Beleodaq

(Belinostat)

ApprovedSmall molecule

Beleodaq is a small molecule that works as a Histone Deacetylase Inhibitor.[2] It is being used across 32 indications, with its most advanced program in Approved.[1]

Beleodaq is one of 670 small molecule programs targeting Non-Hodgkins Lymphoma. It is currently in Approved.

Indications

Total Trials

Active Trials

669

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Non-Hodgkins LymphomaApproved

ToxicityActive, not recruiting

Unspecified Peripheral T-Cell LymphomaActive, not recruiting

Small Cell Lung CarcinomaActive, not recruiting

T-Cell Non-Hodgkin LymphomaActive, not recruiting

LymphomaActive, not recruiting

Cutaneous T-Cell LymphomaApproved

Thymic CarcinomaApproved

ThymomaApproved

LeukemiaActive, not recruiting

Non-Hodgkins LymphomaApproved

Approved

ToxicityPhase 2

Active, not recruiting

Unspecified Peripheral T-Cell LymphomaApproved

Active, not recruiting

Small Cell Lung CarcinomaPhase 1

Active, not recruiting

T-Cell Non-Hodgkin LymphomaApproved

Active, not recruiting

LymphomaPhase 3

Active, not recruiting

Cutaneous T-Cell LymphomaApproved

Approved

Thymic CarcinomaApproved

Approved

ThymomaApproved

Approved

LeukemiaPhase 2

Active, not recruiting

Showing 10 of 32 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Beleodaq

AAcrotech Biopharma Inc.

Approved

1 2

Megace

Bristol-Myers Squibb

Preclinical

4 3

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 4

MS Contin

Merck & Co.

Preclinical

2 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 6

Effexor

WWyeth-Lederle Vaccines

Preclinical

2 7

Vfend

PPrism Pharmaceuticals

Preclinical

—8

Conventional Chemotherapy

SShanghai Jiao Tong University School of Medicine

Preclinical

1 9

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

1 10

Beta Blocker

WWeill Medical College of Cornell University

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 1Recruiting

Ovarian Cancer

NCT04315233

Phase 1Active, not recruiting

Lymphoma

NCT05627245

Q1 2027

Phase 2Active, not recruiting

Chondrosarcoma

NCT04340843

Q4 2027

Phase 1Active, not recruiting

Urothelial Carcinoma

NCT05154994

Q1 2028

Phase 2Active, not recruiting

Uveal Melanoma

NCT05170334

Clinical

Trials by Indication[1]

Lymphoma12 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

Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma

Completed· Spectrum Pharmaceuticals, Inc logo

Spectrum Pharmaceuticals, Inc·Phase 2·NCT00865969·129 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 9 more trials

Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment

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

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

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

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

Withdrawn·YYale University·Phase 1·NCT02875002

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

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

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

Ovarian Cancer2 trials

Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics

Recruiting·UUniversity of Utah·Phase 1·NCT04315233·34 enrolled

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

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

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

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

27 more indications

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

Leukemia1 trial

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

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

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

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

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 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

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

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

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

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

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

Myelodysplastic Syndromes1 trial

Belinostat in Treating Patients With Myelodysplastic Syndromes

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

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

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

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

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

Urothelial Carcinoma1 trial

Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in Urothelial Carcinoma

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

Relapsed/Refractory1 trial

Carfilzomib Plus Belinostat in Relapsed/Refractory NHL

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

Chondrosarcoma1 trial

Testing the Combination 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

Efficacy1 trial

To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL

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

Carcinoma, Neuroendocrine1 trial

A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity

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

Aug 10, 2026

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

Q3 2026

Q1 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Lymphoma12 trials

Ovarian Cancer2 trials

Myelodysplastic Syndrome2 trials

Acute Myeloid Leukemia2 trials

Fallopian Tube Cancer2 trials

Trial1 trial

Leukemia1 trial

Metastatic1 trial

PTCL1 trial

Breast Cancer1 trial

Hematologic Cancer1 trial

Advanced Cancer1 trial

GBM1 trial

Diffuse Large B-Cell Lymphoma1 trial

Patients With Advanced Solid Tumors1 trial

Renal Impairment1 trial

Uveal Melanoma1 trial

Advanced Stage1 trial

Patients With Solid Tumors1 trial

Small Cell Lung Carcinoma1 trial

Myelodysplastic Syndromes1 trial

Aggressive B-cell NHL1 trial

Liver Cancer1 trial

Prostate Cancer1 trial

Azacytidine1 trial

Malignant Mesothelioma1 trial

Urothelial Carcinoma1 trial

Relapsed/Refractory1 trial

Chondrosarcoma1 trial

Efficacy1 trial

Carcinoma, Neuroendocrine1 trial

Recurrent Anaplastic Large Cell Lymphoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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