breast cancer, ovarian cancer, urothelial carcinoma, gastrointestinal malignancies including gastric cancer, colorectal cancer, metastatic castration resistant prostate cancer, pancreatic cancer, metastatic uveal melanoma and gynecological malignancies including metastatic ovarian cancer and endometrial cancer, relapsed refractory acute myeloid leukemia and myelodysplastic syndrome, metastatic breast cancer, thymic carcinoma,  refractory solid tumors, hematological malignancies (i.v), liquid and solid tumors (oral). It is administered through intravenous and oral routes. It was under development as second-line therapy for peripheral T-cell lymphoma, fallopian tube cancer, peritoneal cancer, epithelial ovarian cancer and also under development for acute myelocytic leukemia, B-cell lymphomas, advanced multiple myeloma, small-cell lung cancer, epithelial carcinoma, soft tissue sarcoma, thymic carcinoma (second line), hepatocellular carcinoma, diffuse large b-cell lymphoma (third line) and non-small lung cancer (first-line therapy). The oral formulation of belinostat is developed based on amorphous spray-dried dispersion technology.

Acrotech Biopharma overview

Acrotech Biopharma (Acrotech), a subsidiary of Aurobindo Pharma USA Inc develops and commercializes innovative proprietary medications. The company provides products in the therapy areas of gastrointestinal, oncology and genetic disorders.

Quick View Belinostat LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Belinostat
Administration Pathway
  • Intravenous
  • Oral
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.