4-Aminopyridine Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Numerous clinical trials spanning Phase I through Phase IV evaluate 4-aminopyridine's ability to restore nerve conduction and functional recovery across completed, active, recruiting, and terminated studies. Sponsored by pharmaceutical entities like Acorda Therapeutics and Bristol-Myers Squibb alongside academic centers such as the University of Arizona, these studies target conditions including primary and secondary progressive multiple sclerosis, post-ischemic stroke, upper motor neuron disease, and carpal tunnel syndrome. Furthermore, research extends to skin wound healing and safety assessments in healthy volunteers.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06596434	RECRUITING	Burns; Second Degree Burn; Wounds and Injuries	John Elfar	2026-01-01	PHASE2
NCT06003166	RECRUITING	Peripheral Nerve Injury; Crush Injury	University of Arizona	2025-04-21	PHASE2
NCT06294821	NOT_YET_RECRUITING	Compression Neuropathy; Carpal Tunnel Syndrome	John Elfar	2026-11	PHASE2
NCT06333171	RECRUITING	Wounds; Wound of Skin; Wound Heal; Wounds and Injuries	John Elfar	2025-09	PHASE2
NCT07532460	RECRUITING	Cocaine Use Disorder (CUD); Cognitive Impairments	Boris Quednow	2026-05-28
NCT03701581	RECRUITING	Nerve Injury; Prostate Cancer	John Elfar	2021-06-05	PHASE2; PHASE3
NCT06333171	Not yet recruiting	Wounds\|Wound of Skin\|Wound Heal\|Wounds and Injuries	John Elfar\|University of Arizona	2024-07	Phase 2
NCT03578354	WITHDRAWN	Vestibular Migraine; Migraine Disorders; Vestibular Diseases	Massachusetts Eye and Ear Infirmary	2019-01	PHASE2
NCT03899584	UNKNOWN	Spinal Cord Injuries; Chronic	Coordinación de Investigación en Salud, Mexico	2019-07-17	PHASE3
NCT05338450	Recruiting	Multiple Sclerosis\|Internuclear Ophthalmoplegia	Amsterdam UMC location VUmc	2022-08-30	Phase 3
NCT04026568	TERMINATED	Nerve Injury	Milton S. Hershey Medical Center	2021-08-17	PHASE2; PHASE3
NCT03658408	WITHDRAWN	Prostate Disease	University of Rochester	2018-10-03	PHASE2
NCT02656160	COMPLETED	Sleep Apnea, Obstructive	Brigham and Women's Hospital	2016-01	PHASE2
NCT02868567	Active not recruiting	Motor Neuron Disease Upper	Hospital for Special Surgery New York	2016-03	Phase 1
NCT02280096	COMPLETED	Multiple Sclerosis	Coordinación de Investigación en Salud, Mexico	2014-10	PHASE2
NCT01645787	COMPLETED	Spinal Muscular Atrophy	Columbia University	2012-06-01	PHASE2; PHASE3
NCT02422940	Terminated	Post-ischemic Stroke	Acorda Therapeutics	2015-04	Phase 3
NCT02208882	Completed	Healthy Adult Volunteers	Bristol-Myers Squibb	2014-08	Phase 1
NCT02208050	Completed	Secondary Progressive Multiple Sclerosis\|Primary Progressive Multiple Sclerosis	University College Dublin	2014-02-21	Phase 4
NCT00053417	COMPLETED	Multiple Sclerosis	Acorda Therapeutics	2003-02	PHASE2
NCT00056810	COMPLETED	Guillain-Barre Syndrome	FDA Office of Orphan Products Development	2002-09	PHASE2
NCT01543750	WITHDRAWN	Episodic Ataxia Type 2	University of California, Los Angeles		PHASE2

(data from https://clinicaltrials.gov, updated on 2026-03-05)

Check the 4-Aminopyridine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

4-Aminopyridine acts as a non-selective inhibitor of voltage-gated potassium channels, which prevents repolarizing potassium efflux during neuronal depolarization and thereby prolongs the duration of presynaptic action potentials. This enhanced electrical excitation facilitates voltage-gated calcium entry and neurotransmitter release to improve axonal conduction, directly supporting its therapeutic application in multiple sclerosis and nerve-related wound healing 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>).