Betulinic acid
As of the edition of 20 October 2026, Betulinic acid is a small molecule: marketed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed
- Kind
- Small molecule
- Brand name
- Filsuvez
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Chiesi Farmaceutici
- Registered trials
- 2, 1 stopped early
- Disease areas
- Cancer; Inherited and neonatal; 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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 1 | 0 | 0 | 0 |
| Phase 2 | 1 | 0 | 0 | 1 |
| All trials | 2 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Advanced Life Sciences | Lead sponsor of trials | 2008 to now |