JCR Pharmaceuticals Pharma Plans 2026 Approval Bid for DMD Drug Givinostat

TOKYO, Jul 15 (Pulse News Wire) – JCR Pharmaceuticals CO.,LTD. (4552.T) announced plans to file for manufacturing and marketing approval for the Duchenne muscular dystrophy (DMD) treatment drug givinostat in Japan by the end of 2026, based on results from overseas clinical trials.

The company expects to secure approval and begin sales in 2027. Additionally, independent clinical trials focusing on pharmacokinetics and safety among Japanese DMD patients will be conducted separately. According to President Shono Keishi, leveraging overseas data allows for a strategic development approach aimed at delivering the drug earlier to Japanese patients.

With significant unmet medical needs in DMD, JCR Pharma aims to offer new treatment options through continued research and development efforts. The impact on the company's consolidated performance for the fiscal year ending March 2027 is expected to be minor. DMD affects approximately one in 3,500 male births globally and is estimated to affect around 1,000 people in Japan.

Givinostat, developed by Italfarmaco S.p.A., regulates excessive histone deacetylase activity characteristic of DMD muscles, promoting gene expression essential for muscle maintenance and repair without dependency on the specific type of genetic mutation causing DMD.