HDAC Inhibitor Market

DelveInsight’s, “HDAC inhibitors - Pipeline Insight, 2025” report provides comprehensive insights about 50+ companies and 55+ pipeline drugs in HDAC inhibitors  pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. 

 

Geography Covered

• Global coverage

 

HDAC inhibitors: Understanding

HDAC inhibitors: Overview

The histone deacetylase inhibitors (HDACi) are a group of small molecules that target histone deacetylases (HDACs) by inhibiting their activity. HDACi have a long history of use in neurology and psychiatry as antiepileptics and mood stabilizers. Histone deacetylase (HDAC) inhibitors are a relatively new class of anti-cancer agents that play important roles in epigenetic or non-epigenetic regulation, inducing death, apoptosis, and cell cycle arrest in cancer cells. Eighteen human HDAC enzymes have been identified and classified into four groups based on their homology with yeast HDACs. HDACs are both directly and indirectly involved in many biological processes, including development, proliferation, differentiation, and cell death. HDAC knockout mice enable study of their biological functions and provide valuable insights into the development and side effects of selective inhibitors. Despite the 80% sequence homology between HDAC1 and HDAC2, HDAC1 knockout mice have an embryonic lethal phenotype and display severe proliferation defects and general growth retardation, which cannot be compensated for by the upregulation of HDAC2.

 

The mechanisms of action of HDAC inhibitors are thought to be related to altered gene expression and to changes in non-histone proteins via regulation at the epigenetic and post-translational modification levels, respectively. In many tumor cell lines, HDAC inhibitors cause upregulation of the cell cycle gene p21, blocking the cyclin /CDK complexes, leading to cell cycle arrest and inhibiting differentiation. HDAC inhibition modulates the balance between pro- and anti-apoptotic proteins, causing tumor cell death. HDAC inhibition upregulates the intrinsic and extrinsic apoptosis pathways through the induction of the proapop-totic genes, Bmf and Bim and TRAIL and DR5, respectively. HDAC inhibition may also affect tumor cell survival by blocking tumor angiogenesis and by inhibiting intracellular stress response pathways. HIF-1α, a pro-angiogenic transcription factor, is hyperacetylated by HDAC inhibitors, resulting in its degradation.

 

HDAC inhibitors are a group of prominent epigenetic drugs that are being tested in many clinical implications against several diseases. These may act specifically to one of the types of HDACs or it might target all the types of HDACs (pan-inhibitors). They are classified based on their chemical nature There are four different class of HDAC that are Short-chain fatty acid, Hydroxamat, Benzamide, Cyclic tetrapeptide. Studies shows that Histone deacetylase inhibitors inhibit the proliferation of a variety of transformed cells in vitro, including lymphoma, myeloma, leukemia, and NSCLC, and inhibit tumor progression. HDACi induces cell cycle arrest, differentiation, and cell death. They can also modulate the immune response and decrease angiogenesis.

Gain a deeper understanding of the evolving HDAC Inhibitors landscape, Market forecast, key clinical developments, and emerging therapies shaping the future of epigenetic drug research - HDAC Inhibitors Market

“HDAC inhibitors - Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the mechanism of action. A detailed picture of the HDAC inhibitors pipeline landscape is provided which includes the disease overview and HDAC inhibitors treatment guidelines. The assessment part of the report embraces, in depth HDAC inhibitors commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, HDAC inhibitors  collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

 

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence HDAC inhibitors R&D. The therapies under development are focused on novel approaches to treat/improve HDAC inhibitors.

 

HDAC inhibitors Emerging Drugs Chapters

This segment of the HDAC inhibitors report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

 

HDAC inhibitors Emerging Drugs

• AMX0035: Amylyx Pharmaceuticals

AMX0035, a specially formulated oral fixed-dose combination of PB and TURSO, has been shown in numerous preclinical studies to have a robust, synergistic effect in targeting two different destructive neurodegenerative disease pathways by mitigating endoplasmic reticulum stress and the associated unfolded protein response and mitochondrial dysfunction thereby reducing neuronal cell death. Additionally, AMX0035 has been shown to also reduce markers associated with neurodegenerative diseases in clinical trials, including a reduction of tau, a key protein aggregate shared across several neurodegenerative diseases, and YKL-40, a marker of neuroinflammation. Currently the drugs is in Phase III stage of development for the treatment of ALS.

 

• Remetinostat: Medivir AB

Remetinostat is a histone deacetylase (HDAC) inhibitor. HDAC inhibitors are approved for treatment of MF-CTCL in late-stage patients but are not recommended for early-stage patients due to their significant side effects. The unique design of remetinostat enables topical application, making it active only in the skin. As soon as it reaches the blood stream, it is degraded, avoiding the side effects associated with other HDAC inhibitors. Medivir was developing remetinostat as a topical application for use in early stage MF-CTC. . Currently the drugs is in Phase II stage of development for the treatment of Basal cell cancer, cutaneous T-cell lymphoma.

 

• OKI-179: OnKure Therapeutics

OKI-179 is a novel, oral Class I histone deacetylase (HDAC) inhibitor for the potential treatment of a wide range of solid and hematological malignancies. HDAC inhibitors have shown great promise in preclinical models, however they have had little success treating solid tumors, often due to poor tolerability, inappropriate dosing regimens, poorly conceived combinations, and a lack of stratifying biomarkers. OKI-179 is designed to have improved potency, selectivity, tolerability, as well as easy combinability to overcome the historic limitations of other HDAC inhibitors. Currently the drugs is in Phase I/II stage of development for the treatment of solid and hematological malignancies.

 

• TN 301: Tenaya Therapeutics

TN-301 is highly specific first-in-class small molecule histone deacetylase (HDAC) 6 inhibitor, initially being developed for the potential treatment of HFpEF. TN-301 has a multi-modal mechanism of action that includes modifying cytoskeletal and other proteins to coordinate cellular processes. In preclinical studies, TN-301 has been shown to reverse many of the signs and symptoms of HFpEF, with evidence of improved cardiac function and improved glucose tolerance and reduced inflammation and fibrosis. Currently the drugs is in Phase I stage of development for the treatment of heart failure.

Further product details are provided in the report……..

 

HDAC inhibitors: Therapeutic Assessment

 

This segment of the report provides insights about the different HDAC inhibitors drugs segregated based on following parameters that define the scope of the report, such as:

• Major  Players in HDAC inhibitors

There are approx. 50+ key companies which are developing the therapies for HDAC inhibitors. The companies which have their HDAC inhibitors drug candidates in the most advanced stage, i.e. Phase III include, Amylyx Pharmaceuticals.

 

Phases

DelveInsight’s report covers around 55+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

 

Route of Administration

HDAC inhibitors pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

 

Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule

 

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

 

HDAC inhibitors: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses HDAC inhibitors therapeutic drugs key players involved in developing key drugs.

 

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging HDAC inhibitors drugs.

 

HDAC inhibitors Report Insights

• HDAC inhibitors  Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

 

HDAC inhibitors Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

 

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing HDAC inhibitors drugs?
• How many HDAC inhibitors drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of HDAC inhibitors?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the HDAC inhibitors therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for HDAC inhibitors and their status?
• What are the key designations that have been granted to the emerging drugs?