Silodosin

For patients with benign prostatic hyperplasia (BPH) dominated by lower urinary tract symptoms, clinical treatment has long faced the difficulty of balancing the relief of urination disorders and the reduction of the side effect of orthostatic hypotension. The emergence of highly selective α1A receptor blockers provides a better solution to this problem. Silodosin is a third-generation highly selective α1A adrenergic receptor blocker, which can specifically act on α1A receptors in the prostate, bladder neck and urethral smooth muscle. By relaxing smooth muscle to reduce urethral pressure, it can rapidly improve BPH-related lower urinary tract symptoms such as frequent urination, urgent urination and dysuria. Meanwhile, it has extremely low affinity for α1B receptors on vascular smooth muscle. Compared with traditional α receptor blockers, it has a lower incidence of cardiovascular adverse reactions such as orthostatic hypotension, and is more suitable for long-term use in elderly BPH patients with underlying diseases.

The global silodosin market size was approximately USD 870 million in 2023, with a compound annual growth rate of 6.2% from 2019 to 2023. The core growth drivers are the continuous rise in BPH prevalence under the global aging process and the increasing demand of patients for low-side-effect treatment regimens. In terms of the domestic market, after the original research product was approved in China in 2011 and its patent expired in 2021, generic drugs from 7 domestic enterprises have passed the consistency evaluation. The overall domestic market size exceeded RMB 1.2 billion in 2023, among which the market share of generic drugs has increased from 12% in 2020 to 68%. After winning the bid in the centralized procurement, the product accessibility has been further improved, and the demand for upstream API and supporting impurity reference standards has also grown rapidly.

CATO can provide a full set of impurity reference standards for silodosin API. All products meet the quality requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and the full series is in sufficient stock. It can quickly respond to the needs of API manufacturers and R&D institutions for impurity research, quality control and compliance declaration, helping customers shorten the R&D cycle and reduce compliance risks.