Drugs / Belinostat
last change Aug 2026 re-read 9 days ago

Belinostat

Small molecule

Developed for
lymphoma · myelodysplastic syndrome · peripheral T-cell lymphoma, not otherwise specified · anaplastic large cell lymphoma · cancer · mantle cell lymphoma · acute myeloid leukemia · adult T-cell leukemia/lymphoma
+79 more · angioimmunoblastic T-cell lymphoma · Burkitt lymphoma · diffuse large B-cell lymphoma · hematopoietic and lymphoid cell neoplasm · Hodgkins lymphoma · nodal marginal zone B-cell lymphoma · non-small cell lung carcinoma · ovarian carcinoma · acute myeloid leukemia with t(8;21)(q22;q22) translocation · breast cancer · cancer of unknown primary site · chronic lymphocytic leukemia/small lymphocytic lymphoma · fallopian tube cancer · follicular lymphoma · grade III lymphomatoid granulomatosis · intraocular lymphoma · large-cell immunoblastic lymphoma · MALT lymphoma · mycosis fungoides and variants · neoplasm · plasma cell myeloma · post-transplant lymphoproliferative disease · primary cutaneous T-cell lymphoma · primary peritoneal carcinoma · splenic marginal zone lymphoma · thymic carcinoma · thymoma · Waldenstrom macroglobulinemia · acute lymphoblastic leukemia · acute myeloid leukemia with 11q23 abnormalities · acute myeloid leukemia with abnormal bone marrow eosinophils inv(16)(p13q22) or t(16;16)(p13;q22) · acute myeloid leukemia with t(9;11)(p22;q23) · acute myeloid leukemia, inv(16)(p13.1;q22) · acute myeloid leukemia, t(16;16)(p13.1;q22) · acute promyelocytic leukemia · adenocarcinoma · adult acute lymphoblastic leukemia · adult hepatocellular carcinoma · atypical chronic myeloid leukemia, BCR-ABL1 negative · blast phase chronic myelogenous leukemia, BCR-ABL1 positive · borderline epithelial tumor of ovary · brain glioblastoma · breast adenocarcinoma · Brenner tumor · castration-resistant prostate carcinoma · central nervous system non-hodgkin lymphoma · chronic myeloid leukemia · chronic myelomonocytic leukemia · diffuse large B-cell lymphoma germinal center B-cell type · enteropathy-associated T-cell lymphoma · extranodal nasal NK/T cell lymphoma · fallopian tube carcinoma · hepatosplenic T-cell lymphoma · infiltrating bladder urothelial carcinoma sarcomatoid variant · leukemia, myeloid, accelerated-phase · localized chondrosarcoma · malignant epithelial tumor of ovary · monomorphic epitheliotropic intestinal T-cell lymphoma · mycosis fungoides · myeloproliferative neoplasm, unclassifiable · Nodal T-follicular helper cell lymphoma, follicular type · ovarian clear cell cystadenocarcinoma · ovarian endometrioid adenocarcinoma · ovarian mucinous cystadenocarcinoma · ovarian serous cystadenocarcinoma · primary cutaneous aggressive epidermotropic CD8+ T-cell lymphoma · primary cutaneous gamma-delta t-cell lymphoma · primary myelofibrosis · refractory malignant neoplasm · sarcomatoid mesothelioma · small cell carcinoma · small cell lung carcinoma · small intestine lymphoma · soft tissue sarcoma · subcutaneous panniculitis-like T-cell lymphoma · therapy related acute myeloid leukemia and myelodysplastic syndrome · undifferentiated ovarian carcinoma · urinary bladder cancer · uveal melanoma
Investigated by
National Cancer Institute (NCI) · Valerio Therapeutics · Acrotech Biopharma Inc. · Spectrum Pharmaceuticals, Inc · Axis Clinicals Limited · University of Utah
+27 more · M.D. Anderson Cancer Center · Pfizer · Axis Clinical Trials · Bispebjerg Hospital · Bristol-Myers Squibb · City of Hope Medical Center · Copenhagen University Hospital at Herlev · Emory University · Gynecologic Oncology Group · H. Lee Moffitt Cancer Center and Research Institute · Herlev Hospital · Holy Cross Hospital, Florida · Johns Hopkins University · Massachusetts General Hospital · Massey Cancer Center · Mayo Clinic · National Comprehensive Cancer Network · National Institute of Neurological Disorders and Stroke (NINDS) · National Institutes of Health (NIH) · Novartis · Roche Pharma AG · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · University of Arizona · University of Miami · University of Michigan Rogel Cancer Center · Virginia Commonwealth University · Yale University

