Clinical Trials

Neuropeptide Y has been evaluated across multiple clinical trials investigating a diverse array of neuropsychiatric, cardiovascular, and metabolic conditions. Clinical studies spanning Early Phase 1 through Phase 4 have examined its therapeutic potential in indications such as posttraumatic stress disorder, anxiety and mood disorders, hypertension, obesity, and type 2 diabetes mellitus. These studies, conducted by academic investigators and university medical centers including Vanderbilt University and UT Southwestern Medical Center, feature varied recruitment statuses ranging from completed trials like NCT01533519 and NCT02639637 to actively recruiting protocols such as NCT04838678. Research also extends to evaluating its role in sympathetic nervous system modulation, catecholamine secretion, and neurogenic inflammatory disorders.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04838678 RECRUITING
Hypertension; Obesity
University of Texas Southwestern Medical Center
 2021-07-18 EARLY_PHASE1
NCT06606236 COMPLETED
Neurogenic Inflammation; Dental Pulp Disease
Institucion Universitaria Colegios de Colombia
 2024-02-05
NCT04071600 UNKNOWN
Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic, Acute
New York Medical College
 2019-11-01 PHASE1; PHASE2
NCT04650308 COMPLETED
Nutrient Deficiency
Universitas Sumatera Utara
 2020-04-02
NCT03933787 COMPLETED
Physical Activity; Sympathetic Nervous System; Secretion; Catecholamine
Eric Grouzmann
 2018-06-05 EARLY_PHASE1
NCT02639637 COMPLETED
Type 2 Diabetes Mellitus
Vanderbilt University
 2015-12 PHASE4
NCT01533519 COMPLETED
Posttraumatic Stress Disorder
James Murrough
 2012-12 PHASE1
NCT05147753 COMPLETED
Obesity; Hypertension
Aristotle University Of Thessaloniki
 2010-01-11 PHASE4
NCT00748956 COMPLETED
Mood Disorder; Anxiety Disorders
Dennis Charney
 2010-01 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-09-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a 36-amino-acid peptide neurotransmitter, Neuropeptide Y binds to central G-protein-coupled neuropeptide Y receptors, thereby modulating downstream intracellular signaling pathways and enhancing the synthesis and release of nerve growth factor in cortical neurons. This inhibition of β-amyloid-induced neurotoxicity and attenuation of sympathetic nervous system reactivity underlie its therapeutic relevance in clinical trials investigating posttraumatic stress disorder, anxiety disorders, and hypertension.

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>).

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