Multiple clinical trials evaluate therapeutic, diagnostic, and metabolic interventions involving (S)-Glutamic acid across Early Phase 1 through Phase 4 studies. Investigated indications include Parkinson's disease, Type 1 diabetes mellitus, acute aortic syndrome, metabolic associated fatty liver disease, vertigo, and gynecologic malignancies, with recruitment statuses spanning completed, recruiting, active, not yet recruiting, and terminated. Academic medical centers, government institutes, and biotechnology companies—including Nanjing Medical University, the National Institute of Diabetes and Digestive and Kidney Diseases, Diamyd Medical AB, and MeiraGTx, LLC—sponsor these diverse research efforts.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05894343 | ACTIVE_NOT_RECRUITING | Parkinson's Disease |
MeiraGTx, LLC |
2023-05-19 | PHASE1; PHASE2 |
| NCT05018585 | TERMINATED | Type 1 Diabetes Mellitus |
Diamyd Medical AB |
2022-05-19 | PHASE3 |
| NCT05339529 | RECRUITING | Acute Aortic Syndrome; Aortic Dissection Type a |
Nanjing Medical University |
2022-07-01 | |
| NCT05603312 | COMPLETED | Parkinson's Disease |
MeiraGTx, LLC |
2022-10-05 | PHASE1; PHASE2 |
| NCT05221892 | COMPLETED | Vertigo |
Fundação Educacional Serra dos Órgãos |
2021-11-22 | PHASE4 |
| NCT04262479 | COMPLETED | Latent Autoimmune Diabetes in Adults |
Norwegian University of Science and Technology |
2020-03-02 | PHASE2 |
| NCT02002130 | COMPLETED | Type I Diabetes |
University of Alabama at Birmingham |
2015-01 | PHASE1 |
| NCT02872519 | WITHDRAWN | Stage IIIA Fallopian Tube Cancer; Stage IIIA Ovarian Cancer; Stage IIIA Primary Peritoneal Cancer; Stage IIIB Fallopian Tube Cancer; Stage IIIB Ovarian Cancer; Stage IIIB Primary Peritoneal Cancer; Stage IIIC Fallopian Tube Cancer; Stage IIIC Ovarian Cancer; Stage IIIC Primary Peritoneal Cancer; Stage IV Fallopian Tube Cancer; Stage IV Ovarian Cancer; Stage IV Primary Peritoneal Cancer |
Vanderbilt-Ingram Cancer Center |
2018-06 | EARLY_PHASE1 |
| NCT01826045 | COMPLETED | Cervical Intraepithelial Neoplasia |
BioLeaders Corporation |
2013-06 | PHASE2 |
| NCT00369564 | COMPLETED | Kidney Cancer; Leukemia; Lymphoma; Neurotoxicity; Peripheral Neuropathy; Sarcoma |
University of South Florida |
2007-05 | PHASE3 |
| NCT00529399 | COMPLETED | Type 1 Diabetes Mellitus |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2009-02 | PHASE2 |
| NCT00980408 | COMPLETED | Healthy Individuals |
University Hospital, Bonn |
2008-06 | |
| NCT00643890 | TERMINATED | Parkinson's Disease |
Neurologix, Inc. |
2008-08 | PHASE2 |
| NCT00000768 | COMPLETED | Colitis; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-09-01)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).