Psoralen Clinical Trials

Size	Price	Qty
10mg	USD 97
50mg	USD 397

Clinical Trials

Multiple clinical trials evaluate psoralen for managing dermatological disorders—such as vitiligo, dermatitis, and plaque psoriasis—and malignancies, including cutaneous lymphoma, solid tumors, leukemia, and myelodysplastic syndromes, across early phase 1 to phase 4 evaluations. Sponsored by prominent academic institutions, health systems, and industry partners—such as the Mayo Clinic, Medical University of Graz, M.D. Anderson Cancer Center, and Immunolight, LLC—these studies exhibit recruitment statuses ranging from actively recruiting and completed to terminated or unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04389281	RECRUITING	Advanced Solid Tumor Cancer	Immunolight, LLC	2021-12-08	PHASE1
NCT07055529	NOT_YET_RECRUITING	Vitiligo, Generalized	Hayat Abad Medical Complex, Peshawar	2026-06-01	EARLY_PHASE1
NCT01686594	COMPLETED	Patch/Plaque Stage Mycosis Fungoides	Medical University of Graz	2013-02	PHASE3
NCT01792245	UNKNOWN	Vitiligo	University of British Columbia	2013-02	PHASE2
NCT01732965	COMPLETED	Vitiligo	Henry Ford Health System	2013-03	PHASE4
NCT00724061	TERMINATED	Lymphoma	Northwestern University	2008-09
NCT00697593	TERMINATED	Chronic Plaque Psoriasis	Merck KGaA, Darmstadt, Germany	2008-01	PHASE4
NCT00217009	TERMINATED	Dermatitis; Psoriasis	Mayo Clinic	2005-03	EARLY_PHASE1
NCT00005092	COMPLETED	Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes	M.D. Anderson Cancer Center	1999-05-28	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-01-30)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Psoralen intercalates directly into double-stranded DNA, where photoactivation or structural insertion blocks DNA synthesis and halts nucleic acid replication, leading to cell cycle arrest and apoptosis in rapidly dividing cell populations. This inhibition of cellular proliferation provides the mechanistic basis for its therapeutic utility in controlling hyperproliferative skin disorders such as psoriasis and suppressing tumor cell expansion in dermatological and oncological clinical trial settings.

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>).