DEFITELIO (defibrotide sodium)
DEFITELIO is indicated for the treatment of Hepatic Veno-Occlusive Disease; Sinusoidal Obstruction Syndrome; Renal Dysfunction; Pulmonary Dysfunction.
How DEFITELIO Works
Defibrotide sodium protects endothelial cells and enhances the breakdown of blood clots, though its precise mechanism is not fully elucidated. In vitro studies show the drug increases the expression of tissue plasminogen activator and thrombomodulin while decreasing factors that promote cell activation and clotting. These actions enhance fibrinolysis and protect endothelial cells from damage caused by chemotherapy and inflammatory cytokines.
Details
- Status
- Prescription
- First Approved
- 2016-03-30
- Patent Cliff
- 2032
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
DEFITELIO Approval History
What DEFITELIO Treats
4 indicationsDEFITELIO is approved for 4 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hepatic Veno-Occlusive Disease
- Sinusoidal Obstruction Syndrome
- Renal Dysfunction
- Pulmonary Dysfunction
DEFITELIO Target & Pathway
ProTarget
A pro-inflammatory cytokine that plays a central role in immune responses and inflammation. Excess TNF contributes to autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Blocking TNF reduces inflammation and prevents tissue damage.
DEFITELIO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DEFITELIO FDA Label Details
Indications & Usage
FDA Label (PDF)DEFITELIO is indicated for the treatment of Hepatic Veno-Occlusive Disease; Sinusoidal Obstruction Syndrome; Renal Dysfunction; Pulmonary Dysfunction.
DEFITELIO Patents & Exclusivity
Patents (5 active)
Pro Intelligence Preview
Deep insights for DEFITELIO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 5 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.