Nicergoline Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

A Phase 3 clinical trial is evaluating the efficacy of low-dose versus high-dose Nicergoline regimens in patients with dysphagia, exploring the drug's therapeutic potential beyond its traditional vascular indications. Sponsored by academic and medical institutions, including Phramongkutklao College of Medicine and Hospital alongside Silpakorn University, the trial is currently listed as not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05551182	Not yet recruiting	Dysphagia	Phramongkutklao College of Medicine and Hospital\|Silpakorn University	2023-01	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nicergoline selectively binds to and antagonizes alpha-1A adrenergic receptors, thereby inhibiting receptor-mediated intracellular signaling cascades and modulating vascular and neuronal smooth muscle tone. This pharmacological attenuation enhances local microcirculation and muscular responsiveness, providing a mechanistic basis for its clinical investigation in treating dysphagia.

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>).