ABX-1431 Clinical Trials

Size	Price	Qty
2mg	USD 147

Clinical Trials

Several Phase 1 clinical trials have evaluated ABX-1431 to assess its safety, tolerability, and preliminary efficacy across neurological and pain-related conditions. Sponsored by Abide Therapeutics with academic collaboration from the University of Oxford, these studies investigated the compound in peripheral neuropathic pain, central pain conditions such as multiple sclerosis and neuromyelitis optica spectrum disorder, tic disorders including Tourette syndrome, and experimental hyperalgesia in healthy volunteers using functional magnetic resonance imaging. All of these trials have reached completed recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03447756	Completed	Post Herpetic Neuralgia\|Diabetic Peripheral Neuropathy\|Small Fiber Neuropathy\|Post-Traumatic Neuralgia	Abide Therapeutics	2017-10-02	Phase 1
NCT03138421	Completed	Neuromyelitis Optica Spectrum Disorder\|Transverse Myelitis\|Multiple Sclerosis\|Longitudinally Extensive Transverse Myelitis	Abide Therapeutics	2017-08-01	Phase 1
NCT03058562	Completed	Tourette Syndrome\|Chronic Motor Tic Disorder	Abide Therapeutics	2017-02-01	Phase 1
NCT02929264	Completed	Pain	Abide Therapeutics\|University of Oxford	2016-12	Phase 1

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

Check the ABX-1431 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ABX-1431 selectively binds to and inhibits central nervous system monoacylglycerol lipase (MGLL), preventing the enzymatic degradation of the endocannabinoid 2-arachidonoylglycerol and subsequently enhancing signaling through cannabinoid receptors. This elevated endocannabinoid tone modulates neurotransmission and nociceptive signaling pathways, providing a mechanistic basis for mitigating pain and hyperkinesia in clinical conditions such as neuropathic pain and Tourette syndrome.

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>).