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Clinical trials
catalyst calendar across sponsors →Studies where INSM is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
45 interventional · 2 expanded access · 16 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)NCT07234032Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)Open-label · Treatment | Phase 3 | Recruiting | Drug: Treprostinil Palmitil Inhalation Powder, Placebo | Pulmonary Hypertension, Interstitial Lung Disease | 344 | 2031-01-22 | in 1,617 d | 2026-08-13 |
| Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)NCT07179380Change in 6MWD Measured at Peak Exposure From Baseline to Week 24Randomized · Double-masked · Treatment | Phase 3 | Recruiting | Drug: Treprostinil Palmitil Inhalation Powder, Placebo | Pulmonary Hypertension, Interstitial Lung Disease | 344 | 2028-12-30 | in 864 d | 2026-08-14 |
| A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)NCT07481981Change in 6-Minute Walk Distance (6MWD) Measured at 1 to 3 Hours Post-Dose From Baseline at Week 24Randomized · Double-masked · Treatment | Phase 3 | Recruiting | Drug: Treprostinil Palmitil Inhalation Powder, Placebo | Pulmonary Arterial Hypertension | 344 | 2028-12-28 | in 862 d | 2026-08-19 |
| A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of INS1033 in Healthy ParticipantsNCT07765706Number of Participants Who Experienced at-Least One Adverse Event (AE) by Dose LevelRandomized · Double-masked · Treatment | Phase 1 | Not yet recruiting | Drug: INS1033, Placebo | Healthy Volunteers | 116 | 2027-03-22 | in 215 d | 2026-08-14 |
| 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 ImpairmentNCT07643155Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Treprostinil Palmitil (TP) and Treprostinil (TRE)Non-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: Treprostinil Palmitil Inhalation Powder | Hepatic Impairment | 30 | 2027-02-07 | in 172 d | 2026-08-11 |
| An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)NCT05649748Number of Participants Who Experience at Least one Treatment Emergent Adverse Event (TEAE) and TEAEs by SeverityOpen-label · Treatment | Phase 2/3 | Active, not recruiting | Drug: Treprostinil Palmitil, Placebo | Pulmonary Arterial Hypertension | 91 | 2026-12-31 | in 134 d | 2026-07-08 |
| An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)NCT05649722Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)Open-label · Treatment | Phase 2/3 | Completed | Drug: Treprostinil Palmitil Inhalation Powder, Placebo | Pulmonary Hypertension, Interstitial Lung Disease | 31 | 2026-04-01actual | — | 2026-04-23 |
| A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)NCT06685835Percent Change From Baseline in Total Abscess and Inflammatory Nodule (AN) Count at Week 16Randomized · Quadruple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Lack of Efficacy | Drug: Brensocatib, Placebo | Hidradenitis Suppurativa | 214 | 2026-02-12actual | — | 2026-06-29 |
| Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium ComplexNCT04677569Change from Baseline in Respiratory Symptom Score at Month 13Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: ALIS, Azithromycin, Ethambutol, ELC (matching placebo for ALIS) | Mycobacterium Infections, Nontuberculous | 425 | 2025-11-21actual | — | 2026-02-03 |
| 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 ParticipantsNCT07102316Maximum Observed Plasma Concentration (Cmax) of Treprostinil (TRE)Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: TPIP F2, TPIP F3 | Healthy Volunteers | 42 | 2025-10-25actual | — | 2025-11-21 |
| A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)NCT06013241Change From Baseline to the 28-day Average of Daily Sinus Total Symptom Score (sTSS) at Week 24Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Brensocatib, Placebo, Mometasone furoate nasal spray (MFNS) | Chronic Rhinosinusitis Without Nasal Polyps | 288 | 2025-09-30actual | — | 2025-11-10 |
