Announcement of Application for Manufacturing and Marketing Approval in Japan of MD-712, a Treatment for PAH and PH-ILD
2026-04-30 · Mochida Pharmaceutical Company, Ltd. · original mochida.co.jp ↗
News Release April 30, 2026 Mochida Pharmaceutical Co., Ltd. Announcement of Application for Manufacturing and Marketing Approval in Japan of MD-712, a Treatment for Pulmonary Arterial Hypertension and Pulmonary Hypertension Associated with Interstitial Lung Disease Mochida Pharmaceutical Co., Ltd. (Head Office: Shinjuku-ku, Tokyo, Japan; President: Naoyuki Mochida; hereinafter “Mochida”) announces that Mochida has submitted an application to the Ministry of Health, Labour and Welfare (MHLW) for manufacturing and marketing approval for MD- 712 (generic name: treprostinil, hereinafter “the Product”), a treatment for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The Product consists of single-dose plastic cartridges filled with a dry powder containing treprostinil as the active ingredient, which is intended for administration by oral inhalation using a dedicated inhaler. In the United States, the product has been marketed by United Therapeutics since 2022 under the brand name TYVASO DPI® (treprostinil) Inhalation Powder. Pulmonary hypertension is a collective term for a group of conditions characterized by elevated pulmonary arterial pressure resulting from various causes. Among these, PAH and PH-ILD are rare diseases in which patients experience high pulmonary arterial pressure accompanied by symptoms such as dyspnea on exertion, fatigue, palpitations, and dizziness. These diseases progress over time and can lead to heart failure. Since 2014, Mochida has been marketing TREPROST® (treprostinil) Injection, a treatment for PAH in Japan, also under an exclusive distribution agreement with United Therapeutics. In 2023, Mochida launched sales of TREPROST® (treprostinil) Inhalation Solution in Japan for the treatment of PAH, and in 2024, the additional indication for PH-ILD was approved by the MHLW in Japan. Mochida believes that the Product will provide additional therapeutic options for patients with PAH and PH-ILD with its convenience to use and portability. Contact: Mochida Pharmaceutical Co., Ltd. Public Relations, Corporate Planning Department Email: [email protected] ### Note: This document has been translated from the Japanese original for reference purposes only. In the event of any discrepancy between this translated document and the Japanese original, the original shall prevail.
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