URB597 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

The clinical trial landscape for the fatty acid amide hydrolase inhibitor URB597 consists of a clinical trial sponsored by the Central Institute of Mental Health, Mannheim. This early-phase proof-of-concept study aimed to evaluate central glucoregulatory compounds for ameliorating schizophrenia symptoms in healthy volunteers, but the recruitment status was listed as withdrawn. Consequently, there are currently no active or completed clinical trials evaluating URB597, leaving its therapeutic efficacy in psychiatric conditions unconfirmed in human populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00916201	WITHDRAWN	Schizophrenia	Central Institute of Mental Health, Mannheim	2025-01-31	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-03-21)

Check the URB597 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

URB597 acts as a potent and selective inhibitor of fatty acid amide hydrolase (FAAH), thereby blocking the primary enzymatic degradation route of the endocannabinoid anandamide. This inhibition causes an accumulation of anandamide in neuronal tissues to stimulate cannabinoid receptor signaling, generating analgesic and anxiolytic effects that are relevant to modulating neurobehavioral pathways in conditions such as schizophrenia.

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>).