Pioglitazone

For the treatment of type 2 diabetes, improving insulin resistance is one of the core directions of long-term clinical management. Pioglitazone is a thiazolidinedione insulin sensitizer. It highly selectively activates peroxisome proliferator-activated receptor γ (PPARγ), regulates adipocyte differentiation, glucose transport and the expression of genes related to lipid metabolism, reduces insulin resistance in peripheral tissues and the liver, and stably controls blood glucose without stimulating excessive insulin secretion. Clinically, this drug is mainly used for monotherapy or combination therapy in patients with type 2 diabetes, especially suitable for people with abnormal glucose metabolism complicated with obesity and non-alcoholic fatty liver disease. It can also be used in combination with metformin, sulfonylurea drugs or insulin to optimize the effect of blood glucose control.

In recent years, the global pioglitazone market size has remained at around US$3 billion. Driven by the popularization of generic drugs in mature markets, the growth rate has maintained in the range of 2% to 3%. In terms of the domestic market, as the prevalence of type 2 diabetes has risen to 11.9%, the demand for insulin sensitizers has increased steadily. In 2023, the sales of pioglitazone at terminals of domestic public medical institutions were approximately RMB 210 million. Among them, oral regular-release dosage forms have been included in the national centralized procurement, with the maximum price cut of winning bids exceeding 90% compared with the original research drug. Currently, domestic generic drugs account for more than 85% of the market, the competitive landscape is highly fragmented, and the total market share of the top 3 enterprises is less than 40%.

The original research enterprise of pioglitazone is Takeda Pharmaceutical, and the original brand name is Actos. Its core compound patent in the United States expired in 2011, and the compound patent in China expired in 2009. The main approved dosage form of the original research drug is oral tablet, with specifications including 15mg, 30mg and 45mg, which have been included in the China List of Marketed Chemical Drugs and the FDA Reference Listed Drug Catalog. In terms of domestic API registration, 12 enterprises including Takeda have currently obtained A status registration numbers for pioglitazone APIs after passing the review of the Center for Drug Evaluation (CDE). The domestically approved pioglitazone preparations cover multiple dosage forms such as tablets, capsules and dispersible tablets. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for pioglitazone API, covering the full spectrum of process impurities, degradation impurities, etc. Most products are in stock, and in-stock orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully support the full-process needs of pharmaceutical enterprises in API R&D, quality research and registration.