Insmed Launches BRINSUPRI in Japan for NCFB Treatment

Japan's bronchiectasis prescribers now have the country's first approved pharmacological option targeting the underlying inflammatory mechanism of non-cystic fibrosis bronchiectasis (NCFB), as Insmed moves BRINSUPRI® Tablets 25 mg (brensocatib hydrate) into commercial availability following MHLW approval in August 2026.

The approval was grounded in Phase 3 ASPEN study data and covers adults and pediatric patients aged 12 and older, a patient population defined by recurrent pulmonary exacerbations, chronic sputum burden, and progressive airway damage driven by neutrophil serine protease activity. Brensocatib is a reversible, oral, once-daily inhibitor of dipeptidyl peptidase 1 (DPP1), the upstream enzyme responsible for activating those proteases in neutrophils. No prior therapy in Japan had been specifically indicated to interrupt that pathway.

For regulatory affairs teams tracking MHLW's accelerated review pathways for unmet-need indications, the BRINSUPRI dossier represents a useful reference point. The therapy had already secured approval in the United States, where both 10 mg and 25 mg tablet strengths are indicated, and in the European Union and United Kingdom, where the 25 mg strength is approved for patients with two or more exacerbations in the prior 12 months. Japan's label, by contrast, does not carry that exacerbation-frequency qualifier, a labeling distinction that QA and regulatory leads managing multi-regional submissions should note when aligning indication language across dossiers.

The Japan launch also carries a supply-chain dimension: the approved formulation is designated as brensocatib hydrate, a salt form distinct from the free-base brensocatib referenced in U.S. and EU labeling. Teams responsible for CMC documentation and post-approval change management across jurisdictions will need to ensure that specification alignment and stability data reflect the hydrate form for the Japanese market.

Insmed has indicated it will support appropriate use through information provision to Japanese healthcare professionals, consistent with MHLW post-marketing obligations for newly approved therapies in serious chronic disease categories.

The commercial availability of BRINSUPRI in Japan sets a measurable baseline for real-world exacerbation-rate data that will inform both post-marketing commitments and future label discussions across the therapy's three approved geographies.

Source: Insmed Incorporated via PR Newswire, 19 October 2026.