Carbodenafil

Male erectile dysfunction (ED) is a common andrological disease, and the demand for highly selective PDE5 inhibitors in clinical diagnosis and treatment continues to rise. Cabadenafil is a highly selective phosphodiesterase 5 (PDE5) inhibitor, which reduces the degradation of cGMP by specifically inhibiting the activity of PDE5, relaxes the smooth muscle of the corpus cavernosum, and promotes blood inflow to improve erectile function. Compared with traditional drugs of the same category, it has higher selectivity for PDE5, which can reduce the effect on other PDE isoenzymes and lower the incidence of adverse reactions such as facial flushing and dyspepsia. It is mainly used for the symptomatic treatment of erectile dysfunction in adult men, and can also be used for some ED patients with benign prostatic hyperplasia after clinical evaluation.

At present, the global ED drug market size exceeds 47 billion US dollars, and PDE5 inhibitors account for more than 65% of the overall market share. As a new generation product of the same category, cabadenafil has a global market compound growth rate of 12.3% in the past three years. There is no mass launch of generic drugs in the domestic market, and the original research product still occupies the core market share. With the increase in the prevalence of ED in China and the improvement of patients' awareness of diagnosis and treatment, cabadenafil has a large market penetration space in the future. There is no publicly verifiable segment market size data available.

The original research enterprise of cabadenafil is Dong-A Pharmaceutical Co., Ltd. of South Korea, with the original brand name Zydena. Its core compound patent expired in 2019, and the core patent in China expired in 2020. The main marketed dosage form of the original research product is tablet, with specifications including 50mg, 100mg and 200mg. It has been included in the reference preparation catalogs of South Korea, Japan and other countries, and is also listed in the FDA list of foreign reference preparations. As of the search time point, no domestic enterprise has been approved to market cabadenafil preparations, and there is no approved cabadenafil API registration number on the CDE API registration platform. (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 cabadenafil API, most of which 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 Chinese Pharmacopoeia and FDA, and can meet the impurity research needs of enterprises in all stages from drug research and development to registration and declaration.