| A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial HypertensionNCT05147805Change from Baseline in Pulmonary Vascular Resistance at Week 16Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Treprostinil Palmitil, Placebo | Pulmonary Arterial Hypertension | 102 | 2025-03-27actual | — | 2026-03-30 |
| A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis BronchiectasisNCT04594369results2025-12-16Annualized Rate of Pulmonary Exacerbations (PEs)Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Brensocatib 10 mg, Brensocatib 25 mg, Placebo | Non-Cystic Fibrosis Bronchiectasis | 1,767 | 2024-10-28actual | — | 2025-12-16 |
| A Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets in Healthy ParticipantsNCT06344728Relative Bioavailability Between Brensocatib Pediatric Oral Solution and Oral Tablets for Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC∞) of Brensocatib in PlasmaRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Brensocatib Oral Solution, Brensocatib Oral Tablet | Healthy Participants | 24 | 2024-05-24actual | — | 2024-06-13 |
| A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung DiseaseNCT05176951Number of Participants Who Experience Any Number of Treatment Emergent Adverse Events (TEAEs)Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Treprostinil Palmitil, Placebo | Pulmonary Hypertension | 39 | 2024-03-14actual | — | 2025-03-17 |
| A Study of the Palatability and Acceptability of Different Brensocatib Oral Liquid Formulations in Healthy ParticipantsNCT06178783Number of Participants With High Acceptability to Each Brensocatib Formulation Based on Palatability Assessments Measured by the 9-point Hedonic ScaleRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: Brensocatib | Healthy Volunteers | 20 | 2024-01-04actual | — | 2024-01-22 |
| A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy ParticipantsNCT05965570Area Under the Plasma Concentration-time Curve (AUC) of BrensocatibOpen-label · Treatment | Phase 1 | Completed | Drug: Brensocatib, Clarithromycin | Healthy Volunteers | 22 | 2023-09-22actual | — | 2023-12-11 |
| A Study to Assess Pharmacokinetics (PK) of Brensocatib Alone and With Multiple Doses of Rifampin or Esomeprozole in Healthy ParticipantsNCT05826574Parts 1 and 2: Area Under the Concentration-time (AUC) of Brensocatib in PlasmaNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Brensocatib, Rifampin, Esomeprazole | Healthy Volunteers | 32 | 2023-07-16actual | — | 2023-08-21 |
| 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 ImpairmentNCT05517525Area Under the Concentration Time Curve (AUC)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Brensocatib | Hepatic Impairment | 30 | 2023-06-01actual | — | 2023-07-19 |
| Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium ComplexNCT04677543results2024-06-28Psychometric Cross-Sectional Validation of Patient Reported Outcome (PRO): Patient Global Impression of Severity (PGI-S) Respiratory Scale Score at BaselineRandomized · Quadruple-masked · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: ALIS, Azithromycin, Ethambutol, ELC | Mycobacterium Infections, Nontuberculous | 99 | 2023-05-09actual | — | 2024-06-28 |
| A Study of Brensocatib Following a Single Oral Administration in Participants With or Without Renal ImpairmentNCT05673603Area Under the Plasma Concentration Time Curve (AUC) of BrensocatibNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Brensocatib | Renal Impairment | 28 | 2023-02-14actual | — | 2023-04-18 |
| A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic FibrosisNCT05090904results2026-03-12Maximum Plasma Concentration (Cmax) of Brensocatib on Day 1Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Brensocatib, Placebo | Cystic Fibrosis | 29 | 2022-11-01actual | — | 2026-03-12 |
| A Study to Investigate the Effects of Brensocatib on QT Interval in Healthy ParticipantsNCT05355935Part 1: Number of Participants who Experienced at least one Treatment-Emergent Adverse Event (TEAE) as Assessed by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: Brensocatib, Moxifloxacin, Placebo | Healthy Volunteer | 48 | 2022-10-07actual | — | 2023-03-27 |
