This section highlights FDA-related milestones and regulatory updates for drugs developed by Insmed (INSM).
Over the past two years, Insmed has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ARIKAYCE®, Brensocatib, and Treprostinil. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ARIKAYCE® - FDA Regulatory Timeline and Events
ARIKAYCE® is a drug developed by Insmed for the following indication: IN PATIENTS WITH NTM LUNG DISEASE CAUSED BY MAC.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ARIKAYCE®
- Announced Date:
- May 21, 2025
- Indication:
- IN PATIENTS WITH NTM LUNG DISEASE CAUSED BY MAC
Announcement
Insmed Incorporated presented 11 new abstracts at the American Thoracic Society (ATS) 2025 International Conference, which took place May 18-21 in San Francisco, including three prespecified subgroup analyses from the Phase 3 ASPEN trial of brensocatib in non-cystic fibrosis bronchiectasis (NCFBE), signaling the consistency of efficacy and safety outcomes across diverse clinical profiles.
AI Summary
Insmed Incorporated presented 11 new abstracts at the ATS 2025 International Conference in San Francisco. Notably, the company shared three prespecified subgroup analyses from the Phase 3 ASPEN trial for brensocatib in non-cystic fibrosis bronchiectasis (NCFBE). The data showed that brensocatib consistently reduced pulmonary exacerbations, delayed the time to the first exacerbation, and helped maintain lung function compared to a placebo. These findings remained true across various patient groups, including adolescents aged 12 and older, patients receiving maintenance macrolide therapy, and individuals with different blood eosinophil levels. The consistent efficacy and safety outcomes across these diverse clinical profiles reinforce brensocatib’s potential as a foundational treatment for NCFBE—a condition with a significant unmet medical need and no currently approved therapies.
Read Announcement- Drug:
- ARIKAYCE®
- Announced Date:
- May 20, 2024
- Indication:
- IN PATIENTS WITH NTM LUNG DISEASE CAUSED BY MAC
Announcement
Insmed Incorporated announced that late-breaking data from the ARISE study of ARIKAYCE® (amikacin liposome inhalation suspension) were presented at the American Thoracic Society (ATS) 2024 International Conference in San Diego.
AI Summary
Insmed Incorporated announced at the ATS 2024 International Conference in San Diego that late-breaking data from the ARISE study of ARIKAYCE® (amikacin liposome inhalation suspension) showed promising results in patients with MAC lung disease. The study focused on patients with newly diagnosed or recurrent nontuberculous mycobacterial lung infection who had not received antibiotics for their current infection. Data presented in both oral and Breaking News sessions highlighted that patients receiving ARIKAYCE plus a macrolide-based regimen experienced faster and higher rates of culture conversion and continued improvement in respiratory symptoms through Month 7—even one month after treatment ended. Additionally, no patients developed resistance to ARIKAYCE or macrolides, supporting the potential of ARIKAYCE to benefit a broader group of individuals battling MAC lung disease.
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Brensocatib - FDA Regulatory Timeline and Events
Brensocatib is a drug developed by Insmed for the following indication: In Patients with Bronchiectasis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Brensocatib
- Announced Date:
- April 23, 2025
- Indication:
- In Patients with Bronchiectasis
Announcement
Insmed Incorporated announced that positive results from the pivotal phase 3 ASPEN study of brensocatib in patients with non-cystic fibrosis bronchiectasis were published in the New England Journal of Medicine (NEJM).
AI Summary
Insmed Incorporated announced that positive results from its pivotal phase 3 ASPEN study of brensocatib in patients with non-cystic fibrosis bronchiectasis have been published in the New England Journal of Medicine. The ASPEN study, the largest clinical trial ever conducted in bronchiectasis, showed that brensocatib significantly reduced the annualized rate of pulmonary exacerbations compared to placebo. Notably, the 25 mg dose not only reduced lung function decline but also prolonged the time to first exacerbation and increased the proportion of patients who remained exacerbation-free during the 52-week treatment period.
