Lithium carbonate
As of the edition of 20 October 2026, Lithium carbonate is a small molecule: marketed, first approved in 1971 (CA); acts on GSK3A, GSK3B and IMPA1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1982
- Kind
- Small molecule
- Brand name
- Eskalith
- First approved
- 31 December 1971 (CA)
- Approvals on record
- 15 in 2 regions
- Holder of the most recent approval
- Bausch Health; 8 holders in all
- Registered trials
- 65, 8 stopped early
- Disease areas
- Nervous system; Mental health; Cancer; Inherited and neonatal; Injuries; Blood and lymph
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.
Companies that need a new molecule because of this drug
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Lithium carbonate.
See the 3 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 2 | 1 | 1 |
| Phase 1 | 10 | 7 | 0 | 2 |
| Phase 2 | 22 | 15 | 2 | 3 |
| Phase 3 | 13 | 9 | 1 | 2 |
| Phase 4 | 15 | 10 | 1 | 0 |
| All trials | 65 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Acquired holder | 1971 to now |
| Bayer | Later holder | 1985 to now |
| JDS Pharmaceuticals | Acquired holder and Lead sponsor of trials | 2007 to now |
| Noven Therapeutics | Acquired holder | 2008 to now |
| ANI Pharmaceuticals | Acquired holder | 2014 to now |
| GSK | Later holder | |
| Hikma Pharmaceuticals | Later holder | |
| Pfizer | Applicant | |
| Solvay Pharmaceuticals | Later holder |