Last reviewed 2026-04-20 · How we verify

Beleodaq (belinostat)

Beleodaq works by blocking the enzyme that removes acetyl groups from histones, altering gene expression.

Beleodaq (belinostat) is a small molecule Histone Deacetylase Inhibitor (HDACi) developed by Spectrum Pharmaceuticals and currently owned by Acrotech Biopharma. It targets Histone Deacetylase 1 (HDAC1) to treat Peripheral T-cell lymphoma. Beleodaq was FDA-approved in 2014 and remains a branded, patented product with no generic manufacturers. Key safety considerations include its short half-life of 1.6 hours. As a HDACi, Beleodaq works by inhibiting the removal of acetyl groups from histones, leading to changes in gene expression.

At a glance

Mechanism of action

Beleodaq is histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from the lysine residues of histones and some non-histone proteins. In vitro, belinostat caused the accumulation of acetylated histones and other proteins, inducing cell cycle arrest and/or apoptosis of some transformed cells. Belinostat shows preferential cytotoxicity towards tumor cells compared to normal cells. Belinostat inhibited the enzymatic activity of histone deacetylases at nanomolar concentrations (<250 nM).

Approved indications

• Peripheral T-cell lymphoma

Common side effects

• Nausea
• Fatigue
• Pyrexia
• Anemia
• Vomiting
• Constipation
• Diarrhea
• Dyspnea
• Rash
• Peripheral Edema
• Cough
• Thrombocytopenia

Key clinical trials

• Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma (PHASE2)
• Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment (PHASE1)
• A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity (PHASE2)
• 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 (PHASE3)
• Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma (PHASE2)
• Pevonedistat and Belinostat in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome (PHASE1)
• Phase I Trial of AZD1775 and Belinostat in Treating Patients With Relapsed or Refractory Myeloid Malignancies or Untreated Acute Myeloid Leukemia (PHASE1)
• Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in Urothelial Carcinoma (PHASE1)

Patents

Primary sources

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