Defibrotide
As of the edition of 20 October 2026, Defibrotide is a drug: marketed, first approved in 2013 (EU); acts on ADORA1, ADORA2A and F2 and 1 more.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Unknown
- Brand name
- Defitelio
- First approved
- 18 October 2013 (EU)
- Approvals on record
- 7 in 6 regions
- Holder of the most recent approval
- Jazz Pharmaceuticals; 5 holders in all
- Registered trials
- 22, 2 stopped early
- Disease areas
- Heart and blood vessels; Digestive system; Blood and lymph; Infections; Lungs and airways; Cancer
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
11 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product11 company-target rows are on route B because of Defibrotide.
See the 11 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 14 | 7 | 3 | 2 |
| Phase 3 | 4 | 4 | 0 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 22 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Jazz Pharmaceuticals | Applicant and Lead sponsor of trials | 2006 to now |
| Gentium | Applicant | 2013 to now |
| Adium | Applicant | 2019 to now |
| Nippon Shinyaku | Applicant | 2019 to now |