IR News 2025

Kyoto, Japan, March 19, 2025 - Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; Headquarters, Kyoto; President, Toru Nakai) announced today that it has launched Uptravi® tablets for pediatric 0.05 mg (hereinafter “this drug”) for the treatment of pulmonary arterial hypertension (PAH) in Japan. 

PAH is a disease with a poor prognosis characterized by abnormally high blood pressure in the pulmonary artery. It is classified into idiopathic PAH, heritable PAH and PAH associated with various diseases such as connective tissue disease and congenital heart disease. Because the disease pathology of PAH is similar between pediatric and adult patients, combination therapy of prostacyclin pathway drug, endothelin receptor antagonist and phosphodiesterase-5 inhibitor, is also recommended for pediatric PAH patients. However, treatment options for pediatric PAH are limited in Japan. Particularly, in the case of prostacyclin pathway drug, only an injectable formulation requiring continuous intravenous infusion is available. Therefore, there has been an unmet need for oral formulations of prostacyclin pathway drug.

Uptravi® is an oral prostacyclin receptor (IP receptor) agonist with high selectivity for the IP receptor among prostacyclin pathway drugs. Uptravi® is believed to reduce pulmonary arterial pressure by binding to the IP receptors on vascular smooth muscle cells and increasing cAMP production, thereby leading to vasodilation and inhibition of vascular smooth muscle proliferation.

The optimal dose of this drug for each patient is determined by dose titration. This drug allows for finer dosing for pediatric patients, but some patients may need to take a larger number of tablets at one time. To support patents and healthcare professionals who take and dispense this drug, we developed a new pill case especially for this drug. With the dedicated filler for the case, healthcare professionals can dispense the correct number of tablets simply by filling the case. Then, patients can take the correct number of tablets by dispensing them in a single row from the case each time they take this drug.

Nippon Shinyaku focuses on rare and intractable diseases as a key area and continues to make further efforts to develop new treatments and provide product information. With the launch of Uptravi® tablets for pediatric 0.05mg, we hope to contribute even more to pediatric patients suffering from PAH, their families, and healthcare providers.