A Phase 0/1b 'Trigger' Clinical Trial With an Expansion Phase of Quisinostat Plus Fractionated Radiotherapy in Newly-diagnosed and Recurrent Grade 4 IDH-WT Glioblastomas

This is an open-label, multi-center Phase 0/1b study that will enroll up to 18 participants with recurrent WHO grade 4 glioblastoma (rGBM) IDH-wildtype (IDH-WT), Arm A, and 12 participants with presumed newly-diagnosed WHO grade 4 glioblastoma (nGBM) IDH-WT, Arm B. The trial will be composed of a Phase 0 component (subdivided into Arms A and B), and an Expansion Phase 1b. Patients with tumors demonstrating a positive pharmacokinetic (PK) response in the Phase 0 component of the study will graduate to an Expansion Phase that combines therapeutic dosing of quisinostat plus standard-of-care fractionated radiotherapy (RT).

开始日期2025-09-04

申办/合作机构

St. Joseph's Medical Center, Inc.

NCT06932757

/ Recruiting临床2期IIT

Phase 2 Trial of Adjuvant Quisinostat in High-Risk Uveal Melanoma

The purpose of this study is to see if giving participants quisinostat will prevent participants' uveal melanoma tumor from spreading. The researchers want to find out the effects that quisinostat has on participants' condition.

开始日期2025-05-27

申办/合作机构

University of Miami

[+1]

NCT02948075

/ Completed临床2期

Multicenter, Open-label Study of Safety and Efficacy of Quisinostat in Combination With Paclitaxel + Carboplatin Chemotherapy in Patients With Metastatic or Locally Advanced Epithelial Ovarian Cancer, Primarily Peritoneal or Fallopian Tube Carcinoma, Resistant to First Line Platinum and Paclitaxel Based Chemotherapy

This is a multicenter, open-label study of safety and efficacy of Quisinostat in combination with Paclitaxel + Carboplatin chemotherapy in patients with metastatic or locally advanced epithelial ovarian cancer, primarily peritoneal or fallopian tube carcinoma, resistant to first line platinum and Paclitaxel based chemotherapy.
The study will be carried out in 5-8 Russian and Belarusian sites. A maximum of 32 patients with metastatic or locally advanced epithelial ovarian cancer, primarily peritoneal or fallopian tube carcinoma, resistant to first line platinum and Paclitaxel based chemotherapy, will be enrolled in the study.

开始日期2015-09-01

申办/合作机构

NewVac LLC

[+1]

100 项与 Quisinostat Hydrochloride 相关的临床结果

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100 项与 Quisinostat Hydrochloride 相关的转化医学

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100 项与 Quisinostat Hydrochloride 相关的专利（医药）

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130

项与 Quisinostat Hydrochloride 相关的文献（医药）

2026-01-22·JOURNAL OF MEDICINAL CHEMISTRY

Discovery of γ-Tetrahydrocarboline Derivatives as Plasmodium falciparum Histone Deacetylase Inhibitors for Treatment of Malaria

Article

作者: Cai, Yuan ; Hu, Xueping ; Qian, Yunan ; Li, Jiaming ; Jiang, Lubin ; Huang, Zhenghui ; Lai, Zhencheng ; Cui, Sunliang ; Dai, Zeguang ; Cao, Long ; Ni, Hao

Malaria is a life-threatening infectious disease caused by Plasmodium parasites, and the emergence of widespread resistance to existing therapies underscores the urgent need for novel antimalarial agents. Quisinostat was identified as a Plasmodium falciparum histone deacetylase 1 (PfHDAC1) inhibitor against drug-resistant malaria parasites but suffered from intolerable toxicity. To achieve a potent and safe antimalarial agent, we hypothesized a scaffold hopping and linker optimization strategy, in which a total of 33 new structural γ-tetrahydrocarboline derivatives were synthesized and subjected to comprehensive evaluation. Compound 5ac was identified as a PfHDAC1 inhibitor with favorable safety profiles (Pf3D7 IC₅₀ = 4.1 nM, HepG2 IC₅₀ = 1.5 μM, SI = 358; HEK293T IC₅₀ = 15 μM, SI = 3573), improved physicochemical properties, and potent in vivo antimalarial activity. Mechanistic studies showed that 5ac could downregulate the expression of malaria invasion-related genes. Overall, this study establishes γ-tetrahydrocarboline derivatives as new structurally promising PfHDAC-targeted antimalarial agents.