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) BELEODAQ — 2014-07-03 fda.gov ↗

Trials 54

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 127 trials
Phase 1 NCT07691450 Jan 2027 → Nov 2029 expected Nodal T-follicular helper cell lymphoma, follicular type, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, enteropathy-associated T-cell lymphoma +6 City of Hope Medical Center Not yet recruiting No outcome recorded
Phase 1 NCT05627245 Mar 2023 → Jun 2027 expected diffuse large B-cell lymphoma germinal center B-cell type, follicular lymphoma, primary cutaneous T-cell lymphoma National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 1 NCT05154994 Jan 2022 → Aug 2026 overdue infiltrating bladder urothelial carcinoma sarcomatoid variant University of Utah Active not recruiting No outcome recorded
Phase 1 NCT04315233 May 2021 → Mar 2024 breast cancer, ovarian carcinoma University of Utah Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT04703920 Mar 2021 → Dec 2024 breast cancer, castration-resistant prostate carcinoma, ovarian carcinoma, pancreatic adenocarcinoma University of Michigan Rogel Cancer Center Completed No outcome recorded
Phase 1 NCT04315155 Oct 2020 → Sep 2023 adenocarcinoma University of Utah Withdrawn No outcome recorded Stop: Business
Phase 1 NCT04184869 Aug 2019 → Dec 2022 cancer, hematopoietic and lymphoid cell neoplasm Acrotech Biopharma Inc. Completed No outcome recorded
Phase 1 NCT03772925 Jun 2019 → Sep 2022 acute myeloid leukemia, myelodysplastic syndrome National Cancer Institute (NCI) Terminated No outcome recorded
Phase 1 NCT03432741 Mar 2018 → Aug 2022 Hodgkins lymphoma, breast adenocarcinoma, mycosis fungoides, nodal marginal zone B-cell lymphoma Mayo Clinic Terminated No outcome recorded Stop: Business
Phase 1 NCT02875002 Oct 2016 → Mar 2018 lymphoma Yale University Withdrawn No outcome recorded
Phase 1/29 trials
Phase 1/2 NCT02701673 Jun 2016 → Jun 2019 lymphoma M.D. Anderson Cancer Center Withdrawn No outcome recorded
Phase 1/2 NCT01310244 Dec 2010 → Aug 2015 non-small cell lung carcinoma Acrotech Biopharma Inc. Completed No outcome recorded
Phase 1/2 NCT01188707 Oct 2010 → Jun 2011 non-small cell lung carcinoma Herlev Hospital Terminated No outcome recorded
Phase 1/2 NCT01090830 Apr 2010 → Feb 2012 non-small cell lung carcinoma Holy Cross Hospital, Florida Terminated No outcome recorded
Phase 1/2 NCT01100944 Mar 2010 → Oct 2015 thymic carcinoma, thymoma National Cancer Institute (NCI) Terminated No outcome recorded
Phase 1/2 NCT00878722 Aug 2007 → May 2009 acute myeloid leukemia Valerio Therapeutics Completed No outcome recorded
Phase 1/2 NCT00878800 Dec 2006 → Oct 2012 soft tissue sarcoma Valerio Therapeutics Completed No outcome recorded
Phase 1/2 NCT00321594 May 2006 → Aug 2010 adult hepatocellular carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 1/2 NCT00421889 Aug 2005 → Feb 2009 fallopian tube cancer, malignant epithelial tumor of ovary, urinary bladder cancer Valerio Therapeutics Completed No outcome recorded
Phase 218 trials · 2 missed
Phase 2 NCT06406465 Oct 2026 → Jul 2027 expected small cell carcinoma National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 2 NCT05170334 Dec 2021 → Dec 2025 overdue uveal melanoma H. Lee Moffitt Cancer Center and Research Institute Active not recruiting No outcome recorded
Phase 2 NCT04340843 Sep 2020 → Feb 2024 overdue localized chondrosarcoma National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 2 NCT02737046 Dec 2016 → Dec 2024 adult T-cell leukemia/lymphoma University of Miami Completed No outcome recorded
Phase 2 NCT02137759 May 2014 → Aug 2023 brain glioblastoma Emory University Unknown No outcome recorded
Phase 2 NCT01686165 Aug 2012 → Feb 2016 anaplastic large cell lymphoma, diffuse large B-cell lymphoma, mantle cell lymphoma University of Arizona Completed Missed primary
Phase 2 NCT00993616 Dec 2009 → Jul 2012 Brenner tumor, fallopian tube cancer, ovarian clear cell cystadenocarcinoma, ovarian endometrioid adenocarcinoma +4 National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT00873119 Feb 2009 → Dec 2012 cancer of unknown primary site Valerio Therapeutics Completed No outcome recorded
Phase 2 NCT00865969 Dec 2008 → Nov 2013 peripheral T-cell lymphoma, not otherwise specified Spectrum Pharmaceuticals, Inc Completed No outcome recorded
Phase 2 NCT00589290 Dec 2007 → Jul 2013 thymic carcinoma, thymoma National Cancer Institute (NCI) Completed No outcome recorded
Comparator or background therapy3 trials
Phase 2 NCT04747236 Comparator Feb 2021 → Jun 2028 expected — University of Virginia Recruiting No outcome recorded
Phase 3 NCT06561048 Comparator Oct 2024 → Nov 2027 expected Nodal T-follicular helper cell lymphoma, follicular type, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, peripheral T-cell lymphoma, not otherwise specified Corvus Pharmaceuticals, Inc. Recruiting No outcome recorded
Phase 3 NCT06072131 Comparator Oct 2023 → Jul 2030 expected peripheral T-cell lymphoma, not otherwise specified Acrotech Biopharma Inc. Recruiting No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 60 sources stand behind the page.

