Histamine 2HCl Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Several clinical trials evaluate conditions associated with histamine metabolic and physiological pathways, including pregnancy complications, lower urinary tract symptoms, histamine intolerance, skeletal muscle relaxation, airway disease, Barrett esophagus, and gastroesophageal reflux disease. Ranging from Phase 1 safety and pharmacokinetic evaluations to observational designs, these studies are sponsored by academic medical centers, research foundations, and pharmaceutical entities such as Fujian Shengdi Pharmaceutical Co. Ltd. and Hospital Universitari Vall d'Hebron Research Institute. Across these protocols, recruitment statuses encompass currently recruiting trials, studies enrolling by invitation, and completed protocols.

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 2HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Histamine 2HCl selectively stimulates histamine H1 and H2 receptors on target cells, activating G-protein-coupled signaling pathways that regulate downstream intracellular messenger cascades including cyclic AMP production and calcium mobilization. This receptor activation alters cellular physiology to drive responses such as gastric acid secretion, vascular permeability, and smooth muscle tone modulation, directly underlying its clinical relevance in conditions such as gastroesophageal reflux disease, airway 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>).