2025-12-31·CANCER BIOLOGY & THERAPY

High-throughput screening identifies the activity of histone deacetylase inhibitors in patient-derived models of soft tissue sarcoma

Article

作者: Krishna, Rashi ; Danks, Molly R. ; Huang, Paul H. ; Culley, Jayne ; Carragher, Neil O. ; Beetham, Henry ; Dawson, John C. ; Brunton, Valerie G. ; Manasterski, Piotr J. ; Kerrison, William G. J. ; Muir, Morwenna ; Elliott, Richard J. R. ; Ewing, Ailith ; Oswald, Ailsa J. ; Thomson, John P. ; Nixon, Ioanna

BACKGROUND:

Undifferentiated pleomorphic sarcoma (UPS) is a rare and aggressive soft tissue sarcoma with limited treatment options and a poor prognosis. As a complex karyotype tumor, UPS lacks recurrent targetable mutations, and response rates to standard first-line doxorubicin therapy are low. Phenotypic drug screening offers an alternative approach to identify new therapeutic targets without requiring prior knowledge of molecular mechanisms.

METHODS:

A library of FDA-approved compounds and a custom histone deacetylase (HDAC) inhibitor library were screened using well-annotated patient-derived cell lines. Hit compounds were further characterized using apoptosis assays and in vivo xenograft studies. Biomarkers of activity were evaluated using gene expression and western blot analyses. Synergy with doxorubicin was evaluated in combination assays.

RESULTS:

HDAC inhibitors emerged as a promising therapeutic class, demonstrating low IC₅₀ values across cell lines (14.8-26.89 nM), with quisinostat taken forward for further evaluation. Gene expression changes in EPAS1, FOXO1, AMOT, and FOSL1 were observed as potential biomarkers of activity. Combination assays revealed synergy between quisinostat and doxorubicin (average ZIP score: 1.02-15.65; ZIP_max: 3.98-33.71), increasing apoptotic cell death in vitro. In vivo, quisinostat alone and in combination with doxorubicin significantly reduced the tumor volume (vehicle 160.0 ± 63.2 mm³, doxorubicin 78.0 ± 35.2 mm³, quisinostat 84.3 ± 13.1 mm³, and combination 49.2 ± 10.2 mm³). Quisinostat also showed potent activity in leiomyosarcoma (LMS) cell lines (5.82-31.32 nM), which represent an additional complex karyotype soft tissue sarcoma.

CONCLUSIONS:

Quisinostat demonstrated strong preclinical activity and synergy with standard-of-care doxorubicin in models of UPS and LMS.

2025-11-14·ACS Pharmacology & Translational Science

Chrono-Pharmacology for Cancer: Harnessing Circadian Regulations of the Cell Cycle and Immune Response Dynamics for Precision Therapy

Review

作者: M, Kavipriya ; Madhukar, Murlidhar ; Rengan, Aravind Kumar ; Ray, Sandipan ; Das, Sandip

