Biotech · INSM · 46 trials led

Insmed clinical trial pipeline

46 trials as lead sponsor, 2 recruiting now, 14 in phase 3. Live from ClinicalTrials.gov, updated daily.

  • Status changeStatus moved to completedWas recruiting · always alerts
  • Completion date movePrimary completion slipped 210 daysSlips and pull-ins of 30+ days
  • New trialNew trial registered in your scopeFirst posted within 30 days
  • Enrollment changeEnrollment grew to 1,200Moves of 15%+ or count finalised
  • Substantive record editPrimary endpoint redefined from 24 to 52 weeksRead overnight and flagged in plain English
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Archive historyOct 2022 to Jun 2026

68 recorded changes across Insmed trials

Every status move, completion date shift and enrollment change ComplyRx has recorded across 19 of these trials. One is shown below.

Status changeStatus moved to recruiting from not yet recruitingNCT07481981 · recorded 1 Jun 2026
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+64 more recorded changes · Track a drug to see every change the night it lands

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Most active programmes

The drugs appearing most often across Insmed's recently active trials. Comparator arms are excluded.

  • Brensocatib10 trials
  • Treprostinil Palmitil Inhalation Powder6 trials
  • Treprostinil Palmitil5 trials
  • ALIS2 trials
  • Azithromycin2 trials
  • Ethambutol2 trials

Upcoming readouts

Next primary completion dates among Insmed's active phase 2 and phase 3 trials. Dates are registry estimates and move often, which is exactly what the tracker watches.

Top therapeutic areas

Conditions studied most often across Insmed's recently active trials.

  • Cystic Fibrosis7 trials
  • Pulmonary Arterial Hypertension5 trials
  • Pulmonary Hypertension4 trials
  • Mycobacterium Infections, Nontuberculous4 trials
  • Interstitial Lung Disease3 trials
  • Non-Cystic Fibrosis Bronchiectasis3 trials

Insmed trials

The 46 most significant of Insmed's recently active trials, soonest estimated readout first.
Select any row for the full record; the change timeline unlocks with tracking.

