{"entity":{"id":"tucidinostat","kind":"drug","name":"Tucidinostat (chidamide)","aka":["Chidamide"],"tldr":"Chidamide, approved in 2014, was the first epigenetic cancer drug invented in China and the first oral drug of its kind anywhere, used for T-cell lymphoma and, with hormone therapy, for breast cancer.","summary":"Chipscreen Biosciences' chidamide was approved by the CFDA in December 2014 for relapsed or refractory peripheral T-cell lymphoma, the first China-origin small molecule in a new chemical class and the first oral subtype-selective HDAC inhibitor approved anywhere. The ACE trial (Lancet Oncology 2019) added HR-positive advanced breast cancer with exemestane after endocrine therapy, approved in 2019. Licensed to HUYA Bioscience as HBI-8000, it was approved in Japan in 2021 for adult T-cell leukaemia-lymphoma and is being tested with PD-1 antibodies in melanoma.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Chidamide","links":[{"label":"Chipscreen Biosciences","url":"https://www.chipscreen.com/en/"},{"label":"ACE trial (Lancet Oncol 2019)","url":"https://doi.org/10.1016/S1470-2045(19)30164-0"},{"label":"NMPA (National Medical Products Administration)","url":"https://www.nmpa.gov.cn"}],"tags":["china"],"related":[],"cancers":["peripheral-t-cell-lymphoma","breast-hr-positive"],"sections":[],"technologies":["epigenetic-drugs"],"targets":[],"drugs":[],"companies":["chipscreen"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06497985","nct06776952","nct05833724","nct04668690"],"people":[],"bottlenecks":[],"keyPapers":["paper-jiang-lancet-oncol"],"journals":[],"dependsOn":[],"notes":[],"brand":"Epidaza","code":"chidamide, HBI-8000, CS055","modality":"Small-molecule oral subtype-selective HDAC inhibitor","mechanism":"Benzamide-class inhibitor of class I HDACs 1, 2 and 3 and class IIb HDAC10, relaxing chromatin, restoring tumour suppressor expression and enhancing NK and T-cell activity.","approvals":[{"region":"China","year":2014,"indication":"Relapsed or refractory peripheral T-cell lymphoma"},{"region":"China","year":2019,"indication":"HR-positive, HER2-negative advanced breast cancer with exemestane after endocrine therapy (ACE)"},{"region":"Japan","year":2021,"indication":"Relapsed or refractory adult T-cell leukaemia-lymphoma (HBI-8000)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/tucidinostat/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"peripheral-t-cell-lymphoma","kind":"cancer","name":"Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma)","route":"/cancers/peripheral-t-cell-lymphoma/"}],"technology":[{"id":"epigenetic-drugs","kind":"technology","name":"Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)","route":"/technologies/epigenetic-drugs/"}],"company":[{"id":"chipscreen","kind":"company","name":"Chipscreen Biosciences","route":"/companies/chipscreen/"},{"id":"huyabio","kind":"company","name":"HUYABIO International","route":"/companies/huyabio/"}],"trial":[{"id":"nct06979908","kind":"trial","name":"A Clinical Study on the Efficacy and Safety of Fruquintinib in Combination With PD-1 Monoclonal Antibody and Chidamide in Refractory MSS Metastatic Colorectal C","route":"/trials/nct06979908/"},{"id":"nct06218888","kind":"trial","name":"A Phase II Clinical Study of the Efficacy and Safety of Tislelizumab Combined With Fruquintinib and Chidamide in the Treatment of Unresectable or Advanced Micro","route":"/trials/nct06218888/"},{"id":"nct06776952","kind":"trial","name":"A Randomized, Double-blind, Multicenter Phase III Study of XNW5004 Tablets in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma","route":"/trials/nct06776952/"},{"id":"nct06497985","kind":"trial","name":"A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients","route":"/trials/nct06497985/"},{"id":"nct05833724","kind":"trial","name":"Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL)","route":"/trials/nct05833724/"},{"id":"nct04668690","kind":"trial","name":"Clinical Study of Mitoxantrone Hydrochloride Liposome Injection vs. Chidamide in Patients With Relapsed/Refractory PTCL","route":"/trials/nct04668690/"},{"id":"nct06709885","kind":"trial","name":"HDAC Inhibitor Combination With Chemoimmunotherapy in the Neoadjuvant Treatment of pMMR Locally Advanced Colon Cancer","route":"/trials/nct06709885/"},{"id":"nct06951997","kind":"trial","name":"QL1706 Plus Chidamide, AG as First-line Treatment for Metastatic Pancreatic Cancer","route":"/trials/nct06951997/"},{"id":"nct06685276","kind":"trial","name":"Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS/pMMR Metastatic Colorectal Cancer","route":"/trials/nct06685276/"}],"paper":[{"id":"paper-jiang-lancet-oncol","kind":"paper","name":"Tucidinostat plus exemestane for postmenopausal patients with advanced, hormone receptor-positive breast cancer (ACE): a randomised, double-blind, placebo-controlled, phase 3 trial","route":"/key-papers/paper-jiang-lancet-oncol/"}],"roadmap":[{"id":"epigenetics-roadmap","kind":"roadmap","name":"Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome","route":"/roadmaps/epigenetics-roadmap/"}],"target":[{"id":"hdac10","kind":"target","name":"HDAC10","route":"/targets/hdac10/"}]}}