HDAC Inhibitor Treatment Drugs, Clinical Trials, Pipeline Insights, and Companies 2024

DelveInsight's, "HDAC Inhibitor Pipeline Insight 2024" report provides comprehensive insights about 40+ companies and 50+ pipeline drugs in HDAC Inhibitor 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.

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Key Takeaways from the HDAC Inhibitor Pipeline Report

* In January 2024:- Xynomic Pharmaceuticals Inc.-This study in patients with relapsed/refractory follicular lymphoma who have undergone at least 3 lines of therapy. Patients will receive abexinostat 80 mg (4 times 20 mg tablets) twice a day (BID) in a "one week on, one week off" schedule. Open-label, Single-Arm, Phase 2 Study of Oral HDAC-inhibitor Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma (FORERUNNER).
* DelveInsight's HDAC Inhibitor pipeline report depicts a robust space with 40+ active players working to develop 40+ pipeline therapies for HDAC Inhibitor treatment.
* The leading HDAC Inhibitor Companies such as Italfarmaco, Amylyx Pharmaceuticals, Chong Kun Dang pharmaceuticals, Cereno Scientific, Xynomic Pharmaceuticals, HUYA Bioscience, Recursion Pharmaceuticals Inc., Regenacy Pharmaceuticals, Acrotech Biopharma, Aphios Corporation , and others.
* Promising HDAC Inhibitor Therapies such as Abexinostat, Givinostat, AMX0035, CKD-506, CS1, CS014, and others.

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HDAC inhibitors Emerging Drugs

* Givinostat: Italfarmaco

Givinostat (ITF2357) is an orally bioavailable hydroxymate inhibitor of histone deacetylase (HDAC) with potential anti-inflammatory, anti-angiogenic, and antineoplastic activities. Givinostat inhibits class I and class II HDACs, resulting in an accumulation of highly acetylated histones, followed by the induction of chromatin remodeling and an altered pattern of gene expression. At low nonapoptotic concentrations, this agent inhibits the production of pro-inflammatory cytokines such as tumor necrosis factor (TNF), interleukin-1 (IL-1), IL-6, and interferon-gamma. This reduces the expression of tumor necrosis factor (TNF), interleukin 1 and , and interleukin. It has also been shown to activate the intrinsic apoptotic pathway, inducing apoptosis in hepatoma cells and leukemic cells. This agent may also exhibit anti-angiogenic activity, inhibiting the production of angiogenic factors such as IL-6 and Vascular Endothelial Cell Growth Factor (VEGF) by bone marrow stromal cells. Currently, the drug is in the Phase III stage of its development for the treatment of Polycythemia Vera.

* AMX0035: Amylyx Pharmaceuticals

AMX0035 is an oral, fixed-dose combination of sodium phenylbutyrate (PB) and taurursodiol (TURSO; also known as ursodoxicoltaurine outside of the US). AMX0035 was designed to slow or mitigate neurodegeneration by targeting endoplasmic reticulum (ER) stress and mitochondrial dysfunction, two connected central pathways that lead to cell death and neurodegeneration. The company believes that the proprietary combination of PB and TURSO and their complementary mechanisms of action will allow to synergistically target abnormal cell death to better prevent neurodegeneration than treatment targeted at either mechanism of action alone. AMX0035 is being studied as a potential treatment for Wolfram syndrome and progressive supranuclear palsy, two neurodegenerative disease. Currently, the drug is in the Phase III stage of its development for the treatment of Progressive Supranuclear Palsy.

* CKD-506: Chong Kun Dang pharmaceuticals

CKD-506 is a novel selective histone deacetylase 6 (HDAC6) inhibitor developed by Chong Kun Dang Pharmaceuticals. It is primarily being investigated for its therapeutic potential in treating autoimmune diseases, including rheumatoid arthritis and systemic lupus erythematosus (SLE). CKD-506 functions by selectively inhibiting HDAC6, an enzyme involved in the regulation of inflammatory responses. This inhibition leads to the suppression of inflammatory cytokines such as TNF- and type 1 interferons, which are significant contributors to the pathogenesis of various autoimmune conditions. Studies have shown that CKD-506 can improve the function of regulatory T cells (Tregs) and enhance gut barrier function, further supporting its role in reducing inflammation. It is currently in Phase II for Rheumatoid Arthritis.

* CS1: Cereno Scientific

The drug candidate CS1 is an HDAC inhibitor that works through epigenetic modulation, being developed as a treatment for the rare disease PAH. CS1 has the potential to be an effective, safe and disease-modifying drug. CS1's unique efficacy profile fits well with the pathogenetic mechanisms of PAH and is believed to be able to address today's major unmet need for better treatment alternatives. The aim of CS1's development is to offer improved quality of life and prolonged life with CS1 for patients with PAH. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Pulmonary Arterial Hypertension.

* CS014: Cereno Scientific

The investigational drug candidate CS014 belongs to Cereno's HDAC inhibitor program, capitalizing on the principle of epigenetic modulation. The innovative drug candidate represents a novel approach to antithrombotic treatment without an increased risk of bleeding. CS014 is a new chemical entity with a multi-modal mechanism of action as an epigenetic modulator - regulating platelet activity, local fibrinolysis, and clot stability for the prevention of thrombosis without increasing the risk of bleeding, as documented in preclinical studies. Given the potential for the disease-modifying properties seen with HDAC inhibition, additional cardiovascular benefits of CS014 may be expected, including amelioration of inflammation, fibrosis, vascular remodeling and elevated blood pressure. HDAC inhibition as a therapy to avoid thrombosis could fundamentally change the thrombosis prevention landscape and meet a major unmet medical need. It is currently in Phase I for Thrombosis prevention.

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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

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

* Oligonucleotide
* Peptide
* Small molecule

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Scope of the HDAC Inhibitor Pipeline Report

* Coverage- Global
* HDAC Inhibitor Companies- Italfarmaco, Amylyx Pharmaceuticals, Chong Kun Dang pharmaceuticals, Cereno Scientific, Xynomic Pharmaceuticals, HUYA Bioscience, Recursion Pharmaceuticals Inc., Regenacy Pharmaceuticals, Acrotech Biopharma, Aphios Corporation, and others.
* HDAC Inhibitor Therapies- Abexinostat, Givinostat, AMX0035, CKD-506, CS1, CS014, 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

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Table of Content

* Introduction
* Executive Summary
* HDAC inhibitors : Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* HDAC inhibitors - DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Givinostat: Italfarmaco
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* CKD-506: Chong Kun Dang pharmaceuticals
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* CS014: Cereno Scientific
* Preclinical Stage Products
* Drug Name: Company Name
* Drug profiles in the detailed report.....
* Inactive Products
* HDAC inhibitors - Collaborations Assessment- Licensing / Partnering / Funding
* HDAC inhibitors - Unmet Needs
* HDAC inhibitors - Market Drivers and Barriers
* Appendix

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