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Romidepsin
Istodax (romidepsin) is a protein pharmaceutical. Romidepsin was first approved as Istodax on 2009-11-05. It is used to treat t-cell lymphoma cutaneous and t-cell lymphoma peripheral in the USA. The pharmaceutical is active against histone deacetylase 1. In addition, it is known to target histone deacetylase 8, histone deacetylase 4, histone deacetylase 9, histone deacetylase 3, histone deacetylase 7, histone deacetylase 6, histone deacetylase 5, and histone deacetylase 2.
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BMS
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Istodax (generic drugs available since 2021-10-12)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Romidepsin
Tradename
Company
Number
Date
Products
ISTODAXCelgeneN-022393 RX2009-11-05
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
istodaxNew Drug Application2020-09-16
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
t-cell lymphoma cutaneous—D016410C84.A
t-cell lymphoma peripheral—D016411C84.9
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XH: Histone deacetylase (hdac) inhibitors
— L01XH02: Romidepsin
HCPCS
Code
Description
J9318
Injection, romidepsin, non-lyophilized, 0.1 mg
J9319
Injection, romidepsin, lyophilized, 0.1 mg
Clinical
Clinical Trials
99 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
T-cell lymphoma peripheralD016411C84.910103—119
T-cell lymphomaD016399631——7
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223C85.9105———13
Non-hodgkin lymphomaD008228C85.996———10
T-cell lymphoma cutaneousD016410C84.A62——19
Multiple myelomaD009101C90.056———7
Hodgkin diseaseD006689C8162———6
NeoplasmsD009369C8051———6
Breast neoplasmsD001943EFO_0003869C5043———5
Large-cell lymphoma anaplasticD017728C84.633———5
Large b-cell lymphoma diffuseD016403C83.342———5
Pancreatic neoplasmsD010190EFO_0003860C2532———4
Show 66 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Enteropathy-associated t-cell lymphomaD058527C86.22————2
Lung neoplasmsD008175C34.902————2
Hematologic neoplasmsD0193372————2
Adult t-cell leukemia-lymphomaD015459C91.51————1
Myeloproliferative disordersD009196D47.11————1
Prolymphocytic leukemiaD0154631————1
Head and neck neoplasmsD0062581————1
GliomaD005910EFO_00005201————1
Small cell carcinomaD0182881————1
MesotheliomaD008654C451————1
Show 9 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Graft vs host diseaseD006086D89.81————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameROMIDEPSIN
INNromidepsin
Description
Romidepsin is a cyclodepsipeptide consisting of the cyclic disulfide of (2Z)-2-aminobut-2-enoyl, L-valyl, (3S,4E)-3-hydroxy-7-sulfanylhept-4-enoyl, D-valyl and D-cysteinyl residues coupled in sequence and cyclised head-to tail. It has a role as an antineoplastic agent and an EC 3.5.1.98 (histone deacetylase) inhibitor. It is a cyclodepsipeptide, an organic disulfide and a heterocyclic antibiotic.
Classification
Protein
Drug classdepsipeptide derivatives
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C/C=C1\NC(=O)[C@H]2CSSCC/C=C/[C@H](CC(=O)N[C@H](C(C)C)C(=O)N2)OC(=O)[C@H](C(C)C)NC1=O
Identifiers
PDB—
CAS-ID128517-07-7
RxCUI877510
ChEMBL IDCHEMBL343448
ChEBI ID61080
PubChem CID5352062
DrugBankDB06176
UNII IDCX3T89XQBK (ChemIDplus, GSRS)
Target
Agency Approved
HDAC1
HDAC1
Organism
Homo sapiens
Gene name
HDAC1
Gene synonyms
RPD3L1
NCBI Gene ID
3065
Protein name
histone deacetylase 1
Protein synonyms
Protein deacetylase HDAC1, Protein decrotonylase HDAC1, reduced potassium dependency, yeast homolog-like 1
Uniprot ID
Q92534
Mouse ortholog
Hdac1 (433759)
histone deacetylase 1 (P97476)
Alternate
HDAC8
HDAC8
HDAC4
HDAC4
HDAC9
HDAC9
HDAC3
HDAC3
HDAC7
HDAC7
HDAC6
HDAC6
HDAC5
HDAC5
HDAC2
HDAC2
Organism
Homo sapiens
Gene name
HDAC8
Gene synonyms
HDACL1
NCBI Gene ID
55869
Protein name
histone deacetylase 8
Protein synonyms
histone deacetylase-like 1, Protein deacetylase HDAC8, Protein decrotonylase HDAC8
Uniprot ID
Q9BY41
Mouse ortholog
Hdac8 (70315)
histone deacetylase 8 (Q8VH37)
Variants
Clinical Variant
No data
Financial
Istodax - Celgene
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,903 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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356 adverse events reported
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