Bridgewater – – October 19, 2026 -- Insmed (Nasdaq: INSM) has launched BRINSUPRI Tablets 25 mg (brensocatib hydrate) in Japan, making it the first and only approved, commercially available treatment for non-cystic fibrosis bronchiectasis (NCFB) in the country.
Japan's health ministry cleared the once-daily oral tablet in August 2026
The Ministry of Health, Labour, and Welfare approved BRINSUPRI based on results from the Phase 3 ASPEN study. The label covers adults and pediatric patients aged 12 years and older.
Samuele Butera, Insmed's Senior Vice President and General Manager, Global Respiratory, called the launch "a meaningful step forward for the bronchiectasis community." Makoto Nakamura, Senior Vice President and General Manager, Japan, said the company will focus on providing information to healthcare professionals and promoting proper use of the therapy.
Japan joins the US, EU and UK as an approved market for the DPP1 inhibitor
BRINSUPRI is a small molecule, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). It blocks activation of neutrophil serine proteases, which drive chronic airway inflammation in NCFB.
In the United States, the drug is approved in 10 mg and 25 mg tablets for patients 12 and older. In the European Union and United Kingdom, the 25 mg tablet is approved for patients 12 and older with two or more exacerbations in the prior 12 months.
US label data show dermatologic, gingival and liver enzyme signals in ASPEN
The US label warns of increased dermatologic and gingival or periodontal adverse reactions. It advises avoiding live attenuated vaccines during treatment.
In ASPEN, ALT above three times the upper limit of normal occurred in 0% of placebo patients, 1.2% on 10 mg and 0.9% on 25 mg. Skin cancers occurred in 0.5% of patients on 10 mg and 1.9% on 25 mg, versus 1.1% on placebo. Alopecia affected 1.5% on 10 mg and 1.6% on 25 mg, versus 0.4% on placebo.