Beleodaq

(Belinostat)

ApprovedSmall molecule

Beleodaq is a small molecule that works as a Histone Deacetylase Inhibitor.[2] It is being used across 16 indications, with its most advanced program in Approved.[1]

Beleodaq is one of 301 small molecule programs targeting Unspecified Peripheral T-Cell Lymphoma. It is currently in Approved.

Indications

Total Trials

Active Trials

300

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Unspecified Peripheral T-Cell LymphomaActive, not recruiting

Thymic CarcinomaApproved

Non-Hodgkins LymphomaApproved

Adult T-Cell Leukemia/lymphomaApproved

Lymphoid NeoplasmApproved

MesotheliomaApproved

Adult Hepatocellular CarcinomaApproved

Glioblastoma MultiformeApproved

T-Cell Non-Hodgkin LymphomaActive, not recruiting

ThymomaApproved

Unspecified Peripheral T-Cell LymphomaApproved

Active, not recruiting

Thymic CarcinomaApproved

Approved

Non-Hodgkins LymphomaApproved

Approved

Adult T-Cell Leukemia/lymphomaApproved

Approved

Lymphoid NeoplasmApproved

Approved

MesotheliomaApproved

Approved

Adult Hepatocellular CarcinomaApproved

Approved

Glioblastoma MultiformeApproved

Approved

T-Cell Non-Hodgkin LymphomaApproved

Active, not recruiting

ThymomaApproved

Approved

Showing 10 of 16 indications

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Beleodaq

AAcrotech Biopharma Inc.

Approved

47 2

Cytoxan

BBaxter Healthcare Corporation

Phase 3

17 3

Sacituzumab Tirumotecan

Merck & Co.

Phase 3

5 4

Ds-1062a

Daiichi Sankyo

Phase 3

3 5

Remeron

OOrganon and Co

Preclinical

1 6

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

1 8

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 9

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—10

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

Locally Advanced Unresectable Primary Central Chondrosarcoma

NCT04340843

Q2 2027

Phase 1Active, not recruiting

Recurrent B-Cell Non-Hodgkin Lymphoma

NCT05627245

Q4 2027

Phase 1Active, not recruiting

Urothelial Carcinoma

NCT05154994

Q1 2028

Phase 2Active, not recruiting

Uveal Melanoma

NCT05170334

Clinical

Trials by Indication[1]

Lymphoma11 trials

Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

Recruiting·CCorvus Pharmaceuticals, Inc.·Phase 3·NCT06561048·150 enrolled

Study of Oral PXD101 in Patients With Advanced Solid Tumors or Lymphoma

Completed·VValerio Therapeutics·Phase 1·NCT00413075·121 enrolled

PXD101 and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphoma

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT00354185·36 enrolled

Show 8 more trials

Belinostat Combined With Azacitidine/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Refractory or Relapsed Lymphoma

Withdrawn·MM.D. Anderson Cancer Center·Phase 1/2·NCT02701673

Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)

Completed·AAcrotech Biopharma Inc.·Phase 1·NCT01839097·23 enrolled

Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma

Completed· Spectrum Pharmaceuticals, Inc logo

Spectrum Pharmaceuticals, Inc·Phase 2·NCT00865969·129 enrolled

Belinostat for Solid Tumors and Lymphomas in Patients With Varying Degrees of Hepatic Dysfunction

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01273155·72 enrolled

PXD101 in Treating Patients With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00303953·22 enrolled

A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas

Terminated·VValerio Therapeutics·Phase 2·NCT00274651·53 enrolled

PXD101 and Bortezomib in Treating Patients With Advanced Solid Tumors or Lymphomas

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00348985·55 enrolled

Study of Volasertib and Belinostat in Patients With Relapsed and Refractory Aggressive B-cell and T-cell Lymphomas

Withdrawn·YYale University·Phase 1·NCT02875002

Fallopian Tube Cancer2 trials

Belinostat and Carboplatin in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Carboplatin or Cisplatin

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00993616·29 enrolled

Belinostat in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00301756·32 enrolled

