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Drug ReportsVorinostat
Vorinostat
Zolinza (vorinostat) is a small molecule pharmaceutical. Vorinostat was first approved as Zolinza on 2006-10-06. It is used to treat t-cell lymphoma cutaneous in the USA. The pharmaceutical is active against histone deacetylase 1. In addition, it is known to target histone deacetylase 8, histone deacetylase 11, histone deacetylase 6, polyamine deacetylase HDAC10, histone deacetylase 9, histone deacetylase 3, histone deacetylase 5, and histone deacetylase 2.
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Events Timeline
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3M
6M
YTD
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2Y
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EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Zolinza
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Vorinostat
Tradename
Company
Number
Date
Products
ZOLINZAMerck & CoN-021991 RX2006-10-06
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
zolinzaNew Drug Application2023-11-21
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
t-cell lymphoma cutaneous—D016410—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Vorinostat, Zolinza, Msd Sub Merck
84503722028-03-18U-892
74562192027-03-11DP
80932952026-05-16DP
73997872025-02-09U-892
78515092024-02-21DPU-892
76520692023-03-04DP
77324902023-03-04U-892
80674722023-03-04U-892
81016632023-03-04U-892
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XH: Histone deacetylase (hdac) inhibitors
— L01XH01: Vorinostat
HCPCS
No data
Clinical
Clinical Trials
276 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—C85.935333—157
LeukemiaD007938—C9526242——42
Myeloid leukemia acuteD015470—C92.018121——28
Myeloid leukemiaD007951—C9218121——27
Multiple myelomaD009101—C90.015102——23
Non-small-cell lung carcinomaD002289——17111——23
Precursor cell lymphoblastic leukemia-lymphomaD054198——1791——22
Plasma cell neoplasmsD054219——14102——22
Lung neoplasmsD008175HP_0100526C34.9016102—122
T-cell lymphomaD016399——11101—119
Show 9 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RecurrenceD012008——2621———42
NeoplasmsD009369—C80334———35
Non-hodgkin lymphomaD008228—C85.91716———27
Breast neoplasmsD001943EFO_0003869C501113——322
Myelodysplastic syndromesD009190—D461211———20
CarcinomaD002277—C80.01111———19
Large b-cell lymphoma diffuseD016403—C83.31411———19
SyndromeD013577——119———17
PreleukemiaD011289——99———16
Mantle-cell lymphomaD020522——710———15
Show 126 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Germ cell and embryonal neoplasmsD009373——4————4
MedulloblastomaD008527——4————4
OligodendrogliomaD009837EFO_0000631—4————4
PinealomaD010871——3————3
PlasmacytomaD010954—C90.33————3
Esophageal neoplasmsD004938—C152———13
Adult t-cell leukemia-lymphomaD015459—C91.53————3
T-cell leukemiaD015458——3————3
Primary myelofibrosisD055728—D47.42————2
Leukemia myeloid chronic atypical bcr-abl negativeD054438—C92.22————2
Show 46 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DepressionD003863—F33.9————11
PruritusD011537HP_0000989L29————11
Triple negative breast neoplasmsD064726——————11
PheochromocytomaD010673——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameVorinostat
INNvorinostat
Description
Vorinostat is a dicarboxylic acid diamide comprising suberic (octanedioic) acid coupled to aniline and hydroxylamine. A histone deacetylase inhibitor, it is marketed under the name Zolinza for the treatment of cutaneous T cell lymphoma (CTCL). It has a role as an EC 3.5.1.98 (histone deacetylase) inhibitor, an apoptosis inducer and an antineoplastic agent. It is a hydroxamic acid and a dicarboxylic acid diamide. It is functionally related to a suberic acid, a hydroxylamine and an aniline.
Classification
Small molecule
Drug classenzyme inhibitors: histone deacetylase inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
O=C(CCCCCCC(=O)Nc1ccccc1)NO
Identifiers
PDB—
CAS-ID149647-78-9
RxCUI—
ChEMBL IDCHEMBL98
ChEBI ID45716
PubChem CID5311
DrugBankDB02546
UNII ID58IFB293JI (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
HDAC10
HDAC10
HDAC9
HDAC9
HDAC6
HDAC6
Organism
Homo sapiens
Gene name
HDAC10
Gene synonyms
NCBI Gene ID
83933
Protein name
polyamine deacetylase HDAC10
Protein synonyms
HD10, Histone deacetylase 10
Uniprot ID
Q969S8
Mouse ortholog
Hdac10 (170787)
polyamine deacetylase HDAC10 (Q6P3E7)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 15,444 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,038 adverse events reported
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