Insmed

Insmed(INSM)

BRIDGEWATER, NJ
Biotechnology6 H-1B visas (FY2023)

Focus: Inhalable Liposomal Therapeutics

Insmed is a life sciences company focused on Inhalable Liposomal Therapeutics.

NeurologyRare DiseasesCardiovascularRespiratoryOphthalmology
Funding Stage
PUBLIC
Employees
1-50
Open Jobs
83

Products & Portfolio (2)

1 discontinued product not shown

ARIKAYCE KIT
amikacin
Peak
INHALATION · SUSPENSION, LIPOSOMAL
12.1 Mechanism of Action ARIKAYCE is an antibacterial drug [see ]. 12.2 Pharmacodynamics ARIKAYCE exposure-response relationships and the time course of pharmacodynamic response are unknown. 12.3 Pharmacokinetics Sputum Concentrations Following once daily inhalation of 590 mg ARIKAYCE in Mycobacterium avium complex (MAC) patients, sputum concentrations at 1 to 4 hours post-inhalation were 1720, 884, and 1300 mcg/g at 1, 3, and 6 months, respectively. High variability in amikacin concentrations were observed (CV% >100%). After 48 to 72 hours post-inhalation, amikacin sputum concentrations decreased to approximately 5% of those at 1 to 4 hours post-inhalation. Serum Concentrations Following 3 months of once daily inhalation of 590 mg ARIKAYCE in MAC patients, the mean serum AUC 0-24 was 23.5 mcg*hr/mL (range: 8.0 to 46.5 mcg*hr/mL; n=12) and the mean serum C max was 2.8 mcg/mL (range: 1.0 to 4.4 µg/mL; n=12). The maximum C max and AUC 0-24 were below the mean C max of approximately 76 mcg/mL and AUC 0-24 of 154 mcg*hr/mL observed for intravenous administration of amikacin sulfate for injection at the approved dosage of 15 mg/kg once daily in healthy adults. Absorption The bioavailability of ARIKAYCE is expected to vary primarily from individual differences in nebulizer efficiency and airway pathology. Distribution The protein binding of amikacin in serum is ≤ 10%. Elimination Following inhalation of ARIKAYCE in MAC patients, the apparent serum half-life of amikacin ranged from approximately 5.9 to 19.5 hrs. Metabolism Amikacin does not undergo appreciable metabolism. Excretion Systemically absorbed amikacin following ARIKAYCE administration is eliminated principally via glomerular filtration. On average, 7.42% (ranging from 0.72 to 22.60%; n=14) of the total ARIKAYCE dose was excreted in urine as unchanged drug compared to 94% following intravenous administration of amikacin sulfate for injection. Unabsorbed amikacin, following ARIKAYCE inhalation, is probably eliminated primarily by cellular turnover and expectoration. Drug Interaction Studies No clinical drug interaction studies have been conducted with ARIKAYCE [see ]. 12.4 Microbiology Mechanism of Action Amikacin is a polycationic, semisynthetic, bactericidal aminoglycoside. Amikacin enters the bacterial cell by binding to negatively charged components of the bacterial cell wall disrupting the overall architecture of the cell wall. The primary mechanism of action is the disruption and inhibition of protein synthesis in the target bacteria by binding to the 30S ribosomal subunit. Resistance The mechanism of resistance to amikacin in mycobacteria has been linked to mutations in the rrs gene of the 16S rRNA. In clinical trials, MAC isolates developing an amikacin MIC of > 64 mcg/mL after baseline were observed in a higher proportion of subjects treated with ARIKAYCE [see ] . Interaction with Other Antimicrobials There has been no in vitro signal for antagonism between amikacin and other antimicro
no alternative treatment optionsfor the treatment of Mycobacterium avium complex (MAC) lung disease
2018
0
BRINSUPRI
brensocatib
Launch
ORAL · TABLET
competitive, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). DPP1 activates pro-inflammatory neutrophil serine proteases (NSPs) during neutrophil maturation in the bone marrow. Activated NSPs are implicated in the pathogenesis of neutrophil-mediated NCFB inflammation. In cell-based assays, DPP1 inhibition by brensocatib reduces the activity of NSPs including neutrophil elastase, cathepsin G, and proteinase 3.
non-cystic fibrosis bronchiectasis in adultolder
2025
0

