New York, USA, Jan. 08, 2024 (GLOBE NEWSWIRE) -- HDAC Inhibitor Clinical Trial Pipeline Appears Robust With 25+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight
The prevalence of Cancer has been rising over the past few years, which prompts the growing demand for treatment options. The increasing prevalence of Cancer and the growing research and development activities to develop HDAC Inhibitor therapies in treating various Cancers drive the market. The companies developing the potential therapies in the last stage of development include Italfarmaco, Xynomic Pharmaceuticals, Medivir AB, and several others.
DelveInsight’s 'HDAC Inhibitor Pipeline Insight 2023' report provides comprehensive global coverage of pipeline HDAC inhibitors in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the HDAC inhibitor pipeline domain.
Key Takeaways from the HDAC Inhibitor Pipeline Report
- DelveInsight’s HDAC inhibitor pipeline report depicts a robust space with 25+ active players working to develop 30+ pipeline HDAC inhibitors.
- Key HDAC inhibitor companies such as Italfarmaco, Xynomic Pharmaceuticals, Medivir, Mirati Therapeutics, Shuttle Pharmaceuticals, Oncolys BioPharma, Regenacy Pharmaceuticals, PurMinds NeuroPharma, Cereno Scientific, Tenaya Therapeutics, OnKure Therapeutics, Curis, CrystalGenomics, Inc., Mundipharma Research Limited, Amylyx Pharmaceuticals, Biodexa Pharmaceuticals, Rakovina Therapeutics, Neuroene Therapeutics, Medibiofarma, and others are evaluating new HDAC inhibitor drugs to improve the treatment landscape.
- Promising pipeline HDAC inhibitors such as Research programme: kt 3000 HDAC and PARP inhibitors, Givinostat, Research programme: mitochondrial HDAC1 Inhibitors, Research programme: HDAC1/2 inhibitors, Abexinostat, Remetinostat, Mocetinostat, SP-1-303, OBP 801, CS 014, SP-1-161, SP-2-225, TN-301, OKI-179, ORY 4001, Fimepinostat, CG200745, Tinostamustine, AMX-0035, MTX110, MBF 132, MBF-118, and others are under different phases of HDAC inhibitor clinical trials.
- In December 2023, Oryzon Genomics, S.A. announced the start of a preclinical collaboration with the ALS Association. The Association has awarded Oryzon a 498,690 USD grant through its Lawrence and Isabel Barnett Drug Development Program to support the regulatory preclinical development of ORY-4001, a highly selective HDAC6 inhibitor, for amyotrophic lateral sclerosis (ALS).
- In November 2023, Italfarmaco Group announced an extension in the FDA’s review of the New Drug Application (NDA) for Givinostat, the company’s proprietary histone deacetylase (HDAC) inhibitor for the potential treatment of Duchenne. The new Prescription Drug User Fee Act (PDUFA) date, which is the deadline set by the FDA for their decision about whether to approve an investigational product, is March 21, 2024. Italfarmaco shared that the FDA extended the PDUFA date to allow additional time to review information submitted by Italfarmaco as part of the NDA process.
- In October 2023, Tenaya Therapeutics, Inc. released new data for TN-301 at the 2023 Heart Failure Society of America (HFSA) Annual Scientific Meeting. TN-301 is Tenaya’s highly selective small molecule inhibitor of histone deacetylase 6 (HDAC6) being developed for the potential treatment of heart failure with preserved ejection fraction (HFpEF).TN-301 was generally well tolerated across the broad range of doses studied, with no dose-limiting toxicities or serious adverse events observed. The most common adverse events observed were related to gastrointestinal disturbances. These occurred with similar frequency among those who received placebo or TN-301 and did not increase with the TN-301 dose. All participants completed the study.
- In September 2023, Shuttle Pharmaceuticals Holdings, Inc. announced the expansion of its patent portfolio following the issuance of a Canadian patent for its Histone Deacetylase (HDAC) inhibitor platform technology titled "Dual Function Molecules for Histone Deacetylase Inhibition and Ataxia Telangiectasia Mutated (ATM) Activation and Methods of Use Thereof."
- In December 2021, OnKure, Inc., announced positive topline results from the first-in-human Phase I trial of OKI-179, the Company’s oral Class 1 histone deacetylase (HDAC) inhibitor. OKI-179 was shown to be safe and generally well-tolerated as a single agent using intermittent dosing schedules of either 4 days on/3 days off or 5 days on/2 days off for 21 days. The most common adverse events were nausea, fatigue, and anemia. Nausea was manageable with antiemetics.
Request a sample and discover the recent advances in HDAC inhibitor drugs @ HDAC Inhibitor Pipeline Report
The HDAC inhibitor pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage HDAC inhibitor drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the HDAC inhibitor clinical trial landscape.
HDAC Inhibitor Overview
Histone deacetylase (HDAC) inhibitors are a class of compounds that have garnered significant attention in the field of molecular biology and medicine due to their potential therapeutic applications. These inhibitors work by targeting a group of enzymes known as histone deacetylases, which play a crucial role in regulating gene expression and chromatin structure within cells.
