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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07632898

Enrollment

484

Registered

2026-06-08

Start date

2026-10-23

Completion date

2030-12-30

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension (PAH)

Brief summary

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.

Interventions

DRUGIKT-001

IKT-001 tablets for PO administration

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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× the ULN * Bilirubin levels \>2× the ULN * ANC \<1.2 ×10\^9 cells/L, hemoglobin \<9 g/dL, hematocrit \<30%, or platelets \<75 × 10\^9 cells/L * Absolute eGFR \<30 mL/min using creatinine or cystatin C as defined by the CKD-EPI equation (2021) * Currently lactating, pregnant or planning on becoming pregnant during the study. * Receiving treatment with sotatercept.

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame
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)

Contacts

CONTACTMedical Director, Inhibikase Therapeutics

info@inhibikase.com1-302-295-3800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026