Chidamide

The HDAC inhibitor pipeline remains active, with several next-generation agents advancing in clinical trials. Abexinostat (Xynomic Pharmaceuticals) is in Phase III development for renal cell carcinoma, representing a potential expansion into solid tumors. Quisinostat (Viriom) is in Phase II for uveal melanoma, and Entinostat, partnered between EOC Pharma and Syndax, is being explored in Hodgkin lymphoma. LAS VEGAS, Aug. 20, 2025 /PRNewswire/ -- DelveInsight's HDAC Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Multiple Myeloma, Peripheral T-cell Lymphoma (PTCL), Cutaneous T-cell Lymphoma (CTCL), Amyotrophic Lateral Sclerosis (ALS), and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging HDAC inhibitors, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM. Key Takeaways from the HDAC Inhibitors Market Report As per DelveInsight's analysis, the total market size of HDAC inhibitors in the 7MM is expected to surge significantly by 2034. The report provides the total potential number of patients in the indications, such as Multiple Myeloma, Peripheral T-cell Lymphoma (PTCL), Cutaneous T-cell Lymphoma (CTCL), Amyotrophic Lateral Sclerosis (ALS), and others. Leading HDAC inhibitor companies, such as Xynomic Pharmaceuticals, Viriom, EOC Pharma, Syndax Pharmaceuticals, Jubilant Therapeutics, and others, are developing novel HDAC inhibitors that can be available in the HDAC inhibitors market in the coming years. Some of the key HDAC inhibitors in the pipeline include Abexinostat, Quisinostat, Entinostat, JBI-802, and others. Discover which indication is expected to grab the major HDAC inhibitors market share @ HDAC Inhibitors Market Report HDAC Inhibitors Overview Histone deacetylases (HDACs) remove acetyl groups from both histone and non-histone proteins. Because acetylation of histones is linked to an open chromatin structure and active gene transcription, HDAC activity leads to histone deacetylation and epigenetic suppression of gene expression. Since HDACs influence many pathways involved in cancer development, HDAC inhibitors (HDACis) show clinical effects through several mechanisms, including changes in gene expression of cell cycle and apoptotic proteins, acetylation of other proteins involved in cell growth and survival, effects on angiogenesis, aggresome formation, and DNA repair. There are 18 known HDACs, divided into two major groups and four classes based on their cellular location, homology, enzyme mechanism, sequence of discovery, and histone substrate specificity. The first group includes zinc-dependent HDACs, which all share a similar catalytic core for deacetylating acetyl-lysine residues. These comprise Class I (HDAC1, -2, -3, -8), Class II (IIa: HDAC4, -5, -7, -9; IIb: HDAC6, -10), and Class IV (HDAC11). The second group includes Class III HDACs (sirtuins, SIRT1–7), which rely on NAD+ for their enzymatic activity. HDAC Inhibitors Epidemiology Segmentation The HDAC inhibitors market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases of Selected Indications for HDAC Inhibitor Total Eligible Patient Pool of Selected Indications for HDAC Inhibitor Total Treated Cases of Selected Indications for HDAC Inhibitor HDAC Inhibitors Treatment Market Several HDAC inhibitors are currently available on the market. Recent entrants include DUVYZAT (givinostat), while earlier approved drugs include BELEODAQ (belinostat), HIYASTA (tucidinostat), among others. DUVYZAT is a histone deacetylase inhibitor approved for treating Duchenne muscular dystrophy (DMD) in patients aged 6 and above. While it is categorized as an HDAC inhibitor, its exact mechanism of action in DMD is not fully understood. In April 2025, Italfarmaco announced that the CHMP of the European Medicines Agency (EMA) issued a positive