Hydroquinone Clinical Trials

Size	Price	Qty
100mg	USD 147
500mg	USD 347

Clinical Trials

Several clinical trials evaluate therapeutic interventions across conditions such as Prader-Willi syndrome with hyperphagia, chronic musculoskeletal pain, thumb osteoarthritis, and coronary artery disease involving total occlusion. Encompassing Phase 3 as well as non-interventional or phase-not-applicable designs, these studies are currently recruiting or not yet recruiting participants. Sponsorship is provided by industry entities, including Harmony Biosciences LLC and ACADIA Pharmaceuticals Inc., as well as academic and clinical institutions like Karolinska Institutet, the National Institute of Cardiology Warsaw Poland, and a European university consortium.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06366464	Recruiting	Prader-Willi Syndrome	Harmony Biosciences LLC	2024-04-30	Phase 3
NCT06297447	Recruiting	Musculoskeletal Pain\|Chronic Pain	Bettina Eiger\|University of Southern Denmark\|Aalborg University\|Central Denmark Region\|Vrije Universiteit Brussel	2024-03-11	Not Applicable
NCT06275386	Not yet recruiting	Coronary Artery Disease\|Total Occlusion of Coronary Artery	National Institute of Cardiology Warsaw Poland	2024-03-01	Not Applicable
NCT06193499	Recruiting	Osteoarthritis Thumb	Karolinska Institutet	2024-01-17	Not Applicable
NCT06173531	Recruiting	Hyperphagia in Prader-Willi Syndrome	ACADIA Pharmaceuticals Inc.	2023-11-27	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Hydroquinone functions as a melanin synthesis inhibitor that targets enzymatic oxidation pathways, blocking downstream melanin formation to reduce pigment accumulation and oxidative stress within melanocytes. This depigmenting and antioxidant mechanism provides a biochemical basis for controlling hyperpigmentation and cell-level oxidative processes, which connects to clinical trial research investigating metabolic, pain, and cardiovascular conditions such as Prader-Willi syndrome, musculoskeletal pain, and coronary artery disease.

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>).