[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Insmed Incorporated\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":127},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,57,81,107],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100630000","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-once-daily-treprostinil-palmitil-inhalation-powder-tpip-in-participants-with-pulmonary-arterial-hypertension-pah-100630000",false,"NCT07481981","A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)","A Phase 3, Randomized, Double-Blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension","PALM-PAH","Inclusion Criteria\n\n* Participants must have a diagnosis of World Health Organisation (WHO) Group 1 pulmonary hypertension (PAH) in any of the following subtypes, in accordance with European Society of Cardiology European Respiratory Society (ESC\u002FERS) Guidelines:\n\n  * Idiopathic PAH\n  * Heritable PAH\n  * Drug\u002Ftoxin-induced PAH\n  * Connective tissue disease (CTD)-associated PAH\n  * PAH associated with congenital heart disease-related to simple systemic-to-pulmonary shunt at least 1 year following repair.\n* PAH diagnosis for at least 3 months prior to Screening.\n* New York Heart Association (NYHA) or World Health Organization (WHO) functional class II-IV.\n* Participants must be on stable PAH therapy consisting of 1 to 3 medications from the following classes:\n\n  * Endothelin receptor antagonists (eg, ambrisentan, bosentan, macitentan) for at least 90 days prior to Screening with the last 30 days on stable dose\n  * Phosphodiesterase type 5 inhibitors (eg, sildenafil, tadalafil) for at least 90 days prior to Screening with the last 30 days on stable dose\n  * Guanylate cyclase stimulator (eg, riociguat) for at least 90 days prior to Screening with the last 30 days on stable dose\n  * Activin signaling inhibitor (e.g., sotatercept) for at least 6 months prior to Screening, with the last 3 months on stable dose and meeting all the following conditions:\n\n    * no active clinically significant bleeding (eg, epistaxis and gingival bleeding requiring medical interventions) within the past 3 months.\n    * no history of major bleeding events or risks (eg, gastrointestinal or intracranial bleeding) within the past 6 months.\n    * platelet counts ≥100,000 per microlitre (μL) at Screening\n  * For both 6-minute walk tests (6MWTs), the values of 6-minute walk distance (6MWD) should be ≥ 150 and ≤ 450 meters at Screening.\n* Right heart catheterization (RHC) at Screening (or within 6 months prior to Screening, if available). Prior RHC may be used provided there has been no change in background PAH therapy and doses. The RHC must meet all of the following hemodynamic criteria:\n\n  * Mean pulmonary arterial pressure (PAP) \\>20 millimetre of mercury (mmHg) at rest.\n  * pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) ≤15 mmHg.\n  * pulmonary vascular resistance (PVR) of ≥5 wood units (WU).\n\nExclusion Criteria\n\n* Diagnosis of PH WHO Groups 2, 3, 4, or 5, or subtypes of PH WHO Group 1 other than described in inclusion criterion 2 (eg, human immunodeficiency virus (HIV), complex congenital heart disease-associated PAH, portal hypertension-associated PAH, pulmonary veno-occlusive disease, Schistosomiasis associated PAH).\n* Clinically significant left heart disease, including left-sided valvular disease, left ventricular systolic or diastolic dysfunction, echocardiographic findings suggestive of post-capillary pulmonary hypertension, unstable ischemic heart disease, or unstable arrhythmias.\n* Evidence of airflow obstruction defined by forced expiratory volume in 1 second (FEV1) per forced vital capacity (FVC) \\\u003C0.7.\n* Evidence of significant restrictive lung disease as evidenced by FVC \\\u003C70% predicted normal.\n* Evidence of chronic thromboembolic disease or recent (within 6 months of Screening) acute pulmonary embolism.\n* Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (e.g., mannitol, leucine).\n* Any other medical or psychological condition including relevant laboratory abnormalities at Screening that, in the opinion of the Investigator, suggest a new and\u002For insufficiently understood disease and\u002For may present an unreasonable risk to the study participant as a result of his\u002Fher participation in this clinical trial, may impede their ability complete the study or the study assessments or confound the outcomes of the trial.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years","75 Years",{"count":21,"type":22},344,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP compared with placebo on exercise capacity in adults with PAH.",[28],"Pulmonary Arterial Hypertension",[28],"RECRUITING","2026-06-09",{"date":33,"type":34},"2026-06-10","ACTUAL",{"date":36,"type":22},"2026-06-26",{"date":38,"type":22},"2029-01-28",{"name":40,"class":41},"Insmed Incorporated","INDUSTRY",2,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":55,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":56,"locationsCount":4},"100588303","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-100588303","NCT06939647","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)","Treprostinil Palmitil Inhalation Powder (TPIP) in Patients With Pulmonary Arterial Hypertension or Pulmonary Hypertension Associated With Interstitial Lung Disease","Inclusion Criteria\n\n* The participant is ineligible for or cannot be treated satisfactorily with alternative commercially available therapy for PAH or PH-ILD.\n* Participant provides their informed consent to participate as per local requirements.