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
Rhea-AI Summary
Insmed (Nasdaq: INSM) announced that Japan’s Ministry of Health, Labour and Welfare has approved BRINSUPRI (brensocatib 25 mg), a once-daily oral treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and pediatric patients ≥12 years. BRINSUPRI is the first and only treatment approved for NCFB in Japan and is now authorized in the U.S., Europe, and Japan.
According to Insmed, approval is based on the Phase 3 ASPEN study, where brensocatib significantly reduced pulmonary exacerbations versus placebo over 52 weeks, prolonged time to first exacerbation, increased the proportion of exacerbation‑free patients, and was associated with lower lung function decline (FEV1). Brensocatib was generally well tolerated; common adverse events included COVID‑19, nasopharyngitis, cough, and headache.
Positive
- MHLW approval in Japan for BRINSUPRI 25 mg in NCFB patients ≥12 years
- First and only approved NCFB treatment in Japan, now approved in U.S., EU/UK, and Japan
- Phase 3 ASPEN showed significant reduction in pulmonary exacerbations vs placebo over 52 weeks
- ASPEN data showed significantly less lung function decline (FEV1) at week 52 with 25 mg
- Once-daily oral small-molecule DPP1 inhibitor targeting chronic airway inflammation
Negative
- Increased dermatologic reactions (rash, dry skin, hyperkeratosis) require monitoring and possible dermatology referral
- Increased gingival and periodontal reactions prompt recommendation for regular dental care
- Live attenuated vaccines should be avoided during treatment due to unknown safety/effectiveness interaction
- Liver enzyme elevations observed in ASPEN; alkaline phosphatase >1.5× ULN in up to 4.1% on 25 mg
- Skin cancers in 1.9% and alopecia in 1.6% of 25 mg patients vs 1.1% and 0.4% on placebo
- Limited data in pregnancy, lactation, and patients <12 years restricts use in these populations
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Aug 06 | Second-quarter earnings | Positive | +33.9% | Revenue growth, BRINSUPRI sales, and raised 2026 guidance accompanied the earnings release. |
| Jul 23 | Earnings call scheduling | Neutral | +0.7% | The company scheduled its second-quarter results release and investor conference call. |
| Jul 16 | TPIP clinical data | Positive | -2.1% | Twelve-month TPIP extension data showed functional improvements and continued development. |
| Jun 23 | Leadership appointment | Positive | +3.6% | Samuele Butera was appointed global respiratory general manager and executive committee member. |
| Jun 04 | Employee equity grants | Neutral | +1.0% | Inducement equity awards were granted to 103 new employees under the 2025 plan. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent positive or informational announcements produced mixed reactions, ranging from 33.86% higher after earnings to 2.14% lower after clinical data.
Key Terms
non-cystic fibrosis bronchiectasis medical
fev1 medical
dipeptidyl peptidase 1 medical
treatment-emergent adverse events medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
—First-in-Disease and First-in-Class Therapy Approved in
"Today's approval of BRINSUPRI represents a profound milestone for people living with bronchiectasis in
The approval of BRINSUPRI by the MHLW for the treatment of patients living with NCFB is based on results from the Phase 3 ASPEN study, which demonstrated that brensocatib significantly reduced pulmonary exacerbations compared with placebo over the 52-week treatment period and met multiple key secondary endpoints, including significantly prolonging the time to first exacerbation and significantly increasing the proportion of patients remaining exacerbation-free over the treatment period. Patients treated with brensocatib 25 mg also demonstrated significantly lower lung function decline at week 52, as measured by post bronchodilator forced expiratory volume in 1 second (FEV1), a standard measure of lung function. Brensocatib was generally well tolerated in the study. The most common treatment-emergent adverse events (TEAEs) occurring in at least
"In patients living with bronchiectasis, recurrent exacerbations represent a substantial disease burden, making daily life harder to manage and affecting long-term clinical outcomes," said Makoto Nakamura, Senior Vice President, General Manager,
About Bronchiectasis
Non-cystic fibrosis bronchiectasis (NCFB) is a chronic, progressive, and inflammatory lung disease that causes the airways to become permanently widened due to a cycle of infection, inflammation, lung tissue damage, and mucociliary dysfunction. Patients with NCFB often experience repeated exacerbations, requiring antibiotic therapy and/or hospitalizations. Symptoms include chronic cough, excessive sputum production, shortness of breath, fatigue, and repeated respiratory infections, which can worsen the underlying disease.
About BRINSUPRI
BRINSUPRI® (brensocatib) is a small molecule, once-daily, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB. The therapy is approved in
BRINSUPRI® (brensocatib)
Indication in the
BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older.
Important Safety Information in the
WARNINGS AND PRECAUTIONS
Dermatologic Adverse Reactions
Treatment with BRINSUPRI is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis. Monitor patients for development of new rashes or skin conditions and refer patients to a dermatologist for evaluation of new dermatologic findings.
Gingival and Periodontal Adverse Reactions
Treatment with BRINSUPRI is associated with an increase in gingival and periodontal adverse reactions. Refer patients to dental care services for regular dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene.
Live Attenuated Vaccines
It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of these vaccines. The use of live attenuated vaccines should be avoided in patients receiving BRINSUPRI.
ADVERSE REACTIONS
The most common adverse reactions ≥
Less Common Adverse Reactions
Liver Function Test Elevations
In
Skin Cancers
In
Alopecia
In
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no clinical data on the use of BRINSUPRI in pregnant women.
Lactation: There is no information regarding the presence of BRINSUPRI and/or its metabolite(s) in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BRINSUPRI and any potential adverse effects on the breastfed child from BRINSUPRI or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of BRINSUPRI for the treatment of NCFB have been established in pediatric patients aged 12 years and older. Common adverse reactions in pediatric patients aged 12 years and older enrolled in
Please see full US Prescribing Information.
About Insmed
Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines — including two approved therapies to treat chronic, debilitating lung diseases — as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. The Company's research engine is advancing a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue, in the pursuit of future pipeline candidates.
Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram, YouTube, and X.
Forward-looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances), may identify forward-looking statements.
The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events, to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to successfully commercialize BRINSUPRI in the U.S., Europe or Japan, or to maintain U.S., European or Japanese approval for BRINSUPRI; uncertainties in the degree of market acceptance of BRINSUPRI by physicians, patients, third-party payors and others in the health care community; inaccuracies in the Company's estimates of the size of the potential markets for BRINSUPRI or in data the Company has used to identify physicians; expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; the Company's inability to obtain adequate reimbursement from government or third-party payors for BRINSUPRI or acceptable prices for BRINSUPRI; development of unexpected safety or efficacy concerns related to BRINSUPRI, including the risk that data generated in further clinical trials of brensocatib may not be consistent with the results of the ASPEN study, which may result in changes to the product label and may adversely affect sales, or result in withdrawal of BRINSUPRI from the market; failure by us to comply with agreements related to brensocatib, including our license agreement with AstraZeneca AB; risk that health care legislation or other government action materially adversely affects the Company's business; and failure of third parties on which the Company is dependent to manufacture sufficient quantities of brensocatib for commercial needs, or to comply with the Company's agreements or laws and regulations that impact the Company's business or agreements with the Company.
The Company may not actually achieve the results, plans, intentions, or expectations indicated by the Company's forward-looking statements, because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year ended December 31, 2025, and any subsequent Company filings with the Securities and Exchange Commission (SEC).
The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Contact:
Investors:
Sara Bonstein
Chief Financial Officer
investor.relations@insmed.com
Media:
Claire Mulhearn
Vice President, Corporate Communications
media@insmed.com
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SOURCE Insmed Incorporated