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Drug ReportsBelinostat
Belinostat
Beleodaq (belinostat) is a small molecule pharmaceutical. Belinostat was first approved as Beleodaq on 2014-07-03. It is used to treat t-cell lymphoma peripheral in the USA. It is known to target histone deacetylase 7, histone deacetylase 1, histone deacetylase 4, histone deacetylase 9, histone deacetylase 2, histone deacetylase 6, histone deacetylase 5, histone deacetylase 3, and histone deacetylase 8.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Beleodaq
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Belinostat
Tradename
Company
Number
Date
Products
BELEODAQAcrotech BiopharmaN-206256 RX2014-07-03
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
beleodaqNew Drug Application2025-04-07
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
t-cell lymphoma peripheral—D016411—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Belinostat, Beleodaq, Acrotech Biopharma
88355012027-10-27DP
68880272026-08-10DS, DPU-1544
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XH: Histone deacetylase (hdac) inhibitors
— L01XH04: Belinostat
HCPCS
Code
Description
J9032
Injection, belinostat, 10 mg
Clinical
Clinical Trials
56 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.91162——18
T-cell lymphomaD016399——622——10
Non-hodgkin lymphomaD008228—C85.9521——8
T-cell lymphoma peripheralD016411——422——8
Follicular lymphomaD008224—C824—1——5
Large-cell lymphoma anaplasticD017728—C84.6211——4
Immunoblastic lymphadenopathyD007119EFO_1001350C86.52—1——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80112———12
RecurrenceD012008——84———12
CarcinomaD002277—C80.046———9
LeukemiaD007938—C9562———8
SyndromeD013577——61———7
Large b-cell lymphoma diffuseD016403—C83.352———7
Myeloid leukemia acuteD015470—C92.052———6
Myeloid leukemiaD007951—C9252———6
Myelodysplastic syndromesD009190—D4641———5
PreleukemiaD011289——41———5
Show 33 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hematologic neoplasmsD019337——4————4
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.04————4
B-cell lymphomaD016393——4————4
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—3————3
MycosesD009181—B35-B493————3
Hodgkin diseaseD006689—C813————3
B-cell lymphoma marginal zoneD018442—C88.43————3
Mycosis fungoidesD009182—C84.03————3
Breast neoplasmsD001943EFO_0003869C503————3
Blast crisisD001752——2————2
Show 27 more
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBelinostat
INNbelinostat
Description
Belinostat is a hydroxamic acid-type histone deacetylase (HDAC) inhibitor with antineoplastic activity. It has a role as an antineoplastic agent and an EC 3.5.1.98 (histone deacetylase) inhibitor. It is a hydroxamic acid, a sulfonamide and an olefinic compound.
Classification
Small molecule
Drug classenzyme inhibitors: histone deacetylase inhibitors
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Structure (InChI/SMILES or Protein Sequence)
O=C(/C=C/c1cccc(S(=O)(=O)Nc2ccccc2)c1)NO
Identifiers
PDB—
CAS-ID414864-00-9
RxCUI—
ChEMBL IDCHEMBL408513
ChEBI ID61076
PubChem CID6918638
DrugBankDB05015
UNII IDF4H96P17NZ (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
HDAC6
HDAC6
HDAC9
HDAC9
HDAC7
HDAC7
Organism
Homo sapiens
Gene name
HDAC6
Gene synonyms
KIAA0901
NCBI Gene ID
Protein name
histone deacetylase 6
Protein synonyms
alpha-tubulin deacetylase HDAC6, protein phosphatase 1, regulatory subunit 90, Tubulin-lysine deacetylase HDAC6
Uniprot ID
Mouse ortholog
Hdac6 (15185)
histone deacetylase 6 (Q9Z2V5)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Beleodaq – Spectrum Pharmaceuticals
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,717 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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310 adverse events reported
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