The circadian rhythms and cell cycle are closely interlinked, creating a fundamental regulatory axis vital for tissue homeostasis, which is frequently dysregulated in cancers. The circadian apparatus, which is regulated by the core clock components (BMAL1, CLOCK, PER, and CRY in mammals), establishes temporal order on cell proliferation by rhythmically regulating important cell cycle regulators such as WEE1, p21, and the oncogene MYC. This is frequently accomplished through overlapped signaling nodes that include particular kinases and ubiquitin ligases (e.g., FBXW7). Mounting evidence implicates disruption of this circadian clock-cell cycle synchrony, arising from genetic or environmental factors, as a significant contributor to tumorigenesis and progression via impacts on DNA repair fidelity, oncogene stability, and tumor suppressor pathways. This review critically evaluates the new concept of chrono-pharmacology for cancer, focusing on the substantial effects and side effects of different anticancer drugs that depend on the time-of-day efficacy. We discussed some interesting examples, like HSP90 inhibitors (ganetespib), HDAC inhibitors (quisinostat), topoisomerase inhibitors (doxorubicin), and BCL-2 family antagonists (Obatoclax, TW-37), whose therapeutic activities are tightly regulated by circadian control over their molecular targets, pharmacokinetic processes, and downstream physiological pathways. Furthermore, the circadian influence extends to the tumor microenvironment and antitumor immunity, suggesting novel chrono-immunotherapy approaches. By putting together the molecular bases of these temporal dynamics, this review underscores the significant potential of chronotherapythe timed administration of drugs to improve cancer treatment by enhancing therapeutic indices and paving the way for personalized, temporally optimized oncology strategies.

