Ivabradine

Chronic heart failure is a highly prevalent chronic cardiovascular disease worldwide. Abnormally elevated heart rate is an independent risk factor for poor prognosis in patients. Traditional β-blockers are limited by adverse reactions such as bronchospasm and blood pressure reduction, leaving unmet needs in clinical treatment. Ivabradine is the first selective If channel inhibitor. By specifically inhibiting the If inward current of the sinoatrial node, it can purely slow down the heart rate and reduce myocardial oxygen consumption without affecting myocardial contractility and the conduction system. It is mainly used for patients with NYHA class II-IV chronic heart failure who have sinus rhythm with heart rate ≥ 75 beats per minute and are accompanied by cardiac systolic dysfunction. It can also be used for angina pectoris patients who cannot tolerate β-blockers, providing a brand-new treatment path for people intolerant to heart rate control.

The global ivabradine market size exceeded USD 1.2 billion in 2024, with a compound annual growth rate of 7.2% in the past 5 years. Its growth momentum mainly comes from the increased penetration rate of chronic heart failure management and the release of demand in emerging markets. The terminal sales volume of the Chinese market was approximately RMB 1.8 billion in 2024. After the implementation of centralized drug procurement, the price drop reached 88%, with a significant volume expansion effect. At present, more than 15 generic drug enterprises have obtained approval. In addition to the original research drug manufacturer, nearly 10 domestic enterprises have obtained production approvals on the API supply side, and the market competition pattern has gradually shifted from original research dominance to sufficient competition among generic drugs.

The original research enterprise of ivabradine is Servier from France, with the original brand name "Corlentor". The core compound patent expired in China in 2023. The main dosage form approved for the original research drug is tablet, with specifications of 5mg and 7.5mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation listed by FDA. As of June 2025, there are 21 ivabradine-related registration numbers on the API registration platform of China CDE, among which 12 have been publicized with A status. A total of 37 ivabradine preparation varieties have been approved in China, covering dosage forms such as tablets and sustained-release tablets. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the R&D and quality control needs related to ivabradine, CATO provides a full set of impurity reference standards for this API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can directly support R&D needs in different scenarios such as impurity profile study, quality standard establishment and generic drug consistency evaluation.