This promising trial marks an important step for the potential approval of brensocatib, offering hope for millions suffering from this chronic inflammatory disease. By targeting inflammation, brensocatib may become the first approved treatment for bronchiectasis, which currently has no approved therapies, and could transform patient care if approved by the FDA.
Read Announcement- Drug:
- Brensocatib
- Announced Date:
- October 8, 2024
- Indication:
- In Patients with Bronchiectasis
Announcement
Insmed Incorporated presented positive late-breaking subgroup data from the Phase 3 ASPEN study, a global, randomized, double-blind, placebo-controlled Phase 3 study to assess the efficacy, safety, and tolerability of brensocatib in patients with non-cystic fibrosis bronchiectasis.
AI Summary
Insmed Incorporated recently presented promising subgroup data from the Phase 3 ASPEN study at CHEST 2024. The global, randomized, double-blind, placebo-controlled study evaluated brensocatib, an investigational drug, in patients with non-cystic fibrosis bronchiectasis. The subgroup results showed that both doses, especially the 25 mg dose, led to a consistent reduction in the annualized rate of pulmonary exacerbations across most prespecified groups. Additionally, the 25 mg dose helped slow the decline in lung function, as measured by FEV1, for all evaluated subgroups. These positive findings generate excitement among physicians and patients because they suggest that brensocatib could offer a much-needed treatment option for this difficult-to-treat disease. The study also demonstrated that brensocatib was well-tolerated, supporting its potential as a transformative therapy in the management of bronchiectasis.
Read Announcement- Drug:
- Brensocatib
- Announced Date:
- May 28, 2024
- Indication:
- In Patients with Bronchiectasis
Announcement
Insmed Incorporated announced positive topline results from the ASPEN study, a global, randomized, double-blind, placebo-controlled Phase 3 study to assess the efficacy, safety, and tolerability of brensocatib in patients with non-cystic fibrosis bronchiectasis.
AI Summary
Insmed Incorporated announced positive topline results from the global ASPEN Phase 3 study evaluating brensocatib in patients with non-cystic fibrosis bronchiectasis. The double-blind, placebo-controlled study met its primary endpoint, showing that both dosage strengths of brensocatib significantly reduced the annual rate of pulmonary exacerbations compared to placebo. Secondary endpoints were also achieved with statistical significance, further supporting the benefits of treatment.
Brensocatib was found to be well-tolerated in the study, and these findings validate DPP1 inhibition as a new mechanism of action that could benefit various neutrophil-mediated diseases. Based on the positive data, Insmed plans to file a New Drug Application with the FDA in Q4 2024 and anticipates a U.S. launch in mid-2025. These results mark a promising advancement in the treatment landscape for bronchiectasis.
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Treprostinil Palmitil Inhalation Powder (TPIP) - FDA Regulatory Timeline and Events
Treprostinil Palmitil Inhalation Powder (TPIP) is a drug developed by Insmed for the following indication: Pulmonary arterial hypertension (PAH).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Treprostinil Palmitil Inhalation Powder (TPIP)
- Announced Date:
- June 10, 2025
- Indication:
- Pulmonary arterial hypertension (PAH)
Announcement
Insmed Incorporated announced positive topline results from its randomized, double-blind, placebo-controlled Phase 2b study evaluating the efficacy and safety of treprostinil palmitil inhalation powder (TPIP), administered once daily in patients with pulmonary arterial hypertension (PAH, World Health Organization Group 1).
AI Summary
Insmed Incorporated announced positive topline results from its randomized, double-blind, placebo-controlled Phase 2b study evaluating treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary arterial hypertension (PAH). The study met its primary endpoint, showing a statistically significant 35% placebo-adjusted reduction in pulmonary vascular resistance, and achieved all secondary endpoints, including a 35.5-meter improvement in the six-minute walk distance and a 60% reduction in NT-proBNP concentrations. These benefits were maintained throughout the 24-hour dosing period, and TPIP was well tolerated, with most patients titrating to the highest dose. Based on these promising results, Insmed will engage with the U.S. Food and Drug Administration to guide the design of upcoming Phase 3 trials. Future studies are planned for patients with PAH and those with pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Read Announcement
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