Belinostat is under clinical development by Acrotech Biopharma and currently in Phase I for Triple-Negative Breast Cancer (TNBC). According to GlobalData, Phase I drugs for Triple-Negative Breast Cancer (TNBC) have an 83% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Belinostat’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.

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.

For a complete picture of Belinostat’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.