TrialPhaseStabilityStatusEnrollmentEst. readout
An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)NCT05649748Treprostinil PalmitilPhase 2Locked · track to revealOngoingActive, not recruiting91 est.31 Dec 2026
A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Normal Hepatic Function and Participants With Hepatic ImpairmentNCT07643155Treprostinil Palmitil Inhalation PowderPhase 1Not yet scoredOngoingNot yet recruiting30 est.7 Feb 2027
PALM-PAHA Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)NCT07481981Treprostinil Palmitil Inhalation PowderPhase 3Locked · track to revealOngoingRecruiting344 est.28 Dec 2028
PALM-ILDEfficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)NCT07179380Treprostinil Palmitil Inhalation PowderPhase 3Locked · track to revealOngoingRecruiting344 est.30 Dec 2028
An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)NCT07234032Treprostinil Palmitil Inhalation PowderPhase 3Locked · track to revealOngoingNot yet recruiting344 est.22 Jan 2031
An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)NCT05649722Treprostinil Palmitil Inhalation PowderPhase 2Locked · track to revealCompleted31 est.1 Apr 2026
CEDARA Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)NCT06685835BrensocatibPhase 2Locked · track to revealStoppedTerminated214 est.12 Feb 2026
ENCOREStudy to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium ComplexNCT04677569ALISPhase 3Locked · track to revealCompleted425 est.21 Nov 2025
A 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 ParticipantsNCT07102316TPIP F2Phase 1Locked · track to revealCompleted42 est.25 Oct 2025
BiRChA Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)NCT06013241BrensocatibPhase 2Locked · track to revealCompleted288 est.30 Sept 2025
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial HypertensionNCT05147805Treprostinil PalmitilPhase 2Locked · track to revealCompleted102 est.27 Mar 2025
ASPENA Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis BronchiectasisNCT04594369Brensocatib 10 mgPhase 3Locked · track to revealCompleted1,767 est.28 Oct 2024
INS1007A Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets in Healthy ParticipantsNCT06344728Brensocatib Oral SolutionPhase 1Locked · track to revealCompleted24 est.24 May 2024
A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung DiseaseNCT05176951Treprostinil PalmitilPhase 2Locked · track to revealCompleted39 est.14 Mar 2024
A Study of the Palatability and Acceptability of Different Brensocatib Oral Liquid Formulations in Healthy ParticipantsNCT06178783BrensocatibPhase 1Locked · track to revealCompleted20 est.4 Jan 2024
A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy ParticipantsNCT05965570BrensocatibPhase 1Locked · track to revealCompleted22 est.22 Sept 2023
A Study to Assess Pharmacokinetics (PK) of Brensocatib Alone and With Multiple Doses of Rifampin or Esomeprozole in Healthy ParticipantsNCT05826574BrensocatibPhase 1Locked · track to revealCompleted32 est.16 Jul 2023
A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Brensocatib in Participants With Normal Hepatic Function and Participants With Hepatic ImpairmentNCT05517525BrensocatibPhase 1Locked · track to revealCompleted30 est.1 Jun 2023
ARISEValidation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium ComplexNCT04677543ALISPhase 3Locked · track to revealCompleted99 est.9 May 2023
A Study of Brensocatib Following a Single Oral Administration in Participants With or Without Renal ImpairmentNCT05673603BrensocatibPhase 1Locked · track to revealCompleted28 est.14 Feb 2023
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic FibrosisNCT05090904BrensocatibPhase 2Locked · track to revealCompleted29 est.1 Nov 2022
A Study to Investigate the Effects of Brensocatib on QT Interval in Healthy ParticipantsNCT05355935BrensocatibPhase 1Locked · track to revealCompleted48 est.7 Oct 2022
A Study of Treprostinil Palmitil Inhalation Powder (TPIP) In Pulmonary Arterial Hypertension (PAH)NCT04791514Treprostinil PalmitilPhase 2Locked · track to revealStoppedTerminated1 est.26 Aug 2022
A Study of the Absorption, Metabolism, and Excretion of [14C]-Brensocatib Following a Single Oral Administration in Healthy Male ParticipantsNCT05652257[14C]-brensocatibPhase 1Locked · track to revealCompleted7 est.14 Sept 2021
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder (TPIP) in Healthy ParticipantsNCT06091579Treprostinil Palmitil Inhalation PowderPhase 1Locked · track to revealCompleted42 est.12 Jan 2021
Assessment of INS1007 in Participants With Non-Cystic Fibrosis BronchiectasisNCT03218917Brensocatib 10 mgPhase 2Locked · track to revealCompleted256 est.12 Dec 2019
A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of INS1007 in Healthy Japanese and Caucasian ParticipantsNCT05927597INS1007Phase 1Locked · track to revealCompleted82 est.1 Aug 2019
Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212NCT02628600LAI 590 mgPhase 3Locked · track to revealCompleted163 est.17 Oct 2018
CONVERTStudy to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen AloneNCT02344004LAI (Liposomal Amikacin for Inhalation) 590 mgPhase 3Locked · track to revealCompleted336 est.3 Jul 2018
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of C16TR for Inhalation With Tyvaso® Cohort in Healthy ParticipantsNCT06193031C16TRPhase 1Locked · track to revealCompleted24 est.18 Dec 2015
Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) InfectionNCT01316276Liposomal amikacin for inhalationPhase 3Locked · track to revealCompleted206 est.16 Jul 2015
Liposomal Amikacin for Inhalation (LAI) for Nontuberculous MycobacteriaNCT01315236Liposomal amikacin for inhalation (LAI)Phase 2Locked · track to revealCompleted90 est.18 Aug 2014
Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa InfectionsNCT01315678Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer.Phase 3Locked · track to revealCompleted302 est.Jun 2013
Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension PhaseNCT03905642Arikayce™Phase 2Locked · track to revealCompleted49 est.2 Nov 2010
Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas AeruginosaNCT00558844Arikayce™ 560 mgPhase 1Locked · track to revealCompleted41 est.Jun 2009
Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.NCT00775138280 mg Arikayce™Phase 2Locked · track to revealCompleted64 est.11 May 2009
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 1NCT00577577rhIGF-I/rhIGFBP-3Phase 2Locked · track to revealCompleted69 est.29 Dec 2008
Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the LungNCT00102531Cisplatin liposomalPhase 1Locked · track to revealCompleted19 est.Mar 2008
Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™)NCT00777296ARIKACE™Phase 1Locked · track to revealCompleted66 est.27 Feb 2008
Single Dose Escalation Study of TR02 (Sustained Lipid Inhalation Technology [SLIT™] Amikacin) in Participants With Cystic Fibrosis (CF) Having Chronic Infections of Pseudomonas AeruginosaNCT06238856SLIT™ AmikacinPhase 1Locked · track to revealCompleted18 est.8 Feb 2005
A Study to Investigate Lung Deposition of Inhaled Amikacin-loaded Liposomes in Healthy Male ParticipantsNCT05999942Liposomal Amikacin for InhalationPhase 1Locked · track to revealCompleted6 est.29 Jun 2004
IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron SyndromeNCT00368173rhIGF-I/rhIGFBP-3Phase 2Locked · track to revealCompleted
Study to Evaluate Arikace™ in CF Patients With Chronic Infection Due to Pseudomonas AeruginosaNCT01315691Liposomal amikacin for inhalationPhase 3Locked · track to revealStoppedWithdrawn0 est.
Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan SyndromeNCT00351221rhIGF-1/rhIGFBP-3Phase 2Locked · track to revealStoppedTerminated24 est.
An 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)NCT06939647Treprostinil PalmitilNot yet scoredUnknown
An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis BronchiectasisNCT05344508BrensocatibNot yet scoredUnknown
View all trials46

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We check every one of its trials daily and tell you what moved.

  • Status changeStatus moved to completedWas recruiting · always alerts
  • Completion date movePrimary completion slipped 210 daysSlips and pull-ins of 30+ days
  • New trialNew trial registered in your scopeFirst posted within 30 days
  • Enrollment changeEnrollment grew to 1,200Moves of 15%+ or count finalised
  • Substantive record editPrimary endpoint redefined from 24 to 52 weeksRead overnight and flagged in plain English
US registryClinicalTrials.gov
EU registryCTIS · Soon
46

Trials as lead sponsor

2

Recruiting now

14

Phase 3 trials

18

Phase 2 trials

18

Phase 1 trials

0

Phase 4 trials