Insmed (INSM) has upcoming FDA regulatory milestones for ARIKAYCE®. The table below outlines estimated target dates and event types for these pending regulatory actions.
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
BRINSUPRI, Treprostinil, ARIKAYCE®, and Brensocatib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
BRINSUPRI FDA Regulatory Events
BRINSUPRI is a drug developed by Insmed for the following indication: Treatment of Patients With Non-Cystic Fibrosis Bronchiectasis, a Serious, Chronic Lung Disease.
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:
- BRINSUPRI
- Announced Date:
- October 19, 2026
- Indication:
- Treatment of Patients With Non-Cystic Fibrosis Bronchiectasis, a Serious, Chronic Lung Disease
Announcement
Insmed Incorporated announced the commercial launch in Japan of BRINSUPRI® Tablets 25 mg (brensocatib hydrate), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and pediatric patients 12 years and older.
Read Announcement- Drug:
- BRINSUPRI
- Announced Date:
- August 24, 2026
- Indication:
- Treatment of Patients With Non-Cystic Fibrosis Bronchiectasis, a Serious, Chronic Lung Disease
Announcement
Insmed Incorporated announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved BRINSUPRI® (brensocatib 25-mg tablet), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and pediatric patients 12 years and older.
Read Announcement
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:
- October 15, 2026
- Indication:
- Pulmonary arterial hypertension (PAH)
Announcement
Insmed Incorporated a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, will feature the global PALM Clinical Development Program at the American College of Chest Physicians® Annual Meeting 2026 (CHEST 2026), which is investigating treprostinil palmitil inhalation powder (TPIP) in a range of serious pulmonary diseases.
Read Announcement- Drug:
- Treprostinil Palmitil Inhalation Powder (TPIP)
- Announced Date:
- July 16, 2026
- Indication:
- Pulmonary arterial hypertension (PAH)
Announcement
Insmed Incorporated announced positive 12-Month data from the ongoing open-label extension (OLE) study evaluating treprostinil palmitil inhalation powder (TPIP), administered once daily in patients with pulmonary arterial hypertension (PAH, World Health Organization Group 1).
AI Summary
Insmed Incorporated reported positive 12-month results from its ongoing open-label extension study of treprostinil palmitil inhalation powder (TPIP), a once-daily treatment being studied in people with pulmonary arterial hypertension (PAH). The data showed lasting improvement across all major secondary measures, including a lower mortality risk status based on REVEAL Lite 2.0. Patients who switched from placebo also responded well and reached outcomes similar to those who stayed on TPIP by month 12.
TPIP was described as safe and well tolerated, with no new safety concerns seen over the 12-month period. Doses up to 1,280 micrograms once daily were allowed in the study. Insmed said these results, along with the simple once-daily inhaled dosing, support TPIP’s potential to become an important prostanoid treatment option for PAH patients.
Read Announcement- Drug:
- Treprostinil Palmitil Inhalation Powder (TPIP)
- Announced Date:
- September 22, 2025
- Indication:
- Pulmonary arterial hypertension (PAH)
Announcement
Insmed Incorporated announced that it will present seven abstracts from across its late-stage portfolio at the European Respiratory Society (ERS) 2025 Congress, taking place September 27 – October 1, 2025, in Amsterdam.
Read Announcement- 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
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:
- September 21, 2026
- Target Action Date:
- January 28, 2027
- Indication:
- IN PATIENTS WITH NTM LUNG DISEASE CAUSED BY MAC
Announcement
Insmed Incorporated announced that the FDA granted Priority Review to the sNDA and set a target action date of January 28, 2027, under the Prescription Drug User Fee Act (PDUFA).
Read Announcement- Drug:
- ARIKAYCE®
- Announced Date:
- September 21, 2026
- Indication:
- IN PATIENTS WITH NTM LUNG DISEASE CAUSED BY MAC
Announcement
Insmed Incorporated announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's Supplemental New Drug Application (sNDA) for review of ARIKAYCE® (amikacin liposome inhalation suspension) for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen.
Read Announcement- Drug:
- ARIKAYCE®
- Announced Date:
- September 3, 2026
- Indication:
- IN PATIENTS WITH NTM LUNG DISEASE CAUSED BY MAC
Announcement
nsmed Incorporated announced that five abstracts highlighting data from its respiratory portfolio have been accepted for presentation at the European Respiratory Society (ERS) Congress 2026 taking place Sept. 5–9, 2026, in Barcelona.
Read Announcement- Drug:
- ARIKAYCE®
- Announced Date:
- May 4, 2026
- Indication:
- IN PATIENTS WITH NTM LUNG DISEASE CAUSED BY MAC
Announcement
Insmed Incorporated announced that it will present six abstracts from across its respiratory portfolio and pipeline at the American Thoracic Society International Conference 2026 (ATS 2026), taking place May 17–20 in Orlando, Florida.
