(3R,8S)-Falcarindiol Clinical Trials

Size	Price	Qty
1mg	USD 99
5mg	USD 270

Clinical Trials

Several clinical trials, sponsored by academic psychiatric institutions, research foundations, and healthcare organizations, are evaluating interventions for HIV infections and family-based preventive health services for children of parents with mental disorders. These studies focus on alternative administration settings for long-acting antiretroviral therapies as well as preventive family interventions, with a designated phase status of Not Applicable. Currently, the trials are not yet recruiting participants.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06312410	Not yet recruiting	Child\|Parents\|Mental Disorder\|Child of Impaired Parents\|Preventive Health Services	Mental Health Services in the Capital Region Denmark\|Aalborg Psychiatric Hospital\|TrygFonden Denmark\|Novo Nordisk A/S\|Lundbeck Foundation\|Liljeborgfonden\|Ebbefos Fonden\|KV Fonden	2024-03-18	Not Applicable
NCT06159894	Not yet recruiting	HIV Infections	Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz	2023-12	Not Applicable

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

Check the (3R,8S)-Falcarindiol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

(3R,8S)-Falcarindiol attenuates the lipopolysaccharide-induced phosphorylation and activation of JNK, ERK, STAT1, and STAT3 signaling proteins, thereby suppressing the downstream transcription and expression of inducible nitric oxide synthase, tumor necrosis factor alpha, interleukin-6, and interleukin-1 beta. By suppressing these key proinflammatory cascades and immune signaling networks, the compound mitigates cellular inflammatory stress and systemic immune hyperactivation, providing therapeutic relevance in conditions characterized by chronic inflammation such as HIV infections and stress-mediated psychiatric disorders.

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>).