Clinical Trials

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NCT02872519 WITHDRAWN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)

Check the (S)-Glutamic acid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

(S)-Glutamic acid functions as an endogenous, non-selective agonist that binds directly to ionotropic and metabotropic glutamate receptors, triggering cation influx and activating downstream intracellular signaling cascades essential for excitatory neurotransmission and metabolic homeostasis. This agonist-mediated stimulation modulates synaptic plasticity and cellular excitability, providing therapeutic relevance in clinical trial investigations targeting central nervous system disorders such as Parkinson's disease as well as metabolic conditions like Type 1 diabetes mellitus.

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>).

Note: Technical data last updated: Sep 1, 2026.