BML-190 Clinical Trials

Size	Price	Qty
10mg	USD 79

Clinical Trials

A completed Phase 1 clinical trial sponsored by the VA Office of Research and Development, a public organization, evaluated novel therapeutic interventions in patients with rheumatoid arthritis. Having finalized recruitment and evaluation, the study focused on early-stage safety profiles and biological activity. This investigation provides essential human data regarding intervention strategies for chronic inflammatory conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01123655	Completed	Rheumatoid Arthritis	VA Office of Research and Development	2009-10	Phase 1

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

Check the BML-190 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BML-190 functions as a selective cannabinoid CB2 receptor inverse agonist with a Ki of 435 nM, binding the CB2 receptor to reduce constitutive signaling and inhibit downstream inflammatory biochemical pathways. This reduction in receptor-mediated activity suppresses immune cell hyperactivation and cytokine release, offering potential therapeutic relevance for managing inflammatory conditions like rheumatoid arthritis.

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>).