Methisosildenafil

Male erectile dysfunction (ED) is a common reproductive system disease among middle-aged and elderly men. The global prevalence rate continues to rise with age, and PDE5 inhibitors are the core regimen for clinical treatment. Aildenafil belongs to highly selective phosphodiesterase 5 (PDE5) inhibitors. It reversibly inhibits the activity of PDE5, reduces the degradation of cyclic guanosine monophosphate (cGMP), relaxes the smooth muscle of the corpus cavernosum of the penis, and promotes blood perfusion to improve erectile function. Compared with similar drugs, it has higher selectivity for PDE5 and lower incidence of adverse reactions, and is suitable for patients with various types of erectile dysfunction over 18 years old, with significant advantages in clinical medication compliance.

The global market size of ED drugs has exceeded 5 billion US dollars, and the overall scale of PDE5 inhibitors in China's public medical institutions and retail market exceeds 3 billion yuan, with an annual growth rate of about 8%. Previously, the domestic ED drug market has long been dominated by sildenafil and tadalafil. As a third-generation PDE5 inhibitor, aildenafil has gradually seized the market segment with its lower incidence of adverse reactions such as visual abnormalities and headaches. At present, in addition to the original research drug, 3 enterprises have been approved for generic preparations in China. After the centralized procurement, the terminal price has dropped by more than 70%, and the accessibility has been greatly improved. The market share is expected to exceed 10% in the next 3 years.

The original research enterprise of aildenafil is Dong-A Pharmaceutical Co., Ltd. from South Korea, and the original brand name is "Mvix". The core compound patent of aildenafil will expire in South Korea in 2030, and the Chinese compound patent expired in 2022. The main dosage form approved for the original research drug is tablet, with specifications of 50mg and 100mg. The original research tablet has been included in the China List of Marketed Drugs as the reference preparation. In terms of domestic API registration, there are currently 7 aildenafil API registration numbers, 5 of which are in the status of "A" and can be used for associated review; in terms of domestic preparations, in addition to the imported original research drug, 4 domestic aildenafil tablets have been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for aildenafil API. All products meet the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA. Most impurities are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day, which can fully meet the full-process needs of pharmaceutical enterprises in generic drug consistency evaluation, quality research and daily production inspection.