An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for Pulmonary Arterial Hypertension (PAH)

An open-label, long-term study to evaluate the safety of inhaled nitric oxide (iNO) in subjects with pulmonary arterial hypertension (PAH) who participated in IK-7001-PAH-201 and PULSE-PAH-004 to provide these patients with continued access to chronic iNO until the time of approval or development of iNO in PAH is discontinued.

Inclusion Criteria:

• Signed Informed Consent Form prior to the initiation of any study mandated procedures or assessments.
• PAH subjects who have completed all EOS assessments in IK-7001-PAH-201 and PULSE-PAH-004 and have continued drug/device usage.
• Subjects are willing and considered in the judgement of the Investigator able to use the INOpulse device continuously for up to 24 hours per day.
• All female subjects must be willing to continue to take adequate precaution to avoid pregnancy.
• Subjects in need for continued treatment with iNO in the opinion of the treating physician and agreement from Sponsor.

Exclusion Criteria:

• Subjects who require treatment with riociguat
• Subjects who early discontinued drug/device usage due to withdrawal of consent or an AE requiring termination from treatment in IK-7001-PAH-201