Methoxsalen Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

A clinical trial is currently on record investigating Methoxsalen within an exploratory oncological research landscape. Sponsored by Immunolight LLC, this active Phase 1 study is presently recruiting patients with advanced solid tumor cancers, specifically superficial tumors. The trial evaluates the therapeutic safety, clinical efficacy, and biological activity of intra-tumoral injection of activated psoralen therapy for managing these advanced malignant conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04389281	Recruiting	Advanced Solid Tumor Cancer	Immunolight LLC	2021-12-08	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Methoxsalen is a photoactive furocoumarin that intercalates into genomic DNA and covalently binds guanine and cytosine residues upon activation by light or radiation, resulting in interstrand DNA cross-links. This blockade of nucleic acid replication and genomic function prevents cell division and induces targeted cell death, establishing its clinical application in arresting hyperproliferative processes such as advanced solid tumor cancers.

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>).