\n* Participant must have successfully completed the OLE INS1009-203 or INS1009-212 studies.\n* Based on the treating physician's judgement on participant's medical history and an evaluation of the overall risk-benefit profile, the participant will be determined to be suitable for continued TPIP treatment within this program.\n* Requests for the post-OLE INS1009-203 and INS1009-212 TPIP studies must originate from the investigators of INS1009-203 and INS1009-212 TPIP studies, respectively.\n* Female participants must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective contraception (failure rate \\\u003C1% per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose.\n* Male participants with female partners must adhere to contraception requirements to avoid potential exposure to the embryo\u002Ffetus based on the partner's reproductive status. For partners of childbearing potential, effective contraception must be used from Day 1 to at least 90 days after the last dose.\n\nExclusion Criteria:\n\n• No specific exclusion criteria.","EXPANDED_ACCESS","The purpose of this study is to provide continued access to TPIP for participants who have successfully completed the open-label extension (OLE) studies of INS1009-203 for PAH or INS1009-212 for PH-ILD.",[28,53],"Pulmonary Hypertension, Interstitial Lung Disease","AVAILABLE",{"date":33,"type":34},{"name":40,"class":41},{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":17,"minAge":18,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":23,"phases":68,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100643595","phase-1-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-impairment-100643595","NCT07643155","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 Impairment","An Open-label, Phase 1 Trial to Evaluate the Pharmacokinetics and Safety of a Single Dose of 80 μg Treprostinil Palmitil Inhalation Powder in Participants With Normal Hepatic Function and Participants With Hepatic Impairment","Inclusion Criteria:\n\n* Body mass index between 18.0 and 40.0 kilograms per square meter (kg\u002Fm\\^2), inclusive.\n\nInclusion Criteria for Participants with Normal Hepatic Function\n\n* In good health, as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), and vital signs measurements, and clinical laboratory assessments (congenital nonhemolytic hyperbilirubinemia \\[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\\] is not acceptable) at screening and check-in, as assessed by the investigator (or designee).\n\nInclusion Criteria for Participants With Hepatic Impairment:\n\n* Diagnosis of chronic (\\>6 months), stable hepatic impairment with no clinically significant changes within 30 days prior to dosing, as determined by medical history.\n* Participants with type 2 diabetes mellitus may be included, if they have:\n\n  * glycosylated hemoglobin A1C ≤8.5% at screening\n  * fasting blood glucose ≤240 milligrams per deciliter (mg\u002FdL), while participant is using their normal diabetes medication, at screening and check-in.\n\nExclusion Criteria:\n\n* History of stomach or intestinal surgery or resection that would potentially alter absorption and\u002For excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair are allowed).\n* Use or intend to use any moderate or strong inducers or inhibitors of CYP2C8 or CYP2C9 within 30 days prior to dosing.\n* Participation in a clinical trial involving administration of an investigational medicinal product (IMP) (new chemical entity) in the past 30 days or 5 half-lives of that drug (if known) prior to dosing, whichever is longer.\n\nExclusion Criteria for Participants with Normal Hepatic Function\n\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).\n* Positive hepatitis panel and\u002For positive human immunodeficiency virus test. Participants whose results are compatible with prior immunization may be included.\n* Positive urine drug screen at screening or positive alcohol test result or positive urine drug screen at check-in. Results that are compatible with marijuana use are not exclusionary.\n\nExclusion Criteria for Participants With Hepatic Impairment:\n\n* Current organ transplant or waiting for organ transplant scheduled to occur during the trial.\n* Hospitalization for hepatic encephalopathy within 3 months prior to dosing.\n* Encephalopathy ≥Grade 2.\n* History of drug\u002Fchemical abuse within 1 year prior to check-in. Marijuana use is not exclusionary.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.",true,"70 Years",{"count":67,"type":22},30,[69],"PHASE1","The primary purpose of the study is to determine the effect of mild, moderate, and severe hepatic impairment on the PK of total treprostinil palmitil (TP) and treprostinil (TRE) following a single dose of 80 micrograms (μg) TPIP, when compared to normal hepatic function.",[72],"Hepatic Impairment","NOT_YET_RECRUITING","2026-06-08",{"date":76,"type":34},"2026-06-11",{"date":33,"type":22},{"date":79,"type":22},"2027-02-07",{"name":40,"class":41},{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100606732","phase-3-efficacy-and-safety-study-of-treprostinil-palmitil-inhalation-powder-tpip-in-participants-with-pulmonary-hypertension-associated-with-interstitial-lung-disease-ph-ild-100606732","NCT07179380","Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)","A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease","PALM-ILD","Inclusion Criteria\n\n* Diagnosis of PH World Health Organisation (WHO) Group 3 associated with ILD \\[including but not limited to idiopathic interstitial pneumonia (IIP), chronic hypersensitivity pneumonitis (HSP), connective tissue disease-associated interstitial lung disease (CTD-ILD), combined pulmonary fibrosis and emphysema (CPFE)\\].