Tucidinostat is under clinical development by HUYA Bioscience International and currently in Phase II for Anaplastic Large Cell Lymphoma (ALCL). According to GlobalData, Phase II drugs for Anaplastic Large Cell Lymphoma (ALCL) have a 29% 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 neuroendocrine carcinoma,  metastatic colorectal cancer, diffuse large B cell lymphoma, non-small cell lung 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, relapsed or refractory (R/R) 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, non-small cell lung cancer, renal pelvis cancer, ureter cancer, bladder cancer, urethral cancer, triple-negative breast cancer, hepatocellular carcinoma and urothelial cell cancer, acute myelocytic leukemia.

It was also under development for the treatment of prostate cancer, cutaneous T-cell lymphoma, HER2 positive breast cancer, HIV-1 infections, cephalic and cervical adenoid cystic carcinoma, angioimmunoblastic T-cell lymphoma, relapsed and refractory multiple myeloma, extranodal natural killer/T-cell lymphoma and relapsed and refractory acute myeloid leukemia.

HUYA Bioscience International overview

HUYA Bioscience International (HUYA) is a biopharmaceutical company that develops novel oncology and cardiology therapy products. The company’s oncological pipeline products include HBI-8000, HBI-2376 and HBI-ONC. Its HBI-8000, treat 2L lung cancer, 1L melanoma, peripheral T-cell lymphoma and adult T- cell leukemia; HBI-2376, treats solid tumors and HBI-ONC, treats myelodysplastic syndrome and acute myeloid leukemia. HUYA’s cardiology products HBI-3000 and HBI-3800 treat atrial fibrillation and post-myocardial infarction. The company works in collaboration with biopharmaceutical, academic and commercial organizations. It operates in the US, China, South Korea, Japan, Canada and Ireland. HUYA is headquartered in San Diego, California, the US.

For a complete picture of Tucidinostat’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

Data Insights


The gold standard of business intelligence.

Blending expert knowledge with cutting-edge technology, GlobalData’s unrivalled proprietary data will enable you to decode what’s happening in your market. You can make better informed decisions and gain a future-proof advantage over your competitors.


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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.