Clinical Trials
Multiple clinical trials evaluate DL-Glutamine across conditions such as hepatocellular carcinoma, gyrate atrophy associated with chorioretinal degeneration, and Gulf War illness accompanied by irritable bowel syndrome and gastrointestinal symptoms. Sponsored by academic institutions, research foundations, and government agencies—including Sohag University, the Jaeb Center for Health Research with federal partners, and the VA Office of Research and Development—these studies have trial phases designated as unassigned or not applicable. Currently, recruitment statuses for these trials encompass both not yet recruiting and actively recruiting.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06328283 | Not yet recruiting | Hepatocellular Carcinoma |
Sohag University |
2024-04-01 | -- |
| NCT05312736 | Recruiting | Gyrate Atrophy|Gyrata of Choroid and Retina; Atrophy|Ornithine-δ-aminotransferase|OAT|Chorioretinal Degeneration |
Jaeb Center for Health Research|Conquering Gyrate Atrophy Foundation|Food and Drug Administration (FDA)|Department of Health and Human Services |
2023-11-21 | -- |
| NCT05972291 | Recruiting | Gulf War Illness|Irritable Bowel Syndrome|Gastrointestinal Symptoms |
VA Office of Research and Development |
2023-10-16 | Not Applicable |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Compliance for Clinical Use
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>).