Betahistine 2HCl Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Several clinical trials across Phase I and Phase II evaluated betahistine dihydrochloride in healthy volunteers, overweight or obese individuals, and patients with recurrent major depressive disorder exhibiting atypical features. Sponsored by academic, governmental, and industry entities—including the University of Cincinnati, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and OBEcure Ltd.—these studies investigated metabolic outcomes, drug-drug interactions, and psychiatric efficacy. While multiple clinical trials assessing metabolic effects and drug interactions were completed, a clinical trial in major depression was terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00852956	Completed	Healthy	OBEcure Ltd.	2009-02	Phase 1
NCT00585585	Terminated	Recurrent Major Depressive Disorder With Atypical Features	University of Cincinnati	2007-07	Phase 2
NCT00459992	Completed	Obesity\|Overweight\|Overnutrition	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)\|National Institutes of Health Clinical Center (CC)	2007-04-10	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Betahistine functions as a histamine H3 receptor inhibitor with an IC50 of 1.9 μM, blocking presynaptic autoreceptor activity and thereby enhancing histaminergic neurotransmission in the central nervous system. This stimulation of downstream histaminergic signaling modulates neuroendocrine pathways and metabolic function, providing the biological foundation for its clinical evaluation in conditions such as obesity and major depressive disorder.

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>).