Pipeline & Clinical Trials

Clinical Trials (1)
NCT05344508An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis Bronchiectasis
N/A
Treprostinil Palmitil
Pulmonary Arterial Hypertension
N/A
Clinical Trials (1)
NCT06939647An Expanded Access Study to Assess Treprostinil Palmitil Inhalation Powder (TPIP) for Participants With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
N/A
Development of a Canadian Bronchiectasis and NTM Database
Bronchiectasis
N/A
Clinical Trials (1)
NCT06144996Development of a Canadian Bronchiectasis and NTM Database
N/A
Phase 1
Clinical Trials (1)
NCT05965570A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Participants
Phase 1
Phase 1
Clinical Trials (1)
NCT05517525A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Brensocatib in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
Phase 1
Clinical Trials (1)
NCT06817382A Study to Investigate the Safety and Biodistribution of a Single Intrathecal (IT) Injection of INS1201 in Ambulatory Males With Duchenne Muscular Dystrophy (DMD)
Phase 1
[14C]-brensocatib
Healthy Volunteers
Phase 1
Clinical Trials (1)
NCT05652257A Study of the Absorption, Metabolism, and Excretion of [14C]-Brensocatib Following a Single Oral Administration in Healthy Male Participants
Phase 1
SLIT™ Amikacin
Cystic Fibrosis
Phase 1
Clinical Trials (1)
NCT06238856Single Dose Escalation Study of TR02 (Sustained Lipid Inhalation Technology [SLIT™] Amikacin) in Participants With Cystic Fibrosis (CF) Having Chronic Infections of Pseudomonas Aeruginosa
Phase 1
Liposomal Amikacin for Inhalation
Healthy Volunteers
Phase 1
Clinical Trials (1)
NCT05999942A Study to Investigate Lung Deposition of Inhaled Amikacin-loaded Liposomes in Healthy Male Participants
Phase 1
Phase 1
Clinical Trials (1)
NCT05927597A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of INS1007 in Healthy Japanese and Caucasian Participants
Phase 1
Phase 1
Clinical Trials (1)
NCT07102316A Study to Assess the Relative Bioavailability After a Single Inhalation Administration of Treprostinil Palmitil Inhalation Powder (TPIP) Formulation 2 (F2) to TPIP Formulation 3 (F3) in Healthy Participants
Phase 1
Clinical Trials (1)
NCT07290062A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants With Amyotrophic Lateral Sclerosis (ALS)
Phase 1
Brensocatib Oral Solution
Healthy Participants
Phase 1
Clinical Trials (1)
NCT06344728A Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets in Healthy Participants
Phase 1
Treprostinil Palmitil Inhalation Powder
Healthy Volunteers
Phase 1
Clinical Trials (1)
NCT06091579A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder (TPIP) in Healthy Participants
Phase 1
Phase 1
Clinical Trials (1)
NCT05355935A Study to Investigate the Effects of Brensocatib on QT Interval in Healthy Participants
Phase 1
Brensocatib
Renal Impairment
Phase 1
Clinical Trials (1)
NCT05673603A Study of Brensocatib Following a Single Oral Administration in Participants With or Without Renal Impairment
Phase 1
Phase 1
Clinical Trials (1)
NCT05826574A Study to Assess Pharmacokinetics (PK) of Brensocatib Alone and With Multiple Doses of Rifampin or Esomeprozole in Healthy Participants
Phase 1
Phase 1
Clinical Trials (1)
NCT06193031A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of C16TR for Inhalation With Tyvaso® Cohort in Healthy Participants
Phase 1
Phase 1
Clinical Trials (1)
NCT06178783A Study of the Palatability and Acceptability of Different Brensocatib Oral Liquid Formulations in Healthy Participants
Phase 1
ARIKACE™
Cystic Fibrosis
Phase 1/2
Clinical Trials (1)
NCT00777296Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™)
Phase 1/2
Cisplatin liposomal
Osteosarcoma Metastatic
Phase 1/2
Clinical Trials (1)
NCT00102531Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung
Phase 1/2
Arikayce™ 560 mg
Cystic Fibrosis
Phase 1/2
Clinical Trials (1)
NCT00558844Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa
Phase 1/2
Nordihydroguaiaretic Acid
Prostate Cancer
Phase 2
Clinical Trials (1)
NCT00678015Pharmacokinetic and Efficacy Study of Nordihydroguaiaretic Acid (NDGA) in Non Metastatic Recurrent Prostate Cancer
Phase 2
rhIGF-1/rhIGFBP-3
Noonan Syndrome
Phase 2
Clinical Trials (1)
NCT00351221Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan Syndrome
Phase 2
Phase 2
Clinical Trials (1)
NCT03218917Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis
Phase 2
Brensocatib
Cystic Fibrosis
Phase 2
Clinical Trials (1)
NCT05090904A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis
Phase 2
LAI plus multi-drug regimen
Mycobacterium Infections, Nontuberculous
Phase 2
Clinical Trials (1)
NCT03038178Liposomal Amikacin for Inhalation (LAI) in the Treatment of Mycobacterium Abscessus Lung Disease
Phase 2
Treprostinil Palmitil
Pulmonary Arterial Hypertension
Phase 2
Clinical Trials (1)
NCT05147805A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension
Phase 2
Liposomal amikacin for inhalation
Mycobacterium Infections, Nontuberculous
Phase 2
Clinical Trials (1)
NCT01315236Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria
Phase 2
Clinical Trials (1)
NCT06013241A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Phase 2
Phase 2
Clinical Trials (1)
NCT06685835A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)
Phase 2
Arikayce™
Cystic Fibrosis
Phase 2
Clinical Trials (1)
NCT03905642Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase
Phase 2
Treprostinil Palmitil
Pulmonary Arterial Hypertension
Phase 2
Clinical Trials (1)
NCT04791514A Study of Treprostinil Palmitil Inhalation Powder (TPIP) In Pulmonary Arterial Hypertension (PAH)
Phase 2
280 mg Arikayce™
Bronchiectasis
Phase 2
Clinical Trials (1)
NCT00775138Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.
Phase 2
Treprostinil Palmitil
Pulmonary Hypertension
Phase 2
Clinical Trials (1)
NCT05176951A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
Phase 2
rhIGF-I/rhIGFBP-3
Myotonic Dystrophy Type 1
Phase 2
Clinical Trials (1)
NCT00577577Safety 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
Phase 2
Treprostinil Palmitil Inhalation Powder
Pulmonary Hypertension
Phase 2/3
Clinical Trials (1)
NCT05649722An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Phase 2/3
Clinical Trials (1)
NCT00368173IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome
Phase 2/3
Treprostinil Palmitil
Pulmonary Arterial Hypertension
Phase 2/3
Clinical Trials (1)
NCT05649748An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)
Phase 2/3
Clinical Trials (1)
NCT02628600Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212
Phase 3
Clinical Trials (1)
NCT04677543Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
Phase 3
Liposomal amikacin for inhalation
Pseudomonas Aeruginosa Infection
Phase 3
Clinical Trials (1)
NCT01315678Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections
Phase 3
Clinical Trials (1)
NCT02344004Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone
Phase 3
Treprostinil Palmitil Inhalation Powder
Pulmonary Hypertension
Phase 3
Clinical Trials (1)
NCT07234032An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Phase 3
Clinical Trials (1)
NCT04677569Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
Phase 3
Brensocatib
Covid19
Phase 3
Clinical Trials (1)
NCT04817332STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19
Phase 3
Liposomal amikacin for inhalation
Cystic Fibrosis
Phase 3
Clinical Trials (1)
NCT01315691Study to Evaluate Arikace™ in CF Patients With Chronic Infection Due to Pseudomonas Aeruginosa
Phase 3
Treprostinil Palmitil Inhalation Powder
Pulmonary Hypertension
Phase 3
Clinical Trials (1)
NCT07179380Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Phase 3
Phase 3
Clinical Trials (1)
NCT04594369A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
Phase 3
Liposomal amikacin for inhalation
Cystic Fibrosis
Phase 3
Clinical Trials (1)
NCT01316276Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection
Phase 3

