Idebenone
As of the edition of 20 October 2026, Idebenone is a small molecule: marketed, first approved in 2015 (EU).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Small molecule
- Brand name
- Raxone
- First approved
- 8 September 2015 (EU)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Chiesi Farmaceutici
- Registered trials
- 30, 3 stopped early
- Disease areas
- Nervous system; Inherited and neonatal; Nutrition and metabolism; Bones, joints and muscles; Eye; Mental health
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 | 4 | 2 | 0 | 0 |
| Phase 1 | 4 | 3 | 0 | 0 |
| Phase 2 | 8 | 7 | 1 | 0 |
| Phase 3 | 10 | 6 | 1 | 3 |
| Phase 4 | 4 | 1 | 0 | 0 |
| All trials | 30 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Chiesi Farmaceutici | Applicant | 2015 to now |