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

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.

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.