Clinical Trials

Inclusion Criteria:

- Male and female participants who completed end of treatment study visit in Study
INS1009-201, INS1009-202, or any other lead-in PAH TPIP study. Participants for whom
the OLE study was not available at the time of their completion of the lead-in study
are eligible for enrolment within one year of their lead-in end of treatment visit.

- Complete baseline screening assessments to confirm eligibility to participate if more
than 30 days have elapsed since the end of the study visit in Study INS1009-201,
INS1009-202, or any other lead-in PAH TPIP study.

Exclusion Criteria:

- Initiation of parenteral administration of prostacyclin analogues (eg, TRE,
epoprostenol) since the completion of studies INS1009-201, INS1009-202 or other TPIP
studies. Initiation of inhaled prostacyclin analogues (eg, TRE [Tyvaso] or iloprost)
and oral prostacyclin analogues (eg, TRE [Orenitram]) or receptor agonists (eg,
selexipag) are permitted if stopped 24 hours prior to the start of study drug
administration.

- Any new ventricular or supraventricular tachyarrhythmia except for paroxysmal atrial
fibrillation and any new symptomatic bradycardia.

- New-onset of heart disease including left ventricular ejection fraction (LVEF) ≤40% or
clinically significant valvular, constrictive, or symptomatic atherosclerotic heart
disease (eg, stable angina, myocardial infarction, etc).

- New evidence of thromboembolic disease as assessed by ventilation/perfusion (VQ) scan,
pulmonary angiography, or pulmonary computed tomography (CT) scan.

- Active and current symptomatic coronavirus disease 2019 (COVID-19) or previous severe
disease and/or hospitalization due to COVID-19.

- Interval organ transplantation.

- New active liver disease or hepatic dysfunction.

- Interval malignancy with exception of completely treated in situ carcinoma of the
cervix and completely treated non-metastatic squamous or basal cell carcinoma of the
skin.

- Use of any investigational drug/device or participation in any investigational study
within 30 days prior to screening, not including TPIP of the lead-in study.

- Current use of cigarettes (as defined by Centers for Disease Control and Prevention
[CDC]) or e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her
lifetime, who smokes either every day or some days.

- Participants who currently inhale marijuana (recreational or medical).

Note: Other inclusion/exclusion criteria may apply.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/13/2024. