Methyl aminolevulinate

In recent years, the photodynamic therapy field has demonstrated unique advantages in the diagnosis and treatment of skin diseases. As a second-generation prodrug of photosensitizer, methyl 5-aminolevulinate is a porphyrin derivative. Its mechanism of action is that after exogenous supplementation, it can be selectively absorbed by actively proliferating cells and metabolized into protoporphyrin IX with photosensitive activity. Under irradiation of light of a specific wavelength, it generates reactive oxygen species, thereby killing diseased cells with minimal damage to normal tissues. Clinically, it is mainly used for the local treatment of skin diseases such as actinic keratosis and basal cell carcinoma, and can also be used as an adjuvant for clinical intervention in mucosal lesions such as condyloma acuminatum. The applicable population covers adult patients who meet the indications, and it is especially suitable for elderly groups who cannot tolerate invasive treatments such as surgery and cryotherapy.

The global market size related to methyl 5-aminolevulinate was approximately USD 320 million in 2023, and the compound annual growth rate from 2024 to 2030 is expected to remain at around 7.8%. The growth drivers mainly come from the rising incidence of skin cancer and the increasing penetration rate of photodynamic therapy. In terms of competitive landscape, the originator product has long occupied the major global market share. At present, a small number of generic drug companies have been approved for marketing in the EU, India and other regions. There is no generic drug approved in China, and the market is still in the undeveloped stage.

The originator enterprise of methyl 5-aminolevulinate is LEO Pharma from Denmark, and the brand name of the originator product is Metvix. Its core compound patent expired in 2014 in major markets such as the EU and the United States, and the compound patent in China also expired in 2014. The main dosage form of the originator product is cream, with a specification of 160 mg/g. It has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in China's *Catalog of Reference Preparations for Chemical Drugs*. With regard to domestic API registration, there is currently no Class A registration number for methyl 5-aminolevulinate API submitted by any enterprise, and the originator preparation has not yet been approved for marketing by the China NMPA. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for methyl 5-aminolevulinate API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for relevant drug R&D and quality research links.