Vibegron

Chronic overactive bladder (OAB) is a highly prevalent chronic urinary system disease. For a long time, M receptor antagonists have been the mainstay of clinical treatment for OAB, but adverse reactions of this class of drugs such as dry mouth and constipation limit patient compliance. Vebegron is a new generation of β3 adrenoceptor agonist. It works by highly selectively activating β3 receptors on the bladder smooth muscle, relaxing the detrusor muscle and increasing the bladder urine storage capacity, while avoiding non-specific effects on M receptors, which significantly reduces anticholinergic-related adverse reactions. It is clinically indicated mainly for the improvement of symptoms of urinary urgency, frequent urination and urge urinary incontinence in adult patients with overactive bladder, and is particularly suitable for middle-aged and elderly patients who cannot tolerate the adverse reactions of M receptor antagonists.

The global OAB patient population exceeds 400 million, of which approximately 30% require long-term pharmacological intervention. In 2023, the global market size of β3 receptor agonist drugs for OAB reached USD 7.2 billion, with a compound annual growth rate maintained at 11.8%. As the latest approved product in this category, Vebegron, with its higher receptor selectivity and lower risk of cardiovascular adverse events, has rapidly captured the market after launch, and has now been approved for marketing in 17 countries and regions around the world. Currently, the domestic OAB drug market is still dominated by M receptor antagonists, with β3 receptor agonists accounting for less than 15%. The advancement of domestic production of Vebegron is expected to further fill the gap in clinical demand.

The original developer of Vebegron is Astellas Pharma of Japan, with the original brand name Betalmiga. Its core compound patent will expire in 2030 in major markets such as Japan and the United States, and the compound patent in China will expire in 2031. The main dosage form of the original product approved is oral tablet, with a specification of 50 mg per tablet. It has been included in the reference listed drug catalogs of Japan, the United States and other regions, and the domestic application for reference listed drug is currently in the publicity stage. As of the search date, no Vebegron active pharmaceutical ingredient has been approved for marketing and registration in China, and no domestic Vebegron preparation has been approved by the NMPA. The domestic marketing application of the original preparation is under review. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full range of Vebegron impurity reference standards, covering the entire research chain including synthetic starting materials, intermediates and degradation impurities. Most products are in sufficient stock, and orders placed before 16:00 can be shipped on the same day. All products meet the quality control requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the use requirements of different scenarios such as drug development, quality research and consistency evaluation.