Clinical Trials

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centers, hospital systems, and research institutes, with statuses ranging from completed and actively recruiting to withdrawn.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NCT02223299 WITHDRAWN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)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an essential amino acid, L-tryptophan serves as a metabolic substrate for rate-limiting enzymes such as tryptophan hydroxylase and indoleamine 2,3-dioxygenase, driving downstream biochemical cascades that synthesize serotonin, melatonin, and kynurenine pathway intermediates. These downstream metabolites modulate neurotransmitter receptor signaling, cellular immune responses, and mucosal homeostasis, providing direct therapeutic and diagnostic relevance to clinical trial indications including depressive disorders, inflammatory bowel conditions, and neuroendocrine neoplasms.

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.