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 diseases | D004066 |
| cardiovascular diseases | D002318 |
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 |
|---|---|---|---|---|
| DEFITELIO | Jazz Pharmaceuticals | N-208114 RX | 2016-03-30 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| defitelio | New Drug Application | 2025-07-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hepatic veno-occlusive disease | — | D006504 | K76.5 |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
25 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ischemia | D007511 | EFO_0000556 | — | — | — | — | 1 | — | 1 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | — | — | — | 1 | — | 1 |
| Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | — | — | — | 1 | — | 1 |
| Endotoxemia | D019446 | — | — | — | — | — | 1 | — | 1 |
| Healthy volunteers/patients | — | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatic veno-occlusive disease | D006504 | — | K76.5 | — | 4 | 4 | — | 4 | 11 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | U07.1 | 1 | 3 | — | — | — | 4 |
| Syndrome | D013577 | — | — | 1 | 2 | — | — | 1 | 4 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | 2 | — | — | — | 2 |
| Thrombotic microangiopathies | D057049 | — | M31.1 | — | 2 | — | — | — | 2 |
| Neurotoxicity syndromes | D020258 | — | G92 | — | 1 | — | — | — | 1 |
| Respiratory insufficiency | D012131 | — | J96.9 | — | 1 | — | — | — | 1 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | 1 | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | 1 | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | 1 | 1 | — | — | — | 1 |
| Mucocutaneous lymph node syndrome | D009080 | EFO_0004246 | M30.3 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | 1 | — | — | — | — | 1 |
| Severe acute respiratory syndrome-related coronavirus | D045473 | NCBITaxon_227859 | — | 1 | — | — | — | — | 1 |
| Acute lung injury | D055371 | EFO_0004610 | — | 1 | — | — | — | — | 1 |
| Newborn respiratory distress syndrome | D012127 | — | P22 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Defibrotide |
| INN | defibrotide |
| 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 | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 83712-60-1 |
| RxCUI | 1311089 |
| ChEMBL ID | CHEMBL2108396 |
| ChEBI ID | — |
| PubChem CID | 135565962 |
| DrugBank | DB04932 |
| UNII ID | L7CHH2B2J0 (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
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Defitelio – Jazz Pharmaceuticals
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,285 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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