opinion on DUVYZAT. The drug is also being evaluated in other indications: Phase III trial in Becker muscular dystrophy (BMD) and Phase II trial in polycythemia vera. HIYASTA (HBI-8000) is an epigenetic immunomodulator approved for several indications, including use as monotherapy for certain subtypes of relapsed or refractory T-cell non-Hodgkin's lymphoma, specifically adult T-cell leukemia-lymphoma (ATLL) and peripheral T-cell lymphoma (PTCL) in Japan. HUYABIO International is conducting a multinational Phase III trial evaluating HIYASTA in combination with nivolumab for previously untreated metastatic or unresectable malignant melanoma. HIYASTA is an oral HDAC Class I inhibitor that induces cell cycle arrest and apoptosis in tumor cells, which underlies its efficacy in lymphoma. In September 2020, the Japanese Ministry of Health, Labour and Welfare (MHLW) granted orphan drug designation (ODD) to HIYASTA for relapsed/refractory ATL, and in December 2015 for PTCL. In June 2021, HUYABIO also received regulatory approval in Japan for HBI-8000 as monotherapy for relapsed/refractory ATL. Key Emerging HDAC Inhibitors and Companies Xynomic Pharmaceuticals (Abexinostat), Viriom (Quisinostat), EOC Pharma/Syndax Pharmaceuticals (Entinostat), Jubilant Therapeutics (JBI-802), and several other companies are currently engaged in the development and production of HDAC inhibitors, which have the potential to significantly impact and enhance the HDAC inhibitors market. Abexinostat, an oral, broad-spectrum HDAC inhibitor originally developed by Pharmacyclics and later licensed by Xynomic Pharmaceuticals in 2017, has demonstrated encouraging activity in both blood cancers and solid tumors. The drug is currently being studied in several Phase I to III clinical trials worldwide. In September 2019, Xynomic announced that the FDA had granted Fast Track Designation (FTD) to abexinostat as a monotherapy for fourth-line treatment of relapsed or refractory follicular lymphoma. The FDA had previously granted FTD for abexinostat in combination with pazopanib for first- or second-line therapy in renal cell carcinoma. Additional Phase II trials are underway in indications such as Diffuse Large B-cell Lymphoma (DLBCL) and Follicular Lymphoma. Quisinostat is another potent, selective oral pan-HDAC inhibitor, initially developed by Janssen Pharmaceuticals. HDAC inhibitors work by inducing cell cycle arrest, promoting differentiation, and triggering apoptosis in various human cancer cell lines. By inhibiting histone deacetylase, they increase acetylation of histone proteins, resulting in a more transcriptionally active chromatin state and altered gene expression involved in proliferation, apoptosis, and differentiation. Multiple preclinical studies and Phase I/II trials have evaluated quisinostat's safety and effectiveness, showing promising anti-tumor effects in several advanced and treatment-resistant cancers — including platinum-resistant ovarian cancer (in combination with paclitaxel and carboplatin), uveal melanoma, and synovial sarcoma. The anticipated launch of these emerging therapies are poised to transform the HDAC inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the HDAC inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about HDAC inhibitors clinical trials, visit @ HDAC Inhibitors Treatment Recent Developments in the HDAC Inhibitors Space In May 2025, Amylyx Pharmaceuticals announced positive Week 48 data from the Phase II open-label HELIOS clinical trial of AMX0035 in adults living with Wolfram syndrome. In May 2025, the University of Miami, in collaboration with Viriom, initiated a Phase II clinical trial in the US (NCT06932757) to evaluate an oral therapy for patients with uveal melanoma who have undergone at least one prior line