Citicoline
As of the edition of 20 October 2026, Citicoline is a small molecule: marketed, first approved in 1975 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1975
- Kind
- Small molecule
- Brand name
- Somazina
- First approved
- 1 June 1975 (ES)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Ferrer Internacional
- Registered trials
- 31, 6 stopped early
- Disease areas
- Nervous system; Mental health; Heart and blood vessels; Chemically induced; Injuries; 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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 3 | 1 | 1 |
| Phase 1 | 3 | 1 | 0 | 1 |
| Phase 2 | 9 | 4 | 3 | 1 |
| Phase 3 | 8 | 1 | 3 | 2 |
| Phase 4 | 6 | 5 | 0 | 1 |
| All trials | 31 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Ferrer Internacional | Lead sponsor of trials | 2006 to now |
| Omikron Italia | Lead sponsor of trials | 2023 to now |