项与 Quisinostat Hydrochloride 相关的新闻（医药）

2025-11-12

·百度百家

昆医赵冰团队突破药敏检测瓶颈 13 天构建万例宫颈癌类器官评千药

基于类器官的高通量筛选（HTS）正在彻底改变药物研发模式。然而，传统HTS设备处理细胞外基质（ECM）组分的复杂性，导致类器官在筛选过程中被迫采用悬浮培养体系，这种改变会引发其转录组特征与药物应答的显著变异。尽管目前已建立3D ECM包埋类器官的自动化生成技术，但操作简便性与时间效率的局限仍构成实现高通量化的关键障碍。该研究开发了一种全流程三维ECM包裹类器官自动化高通量筛选（wp3D-OAHTS）平台，其通量性能显著优于现有已报道的三维类器官药物筛选系统。该自动化平台在13天内成功构建了超过10,000个均质化的神经内分泌宫颈癌（NECC）三维类器官穹隆结构，并系统评估了其对2,802种化合物的药物反应。这种高效且可重复的研究方法最终成功筛选出5种能显著抑制NECC类器官生长的优选化合物，IC50低于10 nM。代表性候选药物Quisinostat 2HCl展现出显著优于临床现有药物的抗肿瘤疗效。该平台显著提升了三维细胞外基质包裹类器官药物筛选的速率与效率，为罕见病新药研发提供了有力支持。图形摘要文章介绍题目：全流程三维细胞外基质包裹类器官自动化高通量筛选平台加速罕见病药物研发英文题目：Whole-process 3D ECM-encapsulated organoid-based automated high-throughput screening platform accelerates drug discovery for rare diseases 杂志：Life Medicine 影响因子：6.0 PMID：41089667 发表时间：2025年10月 Part.01 研究背景类器官在HTS中的应用，尤其是患者来源类器官（PDO），已在药物研发与精准医疗领域获得广泛认可。类器官通常由封装在ECM中的干细胞或祖细胞发育而成，这种基质对于建立类组织架构、细胞间通讯以及细胞-ECM相互作用至关重要。为适应基于传统液体分配器的高通量筛选平台，类器官培养方式被迫调整——使细胞悬浮于低基质环境中而非封装在三维ECM内。但即便短期悬浮培养也会导致类器官转录组特征改变，包括肿瘤标志物表达和关键信号通路的变化，这可能影响肿瘤细胞的药物敏感性。为克服悬浮类器官高通量筛选与现有三维类器官高通量筛选的局限性，该研究开发了全流程三维细胞外基质包裹类器官自动高通量筛选平台（wp3D-OAHTS）。基于该平台，针对NECC开展了包含2802个小分子的三维类器官HTS，鉴定出7种化合物具有显著活性。代表性候选药物Quisinostat 2HCI对NECC异种移植瘤生长的抑制作用优于现有临床用药。总之，该平台在新药研发（尤其是罕见病治疗领域）具有重要应用潜力。 Part.02 研究关键点开发一种全流程3D ECM封装类器官的自动化高通量筛选平台（wp3D-OAHTS），通过自动化操作实现大规模3D类器官的快速生成和药物反应的自动化评估。利用wp3D-OAHTS对NECC类器官进行两步分层式高通量药物筛选，从2802种小分子化合物中筛选出具有低IC50的候选药物，并验证其药效。体内实验验证Quisinostat 2HCl的抗肿瘤效果，证明其作为NECC治疗药物的潜力。 Part.03 研究结果 1、面向三维ECM包裹类器官构建与药物筛选的自动化高通量平台 wp3D-OAHTS多功能平台可兼容多种类器官培养。该平台集成三维ECM封装类器官点样仪、液体分配模块、自动化温孵模块及多模式检测模块（图1A），能在80%（体积比）ECM浓度下完成类器官封装与维持，实现完全基于三维ECM封装类器官的大规模高速药物筛选。此外，三维ECM包埋类器官点样仪是处理ECM组分的关键设备。细胞-基质混合物经冷却控温、混匀后快速点样至孔板，随后进行凝胶化、培养基添加和孵育培养，全程由机械臂自动化操作，实现类器官生长监测和药物筛选，wp3D-OAHTS平台10天可筛选8694种药物，显著提升高通量筛选效率（图1B）。图1 2、通过wp3D-OAHTS平台优化3D ECM包裹类器官培养的均质性与可重复性手动分配ECM存在显著的孔间变异性，而自动点样仪能确保每个孔内精确的中心定位和微小的孔间差异，为生成稳定的3D ECM封装类器官提供了基础。进一步测试表明，该平台培养的宫颈癌、胃癌和结直肠癌类器官展现出稳定的尺寸、形状均一性和强劲的增殖能力，活性测定结果分布区间狭窄，显著降低了类器官的变异性。这些结果证明wp3D-OAHTS平台能够生成高度生物活性的均质化、可重复的三维ECM包裹类器官，其高精度和可靠性使其成为基于三维类器官的大规模高通量筛选的理想系统（图2）。图2 3、wp3D-OAHTS平台支持在人类NECC类器官上进行2802种药物筛选利用wp3D-OAHTS平台和包含2802个小分子化合物的药物库检测NECC患者来源类器官细胞系的药物敏感性。将NECC类器官单细胞与ECM混合后自动点样至12996孔板中培养，表现出高度均质性和强增殖能力。在加入2802种化合物处理后，筛选出583种抑制率超过90%的化合物。