[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Inhibikase Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100643598","phase-3-open-label-study-of-ikt-001-in-pulmonary-arterial-hypertension-pah-100643598",false,"NCT07632898","Open-Label Study of IKT-001 in Pulmonary Arterial Hypertension (PAH)","Open-Label, Long-Term Extension Study to Evaluate the Safety and Tolerability of IKT-001 in Pulmonary Arterial Hypertension","Inclusion Criteria:\n\n* Capable of giving signed informed consent.\n* Participants who have completed Study IKT-001-201 or any other Phase 2 or 3 controlled clinical study with IKT-001.\n\nExclusion Criteria:\n\n* Any of the following clinical laboratory values at screening:\n\n  * ALT or AST levels \\>3× the ULN\n  * Bilirubin levels \\>2× the ULN\n  * ANC \\\u003C1.2 ×10\\^9 cells\u002FL, hemoglobin \\\u003C9 g\u002FdL, hematocrit \\\u003C30%, or platelets \\\u003C75 × 10\\^9 cells\u002FL\n  * Absolute eGFR \\\u003C30 mL\u002Fmin using creatinine or cystatin C as defined by the CKD-EPI equation (2021)\n* Currently lactating, pregnant or planning on becoming pregnant during the study.\n* Receiving treatment with sotatercept.","ALL","18 Years","75 Years",{"count":20,"type":21},484,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multicenter, open-label extension (OLE), single-arm study designed to assess the long-term safety and tolerability of oral IKT-001 administered once daily.",[27],"Pulmonary Arterial Hypertension (PAH)","NOT_YET_RECRUITING","2026-06-02",{"date":31,"type":32},"2026-06-08","ACTUAL",{"date":34,"type":21},"2026-10-23",{"date":36,"type":21},"2030-12-30",{"name":38,"class":39},"Inhibikase Therapeutics","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":5},"100621031","phase-3-an-adaptive-program-of-ikt-001-in-pulmonary-arterial-hypertension-pah-100621031","NCT07365332","An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH)","An Adaptive, 2-Part, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of IKT-001 in Pulmonary Arterial Hypertension (PAH)","IMPROVE-PAH","Inclusion Criteria:\n\n* Documented diagnosis of WHO PAH Group 1 in any of the following subtypes:\n\n  * Idiopathic PAH\n  * Heritable PAH\n  * Drug\u002Ftoxin-induced PAH\n  * PAH associated with connective tissue disease (CTD)\n  * PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair\n* Men and women 18 and 75 years of age (inclusive)\n* Must have a body mass index (BMI) of ≥18.5 kg\u002Fm\\^2 and ≤35.0 kg\u002Fm\\^2 at screening.\n* Baseline RHC performed during the Screening Period documenting a PVR of ≥ 400 dyn\u002Fsec\u002Fcm\\^5 ; pulmonary capillary wedge pressure (PCWP) ≤15 mmHg and mean pulmonary artery pressure (mPAP) \\>20 mmHg. PVR enrichment criteria to ensure population baseline PVR \\>700 dynes\u002Fsec\u002Fcm\\^5\n* On stable doses of background PAH therapy including endothelin receptor antagonists, phosphodiesterase-5 inhibitors, prostacyclins, and soluble guanylate cyclase stimulators for ≥90 days prior to screening. Current use of sotatercept is not permitted.\n* 6MWD ≥ 100 and ≤ 475 m\n\nExclusion Criteria:\n\n* Diagnosis of PAH WHO Groups 2, 3, 4, or 5.\n* Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis-associated PAH, and pulmonary veno-occlusive disease.\n* Any of the following blood pressure-related values or abnormalities: Uncontrolled systemic hypertension as evidenced by sitting systolic BP \\>160 mmHg or sitting diastolic BP \\>100 mmHg at screening, Baseline systolic BP \\\u003C90 mmHg at screening, Syncope within 3 months prior to screening\n* History of restrictive, constrictive, or congestive cardiomyopathy.\n* ECG with Fridericia's corrected QT interval (QTcF) ≥ 450 msec in males or ≥ 470 msec in females at screening or ≥500 msec in the presence of a right bundle branch block.\n* Personal or family history of long QT syndrome or sudden cardiac death.\n* Presence of a CardioMEMS device or any other implanted hemodynamic monitoring device.\n* Forced vital capacity (FVC) \\\u003C70 percent on pulmonary function test (PFT) performed no more than 6 months prior to screening; or if FVC is 60 percent to 69 percent, must have a chest computed tomography scan within 12 months with no more than mild interstitial lung disease.\n* History of atrial fibrillation or atrial flutter.\n* History of cerebrovascular accident, intracranial hemorrhage, or subdural hematoma at anytime, or a fall associated with head trauma within 3 months of screening.\n* Acutely decompensated right heart failure within 30 days prior to screening, as per investigator assessment.\n* Clinically significant ischemic, valvular, constrictive heart disease, or heart failure with preserved ejection fraction in the opinion of the investigator.\n* History of pneumonectomy.\n* Untreated or inadequately treated (in the opinion of the investigator) obstructive sleep apnea.\n* Acute or chronic hepatitis B or C infection, defined as:\n\n  * Hepatitis B virus: a positive hepatitis B surface antigen test or a positive hepatitis B core antibody test with detectable DNA\n  * Hepatitis C virus (HCV): a positive hepatitis C antibody test with detectable HCV ribonucleic acid (RNA).Participants with a positive hepatitis C antibody test, but no detectable HCV RNA who completed treatment with direct-acting antivirals may be considered after discussion with the medical monitor.\n* History of or currently diagnosed with a bleeding disorder, including but not limited to hemophilia, von Willebrand disease, thrombocytopenia, or significant bleeding history defined as any bleeding event requiring medical intervention.\n* Received treatment with any of the following excluded medications:\n\n  * Currently receiving strong cytochrome P450 (CYP) 3A inducers or CYP3A inhibitors (except for topical administration)\n  * Currently receiving or anticipated need to receive any anticoagulant (e.g., heparins, vitamin K antagonists, direct oral anticoagulants, or direct thrombin inhibitors).\n  * Current use of sotatercept. Note: participants who previously received sotatercept may be considered if the last dose administered was \\>6 months prior to screening, participant had no significant bleeding events while on sotatercept.\n* Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to screening or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible).\n* History of atrial septostomy within 180 days prior to screening.\n* Current participation in another investigational clinical trial and\u002For receipt of any investigational medication within 90 days prior to screening.\n* Previous randomization into this or another IKT-001 study.\n* Any social, behavioral, or medical reason that would preclude completion of the study, in the judgement of the investigator.\n* Currently lactating, pregnant or planning on becoming pregnant during the study.\n* Prior receipt of a solid organ transplant or stem cell transplant.\n* Planned surgery that would require any study drug interruption or interfere with study assessments during the study (minor procedures may be allowed in consultation with the medical monitor).\n* Malignancy within the last 5 years prior to consent except completely treated non-metastatic-basal cell, squamous cell, in situ cervical cancer, and clinically localized National Comprehensive Cancer Network very low to low risk prostate cancer under active surveillance.",{"count":49,"type":21},486,[24],"This is an adaptive, 2-part, randomized, multicenter, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of IKT-001 in adult participants with WHO Group 1 PAH.",[53],"Pulmonary Arterial Hypertension","RECRUITING","2026-05-11",{"date":57,"type":32},"2026-05-12",{"date":59,"type":32},"2026-04-23",{"date":61,"type":21},"2029-12",{"name":38,"class":39},""]