Recent Updates
Recently added Catalysts

IKT-001

Phase 3

Pulmonary Arterial Hypertension (PAH) | Small molecule | Cardiovascular |Inhibikase Therapeutics, Inc.|Last Updated: Jun 8, 2026

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment484
FDA Designations
ORPHAN_DRUG
Clinical trial landscape

IKT-001 · 2 trials · 2 indications

Phase 3 2
NCT07632898Open-Label Study of IKT-001 in Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial Hypertension (PAH)
NOT YET_RECRUITING484 Analytics
NCT07365332An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial Hypertension
RECRUITING486 Analytics
PHASE3NOT YET_RECRUITING
Open-Label Study of IKT-001 in Pulmonary Arterial Hypertension (PAH)
Pulmonary Arterial Hypertension (PAH)
NCT07632898484
Unlock trial analytics
PHASE3RECRUITING
An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH)
Pulmonary Arterial Hypertension
NCT07365332486
Unlock trial analytics
Study Endpoints
Primary Endpoints
Incidence of Treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs of special interest
From baseline to end of study (up to 2 years or availability of commercial product)

The number of participants who experience a TEAE, serious TEAE or TEAE of special interest will be reported.

[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
Change from baseline in 6-minute walk distance (6MWD)
From baseline to end of study (up to 2 years or availability of commercial product)
Change from baseline in NT-proBNP
From baseline to end of study (up to 2 years or availability of commercial product)
To characterize the effects of IKT-001 on WHO Functional Class
Baseline up to Week 48
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
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
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Capable of giving signed informed consent. * Participants who have completed Study IKT-001-201 or any other Phase 2 or 3 controlled clinical study with IKT-001. Exclusion Criteria: * Any of the following clinical laboratory values at screening: * ALT or AST levels \>3× th...

Countries:United States
Unlock Eligibility Criteria
Competitive Landscape -Pulmonary Arterial Hypertension 40 trials (matched to "Pulmonary Arterial Hypertension (PAH)")
CompanyTickerTrialsLead PhaseDrugs
United Therapeutics CorporationUTHR5PHASE3Ralinepag
Merck & Co., Inc.MRK6PHASE3Riociguat
Insmed IncorporatedINSM4PHASE3Treprostinil Palmitil
Johnson & JohnsonJNJ4PHASE3Selexipag
Liquidia CorporationLQDA4PHASE3L606
Tenax Therapeutics, Inc.TENX3PHASE3TNX-103
Gossamer Bio, Inc.GOSS2PHASE3Seralutinib
Inhibikase Therapeutics, Inc.IKT1PHASE3IKT-001
Regeneron Pharmaceuticals, Inc.REGN1PHASE2REGN13335
Pfizer Inc.PFE2PHASE2PF-07868489
Tectonic Therapeutic IncTECX1PHASE2TX000045- Dose A, TX000045- Dose B
Abbott LaboratoriesABT1N/AUndisclosed
Third Pole Therapeutics, Inc.THRD1N/AUndisclosed
Unlock Competitive Intelligence
Recent Changes (Last 90 Days)
LOWJun 8, 2026NCT07632898NEW_TRIAL: changed
LOWJun 8, 2026NCT07632898NEW_TRIAL: changed
LOWJun 8, 2026NCT07632898NEW_TRIAL: changed
LOWMay 26, 2026NCT07365332Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07365332studyFirstPostDate: changed