Press Releases / Notices

Kyoto, Japan, March 18, 2026 - Nippon Shinyaku Co., Ltd. (Headquarters: Kyoto; President: Toru Nakai) announced it has started co-promotion activities with Johnson & Johnson  for Opsumit® Pediatric Dispersible Tablets 1mg and 2.5mg (age >=3 Months), an endothelin receptor antagonist, for pediatric pulmonary arterial hypertension (PAH).

PAH is a disease with a poor prognosis characterized by an abnormally elevated blood pressure in the pulmonary arteries, which carry blood from the heart to the lungs. It is categorized into idiopathic PAH of unknown cause, hereditary PAH, and PAH associated with various diseases (such as connective tissue disorders and congenital heart disease). The pathophysiology of PAH in adults and children is similar; however, the drugs available for pediatric PAH within Japan are limited, necessitating the development of new therapeutic agents.

Japan’s Ministry of Health, Labor and Welfare (MHLW) for Opsumit® Pediatric Dispersible Tablets in 1 mg and 2.5 mg on December 22, 2025.

Nippon Shinyaku is focusing on the field of intractable, rare disorders, and PAH is one of them. Currently, for adult PAH, we offer a portfolio of products including Uptravi® (selexipag), Opsumit® (macitentan), Adcirca® (tadalafil), and Yuvanshi® Combination Tablets (macitentan/tadalafil). For pediatric PAH, in addition to Uptravi®, we believe that the additional indication for Opsumit® will further contribute to the treatment of PAH.

Corporate Communications Dept., Nippon Shinyaku