of treatment. In April 2025, Xynomic Pharmaceuticals concluded a Phase I/II clinical trial in the United States (NCT03939182), evaluating a combination oral therapy for patients with Diffuse Large B-cell Lymphoma and Mantle Cell Lymphoma who had received at least one prior line of treatment. Discover more about HDAC inhibitors in development @ HDAC Inhibitors Clinical Trials HDAC Inhibitors Market Dynamics HDAC inhibitors are a class of epigenetic drugs that modify gene expression by altering chromatin structure. Initially developed as anticancer agents, they have shown significant therapeutic potential in various malignancies, especially hematologic cancers like T-cell lymphoma and multiple myeloma. The market initially gained traction with FDA approvals of drugs such as Vorinostat, Romidepsin, and Panobinostat. Their unique mechanism of action targeting epigenetic regulation drew interest as precision medicine and oncology research grew, driving pharmaceutical investment in this segment. The HDAC inhibitors market continues to expand largely due to the rising prevalence of cancer worldwide and the need for more targeted therapies with better safety profiles. Additionally, ongoing clinical trials are exploring HDAC inhibitors in combination with other therapies, such as immune checkpoint inhibitors, proteasome inhibitors, and traditional chemotherapeutics. These combination approaches aim to overcome resistance and enhance efficacy, creating more opportunities for market growth. As more data emerges demonstrating synergistic benefits, partnerships between biotech startups and large pharmaceutical firms are accelerating further development. Despite this positive outlook, the market faces several challenges. Many HDAC inhibitors are associated with toxicity issues such as fatigue, gastrointestinal disturbances, and thrombocytopenia, which limit broader adoption. Competition from newer targeted therapies and immuno-oncology drugs also puts pressure on the HDAC inhibitor segment. Moreover, several compounds failed in late-stage trials due to a lack of efficacy, leading to cautious investor sentiment and prioritization of combination rather than monotherapy approaches. Looking ahead, the market dynamics are expected to be shaped increasingly by precision oncology trends and biomarker-driven patient selection, allowing more effective targeting of responders. If safety profiles can be improved and combination regimens continue to show strong results, HDAC inhibitors will retain a meaningful role in the evolving oncology landscape. Novel formulations, selective HDAC isoform inhibitors, and expansion into non-oncology indications such as neurodegenerative or inflammatory diseases may further diversify the market and drive its next phase of growth. Learn more about the HDAC inhibitors @ HDAC Inhibitors Analysis Scope of the HDAC Inhibitors Market Report HDAC Inhibitors Therapeutic Assessment: HDAC Inhibitors' current marketed and emerging therapies HDAC Inhibitors Market Dynamics: Conjoint Analysis of Emerging HDAC Inhibitor Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, HDAC Inhibitors Market Access and Reimbursement Table of Contents Related Reports Multiple Myeloma Market Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Sanofi, Karyopharm Therapeutics, Takeda Pharmaceutical, Celgene, Bristol-Myers Squibb, RAPA Therapeutics, Pfizer, Array Biopharma, Cellectar Biosciences, BioLineRx, Celgene, Aduro Biotech, ExCellThera, Janssen Pharmaceutical, Precision BioSciences, Takeda, Glenmark (Ichnos Sciences SA), Poseida Therapeutics, Molecular Partners AG, Chipscreen Biosciences, AbbVie, Genentech (Roche), Janssen Biotech, Nanjing Legend Biotech, Merck Sharp & Dohme Corp., among others. Amyotrophic Lateral Sclerosis Market