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Drug ReportsRomidepsin
Romidepsin
Istodax, Romidepsin (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 7, 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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Clinical
Drug
Target
Variants
Financial
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Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Istodax, Romidepsin (discontinued: Romidepsin)
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
ISTODAXBristol Myers SquibbN-022393 RX2009-11-05
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
istodaxNew Drug Application2023-01-31
romidepsinANDA2021-11-19
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
t-cell lymphoma peripheral—D016411—
t-cell lymphoma cutaneous—D016410C84.A
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
106 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—C85.929164—140
T-cell lymphomaD016399——22154—133
T-cell lymphoma peripheralD016411——21135—132
Immunoblastic lymphadenopathyD007119EFO_1001350C86.5432——7
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
T-cell lymphoma cutaneousD016410—C84.A124——116
Non-hodgkin lymphomaD008228—C85.91110———16
RecurrenceD012008——46——111
NeoplasmsD009369—C8084———10
LeukemiaD007938—C9542——17
Large-cell lymphoma anaplasticD017728—C84.654———7
Multiple myelomaD009101—C90.056———7
Mycosis fungoidesD009182—C84.062———7
Hodgkin diseaseD006689—C8162———6
B-cell chronic lymphocytic leukemiaD015451—C91.142———5
Show 96 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hematologic neoplasmsD019337——3————3
Enteropathy-associated t-cell lymphomaD058527—C86.22————2
T-cell leukemiaD015458——2————2
Malignant mesotheliomaD000086002——2————2
MesotheliomaD008654—C452————2
GliomaD005910EFO_0000520—2————2
Adult t-cell leukemia-lymphomaD015459—C91.51————1
Intestinal diseasesD007410—K63.91————1
Prolymphocytic leukemia t-cellD015461—C91.61————1
Prolymphocytic leukemiaD015463——1————1
Show 17 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acute diseaseD000208——————11
Lymphoid leukemiaD007945—C91————11
Graft vs host diseaseD006086—D89.81————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)Loading
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
RxCUI—
ChEMBL IDCHEMBL343448
ChEBI ID61080
PubChem CID5352062
DrugBankDB06176
UNII IDCX3T89XQBK (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
HDAC7
HDAC7
Organism
Homo sapiens
Gene name
HDAC7
Gene synonyms
HDAC7A
NCBI Gene ID
51564
Protein name
histone deacetylase 7
Protein synonyms
HD7a, Histone deacetylase 7A
Uniprot ID
Q9UFU7
Mouse ortholog
Hdac7 (56233)
histone deacetylase 7 (Q9JL72)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Istodax – Celgene
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 11,884 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,624 adverse events reported
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