Acute Myeloid Leukemia2 trials

PXD101 in Treating Patients With Acute Myeloid Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00357032·12 enrolled

Phase I Trial of AZD1775 and Belinostat in Treating Patients With Relapsed or Refractory Myeloid Malignancies or Untreated Acute Myeloid Leukemia

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT02381548·20 enrolled

Myelodysplastic Syndrome2 trials

Belinostat and Bortezomib in Treating Patients With Relapsed or Refractory Acute Leukemia or Myelodysplastic Syndrome

Completed·VVirginia Commonwealth University·Phase 1·NCT01075425·41 enrolled

Pevonedistat and Belinostat in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT03772925·18 enrolled

Patients With Advanced Solid Tumors1 trial

Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors

Completed·VValerio Therapeutics·Phase 1·NCT00413322·35 enrolled

29 more indications

Advanced Cancer1 trial

Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer

Completed·AAcrotech Biopharma Inc.·Phase 1·NCT01583777·6 enrolled

GBM1 trial

MRSI to Predict Response to RT/TMZ ± Belinostat in GBM

Unknown status·EEmory University·Phase 2·NCT02137759·29 enrolled

Diffuse Large B-Cell Lymphoma1 trial

A Phase Ib Study of Belinostat With RDHAP Chemotherapy (Dexamethasone, Cytarabine, Cisplatinum) in Adults With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT02532192

Patients With Solid Tumors1 trial

Belinostat and Isotretinoin in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00334789·51 enrolled

Trial1 trial

Extension Study for Patients Who Had Not Met Criteria for Discontinuation in Previous Sponsored Belinostat Trials

Completed·AAcrotech Biopharma Inc.·Phase 1·NCT04184869·8 enrolled

Metastatic1 trial

Evaluating Safety & Efficacy Belinostat Combo w Nivo Alone & w Ipi in Patients w Treated Metastatic/Advanced Carcinomas w ARID1A Lof Mutation

Withdrawn·UUniversity of Utah·Phase 1·NCT04315155

PTCL1 trial

A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19)

Recruiting·DDizal Pharmaceuticals·Phase 3·NCT07234162·218 enrolled

Myelodysplastic Syndromes1 trial

Belinostat in Treating Patients With Myelodysplastic Syndromes

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00357162·21 enrolled

Azacytidine1 trial

Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL

Recruiting·UUniversity of Virginia·Phase 2·NCT04747236·50 enrolled

Liver Cancer1 trial

Belinostat in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT00321594·54 enrolled

Breast Cancer1 trial

Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer

Terminated·MMayo Clinic·Phase 1·NCT03432741·17 enrolled

Leukemia1 trial

Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma

Completed·UUniversity of Miami·Phase 2·NCT02737046·15 enrolled

Uveal Melanoma1 trial

Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma

Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT05170334·7 enrolled

Urothelial Carcinoma1 trial

Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in Urothelial Carcinoma

Active, not recruiting·UUniversity of Utah·Phase 1·NCT05154994·9 enrolled

Aggressive B-cell NHL1 trial

Belinostat and Yttrium Y 90 Ibritumomab Tiuxetan in Patients W/Relapsed Aggressive B-Cell NHL

Completed·UUniversity of Arizona·Phase 2·NCT01686165·5 enrolled

Ovarian Cancer1 trial

A Study of Belinostat + Carboplatin or Paclitaxel or Both in Patients With Ovarian Cancer in Need of Relapse Treatment

Completed·VValerio Therapeutics·Phase 1/2·NCT00421889·80 enrolled

Small Cell Lung Carcinoma1 trial

A Phase I Study of Belinostat in Combination With Cisplatin and Etoposide in Adults With Small Cell Lung Carcinoma and Other Advanced Cancers

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00926640·28 enrolled

Hematologic Cancer1 trial

Belinostat and Azacitidine in Treating Patients With Advanced Hematologic Cancers or Other Diseases

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00351975·56 enrolled

Renal Impairment1 trial

To Evaluate Safety and Pharmacokinetics of Belinostat in Patients Who Have Mild, Moderate and Severe Renal Impairment.

