(R,S)-3,5-DHPG Hydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 297

Clinical Trials

Multiple completed clinical trials evaluate interventions for attention deficit hyperactivity disorder (ADHD), spanning from early exploratory research to Phase 2 and Phase 3 protocols. Sponsored by academic, government, and industry entities, these studies encompass pharmacokinetic and pharmacodynamic evaluations as well as randomized, placebo-controlled efficacy trials. Collectively, these trials provide detailed datasets on therapeutic outcomes and safety parameters in patient populations diagnosed with ADHD.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03154359	Completed	ADHD	Children''s Mercy Hospital Kansas City\|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2017-12-12	--
NCT02428088	Completed	Attention Deficit Hyperactivity Disorder	Sumitomo Pharma America Inc.	2015-04	Phase 2\|Phase 3

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

Check the (R,S)-3,5-DHPG Hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

(R,S)-3,5-DHPG hydrochloride acts as a selective agonist that directly binds group I metabotropic glutamate receptors (mGluR1 and mGluR5), stimulating intracellular phospholipase C activity and calcium mobilization to regulate neuronal excitability and synaptic transmission. This modulation of central glutamatergic signaling provides a physiological basis for targeted therapeutic strategies in neurodevelopmental conditions such as attention deficit hyperactivity 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>).