Beleodaq (belinostat) / Valerio Therap, Aurobindo, Assertio - LARVOL DELTA

Characterizing the belinostat response in patients with relapsed or refractory angioimmunoblastic T-cell lymphoma. (PubMed, Leuk Lymphoma) - No abstract available

Clinical • Journal • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

CHARGE: Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics (clinicaltrials.gov) - P1 | N=12 | Terminated | Sponsor: University of Utah | N=34 ➔ 12 | Trial completion date: Aug 2026 ➔ Sep 2025 | Recruiting ➔ Terminated; No accrual in one year

Enrollment change • Platinum resistant • Trial completion date • Trial termination • Breast Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • Triple Negative Breast Cancer • HER-2

Early Refractory Nodal T-Follicular Helper Cell Lymphoma in a Young Woman: Diagnostic and Therapeutic Challenges (SOHO 2026) - "The patient was diagnosed with advanced-stage disease and received 2 cycles of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone (CHOEP)...Because of refractory disease, belinostat application was planned, and salvage dexamethasone, cytarabine, and cisplatin (DHAP) chemotherapy was initiated on January 22, 2026... Lymph node biopsy confirmed nodal TFH cell lymphoma. The neoplastic cells were positive for cluster of differentiation (CD)3, CD5, C-X-C motif chemokine ligand 13 (CXCL13), programmed cell death protein 1 (PD-1), and weak CD10, while CD21 and CD23 highlighted expanded follicular dendritic cell meshworks. CD20, CD30, paired box 5 (PAX5), GATA-binding protein 3 (GATA3), multiple myeloma oncogene 1 (MUM1), and Epstein-Barr virus-encoded RNA in situ hybridization (EBER-ISH) were negative."

Clinical • IO biomarker • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD20 • CD21 • CD5 • CXCL13 • FCER2 • GATA3 • IRF4 • MME • PAX5 • PD-1 • TNFRSF8

Dual HDAC and EZH2 inhibition modulates RFX5 activity to increase the immunogenicity of germinal center-derived B-cell lymphoma (ASH 2025) - P1 | "Belinostat (BEL), an HDAC inhibitor, and tazemetostat (TAZ), an EZH2inhibitor, counteract the epigenetic derangements caused by CREBBP and EZH2 mutations, and togetherincrease immune activity and antigen presentation targets to create a "hot" tumor environment. RFX5 expression was knocked down (KD) in SU-DHL-4 cells usingsiRNAs. RFX5 WT and KD cells were treated with vehicle, BEL, TAZ, or BEL+TAZ for six days and co-cultured with T cells for 24 h. Decreased cell viability was observed in the RFX5 WT cells but not the KDsfollowing treatment (n=3), revealing the critical role of RFX5 expression in BEL+TAZ-mediated cell kill.Lastly, RFX5 knockout (KO) murine A20 lymphoma cells were generated using CRISPR-Cas9 gene editing.An experiment is currently underway evaluating tumor growth and overall survival in vehicle-, BEL-, TAZ-,and BEL+TAZ-treated BALB/c mice xenografted with either RFX5 WT or KO murine A20 cells.In conclusion, dual HDAC and EZH2 inhibition..."

B Cell Lymphoma • Gene Therapies • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • B2M • CD4 • CD8 • CREBBP • HLA-DQA1 • HLA-DRA • TAFAZZIN

Late Breaking Abstract - Combining an iPSC-derived pulmonary fibrosis onset model with a deep generative neural network for drug discovery (ERS 2026) - "These included drugs already being used in clinical practice (PDE4 inhibitors) and drugs newly identified by UNAGI (HDAC inhibitor belinostat, PDE4 inhibitors cilomilast, ibudilast). In vitro experiments using iAT2 cells to validate candidate treatments are currently underway. This study is the first to combine novel human preclinical iPSC models of pulmonary fibrosis with novel generative neural networks approaches to identify novel insights in drug discovery."

Late-breaking abstract • Immunology • Pulmonary Disease • Respiratory Diseases • COL1A1 • ROBO2

Structure-guided identification of histone deacetylase 11 inhibitors for targeted chemotherapy through long-timescale molecular dynamics simulation. (PubMed, J Mol Model) - "Mocetinostat exhibited the highest binding affinity toward HDAC11 (-8.70 kcal/mol) with acceptable pharmacokinetic properties (LogP: 2.25; TPSA: 99.11 Å2), while Belinostat showed the safest toxicity profile (LD50: 6000 mg/kg; Class 6)...Comparative MD analyses over 500 ns revealed high structural stability for the Nanatinostat-HDAC11 and Resminostat-HDAC11 complexes by lower RMSD, reduced residue fluctuations, and more stable hydrogen bond interactions...A total of 3.5 µs of molecular dynamics simulations were performed, including a 500 ns production run and triplicate 100 ns validation runs for each complex. MD trajectory analyses, including RMSD, RMSF, radius of gyration, solvent-accessible surface area, hydrogen bond analysis, and kernel density estimation, were used to evaluate structural stability and interaction dynamics."