AI Summary
Insmed Incorporated will present six abstracts from across its respiratory portfolio and pipeline at the American Thoracic Society International Conference 2026 (ATS 2026), taking place May 17–20 in Orlando, Florida. The company will also host a Medical Affairs exhibit booth (location #937) during the meeting.
New data in non-cystic fibrosis bronchiectasis further define the impact of BRINSUPRI on respiratory symptoms. Separate findings from a pharmacokinetic study continue to support further evaluation of treprostinil palmitil inhalation powder as part of a Phase 3 development program.
Insmed is providing an independent research grant to the American Thoracic Society for a landmark quality initiative to improve bronchiectasis diagnosis across the U.S. Presentations include: Late Breaking Science A71 (Sun, May 17, 11:30 AM–1:15 PM EDT); Poster Sessions B45, B106, B107 (Mon, May 18); Poster Session C58 (Tue, May 19); and Mini Symposium D92 (Wed, May 20).
Read Announcement- Drug:
- ARIKAYCE®
- Announced Date:
- March 23, 2026
- Indication:
- IN PATIENTS WITH NTM LUNG DISEASE CAUSED BY MAC
Announcement
Insmed Incorporated announced positive topline results from the Phase 3b ENCORE study.
AI Summary
Insmed announced positive topline results from the Phase 3b ENCORE study of ARIKAYCE. The trial met its primary and all multiplicity-controlled secondary culture conversion endpoints, showing statistically significant and clinically meaningful improvements in respiratory symptom scores and culture conversion rates versus the comparator. These results support the drug’s efficacy in the studied population.
The safety profile observed in ENCORE was consistent with ARIKAYCE’s known profile and revealed no new safety signals. Common treatment-emergent adverse events occurred more often in the ARIKAYCE arm; hemoptysis was reported more frequently with ARIKAYCE plus background regimen (17.9%) versus background regimen alone (12.5%). Nephrotoxicity was seen but not at higher rates than the comparator.
Insmed plans to file a supplemental NDA for ARIKAYCE with the FDA in the second half of 2026 and will submit the data to Japan’s PMDA to support possible label changes. The company will host an investor call on March 23, 2026, at 8:00 AM ET.Read Announcement
- 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
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 7, 2026
- Indication:
- In Patients with Bronchiectasis
Announcement
Insmed Incorporated announced that the Phase 2b CEDAR study, which evaluated brensocatib in adult patients with moderate to severe hidradenitis suppurativa (HS), did not meet its primary or secondary efficacy endpoints in either the 10 mg or 40 mg treatment arms.
AI Summary
Insmed Incorporated announced that the Phase 2b CEDAR study of brensocatib in adults with moderate to severe hidradenitis suppurativa (HS) did not meet its primary or secondary efficacy endpoints in either the 10 mg or 40 mg treatment arms. Because the trial failed to show benefit, Insmed said it will discontinue its HS development program for brensocatib. The study tested whether the drug could reduce abscesses and inflammatory nodules compared with placebo, but it did not demonstrate the expected clinical improvements.
At Week 16, participants showed a 45.5% reduction in total abscess and inflammatory nodule (AN) count in the 10 mg arm and a 40.3% reduction in the 40 mg arm, versus a 57.1% reduction in the placebo arm. Safety findings were consistent with earlier studies and no new safety signals were identified for either dose of brensocatib. Insmed will focus resources away from the HS indication following these results.
Read Announcement- Drug:
- Brensocatib
- Announced Date:
- December 17, 2025
- Indication:
- In Patients with Bronchiectasis
Announcement
Insmed Incorporated nnounced today that the Phase 2b BiRCh study of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) did not meet its primary or secondary efficacy endpoints in either the 10 mg or 40 mg treatment arms.
AI Summary
Insmed reported that the Phase 2b BiRCh study of brensocatib in chronic rhinosinusitis without nasal polyps (CRSsNP) did not meet its primary or secondary efficacy endpoints for either the 10 mg or 40 mg daily doses. About 288 patients were randomized across three arms (brensocatib 10 mg, brensocatib 40 mg, and placebo). The primary endpoint measured change in the 28‑day average Sinus Total Symptom Score (sTSS) at Week 24; least squares mean changes were –2.44 for placebo, –2.21 for brensocatib 10 mg, and –2.33 for brensocatib 40 mg, showing no clear treatment benefit.
Safety was consistent with previous studies and no new safety signals were identified, including at the 40 mg dose. Rates of any treatment‑emergent adverse events were similar across groups. Insmed has discontinued its brensocatib program in CRSsNP and plans to present the full data at a future scientific congress. The company thanked study participants and investigators for their contributions.
Read Announcement- Drug:
- Brensocatib
- Announced Date:
- November 18, 2025
- Indication:
- In Patients with Bronchiectasis
Announcement
Insmed Incorporated announced that the European Commission has approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months.
