Clinical Trials

Multiple clinical trials examine conditions related to invasive fungal infections and invasive aspergillosis, ranging from Phase 3 studies to unassigned-phase pilot research sponsored by organizations such as Owlstone Ltd, Erasmus Medical Center, and Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne. Reflecting recruiting, completed, and terminated statuses, these trials evaluate volatile organic compounds for diagnosing aspergillosis in lung transplant recipients, define fungal infection criteria in hematological malignancy patients, and investigate combination antifungal strategies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06344117 Recruiting
Invasive Aspergillosis
Owlstone Ltd
2023-12-12 --
NCT04876716 Terminated
Invasive Aspergillosis
Erasmus Medical Center|ZonMw: The Netherlands Organisation for Health Research and Development|Stichting Hemato-Oncologie voor Volwassenen Nederland
2021-05-11 Phase 3
NCT04024995 Completed
Invasive Fungal Infections
Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne
2019-09-01 --

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the L-Glutamic acid monosodium salt product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

L-Glutamic acid monosodium salt functions as an excitatory neurotransmitter that binds to and activates all major subtypes of glutamate receptors, including metabotropic, kainate, NMDA, and AMPA receptors. This receptor activation triggers downstream signaling cascades that directly stimulate dopamine release from dopaminergic nerve terminals to promote cellular excitation. Clinically, understanding these excitatory signaling and metabolic pathways provides fundamental insights into host biological responses under investigation in invasive fungal infections, including invasive aspergillosis.

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.