Terminated·AAcrotech Biopharma Inc.·Phase 1·NCT02679131·18 enrolled

Prostate Cancer1 trial

Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 1·NCT04703920·26 enrolled

Malignant Mesothelioma1 trial

PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00365053·13 enrolled

Relapsed/Refractory1 trial

Carfilzomib Plus Belinostat in Relapsed/Refractory NHL

Completed·MMassachusetts General Hospital·Phase 1·NCT02142530·19 enrolled

Advanced Stage1 trial

Belinostat (PXD101) to Treat Tumors of the Thymus at an Advanced Stage

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00589290·41 enrolled

Recurrent B-Cell Non-Hodgkin Lymphoma1 trial

Phase 1/Expansion Study of Tazemetostat Plus Belinostat for the Treatment of Relapsed or Refractory Lymphoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05627245·48 enrolled

Carcinoma, Neuroendocrine1 trial

A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06406465·60 enrolled

Locally Advanced Unresectable Primary Central Chondrosarcoma1 trial

A Phase 2 Study of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04340843·19 enrolled

Metastatic Breast Cancer1 trial

A Phase I/Ib Trial of the CDK4/6 Antagonist Ribociclib And The HDAC Inhibitor Belinostat In Patients With Metastatic Triple Negative Breast Cancer And Recurrent Ovarian Cancer With Response Prediction By Genomics (CHARGE)

Terminated·UUniversity of Utah·Phase 1·NCT04315233·12 enrolled

Peripheral T-Cell Lymphoma1 trial

A Phase 3, Randomized, Open-Label Study Comparing the Efficacy and Safety of the Combination of Beleodaq-CHOP or Folotyn-COP to the CHOP Regimen Alone in Newly Diagnosed Patients With Peripheral T-Cell Lymphoma

Recruiting·AAcrotech Biopharma Inc.·Phase 3·NCT06072131·504 enrolled

Recurrent Anaplastic Large Cell Lymphoma1 trial

Phase 1 Investigation of Belinostat-Based Combinations in Relapsed/Refractory T-Cell Lymphoma

Not yet recruiting·CCity of Hope Medical Center·Phase 1·NCT07691450·40 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 3, 2014

BELEODAQ

NDA NDA206256

Sources

References

[1]
ClinicalTrials.gov — 47 trial records for Belinostat. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Belinostat compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Belinostat. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA206256). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Beleodaq. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Acrotech Biopharma Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Histone Deacetylase Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AAcrotech Biopharma Inc.

Patent Landscape[5]

Patent Cliff

Oct 27, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

6888027Aug 10, 2026

8835501Oct 27, 2027

Beleodaq

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Lymphoma11 trials

Fallopian Tube Cancer2 trials

Acute Myeloid Leukemia2 trials

Myelodysplastic Syndrome2 trials

Patients With Advanced Solid Tumors1 trial

Advanced Cancer1 trial

GBM1 trial

Diffuse Large B-Cell Lymphoma1 trial

Patients With Solid Tumors1 trial

Trial1 trial

Metastatic1 trial

PTCL1 trial

Myelodysplastic Syndromes1 trial

Azacytidine1 trial

Liver Cancer1 trial

Breast Cancer1 trial

Leukemia1 trial

Uveal Melanoma1 trial

Urothelial Carcinoma1 trial

Aggressive B-cell NHL1 trial

Ovarian Cancer1 trial

Small Cell Lung Carcinoma1 trial

Hematologic Cancer1 trial

Renal Impairment1 trial

Prostate Cancer1 trial

Malignant Mesothelioma1 trial

Relapsed/Refractory1 trial

Advanced Stage1 trial

Recurrent B-Cell Non-Hodgkin Lymphoma1 trial

Carcinoma, Neuroendocrine1 trial

Locally Advanced Unresectable Primary Central Chondrosarcoma1 trial

Metastatic Breast Cancer1 trial

Peripheral T-Cell Lymphoma1 trial

Recurrent Anaplastic Large Cell Lymphoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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