Lubiprostone

As a chronic digestive disease with high incidence worldwide, constipation can only have its symptoms relieved by traditional laxatives, which however cannot address the root cause of the disease. The advent of lubiprostone has filled this clinical gap. As the world's first selective chloride channel-2 (ClC-2) agonist, it can specifically activate ClC-2 channels on the membrane of gastrointestinal epithelial cells, promote intestinal fluid secretion and increase intestinal peristalsis, without affecting the balance of sodium and potassium ions. The currently approved indications of this drug include chronic idiopathic constipation in adults, constipation-predominant irritable bowel syndrome (only for women aged 18 and above), and opioid-induced constipation (in patients with non-cancer pain), providing a long-term safe treatment option for patients who are intolerant to traditional laxatives or have poor treatment response.

The global lubiprostone market size has maintained a steady growth trend in recent years. In 2023, the market size exceeded 480 million US dollars, and the compound annual growth rate is expected to remain around 4.2% by 2028. Affected by the expiration of the originator drug's patents, the substitution effect of generic drugs has gradually emerged. In the US market, generic drugs from 12 enterprises have been approved for marketing. The Chinese market is still in the stage of originator drug exclusivity at present, and the R&D of local generic drugs is in the clinical declaration stage. With the increase of indication penetration rate in the future, the domestic market has great growth potential.

The originator enterprise of lubiprostone is Japan's Mitsubishi Tanabe Pharma, and the original brand name is "Amitiza". Its US compound patent expired in 2021, and the crystal form patent will expire in 2025. The marketed dosage form of the originator drug is soft capsule, available in two specifications of 8μg and 24μg. It has been included in the FDA Reference Listed Drug Catalog, and also included in the *Catalog of Reference Preparations for Chemical Drugs (Third Batch)* of China. Up to now, only the imported lubiprostone soft capsules of the originator drug have been approved for marketing in China, and no domestic preparation has been approved. There are a total of 7 relevant API registration information on the API registration platform, among which 2 have obtained Class A status through the joint evaluation and approval with preparations, and the rest are still in the process of evaluation. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of lubiprostone impurity reference standards, covering all research scenarios such as process impurities and degradation impurities. Most products are available from stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the research needs of enterprises in different stages such as generic drug R&D, quality research and consistency evaluation.