Amino acids
As of the edition of 20 October 2026, Amino acids is a drug: marketed, first approved in 1982 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Unknown
- Brand name
- Aminosyn 3.5% M
- First approved
- 1 January 1982 (US)
- Approvals on record
- 163 in 2 regions
- Holder of the most recent approval
- Recordati Rare Diseases; 12 holders in all
- Registered trials
- 34, 5 stopped early
- Disease areas
- Cancer; Nervous system; Pregnancy and women's health; Urinary and reproductive; Digestive system; Nutrition and metabolism
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 16 | 9 | 4 | 0 |
| Phase 1 | 4 | 1 | 1 | 1 |
| Phase 2 | 7 | 2 | 3 | 2 |
| Phase 3 | 4 | 1 | 3 | 0 |
| Phase 4 | 3 | 0 | 0 | 2 |
| All trials | 34 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Acquired holder and Later holder | 1982 to now |
| Abbott | Acquired holder and Later holder | 2003 to now |
| Baxter Healthcare Internati0Nal Specialty Therapies | Acquired holder | 2003 to now |
| Baxter Healthcare | Later holder and Lead sponsor of trials | 2013 to now |
| Recordati Rare Diseases | Applicant | 2025 to now |
| Otsuka | Acquired holder | 2025 to now |
| B. Braun Medical | Applicant and Earlier holder |