Sivelestat
As of the edition of 20 October 2026, Sivelestat is a small molecule: in active development; acts on ELANE.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Active, 2004
- Kind
- Small molecule
- Registered trials
- 19, 0 stopped early
- Disease areas
- Lungs and airways; Heart and blood vessels; Infections; Nervous system; Blood and lymph; Eye
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ELANE | Neutrophil elastase | P08246 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 9 | 2 | 2 | 0 |
| Phase 2 | 5 | 2 | 3 | 0 |
| Phase 3 | 2 | 1 | 0 | 0 |
| Phase 4 | 3 | 2 | 1 | 0 |
| All trials | 19 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Eli Lilly | Lead sponsor of trials | 2001 to now |
| Ono Pharmaceutical | Lead sponsor of trials | 2004 to now |