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New pill could ease rare lung disease

NCT ID NCT07365332

Disease control Sponsor: Inhibikase Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This study tests an experimental drug called IKT-001 in people with pulmonary arterial hypertension (PAH), a condition where high blood pressure in the lungs makes it hard to breathe and move. About 486 adults will receive either IKT-001 or a placebo to see if the drug improves blood flow and walking distance. The goal is to find a new way to manage PAH symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IKT-001 (tablet)
What this could lead to
If successful, this could provide a new treatment option to help control pulmonary arterial hypertension and improve daily function.
What could go wrong
This is a Phase 3 trial, but results are not guaranteed. The drug may not work better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 486 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Documented diagnosis of WHO PAH Group 1 in any of the following subtypes: * Idiopathic PAH * Heritable PAH * Drug/toxin-induced PAH * PAH associated with connective tissue disease (CTD) * PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair * Men and women 18 and 75 years of age (inclusive) * Must have a body mass index (BMI) of ≥18.5 kg/m\^2 and ≤35.0 kg/m\^2 at screening. * Baseline RHC performed during the Screening Period documenting a PVR of ≥ 400 dyn/sec/cm\^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/sec/cm\^5 * 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. * 6MWD ≥ 100 and ≤ 475 m Exclusion Criteria: * Diagnosis of PAH WHO Groups 2, 3, 4, or 5. * 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. * 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 \<90 mmHg at screening, Syncope within 3 months prior to screening * History of restrictive, constrictive, or congestive cardiomyopathy. * 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. * Personal or family history of long QT syndrome or sudden cardiac death. * Presence of a CardioMEMS device or any other implanted hemodynamic monitoring device. * Forced vital capacity (FVC) \<70 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. * History of atrial fibrillation or atrial flutter. * History of cerebrovascular accident, intracranial hemorrhage, or subdural hematoma at anytime, or a fall associated with head trauma within 3 months of screening. * Acutely decompensated right heart failure within 30 days prior to screening, as per investigator assessment. * Clinically significant ischemic, valvular, constrictive heart disease, or heart failure with preserved ejection fraction in the opinion of the investigator. * History of pneumonectomy. * Untreated or inadequately treated (in the opinion of the investigator) obstructive sleep apnea. * Acute or chronic hepatitis B or C infection, defined as: * Hepatitis B virus: a positive hepatitis B surface antigen test or a positive hepatitis B core antibody test with detectable DNA * 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. * 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. * Received treatment with any of the following excluded medications: * Currently receiving strong cytochrome P450 (CYP) 3A inducers or CYP3A inhibitors (except for topical administration) * Currently receiving or anticipated need to receive any anticoagulant (e.g., heparins, vitamin K antagonists, direct oral anticoagulants, or direct thrombin inhibitors). * 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. * 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). * History of atrial septostomy within 180 days prior to screening. * Current participation in another investigational clinical trial and/or receipt of any investigational medication within 90 days prior to screening. * Previous randomization into this or another IKT-001 study. * Any social, behavioral, or medical reason that would preclude completion of the study, in the judgement of the investigator. * Currently lactating, pregnant or planning on becoming pregnant during the study. * Prior receipt of a solid organ transplant or stem cell transplant. * 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). * 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.

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary arterial hypertension

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    43 sites in 14 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Amsterdam UMC site VUMC

    RECRUITING

    Amsterdam, North Holland, 1081 BT, Netherlands

  • Arizona Pulmonary Specialists, LTD

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Auckland City Hospital

    RECRUITING

    Auckland, Auckland, 1051, New Zealand

  • CHRU Strasbourg

    RECRUITING

    Strasbourg, Grand Est, 67091, France

  • Cedars Sinai

    RECRUITING

    Beverly Hills, California, 90211, United States

  • Chonnam National University Hospital

    RECRUITING

    Gwangju, 61469, South Korea

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Fondazione IRCCS San Gerardo dei Tintori

    RECRUITING

    Monza, Monza and Brianza, 20900, Italy

  • Golden Jubilee National Hospital

    RECRUITING

    Glasgow, West Dunbartonshire, G81 4DY, United Kingdom

  • Hospital Clínic de Barcelona

    RECRUITING

    Barcelona, Barcelona, 08036, Spain

  • Hospital Costa del Sol

    RECRUITING

    Marbella, Malaga, 29603, Spain

  • Hospital General Universitario de Toledo

    RECRUITING

    Toledo, Toledo, 45007, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitari i Politecnic La Fe de Valencia

    RECRUITING

    Valencia, Valencia, 46026, Spain

  • Hospital Universitario Doce de Octubre

    RECRUITING

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario Marqués De Valdecilla

    RECRUITING

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, Sevilla, 41009, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, Andalusia, 29010, Spain

  • Hospital Universitario la Paz

    RECRUITING

    Madrid, Madrid, 28046, Spain

  • Hôpital Bicêtre

    RECRUITING

    Le Kremlin-Bicêtre, France, 94270, France

  • Hôpital Universitaire de Bruxelles - Erasme

    RECRUITING

    Anderlecht, Brussels Capital, 1070, Belgium

  • Imperial College Healthcare NHS Trust

    RECRUITING

    London, W12 0HS, United Kingdom

  • Jeffrey S. Sager, MD Medical Corporation

    RECRUITING

    Santa Barbara, California, 93105, United States

  • Lundquist at Harbor UCLA

    RECRUITING

    Torrance, California, 90502, United States

  • Medizinische Hochschule Hannover, Abteilung Pneumologie und Infektiologie

    RECRUITING

    Hanover, Lower Saxony, 30625, Germany

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Norton Healthcare

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Pulmonary Hypertension Research Queensland PHRQ

    RECRUITING

    Auchenflower, Queensland, 4066, Australia

  • Royal Papworth Hospital

    RECRUITING

    Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Sanatorio de la Trinidad Palermo

    RECRUITING

    Buenos Aires, Buenos Aires, 1425, Argentina

  • Te Whato Ora, Health New Zealand, Waikato Hospital

    RECRUITING

    Hamilton, Waikato Region, 3204, New Zealand

  • Tufts Medical Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Unidade Local de Saúde de Santo António - Hospital de Santo António

    RECRUITING

    Porto, Porto District, 4099-001, Portugal

  • University of Alberta Hospital

    RECRUITING

    Edmonton, Alberta, T6G 2B7, Canada

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Colorado Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66103, United States

  • University of Otago Christchurch

    RECRUITING

    Christchurch, Canterbury, 8011, New Zealand

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232-7610, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Westchester Medical Center

    RECRUITING

    Valhalla, New York, 10595, United States

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