# Tucidinostat (chidamide)

Source: https://onco.cc/drugs/tucidinostat/  
OnCo record `tucidinostat` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Also known as: Chidamide
- Tags: china
- 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: China 2014: Relapsed or refractory peripheral T-cell lymphoma; China 2019: HR-positive, HER2-negative advanced breast cancer with exemestane after endocrine therapy (ACE); Japan 2021: Relapsed or refractory adult T-cell leukaemia-lymphoma (HBI-8000)

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Chidamide
- Chipscreen Biosciences: https://www.chipscreen.com/en/
- ACE trial (Lancet Oncol 2019): https://doi.org/10.1016/S1470-2045(19)30164-0
- NMPA (National Medical Products Administration): https://www.nmpa.gov.cn

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma)](https://onco.cc/cancers/peripheral-t-cell-lymphoma/)
- technologies: [Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)](https://onco.cc/technologies/epigenetic-drugs/)
- companies: [Chipscreen Biosciences](https://onco.cc/companies/chipscreen/), [HUYABIO International](https://onco.cc/companies/huyabio/)
- trials: [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](https://onco.cc/trials/nct06979908/), [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](https://onco.cc/trials/nct06218888/), [A Randomized, Double-blind, Multicenter Phase III Study of XNW5004 Tablets in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma](https://onco.cc/trials/nct06776952/), [A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients](https://onco.cc/trials/nct06497985/), [Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL)](https://onco.cc/trials/nct05833724/), [Clinical Study of Mitoxantrone Hydrochloride Liposome Injection vs. Chidamide in Patients With Relapsed/Refractory PTCL](https://onco.cc/trials/nct04668690/), [HDAC Inhibitor Combination With Chemoimmunotherapy in the Neoadjuvant Treatment of pMMR Locally Advanced Colon Cancer](https://onco.cc/trials/nct06709885/), [QL1706 Plus Chidamide, AG as First-line Treatment for Metastatic Pancreatic Cancer](https://onco.cc/trials/nct06951997/), [Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS/pMMR Metastatic Colorectal Cancer](https://onco.cc/trials/nct06685276/)
- key papers: [Tucidinostat plus exemestane for postmenopausal patients with advanced, hormone receptor-positive breast cancer (ACE): a randomised, double-blind, placebo-controlled, phase 3 trial](https://onco.cc/key-papers/paper-jiang-lancet-oncol/)
- roadmaps: [Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome](https://onco.cc/roadmaps/epigenetics-roadmap/)
- targets: [HDAC10](https://onco.cc/targets/hdac10/)

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