The listing status and dynamics of mitapivat-Pyrukynd on the market

Mitapivat, marketed under the trade name Pyrukynd, is an oral pyruvate kinase (PK) activator that was first approved by the FDA for the treatment of hemolytic anemia caused by pyruvate kinase (PK) deficiency in adults. This drug fills the treatment gap for PK deficiency and provides an effective treatment option for patients suffering from this rare genetic disease. The main mechanism of Metapival is to enhance the metabolic function of red blood cells and reduce hemolysis by activating pyruvate kinase, thereby improving patients' anemia symptoms and quality of life.

On February 17, 2022, the US FDA approved metapival as a drug for the treatment of hemolytic anemia caused by PK deficiency in adults. PK deficiency is an inherited metabolic disease caused by a lack of pyruvate kinase, resulting in a lack of energy in red blood cells, resulting in red blood cell rupture, hemolytic anemia, jaundice and other symptoms. The approval of metapival marks a breakthrough in treating the disease, allowing patients to take oral medications rather than rely on traditional treatments such as blood transfusions. Metapival has shown good efficacy in clinical trials and can effectively improve the symptoms of hemolytic anemia and reduce the need for blood transfusions.

Metapival not only targetsPK deficiency, but on January 5, 2026, the FDA also approved its use to treat anemia in adults with alpha- or beta-thalassemia, making it the first oral therapeutic drug. Although metapival has been approved in the United States and many countries, it is not currently available in the Chinese market. Patients in China still have to wait for the drug’s registration and approval process in the country. Since Metapival is a treatment drug for rare diseases, the approval process for domestic marketing may be relatively slow. However, as the drug's global efficacy gradually becomes apparent and more clinical data accumulates, the prospect of Metapival entering the Chinese market is worth looking forward to.

Reference materials:https://en.wikipedia.org/wiki/Mitapivat