Pentoxifylline
As of the edition of 20 October 2026, Pentoxifylline is a small molecule: marketed, first approved in 1979 (ES); acts on ADORA2A and ADORA2B.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1984
- Kind
- Small molecule
- Brand name
- Trental
- First approved
- 1 January 1979 (ES)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Validus Pharmaceuticals; 2 holders in all
- Registered trials
- 121, 18 stopped early
- Disease areas
- Digestive system; Urinary and reproductive; Pregnancy and women's health; Cancer; Infections; Skin and connective tissue
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
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Pentoxifylline.
See the 4 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 | 27 | 10 | 3 | 5 |
| Phase 1 | 14 | 6 | 1 | 2 |
| Phase 2 | 39 | 23 | 4 | 6 |
| Phase 3 | 28 | 15 | 4 | 3 |
| Phase 4 | 13 | 6 | 2 | 2 |
| All trials | 121 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Earlier holder | 1984 to now |
| Validus Pharmaceuticals | Acquired holder | 2021 to now |