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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
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
Mock data
Subscribe for the real data
Subscribe for the real data
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
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Peripheral arterial disease | D058729 | EFO_0004265 | — | — | — | — | 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 | 1 | — | — | 1 | 3 |
| 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 |
Show 5 more
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
View more details
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
Revenue by drug
$
€
£
₣
Defitelio – Jazz Pharmaceuticals
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 1,557 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
3,988 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use