Treats relapsed or refractory peripheral T-cell lymphoma (PTCL). Sold as Beleodaq. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Belinostat (sold as Beleodaq), first approved Jul 3, 2014, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Beleodaq | Part B | $11.6M | -14% | 65 |
| Belinostat in Combination With Azacitidine or Pralatrexate for the Treatment of Relapse or Refractory T-cell LymphomaRecurrent Anaplastic Large Cell Lymphoma, Recurrent Enteropathy-Associated T-Cell Lymphoma · City of Hope Medical Center | Phase 1 | Recruiting | Jul 9, 2026 |
| 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 LymphomaPeripheral T-Cell Lymphoma, Not Otherwise Specified, Angioimmunoblastic T-cell Lymphoma · Corvus Pharmaceuticals, Inc. | Phase 3 | Recruiting | Aug 19, 2024 |
| A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and ToxicityCarcinoma, Neuroendocrine, Tumor, Neuroendocrine · National Cancer Institute (NCI) | Phase 2 | Recruiting | May 9, 2024 |
| To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCLPeripheral T Cell Lymphoma · Acrotech Biopharma Inc. | Phase 3 | Active, not recruiting | Oct 10, 2023 |
| Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted TreatmentRecurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type · National Cancer Institute (NCI) | Phase 1 | Active, not recruiting | Nov 25, 2022 |
| Binimetinib Plus Belinostat for Subjects With Metastatic Uveal MelanomaMetastatic Uveal Melanoma · H. Lee Moffitt Cancer Center and Research Institute | Phase 2 | Active, not recruiting | Dec 27, 2021 |
| Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCLPTCL · University of Virginia | Phase 2 | Recruiting | Feb 10, 2021 |
| Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional ChondrosarcomaLocally Advanced Unresectable Primary Central Chondrosarcoma, Metastatic Primary Central Chondrosarcoma · National Cancer Institute (NCI) | Phase 2 | Active, not recruiting | Apr 10, 2020 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Jul 3, 2014 | BeleodaqNDA 206256 · New molecular entity | Acrotech Biopharma | 5 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
