Lysine
As of the edition of 20 October 2026, Lysine is a small molecule: marketed, first approved in 1969 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- LysaKare
- First approved
- 1 May 1969 (ES)
- Approvals on record
- 37 in 6 regions
- Holder of the most recent approval
- FUJIFILM Toyama Chemical; 6 holders in all
- Registered trials
- 10, 0 stopped early
- Disease areas
- Cancer; Heart and blood vessels; Nutrition and metabolism; Digestive system; Hormones; Inherited and neonatal
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 | 2 | 2 | 0 | 0 |
| Phase 1 | 6 | 4 | 1 | 0 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 10 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| B. Braun Medical | Applicant | 1980 to now |
| Baxter Healthcare | Applicant | 1991 to now |
| Novartis | Applicant and Lead sponsor of trials | 2019 to now |
| FUJIFILM Toyama Chemical | Applicant | 2021 to now |