Brensocatib Launches in Japan for Non-CF Bronchiectasis

Brensocatib hydrate (Brinsupri; Insmed Inc) launched commercially in Japan on October 19 for adults and children 12 years and older with noncystic fibrosis bronchiectasis (NCFB), expanding its global reach.¹

Japan’s Ministry of Health, Labour and Welfare (MHLW) approval of brensocatib was announced on August 24, 2026, following prior approvals by the FDA and the European Commission on August 12, 2025, and November 18, 2025, respectively.^2-4 Now approved on 3 continents, brensocatib has been shown to be safe and effective in treating patients with NCFB, and its approval in Japan continues to broaden treatment access for patients living with this disease.¹ The once daily, oral treatment is the first and only NCFB treatment approved by the MHLW and the only commercially available NCFB treatment in Japan.¹

“As the first approved therapy specifically designed to address the underlying inflammatory process of NCFB, we are pleased that Brinsupri can be made widely available to appropriate patients in Japan who have long needed a treatment option that addresses an unmet driver of their disease,” Samuele Butera, senior vice president and general manager of Global Respiratory for Insmed, said in a press release.¹

ASPEN Trial Data Supported Brensocatib Approvals in 3 Regions

All 3 approvals of brensocatib were based on findings from the phase 3 ASPEN (NCT04594369) clinical trial, and the FDA and European Commission approvals were also supported by data from the phase 2 WILLOW (NCT03218917) clinical trial.^2-4

The phase 3, double-blind ASPEN trial randomized adults 1:1:1 and adolescents 2:2:1 to receive 10 mg or 25 mg of brensocatib per day or placebo. The primary end point was the annualized rate of adjudicated pulmonary exacerbations over a 52-week period.⁵ Patients who received 10 mg or 25 mg of brensocatib experienced a 21.1% and a 19.4% reduction in the annual rate of exacerbations, respectively, compared with placebo.⁴

Of the 1721 patients in the ASPEN trial, 1680 were adults, and 41 were adolescents.^4,5 Both doses of brensocatib also met multiple secondary endpoints, including significantly prolonged time to first exacerbation and an increase in the proportion of patients who remained exacerbation-free over the course of the treatment period.⁴

Patients who received the 25-mg dose experienced a statistically significantly smaller decline in lung function, as measured by forced expiratory volume in 1 second (FEV₁) after bronchodilator use, at week 52 (24 mL vs 62 mL with placebo).^3,5

Brensocatib Safety Profile and the Burden of Bronchiectasis

The ASPEN trial assessed the safety of brensocatib in adults and adolescents aged 12 years and older, and the WILLOW trial assessed its safety in adults.⁴ The most frequently reported adverse reactions were headache (9.2%), hyperkeratosis (5.9%), dermatitis (4.2%), rash (4.1%), upper respiratory tract infections (3.9%), and dry skin (3.0%).³

“Patients have long faced a relentless cycle of exacerbations and declining lung function, with available care largely limited to symptom management,” Martina Flammer, MD, MBA, chief medical officer of Insmed, said in a press release announcing the Japanese approval. “This approval reflects the contributions of patients and researchers who made this clinical evidence possible, as well as Insmed’s enduring commitment to developing therapies that address significant unmet needs in respiratory diseases, including bronchiectasis care.”²

Bronchiectasis continues to carry a substantial burden, with mortality rates of 16% to 24.8% reported over 4 to 5 years of follow-up and reported prevalence in the general population ranging from 52.3 to more than 1000 per 100,000 people.⁶

“By offering Brinsupri as a new treatment option for appropriate patients in Japan, we hope to contribute to better disease management for eligible patients,” Makoto Nakamura, senior vice president and general manager of Japan for Insmed, said in a press release. “Insmed remains committed to supporting the bronchiectasis community through appropriate information provision to healthcare professionals and advancing the proper use of this therapy.”¹

References

1. Insmed launches BRINSUPRI tablets 25 mg (brensocatib hydrate) for the treatment of non-cystic fibrosis bronchiectasis in Japan. News release. Insmed. October 19, 2026. Accessed October 22, 2026. https://www.prnewswire.com/news-releases/insmed-launches-brinsupri-tablets-25-mg-brensocatib-hydrate-for-the-treatment-of-non-cystic-fibrosis-bronchiectasis-in-japan-302911560.html

2. BRINSUPRI (brensocatib) approved by Japan’s Ministry of Health, Labour and Welfare for the treatment of patients with non-cystic fibrosis bronchiectasis, a serious, chronic lung disease. News release. Insmed. August 24, 2026. Accessed October 22, 2026. https://investor.insmed.com/2026-08-24-BRINSUPRI-R-brensocatib-Approved-by-Japans-Ministry-of-Health,-Labour-and-Welfare-for-the-Treatment-of-Patients-With-Non-Cystic-Fibrosis-Bronchiectasis,-a-Serious,-Chronic-Lung-Disease

3. European Commission approves BRINSUPRI (brensocatib) as the first and only treatment approved for non-cystic fibrosis bronchiectasis in the European Union. News release. Insmed. November 18, 2025. Accessed October 22, 2026. https://investor.insmed.com/2025-11-18-European-Commission-Approves-BRINSUPRI-TM-brensocatib-as-the-First-and-Only-Treatment-Approved-for-Non-Cystic-Fibrosis-Bronchiectasis-in-the-European-Union

4. FDA approves BRINSUPRI (brensocatib) as the first and only treatment for non-cystic fibrosis bronchiectasis, a serious, chronic lung disease. News release. Insmed. August 12, 2025. Accessed October 22, 2026. https://investor.insmed.com/2025-08-12-FDA-Approves-BRINSUPRI-TM-brensocatib-as-the-First-and-Only-Treatment-for-Non-Cystic-Fibrosis-Bronchiectasis,-a-Serious,-Chronic-Lung-Disease

5. Chalmers JD, Burgel PR, Daley CL, et al. Phase 3 trial of the DPP-1 inhibitor brensocatib in bronchiectasis. N Engl J Med. 2025;392(16):1569-1581. doi:10.1056/NEJMoa2411664

6. Nigro M, Laska I, Traversi L, Simonetta E, Polverino E. Epidemiology of bronchiectasis. Eur Respir Rev. 2024;33(174):240091. doi:10.1183/16000617.0091-2024