Atosiban

In response to the demand for precise tocolysis in clinical intervention for preterm labor, atosiban is an anti-preterm labor drug belonging to the oxytocin receptor antagonist class. It competitively binds to oxytocin receptors on the uterine smooth muscle and decidua, blocks the oxytocin-mediated uterine contraction signaling pathway, and reduces the frequency and amplitude of uterine contractions. Compared with traditional β-receptor agonists, it has a significantly lower incidence of cardiovascular adverse reactions. It is mainly used for pregnant women with threatened preterm labor between 24 and 33 weeks of gestation with normal fetal heart rate. It is currently the only preterm labor treatment drug with uterine specificity, which can effectively prolong pregnancy duration and reduce the risk of preterm-related adverse neonatal outcomes.

The global atosiban market size was approximately USD 480 million in 2023, with a compound annual growth rate of 6.2% from 2019 to 2023. The growth momentum mainly comes from the rising incidence of preterm labor and the increasing clinical demand for high-safety tocolytic drugs. The growth rate of the Chinese market in the past three years is higher than the global average, and its terminal sales exceeded RMB 1.2 billion in 2023. The current competitive landscape is jointly dominated by the original research drug and domestic generics. Since 2021, generic preparations from 3 domestic pharmaceutical companies have passed the consistency evaluation, and have been included in the medical insurance reimbursement catalogs of multiple provinces, so the accessibility for patients is continuously improving.

The original research enterprise of atosiban is Ferring Pharmaceuticals, a subsidiary of Pfizer, and the original brand name is "Tractocile". Its core compound patent in China expired in 2020, and the core patent in the US market expired in 2021. The dosage form approved for the original research drug is injection, with specifications including 0.9ml:7.5mg/vial and 5ml:37.5mg/vial. It has been included in the Reference Listed Drug Catalogue for Chemical Drugs issued by China's NMPA, and is also listed in the FDA Reference Listed Drug Catalogue. As of now, there are 8 atosiban API registration numbers on China's CDE API Registration Platform, of which 5 are in Status A, and atosiban injections from 11 domestic enterprises have been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of atosiban impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the experimental needs related to API R&D, quality research and consistency evaluation.