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IKT-001

Phase 3

Pulmonary Arterial Hypertension | Small molecule | Cardiovascular |Inhibikase Therapeutics, Inc.|Last Updated: May 12, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment486
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07365332An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH)PHASE3 RECRUITING 486 — — Apr 23, 2026Dec 1, 2029May 12, 20262 United States
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Study Endpoints
Primary Endpoints
[Part A] To evaluate the effect on Pulmonary Vascular Resistance (PVR) in participants with WHO Group 1 PAH treated with IKT-001 compared to placebo
Baseline to Week 24

Change in Pulmonary Vascular Resistance (PVR)

[Part B] To characterize the effects of IKT-001 on symptoms and characteristics of Pulmonary Arterial Hypertension compared to placebo
Baseline to Week 24

Change in 6-minute walk distance (6MWD)

Secondary Endpoints
To characterize the effects of IKT-001 on WHO Functional Class
Baseline up to Week 48
To characterize the effects of IKT-001 on time to clinical worsening
Baseline up to Week 48
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IKT-001EXPERIMENTALIKT-001 tablets for PO administration
PlaceboPLACEBO_COMPARATORMatching placebo to IKT-001 tablets for PO administration
Interventions
NameTypeDescription
IKT-001DRUGIKT-001 tablets for PO administration
PlaceboDRUGPlacebo to IKT-001 tablets for PO administration
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

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...

Countries:United States
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Competitive Landscape -Pulmonary Arterial Hypertension 40 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK6PHASE3Riociguat, Sotatercept, Frespaciguat, Background PAH Therapy
United Therapeutics CorporationUTHR5PHASE3Ralinepag, treprostinil
Insmed IncorporatedINSM4PHASE3Treprostinil Palmitil
Johnson & JohnsonJNJ4PHASE3Selexipag, Macitentan, selexipag
Liquidia CorporationLQDA4PHASE3L606, LIQ861 Treprostinil, LIQ861
Tenax Therapeutics, Inc.TENX3PHASE3TNX-103
Gossamer Bio, Inc.GOSS2PHASE3Seralutinib, GB002
Inhibikase Therapeutics, Inc.IKT1PHASE3IKT-001
Regeneron Pharmaceuticals, Inc.REGN1PHASE2REGN13335
Pfizer Inc.PFE2PHASE2PF-07868489
Tectonic Therapeutic IncTECX1PHASE2TX000045- Dose A, TX000045- Dose B
Abbott LaboratoriesABT1NAUndisclosed
Third Pole Therapeutics, Inc.THRD1NAUndisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07365332Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07365332studyFirstPostDate: changed