CDEK
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belinostat

Trade name: beleodaq

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Jul 3, 2014

Belinostat is a hydroxamate-type histone deacetylase inhibitor indicated for the treatment of relapsed or refractory peripheal T-cell lymphoma. The compound received orphan drug designation for the treatment of malignant thymomas. Acting on a histone deacetylase Belinostat causes the accumulation of acetylated histones and other proteins, inducing cell cycle arrest and/or apoptosis of some transformed cells. Belinostat targets HDAC enzymes, thereby inhibiting tumor cell proliferation, inducing apoptosis, promoting cellular differentiation, and inhibiting angiogenesis. This agent may sensitize drug-resistant tumor cells to other antineoplastic agents, possibly through a mechanism involving the down-regulation of thymidylate synthase. PXD101 has been shown in preclinical studies to have the potential to treat a wide range of solid and hematologic malignancies either as a monotherapy or in combination with other active agents, and both an oral and intravenous formulation of the drug are being evaluated in clinical trials. — NCATS

Clinical trial activity

57 trials · 66 clinical orgs · 3 marketing orgs

Phase 1
35
Phase 2
31
Phase 3
3
Phase 4
0

Earliest trial started Jan 1, 2005 (NCT00131261)

Timeline

2000s

  1. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

  3. Sep 3, 2009

    Orphan Drug Designation

2010s

  1. Jul 3, 2014

    Spectrum Pharmaceuticals — Earliest FDA Approval

  2. Jul 3, 2014

    Aurobindo Pharma — Marketing Organization

  3. Jul 3, 2014

    Spectrum Pharmaceuticals — NDA Organization

  4. Jul 3, 2014

    Acrotech Biopharma LLC — Marketing Organization

  5. Jul 3, 2014

    Acrotech Biopharma LLC — NDA Secondary Org

2020s

  1. Jan 1, 2023

    Acrotech Biopharma LLC — Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedFast trackJul 3, 2014

Chemistry & pharmacology

Loading structure…

SMILES

ONC(=O)\C=C\C1=CC=CC(=C1)S(=O)(=O)NC2=CC=CC=C2
Mol. weight
318.348 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 2-propenamide, n-hydroxy-3-(3-((phenylamino)sulfonyl)phenyl)-
  • belecodaq
  • beleodaq
  • beleodaq
  • beleodaq
  • belinostat
  • belinostat
  • belinostat
  • belinostat
  • belinostat
  • belinostat
  • belinostat
  • belinostat
  • belinostat
  • belinostat
  • belinostat
  • pxd101
  • pxd101
  • pxd-101
  • pxd-101

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06406465Phase 2Nov 17, 2024National Cancer Institute (NCI)
NCT06561048Phase 3Oct 2, 2024Corvus Pharmaceuticals, Inc.
NCT07234162Phase 3May 13, 2024Dizal (Jiangsu) Pharmaceutical Co., Ltd., Jiao Tong University
NCT06072131Phase 3Oct 4, 2023Acrotech Biopharma LLC
NCT05627245Phase 1Dec 9, 2022National Cancer Institute (NCI), Yale University
NCT05154994Phase 1Dec 31, 2021National Cancer Institute (NCI), University of Utah
NCT05170334Phase 2Dec 8, 2021Acrotech Biopharma LLC, Pfizer, University of South Florida
NCT04703920Phase 1Mar 4, 2021Acrotech Biopharma LLC, Pfizer, University of Michigan
NCT04747236Phase 2Feb 19, 2021Celgene, University of Virginia
NCT04315155Phase 1Sep 30, 2020Acrotech Biopharma LLC, Bristol-Myers Squibb, University of Utah
NCT04315233Phase 1Aug 31, 2020Acrotech Biopharma LLC, Novartis, University of Utah
NCT04340843Phase 2Apr 10, 2020National Cancer Institute (NCI), Yale University
NCT04184869Phase 1Aug 5, 2019Acrotech Biopharma LLC, AXIS Clinicals Limited
NCT03772925Phase 1Feb 28, 2019National Cancer Institute (NCI), University of Toronto
NCT03432741Phase 1Mar 27, 2018Mayo Clinic, National Cancer Institute (NCI)
NCT02737046Phase 2Dec 12, 2016University of Miami
NCT02875002Phase 1Oct 1, 2016Johns Hopkins University, Virginia Commonwealth University, Yale University
NCT02701673Phase 1/Phase 2 (Phase 2)Jun 1, 2016University of Texas at Houston
NCT02680795Phase 1Mar 1, 2016Spectrum Pharmaceuticals
NCT02679131Phase 1Mar 1, 2016Spectrum Pharmaceuticals
Showing 20 of 57 trials
Page 1 / 3

Organizations

Research & Development (66)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government262022006
ValerioFor profit13922005
Spectrum PharmaceuticalsFor profit12722006
Acrotech Biopharma LLCFor profit6232019
City of Hope National Medical CenterAcademic/Hospital4022006
University of UtahAcademic/Hospital4312010
University of Texas at HoustonAcademic/Hospital3222008
University of TorontoAcademic/Hospital3022006
Virginia Commonwealth UniversityAcademic/Hospital3122008
Yale UniversityAcademic/Hospital3122016
Johns Hopkins UniversityAcademic/Hospital2022014
Mayo ClinicAcademic/Hospital2122006
National Institutes of Health (NIH)Government2012007
PfizerFor profit2022021
University of ChicagoAcademic/Hospital2022006
University of MiamiAcademic/Hospital2212010
Washington University in St. LouisAcademic/Hospital2012008
AXIS Clinicals LimitedFor profit1012019
Badalona Hospital Germans Trias i PujolAcademic/Hospital1012008
Boca Raton Clinical Research AssociatesAcademic/Hospital1012008
66 organizations
Page 1 / 4

Marketing (4)

OrganizationOrg typeRelationshipDate
Acrotech Biopharma LLCFor profitMKTGJul 3, 2014
Acrotech Biopharma LLCFor profitNDA2Jul 3, 2014
Aurobindo PharmaFor profitMKTGJul 3, 2014
Spectrum PharmaceuticalsFor profitNDAJul 3, 2014