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Drug ReportsDefibrotide sodium
Defitelio(defibrotide)
Defitelio (defibrotide) is an oligonucleotide pharmaceutical. Defibrotide was first approved as Defitelio on 2013-10-18. It is used to treat hepatic veno-occlusive disease in the USA. It has been approved in Europe to treat hepatic veno-occlusive disease.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
cardiovascular diseasesD002318
Trade Name
FDA
EMA
Defitelio
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Defibrotide sodium
Tradename
Company
Number
Date
Products
DEFITELIOJazz PharmaceuticalsN-208114 RX2016-03-30
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
defitelioNew Drug Application2025-07-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hepatic veno-occlusive diseaseD006504K76.5
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Defibrotide Sodium, Defitelio, Jazz Pharms Inc
110850432032-06-22DP
112363282032-06-22U-3301
117463482032-06-22DP
ATC Codes
B: Blood and blood forming organ drugs
B01: Antithrombotic agents
B01A: Antithrombotic agents
B01AX: Other antithrombotic agents in atc
B01AX01: Defibrotide
HCPCS
No data
Clinical
Clinical Trials
25 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
Hepatic veno-occlusive diseaseD006504K76.52416
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382U07.1112
Neurotoxicity syndromesD020258G9211
Graft vs host diseaseD006086D89.8111
NeuroblastomaD009447EFO_000062111
Vascular diseasesD014652EFO_0004264I7711
Thrombotic microangiopathiesD057049M31.111
Indications Phases 1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDefibrotide
INNdefibrotide
Description
Defibrotide, sold under the brand name Defitelio, is a mixture of single-stranded oligonucleotides that is purified from the intestinal mucosa of pigs. It is used to treat veno-occlusive disease of the liver of people having had a bone marrow transplant, with different limitations in the US and the European Union. It works by protecting the cells lining blood vessels in the liver and preventing blood clotting; the way it does this is not well understood.
Classification
Oligonucleotide
Drug class
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Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID83712-60-1
RxCUI1311089
ChEMBL IDCHEMBL2108396
ChEBI ID
PubChem CID135565962
DrugBankDB04932
UNII IDL7CHH2B2J0 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Defitelio Jazz 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 1,280 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,817 adverse events reported
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