Sulodexide
As of the edition of 20 October 2026, Sulodexide is a drug: marketed, first approved in 1982 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1982
- Kind
- Unknown
- Brand name
- Aterina
- First approved
- 1 July 1982 (ES)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Alfasigma Espana S.L.
- Registered trials
- 10, 6 stopped early
- Disease areas
- Hormones; Pregnancy and women's health; Urinary and reproductive; Heart and blood vessels; Nutrition and metabolism; Immune system
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 1 | 0 | 0 | 1 |
| Phase 3 | 4 | 1 | 1 | 1 |
| Phase 4 | 4 | 0 | 0 | 4 |
| All trials | 10 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Akebia Therapeutics | Lead sponsor of trials | 2005 to now |
| Bama GeVe S.L.U | Lead sponsor of trials | 2015 to now |
| Alfa Wassermann Tunisia | Lead sponsor of trials | 2019 to now |