Histone deacetylases are responsible for removing acetyl groups from histone proteins, which are critical components of chromatin – the complex of DNA and proteins that make up the structure of chromosomes. Acetylation of histones is associated with a relaxed chromatin structure that allows easier access of transcription factors and other proteins to DNA, leading to increased gene expression. On the other hand, deacetylation of histones by HDACs leads to a more condensed chromatin structure, inhibiting gene expression.
There are several classes of HDAC inhibitors, including hydroxamic acids (e.g., trichostatin A, vorinostat), cyclic peptides (e.g., romidepsin), and benzamides (e.g., entinostat). Some HDAC inhibitors are already approved by regulatory agencies for the treatment of certain cancers, such as cutaneous T-cell lymphoma. However, research is ongoing to explore their potential in various other conditions.
Find out more about HDAC inhibitor drugs @ HDAC Inhibitor Analysis
A snapshot of the Pipeline HDAC Inhibitor Drugs mentioned in the report:
| Drugs | Company | Phase | Indication | RoA |
| Givinostat | Italfarmaco | Registered | Duchenne muscular dystrophy | Oral |
| Abexinostat | Xynomic Pharmaceuticals | Phase III | Renal cell carcinoma | Oral |
| Remetinostat | Medivir AB | Phase II | Basal cell cancer; Cutaneous T-cell lymphoma; Squamous cell cancer | Topical |
| Mocetinostat | Mirati Therapeutics | Phase II | Metastatic Non-Small Cell Lung Cancer | Oral |
| OKI-179 | OnKure Therapeutics | Phase I/II | Advanced NRAS-Mutated Melanoma | Oral |
| TN 301 | Tenaya Therapeutics | Phase I | Heart Failure with Preserved Ejection Fraction | Oral |
Learn more about the emerging HDAC inhibitor @ HDAC Inhibitor Clinical Trials
HDAC Inhibitor Therapeutics Assessment
The HDAC inhibitor pipeline report proffers an integral view of the emerging HDAC inhibitor segmented by stage, product type, molecule type, and route of administration.
Scope of the HDAC Inhibitor Pipeline Report
- Coverage: Global
- Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
- Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
- Therapeutics Assessment By Route of Administration: Infusion, Intradermal, Intramuscular, Intranasal, Intravaginal, Oral, Parenteral, Subcutaneous, Topical
- Therapeutics Assessment By Molecule Type: Vaccines, Monoclonal Antibody, Peptides, Polymer, Small molecule
- Key HDAC Inhibitor Companies: Italfarmaco, Xynomic Pharmaceuticals, Medivir, Mirati Therapeutics, Shuttle Pharmaceuticals, Oncolys BioPharma, Regenacy Pharmaceuticals, PurMinds NeuroPharma, Cereno Scientific, Tenaya Therapeutics, OnKure Therapeutics, Curis, CrystalGenomics, Inc., Mundipharma Research Limited, Amylyx Pharmaceuticals, Biodexa Pharmaceuticals, Rakovina Therapeutics, Neuroene Therapeutics, Medibiofarma and others
- Key HDAC Inhibitor Pipeline Therapies: Research programme: kt 3000 HDAC and PARP inhibitors, Givinostat, Research programme: mitochondrial HDAC1 Inhibitors, Research programme: HDAC1/2 inhibitors, Abexinostat, Remetinostat, Mocetinostat, SP-1-303, OBP 801, CS 014, SP-1-161, SP-2-225, TN-301, OKI-179, ORY 4001, Fimepinostat, CG200745, Tinostamustine, AMX-0035, MTX110, MBF 132, MBF-118 and others
Dive deep into rich insights for new HDAC inhibitors, visit @ HDAC Inhibitor Drugs
Table of Contents
| 1. | HDAC Inhibitor Pipeline Report Introduction |
| 2. | HDAC Inhibitor Pipeline Report Executive Summary |
| 3. | HDAC Inhibitor Pipeline: Overview |
| 4. | Analytical Perspective In-depth Commercial Assessment |
| 5. | HDAC Inhibitor Clinical Trial Therapeutics |
| 6. | HDAC Inhibitor Pipeline: Late-Stage Products (Pre-registration) |
| 7. | HDAC Inhibitor Pipeline: Late-Stage Products (Phase III) |
| 8. | HDAC Inhibitor Pipeline: Mid-Stage Products (Phase II) |
| 9. | HDAC Inhibitor Pipeline: Early-Stage Products (Phase I) |
| 10. | HDAC Inhibitor Pipeline Therapeutics Assessment |
| 11. | Inactive Products in the HDAC Inhibitor Pipeline |
| 12. | Company-University Collaborations (Licensing/Partnering) Analysis |
| 13. | Key Companies |
| 14. | Key Products in the HDAC Inhibitor Pipeline |
| 15. | Unmet Needs |
| 16. | Market Drivers and Barriers |
| 17. | Future Perspectives and Conclusion |
| 18. | Analyst Views |
| 19. | Appendix |
For further information on the HDAC inhibitor pipeline therapeutics, reach out @ HDAC Inhibitor Therapeutics
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