NCT07632898Not yet recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 484 (estimated)
- First submitted
- 26 May 2026
- Start date
- Oct 2026
- Primary completion date
- Jun 2030
- Lead sponsor
- Inhibikase Therapeutics
- NCT number
- NCT07632898
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 484
- From Oct 2026 to the primary completion date, Jun 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving treatment with sotatercept.
Lab values
- 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)
Other
- Currently lactating, pregnant or planning on becoming pregnant during the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.