JNJ-42165279 Clinical Trials

Size	Price	Qty
5mg	USD 187

Clinical Trials

Multiple clinical trials, all now completed, have evaluated JNJ-42165279 across Phase 1 and Phase 2a studies sponsored primarily by Janssen Research & Development LLC and Janssen Pharmaceutica N.V. Belgium. Early-stage Phase 1 trials in healthy volunteers assessed the compound's safety, tolerability, pharmacokinetics, drug interactions, and central brain kinetics. Additionally, a Phase 2a trial evaluated the therapeutic efficacy, safety, and tolerability of JNJ-42165279 in patients diagnosed with depressive disorder and anxiety.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03564379	Completed	Healthy	Janssen Research & Development LLC	2018-06-12	Phase 1
NCT02498392	Completed	Depressive Disorder\|Anxiety	Janssen Research & Development LLC	2015-10-07	Phase 2
NCT02169973	Completed	Healthy	Janssen Research & Development LLC	2014-02	Phase 1
NCT02065739	Completed	Healthy	Janssen Pharmaceutica N.V. Belgium	2014-01	Phase 1

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

Check the JNJ-42165279 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

JNJ-42165279 selectively binds to and inhibits fatty acid amide hydrolase (FAAH), preventing the degradation of endogenous fatty acid amides such as anandamide and consequently increasing endocannabinoid signaling. This elevation in central endocannabinoid tone modulates synaptic neurotransmission and emotional regulation, offering a mechanistic rationale for targeting anxiety and depressive disorders in clinical trials.

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>).