Betahistine Clinical Trials

Size	Price	Qty
25mg	USD 97
1g	USD 970

Clinical Trials

Several clinical trials have evaluated the therapeutic potential of betahistine across early-phase studies, encompassing healthy subjects as well as patients affected by obesity, overweight, overnutrition, and recurrent major depressive disorder with atypical features. Sponsored by commercial entities such as OBEcure Ltd. alongside academic and governmental institutions including the University of Cincinnati and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, these protocols range from completed studies assessing drug interactions and metabolic parameters to a terminated trial evaluating efficacy in major depression.

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Betahistine functions primarily as a histamine H1 receptor agonist and H3 receptor antagonist, thereby stimulating presynaptic histamine release and enhancing central histaminergic neurotransmission. By modulating downstream neuronal signaling pathways involved in appetite regulation, vestibular compensation, and neurochemical transmission, this activity provides the biological rationale for its clinical evaluation in metabolic disorders, such as obesity, as well as psychiatric conditions including 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>).