FieldValueCited text
Known as Belinostat “Belinostat, N-hydroxy-3-(phenylsulphamoylphenyl) acrylamide, is a hydroxamic acid deacetylase inhibitor that is able to inhibit both histone deacetylase inhibitors (HDAC) Class...” NCT01100944 ↗
52

NCT06406465 ↗

NCT00354185 ↗

NCT00357162 ↗

NCT03772925 ↗

NCT02381548 ↗

NCT00926640 ↗

NCT00303953 ↗

NCT00301756 ↗

NCT01317927 ↗

NCT04340843 ↗

Show 42 more sources

Known as Beleodaq “Belinostat (Beleodaq, Spectrum Pharmaceuticals) is a histone deacetylase inhibitor (HDACi) approved for use in relapsed or refractory peripheral T-cell lymphoma (PTCL).” PMID 26921086 ↗ Jun 2016
Known as NSC-726630 ChEMBL registry synonym — accepted as the source's own label CHEMBL408513 ↗
Known as PDX101 “Belinostat (PDX101)” NCT00589290 ↗
Known as PX-105684 ChEMBL registry synonym — accepted as the source's own label CHEMBL408513 ↗
Known as PXD-101 “A Phase 1/2 Study of PXD101 (Belinostat) in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Advanced or Recurrent Thymic, Malignancies” NCT01100944 ↗
7

“Establish the efficacy and safety of PXD101 (belinostat) in patients with myelodysplastic syndromes that progressed after or is ineligible for azacitidine treatment.” NCT00357162 ↗

“Phase I Study of Belinostat (PXD-101) and Velcade (Bortezomib) in Relapsed or Refractory Acute Leukemia/ Myelodysplastic Syndrome” NCT01075425 ↗

“A Phase II Exploratory Study of PXD-101 (Belinostat) Followed by Zevalin in ” NCT01686165 ↗

NCT00431340 ↗

NCT00878800 ↗

NCT00878722 ↗

NCT00131261 ↗

Known as PXD101 (Belinostat) “PXD101 (Belinostat)” NCT00878800 ↗
1

“PXD101, Belinostat” NCT00873119 ↗

Action Inhibit “PXD101 is a new, potent histone deacetylase (HDAC) inhibitor.” NCT00131261 ↗
Modality Small molecule — CHEMBL408513 ↗
Route Intravenous “1000 mg/m(2) intravenously ×5 d of a 21-d cycle” PMID 25404094 ↗ Nov 2014