HDAC Inhibitor Market: Competitive Landscape, Pipeline, and Market Analysis 2023

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Histone deacetylases (HDAC) are a class of enzymes that remove acetyl groups from an N-acetyl lysine amino acid on both histone and non-histone proteins. HDACs allow histones to wrap the DNA more tightly. This is important because DNA is wrapped around histones and DNA expression is regulated by acetylation and de-acetylation. HDAC's action is opposite to that of histone acetyltransferase. HDAC proteins are now also called lysine deacetylases. HDAC involved biological functions including transcription, metabolism, oxidative stress, redox, protein degradation, and cell cycle among others. Histone deacetylases are expressed in different tumors; class I and II HDACs are general oncoproteins that interact with substrates and regulate gene expression to promote tumorigenesis and cancer development either individually or alongside co-repressors. The mechanism of action (MOA) of HDAC Inhibitor is  that work by HDIs block HDAC enzyme activity by binding to the zinc ion in the catalytic site, which blocks substrate access to the site and histone deacetylase inhibitors exert their anti-tumour effects via the induction of expression changes of oncogenes or tumor suppressors. HDAC Inhibitors are used for the treatment of lymphoma, blood coagulation disorders, leukemia, sarcoma, hematologic diseases, Hodgkin disease, gastrointestinal diseases, multiple myeloma, vascular diseases, and breast neoplasm among others. Increased prevalence of sarcoma and lymphoma are the key drivers for the HDAC Inhibitor market. For instance, According to the World Health Organization 2023, Non-Hodgkin lymphoma (NHL) is one of the most common cancers in the United States, accounting for about 4% of all cancers. Launch of newer products by the market players could seek opportunities that influence extensive research and development in  HDAC inhibitors. For instance, Chipscreen Bioscience’s Epidaza (Chidamide) is used to treat relapsed or refractory peripheral T cell lymphoma (PTCL). Moreover, the development of novel molecules by key players are coming up to overcome challenges in therapy. For instance, Italfarmaco’s Givinostat (ITF2357) for the treatment of juvenile idiopathy is under the various stages of clinical studies.

Key Market Developments:

  • In December 2019, Chipscreen Bioscience’s Epidaza (Chidamide) received the approval from China’s National Medical Products Administration (NMPA) for the indication of breast cancer.
  • In December 2022, 4SC’s Resminostat received European Medicine Agency approval for its application of pre-authorization eligibility request in cutaneous T cell lymphoma and resminostat was eligible for submission of an application for a Union Marketing Authorisation according to the centralized procedure as detailed in Regulation (EC) No 726/2004.

Approved Drug Molecules and Brand Names for HDAC Inhibitor:

  • Epidaza (Chidamide)
  • Kinselby (Resminostat)
  • Istodax (Romidepsin)

Drugs under the Pipeline for HDAC Inhibitor:

  • Zolinza (Vorinostat)
  • Jingzhuda (Enostat)
  • Beleodaq (Belinostat)
  • Givinostat (ITF2357)nti
  • Mocetinostat (MGCD0103)
  • Abexinostat (CG-781)
  • Pracinostat (SB939)
  • FX 322
  • Tinostamustine (EDO-S101)
  • Domatinostat (4SC-202)
  • Fimepinostat (CUDC-907)
  • Ivaltinostat (CG-745)
  • Quisinostat (JNJ 26481585)
  • CUDC-101
  • Sulforadex (Sulforafan Alfadex)
  • Nanatinostat (Vrx-3996)
  • Panobinostat (MTX110)
  • Remetinostat (SHP-141)
  • Zabinostat (CXD101)
  • REC-2282
  • Alteminostat (CKD-581)
  • Tefinostat (CHR-2845)
  • Valproic Acid (CT-010)
  • GSK3117391
  • HG146
  • Lunaphen (4 Phenyl Butyrate Prolonged-Release)
  • RDN-929
  • Bocodepsin (OKI-179)
  • Avugane (Valproic Acid)
  • Baceca (Valproic Acid)
  • EVP-0334
  • MPT0E028
  • Savicol (Valproic Acid)
  • Bisthianostat (CF367)
  • Spiruchostatin A (OBP-801)
  • Trichostatin A (VTR-297)
  • Valproic Acid/Prednisone(VAL001)