Journal • Oncology • HDAC1 • HDAC11

ETCTN 10500: Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2026 ➔ Jun 2027 | Trial primary completion date: Sep 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Cutaneous T-cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • EZH2

Early Refractory Nodal T-Follicular Helper Cell Lymphoma in a Young Woman: Diagnostic and Therapeutic Challenges (SOHO 2026) - "Because of refractory disease, belinostat application was planned, and salvage DHAP chemotherapy was initiated on January 22, 2026. Lymph node biopsy confirmed nodal T-follicular helper cell lymphoma. The neoplastic cells were positive for CD3, CD5, CXCL13, PD-1, and weakly positive for CD10, while CD21 and CD23 highlighted expanded follicular dendritic cell meshworks. CD20, CD30, PAX5, GATA3, MUM1, and EBER-ISH were negative."

Clinical • IO biomarker • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD20 • CD21 • CD5 • CXCL13 • FCER2 • GATA3 • IRF4 • MME • PAX5 • PD-1 • TNFRSF8

Real-World Outcomes of Belinostat in Relapsed Refractory T-Cell Lymphomas: A Report from the Lymphoma Study Group of Turkish Society of Hematology. (PubMed, J Clin Med) - "These findings support belinostat as a potential individualized treatment option rather than a broadly effective standard for all patients with R/R TCLs. This multicenter real-world study demonstrates that the observed response rates closely mirror those reported in prospective clinical trials, confirming the reproducibility of belinostat efficacy in routine clinical practice."

Journal • Real-world evidence • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

A Six-year Response to Belinostat in a Highly Probable Case of Relapsed/Refractory MF/SS Initially Classified as PTCL-NOS: A Case Report. (PubMed, Onco Targets Ther) - "After failure of two treatment lines, including CHOEP-based chemotherapy and bendamustine-brentuximab vedotin (B-BV), the patient received belinostat, a histone deacetylase inhibitor (HDACi). This case highlights the potential role of belinostat in the management of advanced MF/SS and suggests that durable disease control may be achievable in selected r/r patients. Further investigations are warranted to better identify the patients most likely to benefit from belinostat therapy."

Journal • Cutaneous T-cell Lymphoma • Dermatology • Hematological Disorders • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • Peripheral T-cell Lymphoma • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • KIR3DL2 • TP53

Thio-hydroxamic acids as HDAC6 inhibitors | Poster Board #1454 (ACS-Fall 2026) - "Histone deacetylase (HDAC) inhibitors such as Vorinostat, Belinostat, and Panobinostat are well-known for their ability to coordinate with Zn ions in the enzyme active site through a hydroxamic acid functional group, thereby inhibiting HDAC activity. Preliminary findings indicate that electron-donating substituents enhance coordination ability, whereas electron-withdrawing groups diminish it. Additionally, this study examines the crystal structures and metal (Fe, Cu) coordination behavior of Vorinostat (SAHA), HPOB, and HPB to better understand structure activity relationships."

Deciphering the Leading-Edge Spatiotemporal Microenvironment of Hepatocellular Carcinoma for Targeted Drug Discovery Using SpaPred. (PubMed, Int J Mol Sci) - "Finally, integration of in silico trajectory-perturbation and pharmacogenomic drug-response analyses prioritized Oxaliplatin, Belinostat, and Temsirolimus as candidate compounds associated with LE-related transcriptional programs. These drug predictions are computational and require experimental validation. Collectively, SpaPred provides a hypothesis-generating framework for investigating spatial heterogeneity and candidate therapeutic vulnerabilities in HCC."

Journal • Hepatocellular Cancer • Oncology • Solid Tumor • IGFBP7 • SPARC

Integrative Multiomics Analysis Reveals a Cancer Stem Cell-Driven Prognostic Signature and Nominates Belinostat for Targeted Therapy in Hepatocellular Carcinoma. (PubMed, Stem Cells Int) - "The histone deacetylase (HDAC) inhibitor belinostat was prioritized via Drug Signature Database (DSigDB) screening and validated by molecular docking as a candidate for targeting the CSC-related signature. This study establishes a novel CSC-associated gene signature for diagnosis and prognosis in HCC and nominates belinostat as a repurposing candidate for targeting stemness-related pathways, offering a promising strategy for personalized therapy."

