Udenafil

Male erectile dysfunction (ED), as a common chronic disease in andrology, has a significant impact on the quality of life and mental health of patients. The advent of the fifth-generation phosphodiesterase 5 (PDE5) inhibitors provides a better option for the clinical intervention of this disease. Udenafil is a highly selective PDE5 inhibitor, which can reversibly inhibit the activity of PDE5, block the degradation of cyclic guanosine monophosphate, increase the concentration of cyclic guanosine monophosphate in the cavernosal smooth muscle, promote smooth muscle relaxation and increase blood flow, thereby improving erectile function. Compared with similar drugs, it has higher selectivity for PDE5 and a moderate half-life, which can balance the onset speed and duration of action. It is mainly clinically used for the treatment of erectile dysfunction in adult males, and some clinical studies have also explored its application potential in diseases such as pulmonary arterial hypertension.

The global prevalence of ED is increasing year by year along with the aging of the population. At present, the global market size of PDE5 inhibitors has exceeded 6 billion US dollars. As a new generation product, udenafil has maintained an annual compound growth rate of around 12% in the past three years by virtue of its lower incidence of adverse reactions. At present, East Asian countries such as South Korea and China are the main consumer markets of udenafil, and the competitive landscape is jointly dominated by the original research product and local generic drugs. Since the first generic drug was approved in China in 2022, the generic drug preparations of 4 enterprises have passed the consistency evaluation, and the promotion of the centralized procurement policy has further promoted the continuous improvement of its clinical accessibility.

The original research enterprise of udenafil is Dong-A ST Co., Ltd. of South Korea, with the original brand name Zydena. Its compound patent in South Korea expired in 2021, and the compound patent in China expired in 2022. The dosage form approved for the original research product is tablet, and the mainstream specifications include 100mg and 200mg. The original research tablet has been included in the Reference Preparation Catalogue of NMPA, and is also listed in the FDA Orange Book. As of now, there are 13 registration numbers of udenafil active pharmaceutical ingredients in China, among which 8 are in status A and can be legally supplied for preparation production, and 11 enterprises have obtained approval for the domestic marketing of udenafil tablets. (Data as of April 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of udenafil impurity reference standards, covering all types of impurities involved in the synthesis process and degradation pathways. 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 regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs in various stages of active pharmaceutical ingredient R&D, quality research and registration declaration.