Lithium
As of the edition of 20 October 2026, Lithium is a small molecule: marketed, first approved in 1934 (CH).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1992
- Kind
- Small molecule
- Brand name
- Lithonate
- First approved
- 31 August 1934 (CH)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Laboratoires Delbert; 4 holders in all
- Registered trials
- 91, 12 stopped early
- Disease areas
- Mental health; Nervous system; Cancer; Infections; Digestive system; Lungs and airways
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 | 19 | 15 | 1 | 1 |
| Phase 1 | 7 | 4 | 0 | 2 |
| Phase 2 | 11 | 8 | 2 | 1 |
| Phase 3 | 23 | 16 | 3 | 4 |
| Phase 4 | 31 | 19 | 1 | 4 |
| All trials | 91 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Hikma Pharmaceuticals | Later holder and Lead sponsor of trials | 2002 to now |
| Solvay Pharmaceuticals | Applicant |