Journal • Hepatocellular Cancer • Oncology • Solid Tumor

From design to clinic: Medicinal chemistry and pharmacology of approved epigenetic drugs. (PubMed, Eur J Med Chem) - "This review explores the ten epigenetic drugs that have attained worldwide regulatory approval for human therapy: the DNA methyltransferase inhibitors azacitidine (2004) and decitabine (2006), the histone deacetylase inhibitors vorinostat (2006), romidepsin (2009), belinostat (2014), panobinostat (2015) tucidinostat (2015) and givinostat (2024), and the histone methyltransferase inhibitors tazemetostat (2020) and valemetostat (2022). The history and strategy of their discovery and development, their biological targets and mechanisms of action and their therapeutic use. In addition, current advancements and efforts, as well as future perspectives in the design and clinical approval of new epigenetic drugs are discussed."

Journal • Review • Oncology

Precision Medicine in Non-Hodgkin Lymphoma: Advances in BTK Inhibition, CD30-Directed Antibody-Drug Conjugates, and HDAC-Mediated Epigenetic Therapy with Pirtobrutinib, Brentuximab Vedotin, and Belinostat. (PubMed, J Clin Med) - "Cumulatively, these therapies illustrate both the progress and the ongoing challenges of biomarker-driven treatment in NHL, including resistance mechanisms, toxicity management, optimal therapeutic sequencing, and variability in evidence maturity across targeted strategies. While pirtobrutinib and brentuximab vedotin are supported by increasingly robust clinical evidence in selected lymphoma subtypes, the role of belinostat remains constrained by modest response rates and limited randomized data, underscoring the continued need for biomarker refinement and more precisely individualized therapeutic approaches in NHL precision medicine."

Journal • Review • B Cell Lymphoma • Gene Therapies • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • TNFRSF8

Beyond Romidepsin: Novel Therapeutic Targets and Emerging Strategies for Relapsed and Refractory Peripheral T-Cell Lymphoma. (PubMed, Clin Lymphoma Myeloma Leuk) - "Following romidepsin's withdrawal from the R/R PTCL indication in 2021, the only FDA-approved agents are belinostat and pralatrexate, and Brentuximab Vedotin...EZH2 inhibitors represent a mechanistically novel class: valemetostat produced an ORR of 43.7% with a median duration of response of 11.9 months. JAK/STAT inhibitors, including golidocitinib (ORR 44.3%) and cerdulatinib (ORR 51.9% in AITL/TFH), show subtype-selective activity. Rational combinations yield superior efficacy: duvelisib plus romidepsin achieved ORR of 56% (CR 44%), while azacitidine combined with romidepsin produced ORR of 61% (CR 48%), particularly in TFH-phenotype disease (ORR 80%)...The Ro-CHOP trial's failure in unselected populations, contrasted with efficacy signals in nTFHL subsets, underscores a critical lesson: PTCL is not one disease, and future trial designs must incorporate biomarker-driven enrichment strategies to advance precision therapeutics. Improved outcomes can be expected..."

Journal • Review • Gene Therapies • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • DNMT3A • KLRD1 • RHOA • TET2

Belinostat in Combination With Azacitidine or Pralatrexate for the Treatment of Relapse or Refractory T-cell Lymphoma (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: City of Hope Medical Center

New P1 trial • Cutaneous T-cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Hepatosplenic T-cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD8

A MULTICENTER, OPEN-LABEL, PHASE 3, RANDOMIZED TRIAL OF DUVELISIB VS INVESTIGATOR'S CHOICE (GEMCITABINE OR BENDAMUSTINE) IN RELAPSED/REFRACTORY NODAL T-CELL LYMPHOMA WITH T-FOLLICULAR HELPER PHENOTYPE (EHA 2026) - P2, P3 | "Currently, the only agent approved in the EU/UK for treatment of R/R PTCL is brentuximab vedotin for anaplastic large-cell lymphoma. Novel agents such as romidepsin, belinostat, and pralatrexate have received accelerated approvals outside the EU/UK, but to date, none have received full approval...TERZO will test the hypothesis that DUV monotherapy is associated with improved outcomes versus GEM or BEN in patients with R/R nTFHL. TERZO is the only phase 3 study dedicated to nTFHL in the EU/UK, designed to address this serious unmet need."

Clinical • P3 data • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • Small Lymphocytic Lymphoma • T Cell Non-Hodgkin Lymphoma

Study of Class I HDAC-1, -2, and -3 Inhibitors Designed by Bioisosteric Replacement of Zinc Binding Groups and Caps of Traditional Pan Inhibitors: An In Silico Approach. (PubMed, Curr HIV Res) - "This study identified two promising novel HDAC inhibitors, Hdi2 and Hdi10, for further experimental investigation and optimization as potential LRAs for HIV latency reversal. These findings support the rational design of selective HDACis using computational approaches as efficient and cost-effective methods for the identification of future LRAs."