AI Summary
The European Commission has approved BRINSUPRI (brensocatib 25 mg tablets) to treat non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years and older who had two or more exacerbations in the prior 12 months. BRINSUPRI is a first-in-class DPP1 inhibitor that targets neutrophil-driven inflammation and is the first and only medicine approved for NCFB in the European Union. The European Medicines Agency reviewed it under an accelerated assessment because it is considered of major public health interest.
The approval was supported by Phase 3 ASPEN and Phase 2 WILLOW studies. In ASPEN, BRINSUPRI 25 mg reduced the annual rate of exacerbations by 19.4% versus placebo, delayed time to first exacerbation, increased the share of patients who remained exacerbation-free, and lessened decline in lung function (FEV1) at week 52. Common adverse reactions included headache, hyperkeratosis, dermatitis, rash, upper respiratory infections, and dry skin. Insmed will work with EU authorities to make BRINSUPRI available to eligible patients beginning in early 2026.
Read Announcement- Drug:
- Brensocatib
- Announced Date:
- October 17, 2025
- Indication:
- In Patients with Bronchiectasis
Announcement
Insmed Incorporated announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of its DPP1 inhibitor BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months
AI Summary
Insmed Incorporated announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of BRINSUPRI (brensocatib 25 mg tablets). This DPP1 inhibitor is intended for the treatment of non-cystic fibrosis bronchiectasis in patients 12 years of age and older who have had two or more exacerbations in the prior 12 months.
If approved, BRINSUPRI would be the first and only therapy in the European Union specifically for non-cystic fibrosis bronchiectasis. It is a first-in-class DPP1 inhibitor. The CHMP reviewed the marketing application under the EMA’s accelerated assessment pathway because the medicine is considered of major interest for public health and therapeutic innovation. The positive opinion is based on data from the Phase 3 ASPEN and Phase 2 WILLOW studies.
BRINSUPRI previously received Priority Medicines (PRIME) designation from the EMA after positive WILLOW results. The European Commission will now review the CHMP opinion and is expected to issue a final decision in the coming months. If approved, patients with this progressive lung disease could gain access to a much-needed treatment option.
Read Announcement- Drug:
- Brensocatib
- Announced Date:
- October 16, 2025
- Indication:
- In Patients with Bronchiectasis
Announcement
Insmed Incorporated announced that it will present six abstracts from the Phase 3 ASPEN study of BRINSUPRI™ (brensocatib) at CHEST 2025, the American College of Chest Physicians Annual Meeting, taking place October 19 - October 22, 2025, in Chicago, IL.
AI Summary
Insmed Incorporated will present six abstracts from the Phase 3 ASPEN study of BRINSUPRI™ (brensocatib) at CHEST 2025, the American College of Chest Physicians Annual Meeting, October 19–22, 2025, in Chicago.
The presentations include both prespecified and post-hoc subgroup analyses in patients with non-cystic fibrosis bronchiectasis (NCFB). Highlights feature data showing suppression of neutrophil serine proteases (NSPs) and late-breaking results on structural lung changes from a high-resolution CT substudy.
Additional abstracts will share new insights into brensocatib’s efficacy and safety in patients with comorbid chronic obstructive pulmonary disease (COPD), clinical outcomes in Asian populations, and detailed assessments of symptom burden using the Bronchiectasis Exacerbation and Symptom Tool (BEST) during and outside pulmonary exacerbations.
Together, these analyses explore BRINSUPRI’s mechanism of action and its potential impact on disease management for people living with NCFB.
CHEST 2025 brings respiratory experts together to discuss the latest advances in lung disease treatment and research.
Read Announcement- Drug:
- Brensocatib
- Announced Date:
- August 12, 2025
- Indication:
- In Patients with Bronchiectasis
Announcement
Insmed Incorporated announced that the U.S. Food and Drug Administration (FDA) has approved first-in-class BRINSUPRI™ (brensocatib 10 mg and 25 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older.
AI Summary
Insmed Incorporated announced that the U.S. Food and Drug Administration (FDA) has approved BRINSUPRI™ (brensocatib 10 mg and 25 mg tablets), the first oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older.
This chronic lung disease affects about 500,000 patients in the U.S. and leads to widened airways, excess mucus, persistent infections and frequent exacerbations that can cause permanent lung damage.
BRINSUPRI is a first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor that blocks activation of neutrophil enzymes, directly targeting the inflammation at the root of bronchiectasis flares.
In Phase 3 and Phase 2 trials, BRINSUPRI reduced annual exacerbation rates by about 20%, significantly delayed first flare and helped preserve lung function at one year.
Now available by prescription through a specialty pharmacy network, BRINSUPRI offers the first FDA-approved option to manage non-cystic fibrosis bronchiectasis.
Read Announcement- 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
