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HDAC Inhibitors Clinical Trial Pipeline Gains Momentum: 50+ Companies Lead the Charge in Pioneering New Treatments | DelveInsight

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HDAC Inhibitors Clinical Trial Pipeline Gains Momentum: 50+ Companies Lead the Charge in Pioneering New Treatments | DelveInsight

October 30
01:35 2026
HDAC Inhibitors Clinical Trial Pipeline Gains Momentum: 50+ Companies Lead the Charge in Pioneering New Treatments | DelveInsight
The HDAC Inhibitors clinical trial analysis report delivers important insights into ongoing research on 55+ pipeline drugs, clinical strategies, upcoming therapeutics, and commercial analysis.

(Albany, US) On October 29, 2026 – DelveInsight’s, “HDAC Inhibitor Pipeline Insights 2026” report provides comprehensive insights about 50+ companies and 55+ pipeline drugs in HDAC Inhibitor pipeline landscape. It covers the HDAC Inhibitor pipeline drug profiles, including clinical and nonclinical stage products. It also covers the HDAC Inhibitor therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive HDAC Inhibitor pipeline products in this space.

Download DelveInsight’s comprehensive HDAC Inhibitor Pipeline Report @ https://www.delveinsight.com/sample-request/hdac-inhibitor-pipeline-insight

Key Takeaways from the HDAC Inhibitor Pipeline Report

  • On October 22, 2026 – HUYABIO International announced positive Phase 3 results for its HDAC inhibitor HBI-8000 (tucidinostat) in combination with nivolumab for advanced melanoma, reducing the risk of disease progression or death by 27% compared with nivolumab alone.
  • On October 7, 2026 – Italfarmaco and VeriSIM Life announced a strategic collaboration to discover and develop novel HDAC-targeted therapies for neuromuscular, fibrotic, and rare diseases. The agreement has a potential value exceeding US$100 million, including fees, milestones, and royalties.
  • DelveInsight’s HDAC Inhibitor pipeline report depicts a robust space with 40+ active players working to develop 50+ pipeline therapies for HDAC Inhibitor treatment.
  • The leading HDAC Inhibitor Companies such as Amylyx Pharmaceuticals, Medivir AB, OnKure Therapeutics, Tenaya Therapeutics, Medibiofarma, CrystalGenomics, Xynomic Pharmaceuticals, Italfarmaco, Unravel Biosciences, Rakovina Therapeutics, Formosa Pharmaceuticals, Italfarmaco/Iktos, Neuroene Therapeutics, Chengdu Zenitar Biomedical Technology, Biodexa Pharmaceuticals and others.
  • Promising HDAC Inhibitor Therapies such as Resminostat (4SC-201), ITF2357, Abexinostat, Panobinostat, PCI-24781, and others.

Access DelveInsight’s in-depth HDAC Inhibitor Pipeline Analysis for a closer look at promising breakthroughs @ HDAC Inhibitor Clinical Trials and Studies

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.

HDAC Inhibitor Emerging Drugs Profile

  • 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.

Get a detailed analysis of the latest innovations in the HDAC Inhibitor pipeline @ HDAC Inhibitor Unmet Needs

HDAC Inhibitor Companies

Amylyx Pharmaceuticals, Medivir AB, OnKure Therapeutics, Tenaya Therapeutics, Medibiofarma, CrystalGenomics, Xynomic Pharmaceuticals, Italfarmaco, Unravel Biosciences, Rakovina Therapeutics, Formosa Pharmaceuticals, Italfarmaco/Iktos, Neuroene Therapeutics, Chengdu Zenitar Biomedical Technology, Biodexa Pharmaceuticals and others.

HDAC Inhibitor 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

HDAC Inhibitor Products have been categorized under various Molecule types such as

  • Oligonucleotide
  • Peptide
  • Small molecule

Download DelveInsight’s latest report to gain strategic insights into upcoming HDAC Inhibitor Therapies @ HDAC Inhibitor Market Drivers and Barriers, and Future Perspectives

Scope of the HDAC Inhibitor Pipeline Report

  • Coverage- Global
  • HDAC Inhibitor Companies- Amylyx Pharmaceuticals, Medivir AB, OnKure Therapeutics, Tenaya Therapeutics, Medibiofarma, CrystalGenomics, Xynomic Pharmaceuticals, Italfarmaco, Unravel Biosciences, Rakovina Therapeutics, Formosa Pharmaceuticals, Italfarmaco/Iktos, Neuroene Therapeutics, Chengdu Zenitar Biomedical Technology, Biodexa Pharmaceuticals and others.
  • Promising HDAC Inhibitor Therapies- Resminostat (4SC-201), ITF2357, Abexinostat, Panobinostat, PCI-24781, and others.
  • HDAC Inhibitor Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • HDAC Inhibitor Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Which companies are leading the race in HDAC Inhibitor drug development? @ HDAC Inhibitor Emerging Drugs and Major Companies

Table of Content

  1. Introduction
  2. Executive Summary
  3. HDAC inhibitors Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. HDAC inhibitors – DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. AMX0035: Amylyx Pharmaceuticals
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. Remetinostat: Medivir AB
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I)
  14. TN 301: Tenaya Therapeutics
  15. Preclinical Stage Products
  16. Drug Name: Company Name
  17. Drug profiles in the detailed report…..
  18. Inactive Products
  19. HDAC inhibitors Collaborations Assessment- Licensing / Partnering / Funding
  20. HDAC inhibitors Unmet Needs
  21. HDAC inhibitors Market Drivers and Barriers
  22. Appendix

About Us

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

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