Xylometazoline

As a commonly used nasal mucosal decongestant in clinical practice, xylometazoline is an imidazoline derivative. It directly stimulates the α1 and α2 adrenergic receptors of nasal mucosal blood vessels, rapidly constricts local blood vessels and reduces blood flow, thereby alleviating nasal mucosal congestion and swelling caused by inflammation and allergy, and effectively relieving nasal obstruction symptoms. Compared with traditional decongestants, it has a fast onset of action (usually taking effect within 10 minutes), and its action duration can reach 6 to 12 hours, with mild effects on heart rate and blood pressure. It can be used as needed for adults and children over 3 years old with acute and chronic rhinitis, sinusitis, and acute发作 stage of allergic rhinitis, and can also be used in combination with pre-operative preparation for nasal endoscopy to reduce intraoperative bleeding.

The annual global market size of xylometazoline-related preparations is approximately USD 1.8 billion, with a compound annual growth rate of 4.2% in the past three years. The core growth drivers come from the rising prevalence of allergic rhinitis and the increasing demand for symptomatic medications for nasal obstruction related to upper respiratory tract infections. The domestic market is dominated by OTC dosage forms. In 2023, the retail sales exceeded RMB 700 million, with an annual growth rate of 8.7%. Currently, the market is evenly divided between imported original research products and domestic generic pharmaceutical enterprises. Nearly 20 domestic enterprises have been approved to produce related preparations, the domestic substitution process of APIs is continuously accelerating, and there is no record of centralized procurement implementation so far.

The original research enterprise of xylometazoline is Bayer AG of Germany, and the original research trade name is "Otrivin". Its core compound patent expired globally in 1993, and all core preparation patents in the Chinese market also expired in 2015. At present, the dosage forms of the original research product approved in China include xylometazoline hydrochloride nasal drops and nasal spray, covering two specifications of 0.05% (for children) and 0.1% (for adults). They have been included in the Chinese Listed Drug Catalogue as reference preparations, and are also included in the FDA Reference Preparation Catalogue. In terms of API registration, as of now, there are 12 registration numbers of xylometazoline hydrochloride APIs on the CDE platform, of which 7 are in A status (can be used in marketed preparations). More than 15 xylometazoline hydrochloride preparation varieties have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of xylometazoline impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of various R&D and production scenarios such as API quality research, targeted impurity control, and preparation consistency evaluation.