Vilanterol

Chronic obstructive pulmonary disease (COPD) and asthma are highly prevalent chronic respiratory diseases, and the clinical demand for long-acting bronchodilators continues to rise. Vilanterol is a selective long-acting β₂ adrenoceptor agonist (LABA). It binds to β₂ receptors on airway smooth muscle with high affinity, activates adenylate cyclase to increase the level of intracellular cyclic adenosine monophosphate, and continuously relaxes bronchial smooth muscle, with a duration of action of up to 24 hours. It is often used in clinical practice in combination with inhaled corticosteroids as a compound preparation for the long-term control of asthma in adults and adolescents over 12 years old, as well as maintenance treatment for patients with COPD, which can significantly reduce the frequency of acute exacerbations and improve patients' pulmonary function and quality of life.

The global market size of vilanterol-related preparations exceeded US$4.5 billion in 2023, and the compound annual growth rate from 2021 to 2025 is expected to remain at 7.2%. The core driving force for growth comes from the rising global prevalence of COPD and asthma, as well as the consolidation of the first-line position of compound preparations in the treatment of respiratory diseases. In terms of the competitive landscape, the original research product accounts for more than 85% of the global market share. At present, only a few pharmaceutical companies have initiated generic drug research and development. With the expiration of core patents, the gap in the generic drug market will gradually be released. Currently, no generic vilanterol has been approved in the domestic market, and clinical demand is mainly met by imported preparations.

The original research enterprise of vilanterol is GlaxoSmithKline (GSK), and the original trade name is Relvar Ellipta (domestic trade name: Anoro Ellipta, which is a compound preparation of vilanterol and fluticasone furoate). Its core compound patent expires in 2027 in the United States and Europe, and in 2026 in China. The main dosage form of the original research product is dry powder inhaler, with a single-dose specification of 25 μg per actuation, and the compound preparations are mostly combined with different doses of fluticasone furoate or umeclidinium bromide. The original preparation of this product has been included in the NMPA Reference Listed Drug Catalogue for Chemical Drugs. As of July 2025, there is no approved vilanterol single-agent preparation on the market in China, and no enterprise has submitted an A-status registration number for vilanterol on the CDE API registration platform. (Data as of July 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of vilanterol impurity reference standards, covering all impurity types related to the synthesis process and degradation pathways. Meanwhile, it supports custom synthesis services to meet the research and development and quality control needs at different stages. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All products comply with the regulatory requirements of the Chinese Pharmacopoeia and FDA, and can be directly used for registration declaration-related work such as methodological validation and stability studies.