Amyotrophic Lateral Sclerosis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ALS companies, including AB Science, Alector, GSK, Brainstorm Cell Therapeutics, Ionis Pharmaceuticals, Medicinova, Denali Therapeutics, AbbVie, Calico Life Sciences, Clene Nanomedicine Biosciences, Seelos Therapeutics, Prilenia Therapeutics, Rapa Therapeutics, Neurosense Therapeutics, Helixmith, Transposon Therapeutics, Revalesio Corporation, Annexon Biosciences, Corcept Therapeutics, AL-S Pharma, Sanofi, Denali Therapeutics, Orphai Therapeutics, among others. Peripheral T-cell Lymphoma Market Peripheral T-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key PTCL companies, including Secura Bio, Shanghai YingLi Pharmaceutical, Dizal Pharmaceuticals, Viracta Therapeutics, Innate Pharma, CStone Pharmaceuticals, Affimed, Otsuka Pharmaceutical, Astex Pharmaceuticals, Autolus, Myeloid Therapeutics, Merck Sharp & Dohme, Bristol Myers Squibb, among others. Cutaneous T-cell Lymphoma Market Cutaneous T-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CTCL companies, including Pfizer, Helsinn Therapeutics, Kyowa Hakko Kirin, Citius Pharmaceuticals, Soligenix, Prescient Therapeutics, Innate Pharma, Bristol-Myers Squibb, BioInvent International AB, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . 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上海 2025年8月18日 /美通社/ -- 2025年8月18日，深圳微芯生物科技股份有限公司（股票代码：688321.SH）于上海成功举办"源头创新 布局全球"2025年创新研讨峰会。本次峰会深度解读了公司"AI辅助设计+化学基因组学整合式技术平台"在新药研发中的应用，全面展示了公司国内外丰富的临床布局，详细介绍了基于AI整体平台开发的新一代全球First-in-Class早期研发管线。国内 知名 的临床机构研究者、机构投资人、媒体等超百名行业专家参与本次峰会，共探生物医药原创新路径。 微芯生物董事长兼总经理鲁先平博士表示：微芯生物专注于开发针对重大疾病、具有全球专利保护和临床独特效果的原创新分子实体。公司围绕上市品种重点布局肿瘤与代谢两大领域，持续关注神经退行性疾病、自身免疫性疾病等重大未满足临床需求，并关注新技术形式在药物开发中的应用。目前，公司已有西达本胺和西格列他钠两款全球First-in-Class药物成功上市，多个适应症在中国大陆、中国台湾及日本市场商业化。 AI辅助设计+化学基因组学整合式技术平台为研发助力 作为中国AI for R&D领域先行者，微芯生物成立之初便立足全球生物技术前沿，利用微阵列生物芯片技术，深入探索化学结构对人类基因表达的影响，获取药物作用等多方面海量数据，并通过高效算法挖掘有治疗潜力的药物。 微芯生物首席科学官潘德思博士详细展示了AI+化学基因组学核心技术平台新进展。升级的核心技术平台在分子设计与结构优化、成药性评估、临床开发策略和综合风险控制等方面提供更优支持，提高开发成功率、加速研发进程并降低成本。 多靶点、多机制协同的抗肿瘤治疗药物研发策略 尽管随着手术、放化疗、靶向治疗、免疫治疗等新技术的更新，肿瘤治疗进入到多机制手段协同的新时代，但患者的长期生存获益、生活质量仍存在巨大提升空间。 潘德思博士介绍，微芯生物针对复杂的肿瘤特征布局了多种药物形式的治疗方案。在免疫治疗领域，HDAC+IO在国内外临床中展现优异潜力，有望解决免疫难治性肿瘤难题。除西达本胺正在国内外开展的两项注册临床研究，微芯生物亦布局了新一代免疫激活抗体偶联药物NW001、小分子PD-L1抑制剂CS23546等产品。此外，公司在微环境调控、协同致死、靶向化疗等领域均有布局，部分分子已进入全球临床开发阶段。 西奥罗尼一线联合方案挑战"癌王"胰腺癌 世界卫生组织GLOBOCAN最新数据显示，全球胰腺癌年死亡病例近47万例，在所有肿瘤致死病例数中排第6位。目前胰腺导管腺癌的主要治疗手段仍为化疗，以白蛋白紫杉醇为基础的一线标准治疗方案治疗响应率仅23%，中位无进展生存期、中位总生存期分别仅约半年和不到1年。 西奥罗尼是微芯生物开发的First-in-Class分子，可选择性抑制Aurora B、CSF1R和 VEGFR/PDGFR/c-Kit等肿瘤发生发展相关蛋白激酶靶点。基于西奥罗尼在美国胰腺癌患者治疗中展现的初步疗效，微芯生物在中国开展了西奥罗尼联合AG方案一线治疗晚期胰腺导管腺癌的II期临床研究。复旦大学附属肿瘤医院的研究者介绍，西奥罗尼联合AG方案具有良好的抗肿瘤活性和可控的安全性，初步数据支持西奥罗尼在胰腺癌的进一步研究。 综合性代谢疾病治疗，从"糖肝共管"到下一代减重药物 代谢疾病涵盖广泛，存在诸多共病因素。西格列他钠（双洛平）是全球首个PPAR全激动剂，在糖尿病、代谢相关脂肪性肝病的临床研究中表现优异，具有"糖肝共管"的独特优势。微芯生物致力将西格列他钠打造为代谢疾病治疗的基石药物。 肥胖已成为全球性健康问题。近年来，以GLP-1R激动剂为代表的肠促胰素（incretin）类药物颠覆了这一领域的干预范式。然而，现有药物也留下了肌肉流失、体重反弹、胃肠道副作用、中枢神经不良反应及给药便捷性等未满足需求。微芯生物早期研发中心负责人山松博士介绍了公司在高质量减重领域的First-in-Class小分子药物布局，其中不影响食欲的非incretin小分子CDCS28在临床前研究中显示良好的单药减重、体重维持、肌肉保有潜力，且避免中枢神经隐患。 阿尔兹海默症、自身免疫疾病及纤维化早期研究多点开花 阿尔兹海默症仍缺乏有效的治疗药物。ApoE4（载脂蛋白E4）是阿尔兹海默症最强的遗传风险因子，亦有研究者认为其是阿尔兹海默的致病基因。36.7%的阿尔兹海默症患者至少携带1个ApoE4基因。CDCS04是全球首个针对ApoE4靶点的小分子药物开发项目。基于AI辅助设计+化学基因组学整合式技术平台，微芯生物发现了系列ApoE4活性候选分子。这些候选分子具有高血脑屏障通透性、良好的体内安全性，并在临床前研究中显示其对ApoE4细胞神经轴突生长的保护作用、显著降低ApoE4 TR小鼠的皮层和海马Tau蛋白磷酸化水平。 TYK2是银屑病等自身免疫疾病的潜力靶点。CS32582是微芯生物自主发现的、新一代高选择性TYK2小分子变构抑制剂。在I期临床研究中，CS32582展现了优异的体内药效学特征。此外，相对适中的半衰期为CS32582提供了更宽阔的治疗窗口，为其拓展银屑病及以外的适应症提供可能。 动脉型肺动脉高压（PAH）、间质性肺病相关性肺动脉高压（PH-ILD）、特发性肺纤维化（IPF）等纤维化疾病缺乏安全、有效的治疗药物，且传统标准疗法面临专利到期压力。微芯生物基于AI辅助设计+化学基因组学整合式技术平台自主发现的CS1011可高效选择性抑制PDGFR和CSF-1R，阻断成纤维细胞与炎症巨噬细胞的相互作用，从而实现从病理驱动因素的角度改善纤维化疾病的效果。在多种纤维化动物模型上，CS1011均显示出优于现有标准治疗药物的药效。 专注源头创新，布局全球领先疗法。微芯生物作为中国原创新药的先行者，将基于AI辅助设计+化学基因组学整合式技术平台，持续发现解决重大疾病的新分子实体，护航全球人类健康事业发展。