Methyl aminolevulinate

Overview

Methyl aminolevulinate is a prodrug that is metabolised to Protoporphyrin IX (a photosensitizer) used in photodynamic therapy.

Indication

For topical use, in combination with 570 to 670 nm wavelength red light illumination, in the treatment of non-hyperkeratotic actinic keratoses of the face and scalp in immunocompetent patients when used in conjunction with lesion preparation (debridement using a sharp dermal curette).

Associated Conditions

Actinic Keratosis of Face and Scalp

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
ADL-PDT Under Routine Clinical Conditions in Patients With Actinic Keratosis	2023/02/13	NCT05725213	N/A	Completed	Galderma Laboratorium GmbH
New Treatments for Actinic Keratoses of the Scalp	2022/07/13	NCT05456334	Not Applicable	Active, not recruiting	Helsinki University Central Hospital
Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial Neoplasia	2021/11/02	NCT05104099	Phase 2	Completed	Institut de Cancérologie de Lorraine
Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization	2017/01/06	NCT03013647	Not Applicable	UNKNOWN	University of Sao Paulo General Hospital
Comparison of Mechanical Penetration Enhancers on Metvixia Skin Penetration	2015/07/29	NCT02511145	Phase 1	Completed	Galderma R&D
Daylight PDT for Actinic Keratoses: a Multicentre Study Comparing Two Photosensitizers (BF-200 ALA Versus MAL)	2015/06/08	NCT02464709	Phase 4	Completed	Joint Authority for Päijät-Häme Social and Health Care
Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds	2015/03/19	NCT02392390	Not Applicable	Completed	Centre Hospitalier Universitaire de Nīmes
Actinic Keratoses Treatment With Metvix® in Combination With Light	2015/02/27	NCT02373371	Phase 3	Completed	University Hospital, Limoges
Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses	2011/11/21	NCT01475071	Phase 3	Completed	Galderma R&D
Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage	2008/03/06	NCT00629317	Phase 3	Completed	Universidad de Antioquia

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
METVIX methyl aminolevulinate 160mg/g cream tube	93838	Galderma Australia Pty Ltd	Medicine	A	4/4/2003
LUMEXIA methyl aminolevulinate 160 mg/g cream tube	231012	Galderma Australia Pty Ltd	Medicine	A	6/1/2015

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

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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