INSMED Inc (INSM)
Insmed Incorporated operates as a biopharmaceutical enterprise focused on creating and introducing medical solutions for individuals facing severe and uncommon health conditions. The company's marketed treatment, ARIKAYCE, is administered to adult patients suffering from Mycobacterium avium complex (MAC) lung disease, serving as a component of a broader antibacterial drug regimen. In its development pipeline, Insmed is advancing Brensocatib, an oral and reversible inhibitor targeting dipeptidyl peptidase 1, which is being investigated for its potential in treating bronchiectasis and other disorders mediated by neutrophils. Additionally, the firm is developing Treprostinil Palmitil Inhalation Powder, an inhaled version of the treprostinil palmitil prodrug, designed to address pulmonary arterial hypertension and various other rare lung ailments. Founded in 1988, Insmed Incorporated maintains its primary corporate offices in Bridgewater, New Jersey.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Insmed Incorporated
- Cash runway at this date: 2yr
- Cash runway at this date: 2yr
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Completed
Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections
Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer., Tobramycin inhalation solution using a PARI LC® Plus nebulizer.
Pseudomonas Aeruginosa Infection
NCT01315678Enrollment302StartFeb 2012Primary CompletionJun 2013CompletionSep 2013 - Phase 3Withdrawn
Study to Evaluate Arikace™ in CF Patients With Chronic Infection Due to Pseudomonas Aeruginosa
Liposomal amikacin for inhalation, Placebo for liposomal amikacin for inhalation
Cystic Fibrosis
NCT01315691Enrollment0Start-Primary Completion-Completion- - Phase 3Completed
Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection
Liposomal amikacin for inhalation
Cystic Fibrosis
NCT01316276Enrollment206StartOct 2012Primary CompletionJul 2015CompletionJul 2015 - Phase 3Completed
Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone
LAI (Liposomal Amikacin for Inhalation) 590 mg
Mycobacterium Infections, Nontuberculous
NCT02344004Enrollment336StartMay 2015Primary CompletionJul 2018CompletionApr 2019 - Phase 3Completed
Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212
LAI 590 mg, Multi-drug regimen
NTM Lung Infection Due to MAC
NCT02628600Enrollment163StartFeb 2016Primary CompletionOct 2018CompletionOct 2018 - Phase 3Completed
A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
Brensocatib 10 mg, Brensocatib 25 mg
Non-Cystic Fibrosis Bronchiectasis
NCT04594369Enrollment1,767StartDec 2020Primary CompletionOct 2024CompletionOct 2024 - Phase 3Completed
Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
ALIS, Azithromycin
Mycobacterium Infections, Nontuberculous
NCT04677543Enrollment99StartDec 2020Primary CompletionMay 2023CompletionMay 2023 - Phase 3Completed
Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
ALIS, Azithromycin
Mycobacterium Infections, Nontuberculous
NCT04677569Enrollment425StartApr 2021Primary CompletionNov 2025CompletionJan 2026 - Phase 3Recruiting
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Treprostinil Palmitil Inhalation Powder, Placebo
Pulmonary Hypertension, Interstitial Lung Disease
NCT07179380Enrollment344StartJan 2026Primary CompletionDec 2028est.CompletionDec 2028est. - Phase 3Recruiting
An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Treprostinil Palmitil Inhalation Powder, Placebo
Pulmonary Hypertension, Interstitial Lung Disease
NCT07234032Enrollment344StartJul 2026Primary CompletionJan 2031est.CompletionJan 2031est. - Phase 3Recruiting
A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)
Treprostinil Palmitil Inhalation Powder, Placebo
Pulmonary Arterial Hypertension
NCT07481981Enrollment344StartJul 2026Primary CompletionDec 2028est.CompletionJan 2029est. - Phase 3Not yet recruiting
A Study to Assess the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Progressive Pulmonary Fibrosis (PPF)
Treprostinil Palmitil Inhalation Powder, Placebo
Progressive Pulmonary Fibrosis, Interstitial Lung Disease
NCT07805785Enrollment800StartDec 2026est.Primary CompletionAug 2030est.CompletionAug 2030est. - Phase 2/3Completed
IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome
rhIGF-I/rhIGFBP-3
Growth Hormone Insensitivity Syndrome (GHIS), Laron Syndrome
NCT00368173Enrollment-Start-Primary Completion-Completion- - Phase 2/3Completed
An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Treprostinil Palmitil Inhalation Powder, Placebo
Pulmonary Hypertension, Interstitial Lung Disease
NCT05649722Enrollment31StartMay 2023Primary CompletionApr 2026CompletionApr 2026 - Phase 2/3Active, not recruiting
An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)
Treprostinil Palmitil, Placebo
Pulmonary Arterial Hypertension
NCT05649748Enrollment91StartMar 2023Primary CompletionDec 2026est.CompletionDec 2026est. - Phase 2Terminated
Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan Syndrome
rhIGF-1/rhIGFBP-3
Noonan Syndrome
NCT00351221Enrollment24Start-Primary Completion-Completion- - Phase 2Completed
Safety and Efficacy Study of Recombinant Human Insulin-Like Growth Factor-I/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3) In Myotonic Dystrophy Type 1
rhIGF-I/rhIGFBP-3, placebo
Myotonic Dystrophy Type 1
NCT00577577Enrollment69StartDec 2007Primary CompletionDec 2008CompletionDec 2008 - Phase 2Completed
Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.