Open Jobs (83)

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Senior Scientist

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Director, In Vivo Research

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Yesterday
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Executive Director, Clinical Program Lead

NJ Corporate Headquarters
Yesterday
$306K - $417K/yr

Senior Scientist

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Yesterday
$127K - $166K/yr

Sr Director, Programming Infrastructure & Analytics Enablement

NJ Corporate Headquarters
Yesterday
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Systems Engineer II

NJ Corporate Headquarters
Yesterday
$113K - $144K/yr

IT Systems Engineer II (GxP)

NJ Corporate Headquarters
Yesterday
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Senior Analyst, Quality Assurance

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Senior Director, Small molecule -Analytical development and QC

NJ Corporate Headquarters
Yesterday
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Senior Engineer, Supplier Quality

NJ Corporate Headquarters
Yesterday
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Senior Scientist Formulation and Process Development

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Yesterday
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QMS Specialist, Quality Assurance

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Yesterday
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2d ago
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Director, Patient & Professional Advocacy, Market Development

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2d ago
$177K - $242K/yr

Therapeutic Specialist, Peoria, IL

Peoria, IL
4d ago
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4d ago
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4d ago
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5d ago
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Associate Director, Regulatory Affairs CMC, EMEA

UK
5d ago

Senior Associate, Supplier Relationship Management

NJ Corporate Headquarters
5d ago
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View all 83 open positions →
Interview Prep Quick Facts
Portfolio: 3 approved products, 50 clinical trials
Top TAs: Rare Diseases, Cardiovascular, Respiratory
H-1B (2023): 6 approvals
SEC Filings: 2 available
Open Roles: 83 active jobs
Portfolio Health
Launch1 (33%)
Peak1 (33%)
LOE Approaching1 (33%)
3 total products
Therapeutic Area Focus
Rare Diseases
1 marketed11 pipeline
Cardiovascular
8 pipeline
Respiratory
1 marketed3 pipeline
Nephrology
1 pipeline
Neurology
1 pipeline
Oncology
1 pipeline
Marketed
Pipeline

Financials (FY2025)

Revenue
$305M24%
R&D Spend
$571M(187%)44%
Net Income
-$750M
Cash
$555M

Hiring Trend

Actively Hiring
83
Open Roles
+54
Added
-11
Filled/Removed

Based on last 4 crawl cycles

Visa Sponsorship

Sponsors Work Visas
H-1B Petitions (FY2023)
6
Approved
0
Denied
100%
Rate

Source: USCIS H-1B Employer Data Hub