Multiple clinical trials investigate L-tryptophan across conditions including major depressive disorders, gastrointestinal diseases, neuroendocrine neoplasms, and healthy aging. Spanning Phase 1 through Phase 3 along with exploratory studies, these trials are sponsored by academic medical centers, hospital systems, and research institutes, with statuses ranging from completed and actively recruiting to withdrawn. Ultimately, this body of research underscores L-tryptophan’s utility as both a therapeutic agent and diagnostic biomarker substrate in psychiatric, metabolic, and oncological medicine.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05556473 | RECRUITING | Intracranial Glioma; Metastatic Brain Tumor; Breast Cancer; Neuroendocrine Tumors; Rectal Cancer |
Barbara Ann Karmanos Cancer Institute |
2022-09-29 | PHASE1 |
| NCT07013656 | NOT_YET_RECRUITING | Healthy |
University of Adelaide |
2025-06-28 | |
| NCT05576038 | RECRUITING | Tryptophan Metabolism Alterations; Celiac Disease |
McMaster University |
2022-12-01 | |
| NCT06089811 | UNKNOWN | Stress, Psychological |
KU Leuven |
2023-10-10 | |
| NCT06283706 | Not yet recruiting | Healthy Aging |
The Hospital for Sick Children|Canadian Institutes of Health Research (CIHR) |
2024-06-01 | Not Applicable |
| NCT06365801 | Not yet recruiting | Irritable Bowel Syndrome |
The Third Affiliated hospital of Zhejiang Chinese Medical University |
2024-04 | -- |
| NCT06228352 | Not yet recruiting | Ulcerative Colitis |
Assistance Publique - Hôpitaux de Paris |
2024-03 | -- |
| NCT06021535 | Not yet recruiting | Aortic Stenosis|Gastrointestinal Microbiome|Metabolomics |
Insel Gruppe AG University Hospital Bern |
2024-01-01 | -- |
| NCT03089606 | COMPLETED | Melanoma |
UNC Lineberger Comprehensive Cancer Center |
2017-04-19 | PHASE2 |
| NCT03453489 | COMPLETED | Carcinoid Syndrome; Metastatic Nonfunctional Well Differentiated Neuroendocrine Neoplasm |
Barbara Ann Karmanos Cancer Institute |
2018-06-20 | PHASE2 |
| NCT04505800 | COMPLETED | Sleep; Mood; Burnout; Melatonin Deficiency; Cortisol Deficiency |
National Yang Ming Chiao Tung University |
2019-09-01 | |
| NCT04117191 | COMPLETED | Healthy; Chronic Kidney Diseases |
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation |
2019-10-01 | |
| NCT03059862 | COMPLETED | Diet Modification |
McMaster University |
2017-11-01 | |
| NCT02223299 | WITHDRAWN | Depression |
John D. Dingell VA Medical Center |
2015-11 | |
| NCT02823249 | COMPLETED | Endocrine System Diseases |
University Hospital, Basel, Switzerland |
2014-05 | |
| NCT02563847 | COMPLETED | Endocrine System Diseases |
University Hospital, Basel, Switzerland |
2014-05 | |
| NCT01302821 | WITHDRAWN | Breast Cancer |
H. Lee Moffitt Cancer Center and Research Institute |
2013-01 | |
| NCT00865202 | COMPLETED | Post-operative Delirium |
University of Colorado, Denver |
2008-12 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-01-23)
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>).