所有筛选板的Z'因子均高于0.7，且对77种化合物的独立检测显示高度相关性，证明了平台的准确性、稳健性和可重复性。在对NECC类器官进行药物筛选时，自动化平台识别出8种活性化合物，而手动筛选仅识别出6种，遗漏了RSL3和Elvitegravir。自动化平台展现出更好的重复性和准确性。在583个初筛阳性化合物中，392个对NECC类器官有致死效应，且多数为在研药物，仅154个是FDA批准的。这些化合物的作用机制多样，其中蛋白酪氨酸激酶抑制剂占比最高。这表明该平台能揭示罕见疾病的未知靶点，为药物研发提供新方向（图3）。图3 4、通过反向药物浓度梯度筛选确定了7种具有NECC扩展适应症潜力的候选药物。为缩小NECC有效候选药物范围，从初筛活性化合物中选取前50种，采用1 μM和0.1 μM两种浓度进行二次筛选。结果在1 μM浓度下筛选出15种候选药物，在0.1 μM浓度下筛选出7种。这些化合物涵盖多种作用机制，其中DNA损伤抑制剂和表观遗传调节剂占比较高。在0.1 μM浓度下，7种最有效的化合物（Quisinostat 2HCl、Topotecan HCl、Epirubicin HCl、Mitoxantrone 2HCl、Ixazomib、Clofarabine和Flavopiridol）显著降低类器官存活率并引发细胞死亡。进一步的剂量效应曲线分析显示，这7种化合物均以剂量依赖性方式抑制NECC类器官生长，半数抑制浓度在纳摩尔水平，其中5种化合物（Mitoxantrone 2HCl、Clofarabine、Quisinostat 2HCl、Epirubicin HCl、Topotecan HCl）的半数抑制浓度低于10 nM，显示出高效性和作为NECC治疗候选药物的巨大潜力（图4）。 Mitoxantrone 2HCl、Clofarabine、Epirubicin HCl、Topotecan HCl和Ixazomib均为FDA批准的上市药物，而Quisinostat 2HCl与Flavopiridol为曾进入临床试验研究阶段的化合物。FDA目前批准的这些药物适应症中并不包含NECC，且Quisinostat 2HCl与Flavopiridol的临床试验数据也未涉及NECC治疗。本研究结果表明，这两种药物具有扩大治疗适应症范围至NECC的潜在临床应用价值。图4 5、代表性药物Quisinostat 2HCl对NECC展现出显著抑制效应接下来聚焦于新型药物Quisinostat 2HCl，其IC50效价低于10 nM。经0.1 μM Quisinostat 2HCl处理48 h的NECC类器官转录组分析显示，有3815个差异表达基因，涉及多种代谢通路的显著下调，表明该药物可能通过代谢重编程抑制NECC类器官生长。体内实验中，将NECC类器官移植至裸鼠皮下，Quisinostat 2HCl（10 mg/kg）隔日腹腔注射20天，显著抑制了异种移植瘤的生长，瘤体积和重量均减小，Ki67阳性细胞比例降低，cleaved caspase 3+细胞比例增加。与紫杉醇/卡铂联合方案相比，Quisinostat 2HCl单药治疗效果更优，展现出作为NECC治疗药物的潜力。图5 6、wp3D-OAHTS平台通过限制类器官悬浮导致的假阳性，实现精准的药物反应检测为探究基质低悬液培养条件是否会改变类器官药物筛选结果，该研究从2802个小分子化合物的3D ECM包埋类器官药物筛选数据中，选取了不同抑制率区间的化合物，在低基质悬浮培养的NECC类器官中进行验证实验。在悬浮筛选中，类器官在给药当天会从ECM脱离，处于非贴壁悬浮状态，与全流程3D ECM包裹类器官筛选不同。在NECC类器官的药物筛选中，全流程3D ECM筛选与悬浮筛选结果存在差异。在3D筛选中无反应的化合物在悬浮筛选中表现出更高敏感性，且抑制率在30%-60%的化合物在悬浮筛选中抑制率显著提升。这表明降维至二维悬浮系统可提高药物筛选命中率，但可能无法准确反映类器官在三维环境中的真实药物反应及耐药特征。三维ECM封装类器官筛选能保持类器官的三维结构，更准确地重现药物反应，对高通量药物筛选具有重要价值（图6）。图6 小结该研究开发的自动化类器官高通量筛选平台实现了大规模3D类器官的快速生成与药物反应自动化评估，相比人工操作更均一、精确且高通量。利用该平台对NECC类器官进行两步分层式高通量药物筛选，从2802种小分子化合物中确定了7种具有极低IC50的候选药物，其中Quisinostat 2HCl在体内展现出显著抗肿瘤效果。该平台通过消除悬浮培养导致的假阳性干扰，实现了精确的药物反应评估，显著提升了罕见病新药研发的速度与效率。参考文献 Xu Z, Yang H, Zhou Y, Dzakah EE, Zhao B. Whole-process 3D ECM-encapsulated organoid-based automated high-throughput screening platform accelerates drug discovery for rare diseases. Life Med. 2025 Jun 14;4(5):lnaf021. doi: 10.1093/lifemedi/lnaf021.

