Vanillylmandelic acid Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Several clinical trials evaluate conditions such as X-Linked Retinitis Pigmentosa and spastic hemiplegic cerebral palsy across phases ranging from Phase 3 to non-applicable or unspecified stages. Conducted by industry entities like Janssen Research & Development LLC and academic institutions such as Samsung Medical Center, these investigations report recruitment statuses as active, not recruiting, or completed.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04671433	Active not recruiting	X-Linked Retinitis Pigmentosa	Janssen Research & Development LLC	2020-12-04	Phase 3
NCT04312672	Active not recruiting	X-Linked Retinitis Pigmentosa	Janssen Research & Development LLC	2017-07-31	--
NCT03858335	Completed	Cerebral Palsy Spastic Hemiplegic	Samsung Medical Center	2015-09-14	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an end-stage metabolite of catecholamines, vanillylmandelic acid participates in sympathetic metabolic cascades by regulating downstream adrenergic breakdown pathways and intracellular catabolic balance. This regulation alters cellular energy dynamics and neurovascular signaling, providing biochemical relevance to neuromuscular and ocular pathologies evaluated in clinical studies of cerebral palsy and X-linked retinitis pigmentosa.

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>).