\n* Confirmation of fibrotic interstitial lung disease by centrally overread computed tomography (CT) scan performed at Screening or within prior 12 months.\n* PH confirmed by right heart catheterization (RHC) at Screening or within 12 months prior to Screening, with the following hemodynamic findings:\n\n  * Mean pulmonary arterial pressure (mPAP) \\>20 millimetre of mercury (mmHg) and\n  * Pulmonary capillary wedge pressure (PCWP) of ≤15 mmHg and\n  * Pulmonary vascular resistance (PVR) ≥4 wood units (WU).\n* 6 Minute walking distance (6MWD) ≥100 and ≤500 meters at two 6MWTs at Screening performed at least 4 hours apart, with the difference between the 2 distances ≤15%.\n* Participants receiving chronic medication for underlying disease (e.g., antifibrotic, immunomodulators, immunosuppressants, etc.) and\u002For phosphodiesterase 5 (PDE5) inhibitors, should be on this treatment for ≥90 days and on a stable dose for ≥30 days prior to Screening.\n* Capable of giving signed informed consent as described in Section 10.1.5 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion criteria\n\n* Diagnosis of Pulmonary Hypertension WHO Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease.\n* Primary diagnosis of chronic obstructive pulmonary disease (COPD) and\u002For forced expiratory volume in 1 second (FEV1)\u002FFVC \\\u003C0.7 (based on screening or historical spirometry within the prior 6 months).\n* Clinically significant left heart disease:\n\n  * evidence of clinically significant left-sided valvular heart disease,\n  * left ventricular failure with left ventricular ejection fraction (LVEF) \\\u003C45%, or diagnosis of heart failure with preserved ejection fraction (HFpEF)\n  * echocardiography findings at Screening suggestive for postcapillary PH\n  * unstable ischemic heart disease\n  * unstable arrhythmia, including uncontrolled atrial fibrillation (rate-controlled arrhythmia or paroxysmal atrial fibrillation is allowed)\n* Evidence of chronic thromboembolic disease or recent (within 6 months of Screening) acute pulmonary embolism.\n* Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (e.g., mannitol, leucine).\n* Current use of cigarettes or e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime and who currently smokes either every day or some days.\n* Current use of inhaled marijuana, recreational or medical (current use defined as used at least one or more times during the past 30 days prior to Screening) or expected use during the study.\n* Any other medical or psychological condition including relevant laboratory abnormalities at Screening that, in the opinion of the Investigator, suggest a new and\u002For insufficiently understood disease and\u002For may present an unreasonable risk to the study participant as a result of his\u002Fher participation in this clinical trial, may impede their ability complete the study or the study assessments or confound the outcomes of the trial.\n\nNote: Other protocol defined inclusion\u002Fexclusion criteria may apply.",{"count":21,"type":22},[25],"The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP versus placebo on exercise capacity in adults with PH-ILD.",[93,94],"Pulmonary Hypertension","Interstitial Lung Disease",[96,97],"pulmonary hypertension","interstitial lung disease","2026-05-26",{"date":100,"type":34},"2026-05-27",{"date":102,"type":34},"2026-01-07",{"date":104,"type":22},"2028-12-30",{"name":40,"class":41},109,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":4},"100610934","phase-3-an-open-label-extension-study-of-treprostinil-palmitil-inhalation-powder-tpip-in-participants-with-pulmonary-hypertension-associated-with-interstitial-lung-disease-ph-ild-100610934","NCT07234032","An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)","A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease","Inclusion Criteria\n\n* Participants who have completed the lead-in PH-ILD TPIP Study INS1009-311 (NCT07179380).\n* Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n* Agree not to participate in any other interventional trials or use investigational drugs or devices while participating in the INS1009-312 study.\n\nExclusion Criteria\n\n* Participants who experienced any adverse events (AEs) evaluated as causally related to TPIP by the Investigator in a lead-in study, which in the opinion of the Investigator, could pose an unreasonable risk of continued treatments for the participant.\n* Current use or expected need for pulmonary arterial hypertension (PAH)-approved therapy, including prostacyclin, prostacyclin analogues or other prostacyclin receptor agonists, endothelin receptor antagonists, and\u002For soluble guanylate cyclase stimulator, or any PH-ILD approved treprostinil therapy. Use of phosphodiesterase 5 inhibitors in line with applicable guidelines is allowed.\n* Diagnosis of Pulmonary Hypertension World Health Organisation (WHO) Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease (including combined pulmonary fibrosis and emphysema).\n* Evidence of left ventricular failure, heart failure with preserved ejection fraction (HFpEF) or postcapillary PH.\n* Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (eg, mannitol, leucine).\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":21,"type":22},[25],"The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-311 (NCT07179380).",[93,94],[119],"pulmonary hypertension, interstitial lung disease","2026-05-21",{"date":98,"type":34},{"date":123,"type":22},"2026-06-05",{"date":125,"type":22},"2031-01-22",{"name":40,"class":41},""]