Arginine aspartate
As of the edition of 20 October 2026, Arginine aspartate is a small molecule: marketed, first approved in 1995 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2000
- Kind
- Small molecule
- Brand name
- Potenciator
- First approved
- 1 May 1995 (ES)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Viatris; 2 holders in all
- Registered trials
- 3, 1 stopped early
- Disease areas
- Inherited and neonatal; Mouth and teeth; Nervous system; Nutrition and metabolism
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 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 1 | 0 | 0 | 1 |
| All trials | 3 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Sanofi | Lead sponsor of trials | 2008 to now |