临床研究

2025-08-20

·PRNewswire

HDAC Inhibitors Market Sees Upward Trajectory Across the 7MM During the Forecast Period (2025-2034) Driven by Innovation in Cancer Therapies | DelveInsight

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. 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临床2期临床3期快速通道孤儿药免疫疗法

100 项与 Quisinostat Hydrochloride 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10322	Quisinostat Hydrochloride	-	DB12985

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适应症	最高研发状态	国家/地区	公司	日期
葡萄膜黑色素瘤	临床2期	美国	Viriom, Inc.	2025-05-27
输卵管癌	临床2期	俄罗斯	NewVac LLC	2015-09-01
卵巢癌	临床2期	俄罗斯	NewVac LLC	2015-09-01
蕈样真菌病	临床2期	美国	Janssen Research & Development LLC	2011-11-01
蕈样真菌病	临床2期	法国	Janssen Research & Development LLC	2011-11-01
蕈样真菌病	临床2期	德国	Janssen Research & Development LLC	2011-11-01
蕈样真菌病	临床2期	葡萄牙	Janssen Research & Development LLC	2011-11-01
蕈样真菌病	临床2期	西班牙	Janssen Research & Development LLC	2011-11-01
蕈样真菌病	临床2期	英国	Janssen Research & Development LLC	2011-11-01
卵巢上皮癌	临床1期	俄罗斯	NewVac LLC	2013-08-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02948075 (ASCO2017)	临床2期	复发性铂耐药性输卵管癌	31	Quisinostat + Paclitaxel + Carboplatin	鹹壓廠襯艱淵膚窪夢廠(膚積鏇遞築鹽夢願願醖) = 顧鹽艱鹽鬱膚鏇範鹹製憲膚糧網顧構餘製襯範 (齋壓壓鬱蓋範壓廠衊襯 ) 更多	积极	2017-05-30
NCT02728492 (ESMO2016) 人工标引	临床1期	卵巢癌 \| 非小细胞肺癌	51	gemcitabine+cisplatin or paclitaxel +carboplatin+quisinostat	網獵衊鹽膚選夢鏇顧鏇(鹹夢簾製積艱積廠鏇齋) = Q was tolerated to the maximum dose of 12 mg chosen for this study, and therefore there were MTD criteria never met 鑰窪糧簾繭糧憲淵夢遞 (鹹壓鬱糧艱廠構鏇醖襯 ) 更多	积极	2016-10-01
Pubmed \| Leuk Lymphoma	临床1期	复发性多发性骨髓瘤	-	Quisinostat	艱繭願願夢築網獵醖憲(膚積鏇餘願觸淵艱鑰衊) = n = 11 夢襯觸衊艱製願築壓憲 (築繭蓋蓋鏇壓繭構獵夢 ) 更多	-	2016-07-02
NCT01464112 (ASCO2013)	临床1期	复发性多发性骨髓瘤	18	Quisinostat	鹹網襯糧廠襯製齋憲鹹(壓選鑰艱窪糧憲構鹽積) = 齋衊選窪淵衊觸遞鹹製繭製膚淵蓋鑰憲壓遞選 (鬱獵襯餘鏇網鬱夢築範 ) 更多	-	2013-05-20
NCT01486277 (ASH 12012 \| ASH 22012) 人工标引	临床2期	皮肤T细胞淋巴瘤	26	quisinostat	網糧蓋觸廠築夢淵網壓(簾襯積餘鏇範願齋淵齋) = 範遞憲齋淵鑰範簾積壓範構淵構鏇繭餘蓋淵膚 (艱積繭膚蓋網廠鹽顧鏇 ) 更多	积极	2012-11-16
ASCO2011	临床1期	晚期癌症	73	JNJ-26481585 4 days on, 3 days off	窪蓋醖範齋窪構醖鹹齋(鹹網艱襯餘範製簾齋鬱) = 網齋鹽鬱齋構廠選獵獵遞鑰廠鬱鹽夢構壓醖觸 (簾艱範憲簾鹽製膚選襯 ) 更多	-	2011-05-20