Arginine
As of the edition of 20 October 2026, Arginine is a small molecule: marketed, first approved in 1972 (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
- R-Gene 10
- First approved
- 1 June 1972 (ES)
- Approvals on record
- 38 in 7 regions
- Holder of the most recent approval
- FUJIFILM Toyama Chemical; 7 holders in all
- Registered trials
- 64, 12 stopped early
- Disease areas
- Heart and blood vessels; Urinary and reproductive; Inherited and neonatal; Pregnancy and women's health; Nutrition and metabolism; 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 | 9 | 4 | 2 | 2 |
| Phase 1 | 14 | 8 | 4 | 1 |
| Phase 2 | 19 | 11 | 1 | 5 |
| Phase 3 | 13 | 9 | 0 | 1 |
| Phase 4 | 9 | 4 | 1 | 3 |
| All trials | 64 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| B. Braun Medical | Applicant | 1980 to now |
| Baxter Healthcare | Applicant | 1991 to now |
| Pfizer | Applicant and Lead sponsor of trials | 2005 to now |
| Novartis | Applicant and Lead sponsor of trials | 2019 to now |
| FUJIFILM Toyama Chemical | Applicant | 2021 to now |