L-Cysteic acid monohydrate Clinical Trials

Size	Price	Qty
100mg	USD 109

Clinical Trials

Several clinical trials are currently evaluating broad applications across psychiatric, dermatological, and allergic conditions, specifically targeting intensive care unit delirium, acne vulgaris, and pediatric allergy responses. Sponsored by academic institutions such as the University of Southern California, South Valley University, and TC Erciyes University, these protocols encompass Phase 3, Phase 4, and unassigned phase investigations. All of these studies are currently categorized as not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05085808	Not yet recruiting	Delirium\|Morality\|Quality of Life\|Psych\|Treatment Side Effects	University of Southern California	2025-03-01	Phase 4
NCT06340984	Not yet recruiting	Acne Vulgaris	South Valley University	2024-06	Phase 3
NCT06401408	Not yet recruiting	Allergy	TC Erciyes University	2024-06-20	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an active endogenous metabolite derived from cysteine oxidation pathways, L-cysteic acid monohydrate interacts with neuroexcitatory receptor systems to modulate downstream intracellular signaling and cellular metabolic homeostasis. This biochemical modulation alters cellular excitability and systemic oxidative processes, establishing biological relevance to clinical evaluations targeting neurological conditions such as delirium as well as dermatological and allergic 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>).