| A Study of Treprostinil Palmitil Inhalation Powder (TPIP) In Pulmonary Arterial Hypertension (PAH)NCT04791514results2023-09-22Number of Participants Who Experience a Treatment Emergent Adverse Event (TEAE)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Low enrolment | Drug: Treprostinil Palmitil | Pulmonary Arterial Hypertension | 1 | 2022-08-26actual | — | 2023-09-22 |
| A Study of the Absorption, Metabolism, and Excretion of [14C]-Brensocatib Following a Single Oral Administration in Healthy Male ParticipantsNCT05652257Area Under the Concentration Time Curve (AUC) of Brensocatib in PlasmaOpen-label · Treatment | Phase 1 | Completed | Drug: [14C]-brensocatib | Healthy Volunteers | 7 | 2021-09-14actual | — | 2023-03-23 |
| A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder (TPIP) in Healthy ParticipantsNCT06091579Parts A and B: Number of Participants who Experienced an Adverse Event (AE)Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: Treprostinil Palmitil Inhalation Powder, Placebo | Healthy Volunteers | 42 | 2021-01-12actual | — | 2023-10-19 |
| Assessment of INS1007 in Participants With Non-Cystic Fibrosis BronchiectasisNCT03218917results2023-02-08Time to the First Pulmonary Exacerbation Over 24-Week Treatment PeriodRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Brensocatib 10 mg, Brensocatib 25 mg, Placebo | Non-Cystic Fibrosis Bronchiectasis | 256 | 2019-12-12actual | — | 2023-03-27 |
| A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of INS1007 in Healthy Japanese and Caucasian ParticipantsNCT05927597Parts A and B: Number of Participants Who Experienced at Least One Adverse Event (AE)Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: INS1007, Placebo | Healthy Volunteers | 82 | 2019-08-01actual | — | 2023-07-03 |
| Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212NCT02628600results2019-11-19Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Non-randomized · Open-label · TreatmentStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 3 | Completed | Drug: LAI 590 mg, Multi-drug regimen | NTM Lung Infection Due to MAC | 163 | 2018-10-17actual | — | 2020-02-10 |
| Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen AloneNCT02344004results2018-11-20Number of Participants Achieving Culture Conversion by Month 6 in the Liposomal Amikacin for Inhalation (LAI) + Multi-drug Regimen (MDR) Arm Compared to the MDR Alone ArmRandomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: LAI (Liposomal Amikacin for Inhalation) 590 mg | Mycobacterium Infections, Nontuberculous | 336 | 2018-07-03actual | — | 2020-05-07 |
| A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of C16TR for Inhalation With Tyvaso® Cohort in Healthy ParticipantsNCT06193031Number of Participants who Experienced an Adverse Event (AE)Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: C16TR, Placebo, Tyvaso® | Healthy Volunteers | 24 | 2015-12-18actual | — | 2024-01-05 |
| Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) InfectionNCT01316276results2019-07-26Treatment Emergent Adverse Events (TEAEs) up to Day 672Open-label · Treatment | Phase 3 | Completed | Drug: Liposomal amikacin for inhalation | Cystic Fibrosis | 206 | 2015-07-16actual | — | 2020-06-17 |
| Liposomal Amikacin for Inhalation (LAI) for Nontuberculous MycobacteriaNCT01315236results2019-08-21Change in Semi-Quantitative Mycobacterial Culture Results From Baseline to Day 84.Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Liposomal amikacin for inhalation (LAI), placebo | Mycobacterium Infections, Nontuberculous | 90 | 2014-08-18actual | — | 2019-08-21 |
| Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa InfectionsNCT01315678results2019-06-24Pulmonary Function Test: Forced Expiratory Volume in 1 Second (FEV1)Randomized · Open-label · Treatment | Phase 3 | Completed | Drug: Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer., Tobramycin inhalation solution using a PARI LC® Plus nebulizer. | Pseudomonas Aeruginosa Infection | 302 | Jun 2013actual | — | 2020-06-16 |
| Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension PhaseNCT03905642results2019-05-14Adverse Event Profile of 560 mg Once Daily Dose of Arikayce™ Administered for Six Cycles Over Eighteen Months.Open-label · Treatment | Phase 2 | Completed | Drug: Arikayce™ | Cystic Fibrosis | 49 | 2010-11-02actual | — | 2020-07-30 |
| Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas AeruginosaNCT00558844results2019-06-04Number of Participants With Treatment-Emergent Adverse EventsRandomized · Quadruple-masked · Treatment | Phase 1/2 | Completed | Drug: Arikayce™ 560 mg, Placebo for 560 mg, Arikayce™ 70 mg, Arikayce™ 140 mg, Placebo for 70 mg / 140 mg | Cystic Fibrosis | 41 | Jun 2009actual | — | 2019-06-04 |
| Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.NCT00775138results2019-07-10Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of TreatmentRandomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: 280 mg Arikayce™, Matching Placebo for Cohort 1, 560 mg Arikayce™, Matching Placebo for Cohort 2 | Bronchiectasis | 64 | 2009-05-11actual | — | 2019-07-10 |
| 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 1NCT00577577results2022-01-06Change From Baseline to Week 24 in Distance Walked as Assessed by the Six-minute Walk Test (6MWT) DistanceRandomized · Quadruple-masked · Supportive care | Phase 2 | Completed | Drug: rhIGF-I/rhIGFBP-3, placebo | Myotonic Dystrophy Type 1 | 69 | 2008-12-29actual | — | 2022-01-06 |
| Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the LungNCT00102531results2017-08-01The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery.Non-randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: Cisplatin liposomal | Osteosarcoma Metastatic | 19 | Mar 2008actual | — | 2017-08-01 |
| Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™)NCT00777296results2019-07-16Clinically Significant Laboratory Abnormalities.Randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: ARIKACE™, Placebo | Cystic Fibrosis | 66 | 2008-02-27actual | — | 2020-07-30 |
| Single Dose Escalation Study of TR02 (Sustained Lipid Inhalation Technology [SLIT™] Amikacin) in Participants With Cystic Fibrosis (CF) Having Chronic Infections of Pseudomonas AeruginosaNCT06238856Number of Participants who Experience a Treatment Emergent Adverse Event (TEAE)Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: SLIT™ Amikacin, Placebo | Cystic Fibrosis | 18 | 2005-02-08actual | — | 2024-02-02 |
| A Study to Investigate Lung Deposition of Inhaled Amikacin-loaded Liposomes in Healthy Male ParticipantsNCT05999942Pulmonary Deposition of Radiolabelled Amikacin-loaded Liposomes Measured as Percentage Retention of Emitted Dose Deposited in the LungsOpen-label · Treatment | Phase 1 | Completed | Drug: Liposomal Amikacin for Inhalation | Healthy Volunteers | 6 | 2004-06-29actual | — | 2023-08-21 |
| Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan SyndromeNCT00351221Non-randomized · Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Terminated due to a patent legal settlement | Drug: rhIGF-1/rhIGFBP-3 | Noonan Syndrome | 24 | — | — | 2007-03-30 |
| IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron SyndromeNCT00368173Non-randomized · Open-label · Treatment | Phase 2/3 | Completed | Drug: rhIGF-I/rhIGFBP-3 | Growth Hormone Insensitivity Syndrome (GHIS), Laron Syndrome | — | — | — | 2012-09-13 |
| Study to Evaluate Arikace™ in CF Patients With Chronic Infection Due to Pseudomonas AeruginosaNCT01315691Time to first protocol defined pulmonary exacerbationRandomized · Quadruple-masked · Treatment | Phase 3 | Withdrawn | Drug: Liposomal amikacin for inhalation, Placebo for liposomal amikacin for inhalation | Cystic Fibrosis | 0 | — | — | 2018-07-31 |
| An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis BronchiectasisNCT05344508expanded access | — | Approved for marketing | Drug: Brensocatib | Non-Cystic Fibrosis Bronchiectasis | — | — | — | 2025-11-04 |
| 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)NCT06939647expanded access | — | Available | Drug: Treprostinil Palmitil | Pulmonary Arterial Hypertension, Pulmonary Hypertension, Interstitial Lung Disease | — | — | — | 2026-06-10 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19