Isoprenaline

In the clinical treatment of diseases such as bronchial asthma and heart block, β-receptor agonists are an indispensable core category of medications, and isoprenaline is a classic variety of non-selective β-adrenoceptor agonists. It can stimulate both β1 and β2 receptors simultaneously. By stimulating β2 receptors on bronchial smooth muscle, it exerts a potent bronchodilatory effect to relieve acute asthma attacks; stimulating cardiac β1 receptors can enhance myocardial contractility, accelerate conduction, increase heart rate, improve the treatment effect of emergencies such as atrioventricular block and cardiac arrest. Meanwhile, it can also be used for symptomatic treatment of cardiogenic or infectious shock, and the applicable population covers patients of all age groups with the above-mentioned emergencies who meet the indications.

At present, the global market size of isoprenaline API is approximately USD 120 million, and the compound annual growth rate in the past three years has maintained at around 4.7%. The growth drivers mainly come from the increase in the allocation of emergency medications in primary medical institutions and the steady release of demand for the treatment of acute asthma attacks. The domestic market competition pattern is dominated by generic pharmaceutical enterprises. At present, 7 domestic enterprises have obtained the production approval documents for isoprenaline API, and the winning regions cover 23 provincial centralized procurement lists. The overall supply side is highly stable, and the annual price fluctuation is controlled within 8%.

The original research enterprise of isoprenaline is Teva Pharmaceutical Industries Ltd. from Israel, and the original brand name is Isuprel. Its core compound patent in the US market expired in 1980, and all core patents have now entered the public domain. The main dosage forms approved for the original product include injection (1mg/1ml) and aerosol (0.25mg per puff), among which the injection dosage form has been included in the FDA Reference Listed Drug Catalog, and the domestic authority has also included the original product of this dosage form in the *Catalog of Reference Preparations for Chemical Drugs*. Up to now, there are 8 valid registration numbers of isoprenaline API on the API registration platform of China CDE, among which 6 are in status A (can be used for joint review and evaluation with preparations). In China, 11 enterprises have obtained marketing approval for isoprenaline injection, and 2 enterprises have obtained marketing approval for isoprenaline aerosol. (Data as of June 2025, please refer to the official website of CDE for the latest information.)

CATO can provide a full set of impurity reference standards for isoprenaline. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most of the products are in regular stock, and orders placed before 16:00 can be shipped on the same day, which can fully meet the reference standard supply needs of pharmaceutical enterprises in all stages from API R&D, quality research to marketing application.