Clinical Trials

Several clinical trials evaluate conditions involving histamine signaling, metabolic breakdown, and physiological responses, including pregnancy complications, combined airway disease, Barrett esophagus, gastroesophageal reflux disease, skeletal muscle relaxation, and lower urinary tract symptoms. Consisting predominantly of Phase 1 trials and observational protocols, these studies are sponsored by academic medical centers, government health research institutes, and pharmaceutical entities such as NYU Langone Health, Fujian Shengdi Pharmaceutical, and Hospital Universitari Vall d'Hebron Research Institute. Across these investigations, recruitment statuses range from recruiting and enrolling by invitation to completed.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06281366 Recruiting
Pregnancy Complications
Hospital Universitari Vall d''Hebron Research Institute|DR Healthcare
 2024-02-16 --
NCT05216133 Enrolling by invitation
Airway Disease|Barrett Esophagus|Gastroesophageal Reflux Disease
NYU Langone Health|National Institute for Occupational Safety and Health (NIOSH/CDC)
 2023-03-22 --
NCT05701826 Completed
Skeletal Muscle Relaxation
Fujian Shengdi Pharmaceutical Co. Ltd.
 2023-02-15 Phase 1
NCT05676346 Completed
Lower Urinary Tract Symptoms|Histamine Intolerance
Complexo Hospitalario Universitario de A Coruña
 2022-10-11 --

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Histamine phosphate selectively binds to and activates G-protein coupled H1 and H2 histamine receptors, triggering downstream intracellular second messenger cascades that induce arterial vasodilation, endothelial cell activation, and smooth muscle modulation. This receptor-mediated physiological pathway regulates vascular permeability and tissue responsiveness, providing strong clinical relevance to the investigation of airway dysfunction, gastroesophageal reflux disease, and histamine intolerance.

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.