Journal • Human Immunodeficiency Virus • Infectious Disease • HDAC1 • HDAC2 • HDAC3

MECHANISM-GUIDED HDAC INHIBITION INDUCES COMPLETE RESPONSE IN PRIMARY REFRACTORY GATA3-POSITIVE PTCL-NOS: A BIOLOGICALLY INFORMED THERAPEUTIC STRATEGY (EHA 2026) - "Third-line Pralatrexate had to be truncated before completing the first cycle due to intolerable Grade IV mucositis, severe cytopenias, and recurrent bacteremia. (B) Progression (November 2024): Disease progression after first-line CHOEP-TIT, demonstrating increased metabolic activity in right iliac (SUV max 5.83) and inguinal nodes (SUV max 7.0), alongside new bilateral laterocervical involvement (SUV max 5.12). (C) Complete Response (September 2025): Metabolic complete response after 4 cycles of 4th-line Belinostat, with reduction of splenomegaly to 17 cm and minimal residual right inguinal uptake (SUV max 1.87; Deauville Score 2)."

Clinical • Acute Kidney Injury • Cardiovascular • Genetic Disorders • Hematological Disorders • Hematological Malignancies • Lymphoma • Mucositis • Obesity • Peripheral T-cell Lymphoma • Renal Disease • Septic Shock • T Cell Non-Hodgkin Lymphoma • GATA3

REAL-WORLD OUTCOMES OF BELINOSTAT IN RELAPSED REFRACTORY T-CELL LYMPHOMAS: A REPORT FROM THE LYMPHOMA STUDY GROUP OF TURKISH SOCIETY OF HEMATOLOGY (EHA 2026) - "Anthracycline-containing chemotherapy, with or without etoposide, was the most preferred first-line therapy. The median PFS of 3 months and OS of 12 months illustrates the aggressive nature of this malignancy .Adverse events associated with Belinostat were primarily mild, with notable instances of cytopenias and transaminitis, aligning with the established safety profile of histone deacetylase inhibitors. Finally , while Belinostat exhibits certain therapeutic potential, further exploration through larger, randomized controlled trials is essential to delineate its role within the treatment spectrum of TCLs."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Reversing Bladder Cancer Chemo-resistance through Blocking Cell Senescence by a Combination Therapy. (PubMed, Theranostics) - "A co-delivery therapeutic strategy combining the pan-HDAC inhibitor belinostat (PXD101) with paclitaxel (PTX) was developed and evaluated in patient-derived cisplatin-resistant organoids and a platinum-refractory patient-derived xenograft (PDX) model. Modulation of p21 influenced cell-cycle re-entry, senescence burden, and responsiveness to PTX. These findings define an HDAC-p21-senescence axis that sustains chemoresistance in bladder cancer and provide preclinical evidence supporting combined epigenetic and antimitotic therapy as a strategy to overcome acquired drug tolerance."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CDKN1A • HDAC1

Screening and evaluation of potential histone deacetylase inhibitors against Babesia infections. (PubMed, Int J Parasitol Drugs Drug Resist) - "Two compounds, namely panobinostat and belinostat were chosen for in vivo assays. In addition, panobinostat effectively and safely inhibited B. microti growth in BALB/c mice. Our findings support that panobinostat is a potential alternative drug to control babesiosis."

Journal • Infectious Disease

RESOLVE: Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in Urothelial Carcinoma (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: University of Utah | Trial primary completion date: Apr 2026 ➔ Aug 2026

Trial primary completion date • Oncology • Sarcoma • Solid Tumor • Urothelial Cancer

Therapeutic potential of PCNA and HDAC inhibitor combinations in cutaneous T-cell lymphoma and other cancers (AACR 2026) - "Guided by post-translational modification signature enrichment analysis of phosphorylated proteins after AOH1996 treatment, we tested its combination with histone deacetylase inhibitors (HDACi) belinostat and vorinostat...Furthermore, AOH1996 combined with vorinostat or romidepsin, both FDA-approved for treatment of CTCL, showed synergistic growth inhibition in four cell lines derived from CTCL. Mechanistic studies revealed enhanced DNA damage response, cell cycle arrest, and apoptosis in CTCL cells treated with AOH1996 and HDACi. These findings support the therapeutic potential of combining AOH1996 with HDACi for the treatment of cancers, including CTCL."

Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Neuroblastoma • Oncology • Solid Tumor • T Cell Non-Hodgkin Lymphoma • HDAC3 • PCNA