BELEODAQ (belinostat)
BELEODAQ is indicated for the treatment of Peripheral T-Cell Lymphoma.
How BELEODAQ Works
Belinostat is a histone deacetylase (HDAC) inhibitor that blocks the removal of acetyl groups from lysine residues on histones and various non-histone proteins. This inhibition leads to an accumulation of acetylated proteins, which triggers cell cycle arrest and/or apoptosis (programmed cell death) in transformed cells. Belinostat exhibits preferential cytotoxicity toward tumor cells compared to healthy cells and inhibits HDAC enzymatic activity at nanomolar concentrations.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-07-03
- Patent Cliff
- 2027
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
BELEODAQ Approval History
What BELEODAQ Treats
1 indicationsBELEODAQ is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Peripheral T-Cell Lymphoma
BELEODAQ Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in BELEODAQ's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BELEODAQ treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BELEODAQ
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
29 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06406465 | 10001601 001601-C | Ph 2 | recruiting | A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity |
| NCT05627245 | NCI-2022-05327 NCI-2022-05327, CUMC-AAAT9882 | Ph 1 | active not recruiting | Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment |
| NCT05154994 RESOLVE | HCI143952 NCI-2021-12484, HCI143952 | Ph 1 | active not recruiting | Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in Urothelial Carcinoma |
| NCT04340843 results posted | NCI-2020-02187 NCI-2020-02187, 10330 | Ph 2 | active not recruiting | Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma |
| NCT06561048 | CPI-818-004 | Ph 3 | recruiting | 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 |
| NCT05170334 | MCC-20955 | Ph 2 | active not recruiting | Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma |
| NCT02737046 results posted | 20150567 | Ph 2 | completed | Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma |
| NCT03772925 results posted | NCI-2018-03227 NCI-2018-03227, 10246 | Ph 1 | terminated | Pevonedistat and Belinostat in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome |
| NCT02381548 | NCI-2015-00257 NCI-2015-00257, MCC-12-07328 | Ph 1 | terminated | Phase I Trial of AZD1775 and Belinostat in Treating Patients With Relapsed or Refractory Myeloid Malignancies or Untreated Acute Myeloid Leukemia |
| NCT04747236 PTCL | PTCL-001 FD-R-006814-01 | Ph 2 | recruiting | Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL |
| NCT07234162 | DZ2022J0004 | Ph 3 | recruiting | A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19) |
| NCT03432741 | MC1689 NCI-2018-00149, MC1689 | Ph 1 | terminated | 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 |
| NCT04315233 CHARGE | HCI130492 | Ph 1 | recruiting | Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics |
| NCT04703920 | UMCC 2020.122 HUM00187603 | Ph 1 | completed | Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer |
| NCT04184869 | SPI-BEL-502 | Ph 1 | completed | Extension Study for Patients Who Had Not Met Criteria for Discontinuation in Previous Sponsored Belinostat Trials |
| NCT00865969 PTCL results posted | PXD101-CLN-19 2008-005843-40 | Ph 2 | completed | Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma |
| NCT04315155 BENEFIT | HCI130490 | Ph 1 | withdrawn | Evaluating Safety & Efficacy Belinostat Combo w Nivo Alone & w Ipi in Patients w Treated Metastatic/Advanced Carcinomas w ARID1A Lof Mutation |
| NCT01583777 | SPI-BEL-12-103 | Ph 1 | completed | Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer |
| NCT01839097 | SPI-BEL-12-104 | Ph 1 | completed | Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL) |
| NCT02679131 | SPI-BEL-105 | Ph 1 | terminated | To Evaluate Safety and Pharmacokinetics of Belinostat in Patients Who Have Mild, Moderate and Severe Renal Impairment. |
| NCT00993616 results posted | NCI-2010-01663 NCI-2010-01663, CDR0000656707 | Ph 2 | completed | 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 |
| NCT01273155 results posted | 110060 11-C-0060 | Ph 1 | completed | Belinostat for Solid Tumors and Lymphomas in Patients With Varying Degrees of Hepatic Dysfunction |
| NCT00926640 | 090173 09-C-0173 | Ph 1 | completed | A Phase I Study of Belinostat in Combination With Cisplatin and Etoposide in Adults With Small Cell Lung Carcinoma and Other Advanced Cancers |
| NCT01686165 results posted | 12-0288-04 NCI-2012-01131, 1200000288 | Ph 2 | completed | Belinostat and Yttrium Y 90 Ibritumomab Tiuxetan in Patients W/Relapsed Aggressive B-Cell NHL |
| NCT02142530 | 14-096 | Ph 1 | completed | Carfilzomib Plus Belinostat in Relapsed/Refractory NHL |
| NCT02875002 | 1601017105 | Ph 1 | withdrawn | Study of Volasertib and Belinostat in Patients With Relapsed and Refractory Aggressive B-cell and T-cell Lymphomas |
| NCT02701673 | 2015-0560 | Ph 1, Ph 2 | withdrawn | Belinostat Combined With Azacitidine/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Refractory or Relapsed Lymphoma |
| NCT01075425 | MCC-12517 NCI-2010-00127, RC2CA148431 | Ph 1 | completed | Belinostat and Bortezomib in Treating Patients With Relapsed or Refractory Acute Leukemia or Myelodysplastic Syndrome |
| NCT02532192 | 2014-1068 NCI-2015-01521 | Ph 1 | withdrawn | A Phase Ib Study of Belinostat With RDHAP Chemotherapy (Dexamethasone, Cytarabine, Cisplatinum) in Adults With Relapsed or Refractory Diffuse Large B-cell Lymphoma |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BELEODAQ FDA Label Details
Indications & Usage
FDA Label (PDF)BELEODAQ is indicated for the treatment of Peripheral T-Cell Lymphoma.
Pro Intelligence Preview
Deep insights for BELEODAQ
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 2 active patents
Trial Analysis
- • 30 total trials
- • Stage: Stable
Competitive Landscape
- • 2 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment