Clinical trial • Phase II/III • Cardiology

BUTAN-2-YL [1-METHYL-4-[[4-[[4-METHYL-3-[(4-PYRIDIN-3-YLPYRIMIDIN-2-YL)AMINO]PHENYL]CARBAMOYL]PHENYL]METHYL]PIPERAZIN-1-IUM-1-YL]METHYL CARBONATE METHANESULFONATE for Pulmonary arterial hypertension

Phase II/III trial of BUTAN-2-YL [1-METHYL-4-[[4-[[4-METHYL-3-[(4-PYRIDIN-3-YLPYRIMIDIN-2-YL)AMINO]PHENYL]CARBAMOYL]PHENYL]METHYL]PIPERAZIN-1-IUM-1-YL]MET…

Overview

Trial Therapeutic Area: Cardiology
Trial Disease: Pulmonary arterial hypertension
Trial Stage: Phase II/III
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 16-02-2026
First CTIS Authorization Date: 28-04-2026

Trial design

Randomised, placebo to match 100 mg ikt-001 tablets; comparator described as matching placebo for 100 mg ikt-001 tablets. dose described in product name (100 mg matching tablet); schedule not specified in ctis summary.-controlled, adaptive Phase II/III trial in Belgium, Czechia, France and others.

Randomised: Yes
Comparator: Placebo to match 100 mg IKT-001 tablets; comparator described as matching placebo for 100 mg IKT-001 tablets. Dose described in product name (100 mg matching tablet); schedule not specified in CTIS summary.
Adaptive: True, operationally seamless 2-part adaptive design (Part A and Part B). The study enrols and analyzes Part A separately and then continues enrollment into Part B without a pause; Part A evaluates change in PVR and Part B evaluates change in 6MWD. Extended DBPC treatment period of up to 24 additional weeks is planned. No dose-escalation rules or interim analysis details are provided in the CTIS summary.
Target Sample Size: 396
Trial Duration For Participant: 364

Eligibility

Recruits 396 Vulnerable population not selected. Participants must be capable of giving signed informed consent (ICF). All enrolled subjects are adults (18–75 years); no assent procedures or enrolment of minors or other vulnerable groups are described in the CTIS record..

Pregnancy Exclusion: 28. Currently lactating, pregnant or planning on becoming pregnant during the study.
Vulnerable Population: Vulnerable population not selected. Participants must be capable of giving signed informed consent (ICF). All enrolled subjects are adults (18–75 years); no assent procedures or enrolment of minors or other vulnerable groups are described in the CTIS record.

Inclusion criteria

{"criterion_text":"- 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol."}
{"criterion_text":"- 9. NT-proBNP >300 ng/L during screening."}
{"criterion_text":"- 11.\tIf male with a pregnant partner or a partner who is a WOCBP, must agree to use a condom from the time of first dose through 7 days after the last dose of study drug."}
{"criterion_text":"- 10. If female and a WOCBP as defined in Section 7.2.1, must meet all the requirements below: • Agrees to use a contraceptive method that is highly effective (defined as having a failure rate of <1% per year as described in Section 7.2.2) from the time of first dose through 7 days after the last dose of study drug AND • Agrees not to donate eggs (ova, oocytes) for the purpose of reproduction from at least 14 days prior to dosing through the end of the study AND • Has negative pregnancy tests at screening and before the administration of the first dose of study drug"}
{"criterion_text":"- 2. Documented diagnosis of WHO PAH Group 1 in any of the following subtypes: • Idiopathic PAH • Heritable PAH • Drug/toxin-induced PAH • PAH associated with CTD • PAH associated with simple, congenital systemic-to-pulmonary shunts ≥1 year following repair • HIV-associated PAH"}
{"criterion_text":"- 3. Men and women 18 and 75 years of age (inclusive) at the time of signing the ICF."}
{"criterion_text":"- 4. Must have a BMI of ≥18.5 kg/m² and ≤35.0 kg/m² during screening."}
{"criterion_text":"- 5. Baseline RHC performed during the screening period documenting a PVR of ≥400 dyn·sec·cm⁻⁵, a PCWP or left ventricular end-diastolic pressure of ≤15 mmHg, and an mPAP of >20 mmHg."}
{"criterion_text":"- 6. On stable doses of background PAH therapy (≤3 PAH specific medications) including endothelin receptor antagonists, phosphodiesterase-5 inhibitors, prostacyclins, and soluble guanylate cyclase stimulators for ≥90 days before screening. Current use of sotatercept is not permitted in this study."}
{"criterion_text":"- 7. Anticipated to be able to perform the 6MWT according to American Thoracic Society Guidelines for the duration of the study."}
{"criterion_text":"- 8. 6MWD ≥100 and ≤475 m repeated twice at screening (measured at least 4 hours but no longer than 1 week apart), with both values within 15% of each other (calculated from the highest value)."}

Exclusion criteria

{"criterion_text":"- 1. Diagnosis of PAH WHO Groups 2, 3, 4, or 5."}
{"criterion_text":"- 18. Untreated or inadequately treated obstructive sleep apnea, in the opinion of the investigator."}
{"criterion_text":"- 19. 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 • HCV: a positive hepatitis C antibody test with detectable HCV 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."}
{"criterion_text":"- 2. Diagnosis of the following PAH Group 1 subtypes: • PAH associated with portal hypertension • Schistosomiasis-associated PAH • Pulmonary veno-occlusive disease"}
{"criterion_text":"- 20. 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 (eg, transfusion)."}
{"criterion_text":"- 21. Received treatment with any of the following excluded medications: • Currently receiving strong CYP3A inducers or CYP3A inhibitors (except for topical administration) • Currently receiving or anticipated need to receive any anticoagulant (eg, heparins, vitamin K antagonists, direct oral anticoagulants, or direct thrombin inhibitors, with the exception of short-term, periprocedural use of anticoagulants (eg, heparin) administered during RHC, as deemed appropriate by the investigator) • Currently using sotatercept (Note: participants who previously received sotatercept may be considered if the last dose administered was >6 months before screening, participant had no significant bleeding events while on sotatercept, and the case is approved by the medical monitor prior to study entry)"}
{"criterion_text":"- 22. Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days of 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)."}
{"criterion_text":"- 23. History of atrial septostomy within 180 days of screening."}
{"criterion_text":"- 24. Current participation in another investigational clinical trial and/or receipt of any investigational medication within 90 days of screening."}
{"criterion_text":"- 25. Previous randomization into this or another IKT-001 study."}
{"criterion_text":"- 26. Any social, behavioral, or medical reason that would preclude completion of the study, in the judgement of the investigator."}
{"criterion_text":"- 10. FVC <70% on PFT performed no more than 6 months before screening; or if FVC is 60% to 69%, must have a chest computed tomography scan within 12 months with no more than mild interstitial lung disease."}
{"criterion_text":"- 27. Any of the following clinical laboratory values: • ALT or AST levels >3× the ULN • Bilirubin levels >2× the ULN • ANC <1.2 ×10⁹ cells/L, hemoglobin <9 g/dL, hematocrit <30%, or platelets <75 × 10⁹ cells/L • Absolute eGFR <30 mL/min using creatinine or cystatin C as defined by the CKD-EPI equation (2021)"}
{"criterion_text":"- 28. Currently lactating, pregnant or planning on becoming pregnant during the study."}
{"criterion_text":"- 29. Prior receipt of a solid organ transplant or stem cell transplant."}
{"criterion_text":"- 3. Diagnosis or history of any of the following substance-related conditions: • Methamphetamine-associated PAH • History of cocaine or methamphetamine (amphetamine-type stimulant) use within 24 months prior to screening defined by self-report, medical history, or positive drug screen in medical records • Any diagnosis of cocaine or methamphetamine use disorder (per medical record or self-report) within 24 months prior to screening"}
{"criterion_text":"- 30. 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)."}
{"criterion_text":"- 31. Malignancy within the last 5 years before screening 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."}
{"criterion_text":"- 4. Uncontrolled diabetes mellitus, defined as HbA1c ≥9.0%."}
{"criterion_text":"- 5. Any of the following BP-related values or abnormalities: • Uncontrolled systemic hypertension as evidenced by sitting systolic BP >160 mmHg or sitting diastolic BP >100 mmHg at screening after 5 minutes of rest • Baseline systolic BP <90 mmHg at screening • Syncope within 3 months before screening"}
{"criterion_text":"- 6. History of restrictive, constrictive, or congestive cardiomyopathy."}
{"criterion_text":"- 7. ECG with QTcF ≥450 msec in males or ≥470 msec in females at screening or ≥500 msec in the presence of a right bundle branch block."}
{"criterion_text":"- 11. Evidence of LVEF <45% (by Simpson’s biplane method) or evidence of impaired relaxation on screening echocardiogram by E/e’ >13."}
{"criterion_text":"- 30. Personal or family history of long QT syndrome or sudden cardiac death."}
{"criterion_text":"- 9. Presence of a CardioMEMS device or any other implanted hemodynamic monitoring device."}
{"criterion_text":"- 32.\tHistory of clinically significant ophthalmologic disease that, in the opinion of the investigator, could be exacerbated by treatment with IKT-001, including but not limited to pre-existing macular edema, active glaucoma with poorly controlled intraocular pressure (defined as intraocular pressure >21 mmHg), or significant optic neuropathy."}
{"criterion_text":"- 33.\tKnown hypersensitivity or allergy to the investigational medicinal product (IKT-001), its excipients (silicified microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate, and Opadry II Green), or to process-related residuals (eg, butanol and formaldehyde)."}
{"criterion_text":"- 12. History of atrial fibrillation or atrial flutter."}
{"criterion_text":"- 13. History of cerebrovascular accident, intracranial hemorrhage, or subdural hematoma at any time, or a fall associated with head trauma within 3 months of screening."}
{"criterion_text":"- 14. Any symptomatic coronary disease event (myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months of screening."}
{"criterion_text":"- 15. Acutely decompensated right heart failure within 30 days of screening, as per investigator assessment."}
{"criterion_text":"- 16. Clinically significant ischemic, valvular, or constrictive heart disease, or heart failure with preserved ejection fraction, in the opinion of the investigator."}
{"criterion_text":"- 17. History of pneumonectomy."}

Endpoints

Primary endpoints

{"endpoint_text":"- 1. Part A: Change from baseline in PVR at Week 24","definition_or_measurement_approach":"Change from baseline in pulmonary vascular resistance (PVR) at Week 24. Baseline PVR is documented by right heart catheterization (RHC) performed during screening (see inclusion criterion requiring baseline RHC)."}
{"endpoint_text":"- 2. Part B: Change from baseline in 6MWD at Week 24","definition_or_measurement_approach":"Change from baseline in 6-minute walk distance (6MWD) at Week 24. 6MWD is assessed with the 6-minute walk test (6MWT) performed per American Thoracic Society Guidelines; screening requires two repeats with specified criteria (see inclusion criteria)."}

Secondary endpoints

{"endpoint_text":"- 1. Part A only: Change from baseline in 6MWD at Week 24","definition_or_measurement_approach":"Change from baseline in 6MWD at Week 24 measured by 6MWT (ATS guidelines); applies to Part A participants only."}
{"endpoint_text":"- 2. Part B only: Change from baseline in PVR at Week 24","definition_or_measurement_approach":"Change from baseline in PVR at Week 24 measured by right heart catheterization; applies to Part B participants only."}
{"endpoint_text":"- 3. Change from baseline in NT-proBNP concentrations at Week 24","definition_or_measurement_approach":"Change in NT-proBNP concentration from baseline to Week 24 measured by laboratory assay (NT-proBNP >300 ng/L is an inclusion criterion at screening)."}
{"endpoint_text":"- 4. Time to all-cause death or the first occurrence of a clinical worsening event (time to clinical worsening)","definition_or_measurement_approach":"Time-to-event endpoint measured from randomization to all-cause death or first pre-specified clinical worsening event; precise event definition described in protocol (time-to-event analysis)."}
{"endpoint_text":"- 5. Proportion of participants who improve from baseline in WHO FC or maintain WHO FC II from baseline to Week 24","definition_or_measurement_approach":"Proportion based on change or maintenance in WHO functional class (WHO FC) from baseline to Week 24."}
{"endpoint_text":"- 6. Proportion of participants who maintain low or intermediate-low risk score or achieve a lower ESC/ERS 4 strata risk score at Week 24","definition_or_measurement_approach":"Proportion based on ESC/ERS 4-strata risk assessment at Week 24 (low/intermediate-low or improvement to a lower stratum)."}
{"endpoint_text":"- 7. Change from baseline in HRQoL / EmPHasis-10 total score at Week 24","definition_or_measurement_approach":"Change from baseline in health-related quality of life measured by the EmPHasis-10 questionnaire total score at Week 24."}

Recruitment

Planned Sample Size: 396
Recruitment Window Months: 36
Consent Approach: Participants must be capable of giving signed informed consent; the ICF is required (principal inclusion criterion). ICF and related participant information (including pregnancy-specific information) are provided in country/language-specific documents (examples in CTIS: Dutch, French, German, Italian, Spanish, Portuguese, Polish, Czech, Danish, Latvian, English). No procedures for assent (minors) are described; participants are adults (18–75).

Methods

Country-specific patient-facing printed materials (flyers, posters, brochures) distributed at sites and public settings — documents exist for BE, CZ, FR, DE, IT, ES, NL, PL, DK, IE, LV, PT
Patient letters (country-specific) sent/used to inform potential participants — patient letters available in multiple member states
HCP (healthcare professional) letters to referring clinicians to facilitate site-based referrals (country-specific HCP letters listed in CTIS documents)
ICF flipbook and other participant information materials to support informed consent (country-specific ICF flipbooks listed)
GP letters and participant cards (country-specific) to inform primary care and support site referral
Site-based recruitment via participating hospitals/clinics and specialist centres (cardiology/pulmonology departments listed as trial sites)

Geography

Total Number Of Sites: 38
Total Number Of Participants: 88

Belgium

Earliest CTIS Part Ii Submission Date: 13-04-2026
Latest Decision Or Authorization Date: 29-04-2026
Processing Time Days: 16
Number Of Sites: 2
Number Of Participants: 5

Sites

Site Name: Hopital Erasme
Department Name: Cardiology
Contact Person Name: Jean-Luc Vachiery
Contact Person Email: jean.luc.vachiery@hubruxelles.be

Site Name: UZ Leuven
Department Name: Pneumology
Contact Person Name: Marion Delcroix
Contact Person Email: Marion.delcroix@uzleuven.be

Czechia

Earliest CTIS Part Ii Submission Date: 10-04-2026
Latest Decision Or Authorization Date: 29-04-2026
Processing Time Days: 19
Number Of Sites: 2
Number Of Participants: 4

Sites

Site Name: Vseobecna Fakultni Nemocnice V Praze
Department Name: II. Internal Medicine Clinic, VFN and 1st Faculty UK
Contact Person Name: Pavel Jansa
Contact Person Email: pavel.jansa@vfn.cz

Site Name: Institute For Clinical And Experimental Medicine
Department Name: Department of Cardiology
Contact Person Name: Hikmet Al-Hiti
Contact Person Email: hikmet.al-hiti@ikem.cz

France

Earliest CTIS Part Ii Submission Date: 13-04-2026
Latest Decision Or Authorization Date: 29-04-2026
Processing Time Days: 16
Number Of Sites: 4
Number Of Participants: 8

Sites

Site Name: Centre Hospitalier Universitaire De Saint Etienne
Department Name: Vascular medicine and therapeutic department
Contact Person Name: Laurent Bertoletti
Contact Person Email: Laurent.bertoletti@chu-st-etienne.fr

Site Name: Les Hopitaux Universitaires De Strasbourg
Department Name: Pulmonology and Physiology units
Contact Person Name: Marianne Riou
Contact Person Email: Marianne.riou@chru-strasbourg.fr

Site Name: Centre Hospitalier Regional De Marseille
Department Name: Department of pulmonary disease
Contact Person Name: Martine Reynaud- Gaubert
Contact Person Email: martinelouise.reynaud@ap-hm.fr

Site Name: Assistance Publique Hopitaux De Paris
Department Name: Department of Pulmonary and Respiratory Reanimation
Contact Person Name: Olivier Sitbon
Contact Person Email: Olivier.sitbon@u-psud.aphp.fr

Germany

Earliest CTIS Part Ii Submission Date: 10-04-2026
Latest Decision Or Authorization Date: 30-04-2026
Processing Time Days: 20
Number Of Sites: 4
Number Of Participants: 11

Sites

Site Name: Thoraxklinik Heidelberg gGmbH
Department Name: Universitätskliniken Heidelberg, Thoraxklinik, Sektion für Pulmonale Hypertonie
Contact Person Name: Ekkehard Grünig
Contact Person Email: ekkehard.gruenig@med.uni-heidelberg.de

Site Name: Medizinische Hochschule Hannover
Department Name: Klinik für Pneumologie und Infektiologie
Contact Person Name: Marius M. Hoeper
Contact Person Email: hoeper.marius@mh-hannover.de

Site Name: Justus-Liebig-Universitaet Giessen
Department Name: Universitätsklinikum Giessen Medizinische Klinik und Poliklinik II
Contact Person Name: Khodr Tello
Contact Person Email: Khodr.Tello@innere.med.uni-giessen.de

Site Name: Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name: Pneumologisches Studiensekretariat Medizinische Klinikund Poliklinik 1
Contact Person Name: Michaek Halank
Contact Person Email: michael.halank@uni-klinikumdresden.de

Italy

Earliest CTIS Part Ii Submission Date: 19-03-2026
Latest Decision Or Authorization Date: 30-04-2026
Processing Time Days: 42
Number Of Sites: 4
Number Of Participants: 11

Sites

Site Name: Fondazione IRCCS Policlinico San Matteo
Department Name: UO Cardiologia
Contact Person Name: Stefano Ghio
Contact Person Email: s.ghio@smatteo.pv.it

Site Name: Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name: UOC Malattie Cardiovascolari
Contact Person Name: Roberto Badagliacca
Contact Person Email: Roberto.badagliacca@uniroma1.it

Site Name: Multimedica S.p.A.
Department Name: Division of Internal Medicine and Division of Pulmonary Disease, Intensive Respiratory Care Unit
Contact Person Name: Sergio Harari
Contact Person Email: sergio@sergioharari.it

Site Name: Fondazione IRCCS San Gerardo Dei Tintori
Department Name: UOC Pneumologia
Contact Person Name: Giuseppe Paciocco
Contact Person Email: giuseppe.paciocco@unimib.it

Spain

Earliest CTIS Part Ii Submission Date: 13-04-2026
Latest Decision Or Authorization Date: 30-04-2026
Processing Time Days: 17
Number Of Sites: 11
Number Of Participants: 22

Sites

Site Name: Hospital Universitario Marques De Valdecilla
Department Name: Pneumology
Contact Person Name: Jose Manuel Cifrian Martínez
Contact Person Email: jmcifrian@humv.es

Site Name: Hospital Universitario Virgen De La Victoria
Department Name: Cardiology
Contact Person Name: Victor Manuel Becerra Munoz
Contact Person Email: vmbecerram@gmail.com

Site Name: Hospital Clinic De Barcelona
Department Name: Pulmonology
Contact Person Name: Isabel Blanco Vich
Contact Person Email: iblanco2@clinic.cat

Site Name: Hospital Universitario Virgen De La Macarena
Department Name: Cardiology
Contact Person Name: Alejandro Recio Mayoral
Contact Person Email: jandrorm@hotmail.com

Site Name: Hospital Universitario 12 De Octubre
Department Name: Cardiology
Contact Person Name: Pilar Escribano Subias
Contact Person Email: pilar.escribano.subias@gmail.com

Site Name: Hospital Universitario La Paz
Department Name: Pneumology
Contact Person Name: Serio Alcolea Batres
Contact Person Email: sergio.alcolea@salud.madrid.org

Site Name: Hospital Universitario De Salamanca
Department Name: Pneumology
Contact Person Name: Sergio Cadenas Menendez
Contact Person Email: sercam.2007@gmail.com

Site Name: Hospital Universitari Vall D Hebron
Department Name: Pneumology
Contact Person Name: Manuel Lopez Meseguer
Contact Person Email: respiratoryclinicaltrials@vallhebron.cat

Site Name: Hospital Universitario Y Politecnico La Fe
Department Name: Pneumology
Contact Person Name: Raquel Lopez Reyes
Contact Person Email: lopez_raqrey@gva.es

Site Name: Hospital Universitario De Toledo
Department Name: Cardiology
Contact Person Name: Maria Lazaro Salvador
Contact Person Email: maria.lasal@gmail.com

Site Name: Hospital Costa del Sol
Department Name: Cardiology
Contact Person Name: Rafael Bravo Marques
Contact Person Email: rafabravomarques@gmail.com

Netherlands

Earliest CTIS Part Ii Submission Date: 13-04-2026
Latest Decision Or Authorization Date: 28-04-2026
Processing Time Days: 15
Number Of Sites: 1
Number Of Participants: 2

Sites

Site Name: Amsterdam UMC Stichting
Department Name: Pulmonary Medicine
Contact Person Name: Jurjan Aman
Contact Person Email: j.aman@amsterdamumc.nl

Poland

Earliest CTIS Part Ii Submission Date: 10-04-2026
Latest Decision Or Authorization Date: 30-04-2026
Processing Time Days: 20
Number Of Sites: 3
Number Of Participants: 10

Sites

Site Name: Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
Department Name: I Oddzial Kardiologii, Pracownia Badan Czynnosciowych Układu Oddechowego, Ambulatorium Badan Klinicz
Contact Person Name: Katarzyna Mizia-Stec
Contact Person Email: badania.gcm@gmail.com

Site Name: Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Department Name: Oddzial Kliniczny Chorob Serca i Naczyn z Pododdzialem Intensywnego Nadzoru Kardiologicznego
Contact Person Name: Grzegorz Kopec
Contact Person Email: g.kopec@szpitaljp2.krakow.pl

Site Name: Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
Department Name: Oddzial Kardiologiczny Klinika Kardiologii Katedry Kardiologii UM w Lodzi
Contact Person Name: Radoslaw Krecki
Contact Person Email: rkrecki@gmail.com

Denmark

Earliest CTIS Part Ii Submission Date: 13-04-2026
Latest Decision Or Authorization Date: 11-05-2026
Processing Time Days: 28
Number Of Sites: 2
Number Of Participants: 2

Sites

Site Name: Rigshospitalet
Department Name: Department of Cardiology
Contact Person Name: Mads Kristian Ersbøll
Contact Person Email: Mads.kristian.ersboell.02@regionh.dk

Site Name: Region Midtjylland
Department Name: Department of Cardiology
Contact Person Name: Soren Mellemkjaer
Contact Person Email: soren.mellemkjaer@rm.dk

Ireland

Earliest CTIS Part Ii Submission Date: 13-04-2026
Latest Decision Or Authorization Date: 01-05-2026
Processing Time Days: 18
Number Of Sites: 1
Number Of Participants: 2

Sites

Site Name: Mater Misericordiae University Hospital
Department Name: Respiratory Medicine
Contact Person Name: Sarah Cullivan
Contact Person Email: Respiratory_Admin@mater.ie

Latvia

Earliest CTIS Part Ii Submission Date: 10-04-2026
Latest Decision Or Authorization Date: 29-04-2026
Processing Time Days: 19
Number Of Sites: 1
Number Of Participants: 5

Sites

Site Name: Pauls Stradins Clinical University Hospital
Department Name: Cardiology
Contact Person Name: Andris Skride
Contact Person Email: info@pmkp.lv

Portugal

Earliest CTIS Part Ii Submission Date: 10-04-2026
Latest Decision Or Authorization Date: 30-04-2026
Processing Time Days: 20
Number Of Sites: 3
Number Of Participants: 6

Sites

Site Name: Unidade Local De Saude De Almada-Seixal E.P.E.
Department Name: Cardiology
Contact Person Name: Filipa Ferreira
Contact Person Email: filipa.ferreira@ulsas.min-saude.pt

Site Name: Unidade Local De Saude De Santo Antonio E.P.E.
Department Name: Cardiology
Contact Person Name: Mário Silva Santos
Contact Person Email: mariosantos.cardiologia@chporto.min-saude.pt

Site Name: Unidade Local De Saude De Santa Maria E.P.E.
Department Name: Cardiology
Contact Person Name: Rui Plácido
Contact Person Email: 20808@chln.min-saude.pt

Sponsor

Primary sponsor

Full Name: Inhibikase Therapeutics Inc.
Organisation Type: Pharmaceutical company
Country Of Registered Address: United States

Contract research organisations

Name: Icon Clinical Research Limited
Responsibilities: Multiple operational responsibilities including patient recruitment and medical imaging (sponsorDuties codes listed; value fields include 'Patient recruitment, Medical Imaging').

Name: Altasciences Compagnie Inc.
Responsibilities: PK sampling and related bioanalytical handling (sponsorDuties value: 'PK sampling').

Name: Suvoda LLC
Responsibilities: Data capture/clinical operations support (sponsorDuties code: 3).

Name: Medidata Solutions Inc.
Responsibilities: Clinical data platform/related services (sponsorDuties code: 7).

Third parties

{"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Non-Pharmaceutical company"}
{"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"sponsorDuties codes: [14, 15]; value: IMP import","organisation_type":"Pharmaceutical company"}
{"country":"Ireland","full_name":"Millmount Healthcare Limited","duties_or_roles":"sponsorDuties codes: [14, 15]; value: QP release","organisation_type":"Pharmaceutical company"}
{"country":"Netherlands","full_name":"Certe Medische Diagnostiek en Advies Stichting","duties_or_roles":"sponsorDuties codes: [15, 4]; value: HIV confirmatory testing","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Non-Pharmaceutical company"}
{"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"sponsorDuties codes: [15, 4]; value: PK sampling","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Mural Health Technologies Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: Patient reimbursement","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1,10,11,12,13,15,2,4,5,6,7,8]; value example: Patient recruitment, Medical Imaging","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Olink Proteomics Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: Exploratory Pharmacodynamic biomarker analyses per protocol section 9.5.3","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name: IkT-001Pro
Active Substance: BUTAN-2-YL [1-METHYL-4-[[4-[[4-METHYL-3-[(4-PYRIDIN-3-YLPYRIMIDIN-2-YL)AMINO]PHENYL]CARBAMOYL]PHENYL]METHYL]PIPERAZIN-1-IUM-1-YL]METHYL CARBONATE METHANESULFONATE
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL

Investigational Product Name: Placebo to match 100 mg IKT-001 tablets
Modality: Other

Combination Treatment: Yes

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