TucidinostatOther Names: CS-055, Chidamide, Epidaza, HBI-8000 Drug Class: Latency-Reversing Agents Molecular Formula: C22 H19 F N4 O2 Registry Number: 1616493-44-7 (CAS) Chemical Name: Benzamide, N-(2-amino-4-fluorophenyl)-4-(((1-oxo-3-(3-pyridinyl)-2-propen-1-yl)amino)methyl)-Benzamide, N-(2-amino-4-fluorophenyl)-4-((((2E)-1-oxo-3-(3-pyridinyl)-2-propen-1-yl)amino)methyl)- Chemical Class: Benzamide Organization: HUYA Bioscience International; Shenzhen Chipscreen Biosciences Ltd. Phase of Development: Tucidinostat is in Phase 2/3 development as a latency-reversing agent for HIV.
(Compound details obtained from ChemIDplus Advanced,1 HUYA Bioscience International website,2 and Treatment Action Group website3)
What is tucidinostat?
Tucidinostat is anthat is being studied as part of a strategy to cure HIV . Tucidinostat belongs to a group of HIV drugs called .3
How do latency-reversing agents work?
Currently, there is no cure for HIV infection. One of the main obstacles to curing HIV infection is that thecan remain hidden and inactive (latent) inside certain cells of the (such as resting CD4 cells) for many months or even years. The cells where latent HIV hides are known as the . Because HIV in this latent state is inactive, the immune system cannot detect the virus, and the (ARV) drugs that are used to treat HIV have no effect on it.4–6
Latency-reversing agents work by drawing HIV out of its latent state within resting CD4 cells. Once the latent HIV is reactivated, the CD4 cells that harbor the virus are more likely to be recognized and killed by the body’s immune system or may be killed by certain HIV therapies, such as those that can enhance the body’s What is a Latent HIV Reservoir? fact sheet.to HIV. Researchers hope that the combined use of tucidinostat and other HIV-fighting strategies, including ongoing (ART), may fully eliminate HIV from the body.4–6 To learn more, see the AIDSinfo
Which clinical trials are studying tucidinostat?
Study Names: CHARTER; NCT02513901
Status: This study has been completed.
Purpose: The purpose of this study was to look at the safety of tucidinostat and to see whether tucidinostat added to ART could reactivate latent HIV and help reduce the amount of latent HIV in the body.7,8
Study Name: NCT02902185
Status: This study is ongoing, but not recruiting participants.
Purpose: The purpose of this study is to confirm the effectiveness of tucidinostat plus ART in reactivating latent HIV and reducing the amount of latent HIV in the body.9
For more details on the studies listed above, see the Health Professional version of this drug summary.
In addition, a Phase 1 study (NCT03980691) is evaluating whether tucidinostat used in combination with can reduce the size of the latent HIV reservoir in participants on suppressive ART. This study is currently recruiting participants.10
What side effects might tucidinostat cause?
One goal of HIV research is to identify new drugs that have fewer side effects. The following side effects were observed in some of the studies of tucidinostat listed above.CHARTER (NCT02513901):
In this Phase 1b/2a study, no significant side effects occurred, and all reported side effects were mild in severity. Rash and fatigue/sleepiness were reported in one person each.8,11
Because tucidinostat is still being studied, information on possible side effects of the drug is not complete. As testing of tucidinostat continues, additional information on possible side effects will be gathered.
Where can I get more information about clinical trials studying tucidinostat?
More information about tucidinostat-related research studies is available from the AIDSinfo database of study summaries. Click on the title of any trial in the list to see the ClinicalTrials.gov trial summary and more information about the study.
Some clinical trials may be looking for volunteer participants. Your health care provider can help you decide whether participating in a NIH Clinical Research Trials and You.is right for you. For more information, visit
- United States National Library of Medicine. ChemIDplus Advanced: tucidinostat. https://chem.nlm.nih.gov/chemidplus/rn/1616493-44-7. Accessed July 11, 2019
- Huya Bioscience International: Press Release, dated March 6, 2007. HUYA Bioscience licenses chidamide cancer compound from Chipscreen Biosciences. https://www.huyabio.com/huya-bioscience-licenses-chidamide-cancer-compound-chipscreen-biosciences/. Accessed July 11, 2019
- Treatment Action Group website. Research toward a cure trials. http://www.treatmentactiongroup.org/cure/trials. Accessed July 11, 2019
- Siliciano RF, Greene WC. HIV latency. Cold Spring Harb Perspect Med. 2011;1(1):a007096.
- Rasmussen TA, Tolstrup M, Winckelmann A, Østergaard L, Søgaard OS. Eliminating the latent HIV reservoir by reactivation strategies. Hum Vaccines Immunother. 2013;9(4):790–799.
- National Institute of Allergy and Infectious Diseases (NIAID). HIV viral eradication. https://www.niaid.nih.gov/diseases-conditions/hiv-viral-eradication. Accessed July 11, 2019
- Tang-Du Hospital. Safety and efficacy of the histone deacetylase inhibitor chidamide in combination with antiretroviral therapy for eradication of the latent HIV-1 reservoir (CHARTER). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on July 30, 2015. NLM Identifier: NCT02513901. https://clinicaltrials.gov/ct2/show/NCT02513901. Accessed July 11, 2019
- Sun Y, Li J, Ma C. Chidamide disrupts and reduces HIV-1 latency in patients on suppressive antiretroviral therapy. Slides presented at: International AIDS Conference; July 23-27, 2018; Amsterdam, Netherlands. https://programme.aids2018.org/PAGMaterial/PPT/3643_2431/2018-IAS-Chidamide.pptx. Accessed July 11, 2019
- Tang-Du Hospital. Efficacy of the histone deacetylase inhibitor chidamide in combination with antiretroviral therapy for reactivation of the latent HIV-1 reservoir: a randomized controlled clinical trial. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on September 6, 2016. NLM Identifier: NCT02902185. https://clinicaltrials.gov/ct2/show/NCT02902185. Accessed July 11, 2019
- Guangzhou 8th People’s Hospital. Effect of chidamide combined with CAT-T or TCR-T cell therapy on HIV-1 latent reservoir. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 7, 2019. NLM Identifier: NCT03980691. https://clinicaltrials.gov/ct2/show/NCT03980691. Accessed July 11, 2019
- Sun Y, Li J, Ma J. Chidamide reactivates and diminishes latent HIV-1 DNA in patients on suppressive antiretroviral therapy. Abstract presented at: International AIDS Conference; July 23-27, 2018; Amsterdam, Netherlands. Abstract WEAA0101. http://programme.aids2018.org/Abstract/Abstract/9294. Accessed July 11, 2019
Last Reviewed: July 11, 2019