Melanotan II Clinical Trials

Size	Price	Qty
5mg	USD 147
100mg	USD 690

Clinical Trials

Melanotan II is currently being evaluated in a clinical trial to determine its therapeutic potential in dermatological conditions characterized by cutaneous depigmentation. Specifically, research focuses on nonsegmental vitiligo, including stable nonsegmental vitiligo, to evaluate the peptide as an adjunctive treatment with narrow-band phototherapy. Sponsored by Hudson Biotech, this Phase 2 study (NCT07437560) is actively recruiting participants to evaluate safety, tolerability, and repigmentation efficacy. Overall, this clinical effort seeks to clarify the role of synthetic melanocortin receptor agonism in restoring epidermal melanin in patients with vitiligo.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07437560	RECRUITING	NonSegmental Vitiligo; Nonsegmental Vitiligo (Stable)	Hudson Biotech	2026-02-02	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-02-27)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Melanotan II acts as a synthetic cyclic analog of alpha-melanocyte stimulating hormone that binds to and activates melanocortin receptors, driving downstream cyclic AMP signaling to promote melanogenesis and cellular melanin production in melanocytes. This activation enhances skin pigmentation and melanocyte survival, providing a physiological basis for promoting epidermal repigmentation in dermatological disorders such as nonsegmental vitiligo.

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>).