Methoxsalen

Overview

A naturally occurring furocoumarin compound found in several species of plants, including Psoralea corylifolia. It is a photoactive substance that forms DNA adducts in the presence of ultraviolet A irradiation.

Indication

For the treatment of psoriasis and vitiligo

Associated Conditions

Cutaneous T-Cell Lymphoma (CTCL)
Refractory Cutaneous T-cell Lymphoma
Vitiligo
Idiopathic Vitiligo
Severe Psoriasis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis	2024/10/17	NCT06646016	Phase 2	Suspended	Therakos LLC
Steroids Versus ECP and Steroids as First-line Treatment of Grade II Acute GVHD	2023/11/15	NCT06133192	Phase 2	Not yet recruiting	Central Hospital, Nancy, France
Photopheresis in Early-stage Mycosis Fungoides	2023/01/11	NCT05680558	Phase 2	Recruiting	Columbia University
Extracorporeal Photopheresis in Sezary Syndrome	2021/12/15	NCT05157581	N/A	Recruiting	Oleg E. Akilov, MD, PhD
Extracorporeal Photopheresis in Early Diffuse Cutaneous Systemic Sclerosis	2021/08/03	NCT04986605	Phase 2	Not yet recruiting	London Health Sciences Centre OR Lawson Research Institute of St. Joseph's
Extracorporal Photopheresis with UVADEX Plus Standard Steroid Treatment for High Risk Acute Graft-versus-host Disease	2020/03/02	NCT04291261	Phase 2	Active, not recruiting	Universitätsklinikum Hamburg-Eppendorf
Study of Photopheresis in the Treatment of Erythrodermic MF and SS	2018/06/20	NCT03563040	Phase 2	Withdrawn	European Organisation for Research and Treatment of Cancer - EORTC
Methoxsalen and Extracorporeal Photopheresis (ECP) for the Treatment of Pediatric Participants With Steroid Refractory Acute Graft Versus Host Disease	2015/08/17	NCT02524847	Phase 3	Terminated	Therakos, Inc., a Mallinckrodt Company
Biomarkers in Acute Graft-Versus-Host Disease and Extracorporeal Photopheresis Added to Investigator Chosen Therapies of Steroid Refractory Acute GVHD	2014/12/23	NCT02322190	Phase 2	Terminated	National Cancer Institute (NCI)
PUVA Maintenance Therapy in Mycosis Fungoides	2012/09/18	NCT01686594	Phase 3	Completed	Medical University of Graz

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
UVADEX	Therakos, Inc.	64067-216	EXTRACORPOREAL	20 ug in 1 mL	11/10/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
MELADININE TAB 10MG	N/A	William Pharmaceutical Agency	N/A	N/A	12/29/1978

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
UVADEX methoxsalen 200 microgram/10 mL concentrated injection for extracorporeal circulation via photopheresis vial	308832	Ikaria Australia Pty Ltd	Medicine	A	9/16/2019

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
OXSORALEN LOT 10MG/ML	valeant canada lp / valeant canada s.e.c.	01907476	Lotion - Topical	10 MG / ML	12/31/1992
UVADEX	therakos llc	02406233	Solution - Extracorporeal	20 MCG / ML	12/9/2013
ULTRA MOP LOTION 1%	canderm g.p.	00698059	Liquid - Topical	1 %	12/31/1986
ULTRAMOP CAP 10MG	canderm g.p.	00646237	Capsule - Oral	10 MG	12/31/1985
OXSORALEN-ULTRA CAP 10MG	valeant canada lp / valeant canada s.e.c.	00252654	Capsule - Oral	10 MG	12/31/1991
OXSORALEN CAP 10MG	valeant canada lp / valeant canada s.e.c.	01946374	Capsule - Oral	10 MG	12/31/1992

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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