Clinical Activity and Developments of HDAC Inhibitor:

As of June 2023, more than 55 companies have approximately 42 molecules targeting 625 diseases. For these molecules, more than 296 clinical trials are being conducted and the majority are in phase-2, phase-3 clinical trials. For instance,

  • In June 2023, Edding Pharma completed the phase 2 study of epigenetic therapy with Azacitidine and Entinostat with concurrent nivolumab in subjects with metastatic non-small cell lung cancer.
  • In February 2022, 4SC AG completed phase 1, Open-label Study of Resminostat for evaluating the Absorption, Metabolism, Excretion in a Single Oral Dose in Healthy Male subjects.

Molecule Name

Number of Studies

Zolinza (Vorinostat)


Istodax (Romidepsin)


Jingzhuda (Entinostat)


Beleodaq (Belinostat)


Givinostat (ITF2357)



Target Indication Analysis of HDAC Inhibitor

The molecules such as Epidaza (Chidamide) developed by Chipscreen Biosciences for the line of treatment for relapsed or refractory peripheral T cell lymphoma (PTCL). 4SC’s Kinselby (Resminostat) is used to treat Cutaneous T-cell lymphoma (CTCL) a rare type of cancer that begins in white blood cells called T cells (T lymphocytes). Moreover, Italfarmaco’s Givinostat (ITF2357) for the therapy of juvenile idiopathic arthritis, Duchenne muscular dystrophy, and Mundipharma’s Tinostamustine (EDO-S101) to improve drug access to DNA strands within cancer cells, break them, and counteract damage repair is under the clinical development.

Frequently Asked Questions

Epidaza (Chidamide), Kinselby (Resminostat), and Istodax (Romidepsin) are the few FDA-approved PDE4 Inhibitor.

Total revenues of Bristol Myers squibb’s Istodax (Romidepsin) Before the megamerger, Celgene reported that Istodax sales declined 17% year-over-year in FY 2018 to just US$ 63 million in the US.

Major market players include Huya Bioscience, Secura Bio, 4SC, Astellas, and Bristol Myers Squibb are few leading market players.

Major Indications for HDAC Inhibitor are used to treat lymphoma, blood coagulation disorders, leukemia, sarcoma, hematologic diseases, and Hodgkin disease among others

There are a total of 38 molecules that are in Phase-1, Phase-2, and Phase-3 clinical development.

Key Features of the Reports

  • The report provides granular level information about the market size, regional market share, historic market (2019-2023), and forecast (2024-2030)
  • The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The report tracks recent innovations, key developments, and start-up details that are actively working in the market
  • The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario
  • Huya Bioscience
  •  Secura Bio
  •  4SC
  •  Astellas
  •  Bristol Myers Squibb
  •  EOC Pharma
  •  Aurobindo
  •  Spectrum Pharma
  •  Italfarmaco
  •  Mirati
  •  Otsuka
  •  Xynomic
  •  Mundipharma
  •  Curis
  •  Crystal Genomics
  •  Chemrar
  •  Curis
  •  Evgen Pharma
  •  Viracta Therap
  •  Midatech
  •  Medivir
  •  Ingenox Therap
  •  Nuance Biotech
  •  Recursion Pharma
  •  Chong Kun Dang
  •  Chroma Therap
  •  Cerebral Therap
  •  GSK
  •  Hitgen
  •  Lunamed Operations
  •  Naturewise Biotech & Medicals Corp
  •  Alkermes
  •  Onkure
  •  Pfizer
  •  Onxeo
  •  Forum Pharmaceuticals
  •  Shanghai Theorion Pharma

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