Belinostat: first global approval

Drugs. 2014 Sep;74(13):1543-54. doi: 10.1007/s40265-014-0275-8.


Belinostat [Beleodaq(®) (US)], a small-molecule hydroxamate-type inhibitor of class I, II and IV histone deacetylase (HDAC) enzymes, has been developed by TopoTarget and Spectrum Pharmaceuticals for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL). Belinostat has received its first global approval as monotherapy for this indication in the US, under the Food and Drug Administration's accelerated approval program. This article summarizes the milestones in the development of belinostat leading to this first approval for the treatment of PTCL.

MeSH terms

  • Antineoplastic Agents / pharmacology
  • Antineoplastic Agents / therapeutic use
  • Drug Approval
  • Drug Design
  • Histone Deacetylase Inhibitors / pharmacology
  • Histone Deacetylase Inhibitors / therapeutic use*
  • Humans
  • Hydroxamic Acids / pharmacology
  • Hydroxamic Acids / therapeutic use*
  • Lymphoma, T-Cell, Peripheral / drug therapy*
  • Lymphoma, T-Cell, Peripheral / pathology
  • Sulfonamides / pharmacology
  • Sulfonamides / therapeutic use*
  • United States
  • United States Food and Drug Administration


  • Antineoplastic Agents
  • Histone Deacetylase Inhibitors
  • Hydroxamic Acids
  • Sulfonamides
  • belinostat