280 mg Arikayce™, Matching Placebo for Cohort 1
Bronchiectasis
NCT00775138Enrollment64StartJun 2008Primary CompletionMay 2009CompletionMay 2009 - Phase 2Completed
Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria
Liposomal amikacin for inhalation (LAI), placebo
Mycobacterium Infections, Nontuberculous
NCT01315236Enrollment90StartApr 2012Primary CompletionAug 2014CompletionJun 2015 - Phase 2Completed
Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis
Brensocatib 10 mg, Brensocatib 25 mg
Non-Cystic Fibrosis Bronchiectasis
NCT03218917Enrollment256StartOct 2017Primary CompletionDec 2019CompletionDec 2019 - Phase 2Completed
Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase
Arikayce™
Cystic Fibrosis
NCT03905642Enrollment49StartJan 2009Primary CompletionNov 2010CompletionNov 2010 - Phase 2Terminated
A Study of Treprostinil Palmitil Inhalation Powder (TPIP) In Pulmonary Arterial Hypertension (PAH)
Treprostinil Palmitil
Pulmonary Arterial Hypertension
NCT04791514Enrollment1StartMar 2022Primary CompletionAug 2022CompletionAug 2022 - Phase 2Completed
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis
Brensocatib, Placebo
Cystic Fibrosis
NCT05090904Enrollment29StartNov 2021Primary CompletionNov 2022CompletionNov 2022 - Phase 2Completed
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension
Treprostinil Palmitil, Placebo
Pulmonary Arterial Hypertension
NCT05147805Enrollment102StartAug 2022Primary CompletionMar 2025CompletionMar 2025 - Phase 2Completed
A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
Treprostinil Palmitil, Placebo
Pulmonary Hypertension
NCT05176951Enrollment39StartDec 2022Primary CompletionMar 2024CompletionMar 2024
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Completed | Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer., Tobramycin inhalation solution using a PARI LC® Plus nebulizer. | NCT01315678 |
| Phase 3 | Withdrawn | Liposomal amikacin for inhalation, Placebo for liposomal amikacin for inhalation | NCT01315691 |
| Phase 3 | Completed | Liposomal amikacin for inhalation | NCT01316276 |
| Phase 3 | Completed | LAI (Liposomal Amikacin for Inhalation) 590 mg | NCT02344004 |
| Phase 3 | Completed | LAI 590 mg, Multi-drug regimen | NCT02628600 |
| Phase 3 | Completed | Brensocatib 10 mg, Brensocatib 25 mg | NCT04594369 |
| Phase 3 | Completed | ALIS, Azithromycin | NCT04677543 |
| Phase 3 | Completed | ALIS, Azithromycin | NCT04677569 |
| Phase 3 | Recruiting | Treprostinil Palmitil Inhalation Powder, Placebo | NCT07179380 |
| Phase 3 | Recruiting | Treprostinil Palmitil Inhalation Powder, Placebo | NCT07234032 |
| Phase 3 | Recruiting | Treprostinil Palmitil Inhalation Powder, Placebo | NCT07481981 |
| Phase 3 | Not yet recruiting | Treprostinil Palmitil Inhalation Powder, Placebo | NCT07805785 |
| Phase 2/3 | Completed | rhIGF-I/rhIGFBP-3 | NCT00368173 |
| Phase 2/3 | Completed | Treprostinil Palmitil Inhalation Powder, Placebo | NCT05649722 |
| Phase 2/3 | Active, not recruiting | Treprostinil Palmitil, Placebo | NCT05649748 |
| Phase 2 | Terminated | rhIGF-1/rhIGFBP-3 | NCT00351221 |
| Phase 2 | Completed | rhIGF-I/rhIGFBP-3, placebo | NCT00577577 |
| Phase 2 | Completed | 280 mg Arikayce™, Matching Placebo for Cohort 1 | NCT00775138 |
| Phase 2 | Completed | Liposomal amikacin for inhalation (LAI), placebo | NCT01315236 |
| Phase 2 | Completed | Brensocatib 10 mg, Brensocatib 25 mg | NCT03218917 |
| Phase 2 | Completed | Arikayce™ | NCT03905642 |
| Phase 2 | Terminated | Treprostinil Palmitil | NCT04791514 |
| Phase 2 | Completed | Brensocatib, Placebo | NCT05090904 |
| Phase 2 | Completed | Treprostinil Palmitil, Placebo | NCT05147805 |
| Phase 2 | Completed | Treprostinil Palmitil, Placebo | NCT05176951 |
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