Levocarnitine
As of the edition of 20 October 2026, Levocarnitine is a small molecule: marketed, first approved in 1983 (CH).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2012
- Kind
- Small molecule
- Brand name
- Carnitor
- First approved
- 13 July 1983 (CH)
- Approvals on record
- 12 in 5 regions
- Holder of the most recent approval
- Otsuka; 4 holders in all
- Registered trials
- 24, 2 stopped early
- Disease areas
- Immune system; Infections; Urinary and reproductive; Blood and lymph; Cancer; Nervous system
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 | 0 | 1 |
| Phase 1 | 2 | 0 | 1 | 0 |
| Phase 2 | 12 | 9 | 0 | 1 |
| Phase 3 | 3 | 2 | 1 | 0 |
| Phase 4 | 2 | 1 | 1 | 0 |
| All trials | 24 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Otsuka | Applicant | 2012 to now |
| Leadiant Biosciences | Acquired holder | 2017 to now |