NCT07632898

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
484

participants targeted

Target at P50-P75 for phase_3

Timeline
51mo left

Started Oct 2026

Typical duration for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

October 23, 2026

Expected
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2030

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2030

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

3.7 years

First QC Date

May 26, 2026

Last Update Submit

June 2, 2026

Conditions

Pulmonary Arterial Hypertension (PAH)

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs of special interest

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

    From baseline to end of study (up to 2 years or availability of commercial product)

Secondary Outcomes (2)

  • 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)

Study Arms (1)

IKT-001

EXPERIMENTAL

IKT-001 tablets for PO administration

Drug: IKT-001

Interventions

IKT-001DRUG

IKT-001 tablets for PO administration

IKT-001

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Medical Director, Inhibikase Therapeutics

CONTACT

1-302-295-3800info@inhibikase.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2026

First Posted

June 8, 2026

Study Start (Estimated)

October 23, 2026

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

December 30, 2030

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share