Drugs

Tucidinostat

Tucidinostat

Other 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 II/III 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?

What is tucidinostat?

Tucidinostat is an investigational drug that is being studied as part of a strategy to cure HIV infection. Tucidinostat belongs to a general group of HIV drugs called latency-reversing agents.3

To learn how investigational drugs are tested during clinical trials, read the AIDSinfo What is an Investigational HIV Drug? and HIV/AIDS Clinical Trials fact sheets.

How do latency-reversing agents work?

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 the virus can remain hidden and inactive (latent) inside certain cells of the immune system (such as resting CD4 cells) for many months or even years. The cells where latent HIV hides are known as the latent HIV reservoir. Because HIV in this latent state is inactive, the immune system cannot detect the virus, and the antiretroviral (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 may more likely 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 immune response to HIV. Researchers hope that the combined use of tucidinostat and other HIV-fighting strategies, including ongoing antiretroviral therapy (ART), may fully eliminate HIV from the body.4–6

To learn more, see the AIDSinfo What is a Latent HIV Reservoir? fact sheet.

Which clinical trials are studying tucidinostat?

Which clinical trials are studying tucidinostat?

Study Names: CHARTER; NCT02513901
Phase: Ib/IIa
Status: This study has been completed.
Location: China
Purpose: The purpose of this study was to look at the safety of tucidinostat and to see whether tucidinostat added to ART could reactive latent HIV and help reduce the amount of latent HIV in the body.7,8

Study Name: NCT02902185
Phase: II/III
Status: This study is ongoing, but not recruiting participants.
Location: China
Purpose: The purpose this study is to confirm the efficacy 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.

What side effects might tucidinostat cause?

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 Ib/IIa study, no significant side effects occurred, and all reported side effects were mild in severity. Rash and fatigue/sleepiness were reported in 1 person each.8,10

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?

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 ClinicalTrials.gov 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 clinical trial is right for you. For information, visit NIH Clinical Research Trials and You.

References

References

  1. United States National Library of Medicine. ChemIDplus Advanced: tucidinostat. https://chem.nlm.nih.gov/chemidplus/rn/1616493-44-7. Accessed September 6, 2018.
  2. 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 September 6, 2018.
  3. Treatment Action Group website. Research toward a cure trials. http://www.treatmentactiongroup.org/cure/trials. Accessed September 6, 2018.
  4. Siliciano RF, Greene WC. HIV latency. Cold Spring Harb Perspect Med. 2011;1(1): a007096.
  5. 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.
  6. National Institute of Allergy and Infectious Diseases (NIAID). Fact sheet, dated March 20, 2017. HIV viral eradication. https://www.niaid.nih.gov/diseases-conditions/hiv-viral-eradication. Accessed September 6, 2018.
  7. 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 September 6, 2018.
  8. 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 September 6, 2018.
  9. 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 September 6, 2018.
  10. 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 September 6, 2018.

Last Reviewed: September 6, 2018