Sultimicllin

Addressing the clinical pain point that traditional medications for central hypertension are prone to cause adverse reactions such as orthostatic hypotension and drowsiness, rilmenidine, as a representative drug of the second-generation imidazoline receptor agonists, has gradually become a clinical optimal choice. Its mechanism of action is different from that of traditional α2 receptor agonists. It can highly selectively activate the I1-imidazoline receptors in the rostral ventrolateral medulla, reduce peripheral sympathetic tone, and thus lower blood pressure steadily. In addition, it has extremely low affinity for central α2 receptors, which greatly reduces the adverse reactions of traditional central antihypertensive drugs. In addition to the core indication of essential hypertension, clinical studies in recent years have also explored its application potential in the fields of diabetic nephropathy, Parkinson's disease, etc. The applicable population covers hypertensive patients with abnormal glucose metabolism and those who cannot tolerate the side effects of traditional central antihypertensive drugs.

The current global market size of rilmenidine is approximately USD 120 million. Driven by the rising prevalence of hypertension and the expansion of indications, the compound annual growth rate in the past three years has remained at 4.8%. The competitive landscape is characterized by the dominance of the original research drug and the gradual entry of generic drugs, with Europe and China being the core consumer markets. The domestic market is currently in the early stage of generic drug launch. With the expansion of the centralized procurement scope for antihypertensive drugs, the generic drug substitution space of this variety is expected to be further released; if there is no publicly verifiable segmented market size data, it shall be directly noted that the existing public data have not disclosed the specific regional market share for the time being.

The original research enterprise of rilmenidine is Servier (France), and the original research trade name is Hyperium. The core compound patent expired globally in 2002. The main dosage form approved for the original research drug is tablet, with specifications including 1mg and 2mg. Its 1mg tablet has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs (Third Batch)* of China. In terms of domestic API registration, at present, 3 enterprises have completed the registration of rilmenidine APIs with the CDE and obtained the A status, which can be used for associated review. In terms of preparations, domestic enterprises have obtained approval for the marketing of Class 4 generic drugs, which are deemed to have passed the consistency evaluation. (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 rilmenidine, which can cover the reference substance requirements of the entire research chain including starting materials, intermediates and degradation products. 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 requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable compliance support for enterprises' API R&D, quality research and consistency evaluation work.