Nizatidine

Acid-related diseases such as peptic ulcer and gastroesophageal reflux disease have long plagued hundreds of millions of patients worldwide. Histamine H2 receptor antagonists are one of the core categories of clinical acid suppression therapy. As a third-generation H2 receptor antagonist, nizatidine can significantly inhibit basal gastric acid, nocturnal gastric acid and gastric acid secretion induced by food stimulation by competitively blocking H2 receptors on gastric parietal cells. Its acid suppression activity is 5-10 times stronger than that of the first-generation cimetidine, and it has no obvious anti-androgen effect and liver drug enzyme inhibition effect, with better safety. It is clinically mainly used for the treatment of active duodenal ulcer, benign gastric ulcer and prevention of ulcer recurrence, and can also be used for the relief of acid regurgitation symptoms such as gastroesophageal reflux disease and heartburn. The applicable population covers adult patients with acid-related diseases, and the elderly and people with mild to moderate abnormal liver and kidney functions can adjust the dosage for use under the guidance of doctors.

At present, the global nizatidine market size is about US$230 million. Driven by the high infection rate of Helicobacter pylori and the rising prevalence of reflux diseases, the market growth rate has stabilized at around 3.2% in recent years. In terms of the domestic market, with the implementation of hierarchical diagnosis and treatment and the improvement of the diagnosis and treatment capacity for gastrointestinal diseases at the primary level, the domestic market size of nizatidine preparations exceeded 280 million yuan in 2023, with an annual growth rate of 4.7%. The competitive landscape is dominated by generic drugs, with the market share of original research products being less than 8%. 17 domestic enterprises have obtained the approval documents for nizatidine preparations, and the supply of API has been localized. After the volume-based procurement, the terminal price of preparations has dropped by about 62%, and the accessibility for patients has been greatly improved.

The original research enterprise of nizatidine is Eli Lilly and Company, and the original research trade name is "Axid". Its U.S. compound patent expired in 2004, and the core patent in China expired in 2002. The main dosage forms of the original research marketed products include capsules (150mg, 300mg) and injections. Among them, the 150mg and 300mg capsules have been included in the FDA Reference Listed Drug Catalog, while the reference listed drug catalog for this variety has not been announced in China yet. As of the retrieval time point, there are a total of 11 nizatidine API registration entries on the domestic CDE API registration platform, 8 of which have been registered in Status A and are qualified for marketing and sales in China. Multiple dosage forms such as nizatidine capsules, dispersible tablets and injections have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for nizatidine API, which can simultaneously meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products are in stock, and in-stock products ordered before 16:00 can be shipped on the same day, which can provide stable reference material supply support for the R&D and quality control links of API and preparation enterprises.