Clinical Trials

Several clinical trials investigate therapeutic interventions across conditions such as postoperative pain management, lateral epicondylitis, and gene therapy for Charcot-Marie-Tooth neuropathy type 1A. Sponsored by organizations including Mansoura University, Anika Therapeutics Inc., and Nationwide Children's Hospital, these early-stage protocols range from Phase 1/Phase 2 to Phase Not Applicable designations. Recruitment statuses currently vary across the portfolio, with individual studies reported as not yet recruiting, withdrawn, or suspended.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05785377 Not yet recruiting
Analgesia
Mansoura University
2025-12-01 Not Applicable
NCT02861183 Withdrawn
Epicondylitis|Tennis Elbow|Epicondylosis
Anika Therapeutics Inc.
2025-09 Not Applicable
NCT03520751 Suspended
Charcot-Marie-Tooth Neuropathy Type 1A
Nationwide Children''s Hospital
2025-04 Phase 1|Phase 2

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

Check the Vasicine (hydrochloride) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vasicine hydrochloride functions as a dual inhibitor of acetylcholinesterase and butyrylcholinesterase, binding these enzymes to prevent the hydrolysis of acetylcholine and prolong synaptic cholinergic neurotransmission. By elevating acetylcholine levels at neuromuscular and peripheral nerve synapses, this enzymatic blockade enhances signal transduction, providing potential therapeutic utility in conditions involving peripheral nerve dysfunction and pain modulation, such as Charcot-Marie-Tooth neuropathy type 1A and postoperative analgesia.

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>).

Note: Technical data last updated: Sep 1, 2026.