Tucidinostat is under clinical development by HUYA Bioscience International and currently in Phase II for Melanoma. According to GlobalData, Phase II drugs for Melanoma have a 27% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Tucidinostat’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.

Tucidinostat overview

Tucidinostat (Epidaza, Hiyasta) is a member of the benzamide class acts as an anti-neoplastic agent. It is formulated as tablets and film coated tablets for oral route of administration. Tucidinostat is indicated for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) in patients who previously received a systemic chemotherapy and also indicated  in combination with aromatase inhibitor is indicated for the treatment of advanced breast cancer in postmenopausal patients with hormone receptor (HR)-positive, HER2-negative treated with endocrine therapies for recurrence or progression. Hiyasta is indicated for the treatment of relapsed or refractory (R/R) adult T-cell leukemia/lymphoma (ATL)

It is under development for the treatment of acute myelocytic leukemia, neuroendocrine carcinoma, extranodal natural killer/T-cell lymphoma, metastatic rectal cancer, HIV-1 infections, diffuse large B cell lymphoma, non-small cell lung cancer, hormone receptor-positive, HER-2 negative late stage breast cancer, adult T-cell leukemia/lymphoma (ATL), peripheral T-cell lymphoma (PTCL), angioimmunoblastic T-cell lymphoma, hodgkin lymphoma, anaplastic large-cell lymphoma, enteropathy-associated T-cell lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, cephalic and cervical adenoid cystic carcinoma, B-cell non-hodgkin lymphoma including diffuse large B-cell lymphoma, Mycosis fungoides, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, transformed indolent lymphoma.and melanoma, renal cell carcinoma, relapsed and refractory multiple myeloma, non-small cell lung cancer, renal pelvis cancer, ureter cancer, bladder cancer, urethral cancer, triple-negative breast cancer and urothelial cell cancer. It was also under development for the treatment of prostate cancer, cutaneous T-cell lymphoma and HER2 positive breast cancer.

HUYA Bioscience International overview

HUYA Bioscience International (HUYA) is a biopharmaceutical company that develops early and late-stage drug candidates. The company’s pipeline products include HBI-8000, HBI-3000, and HBI-3802. Its HBI-8000 is a novel oral inhibitor of histone deacetylases; HBI-3000 is a channel blocker for the treatment of arrhythmia and HBI-3802 is a small molecule with preclinical activity to improve heart function. HUYA also identifies and licenses pre-clinical and clinical stage compounds. The company develops drugs in the areas of oncology and cardiovascular. It has operations in the US, Ireland, China, Japan and South Korea. HUYA is headquartered in Pudong, Shanghai, China.

For a complete picture of Tucidinostat’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.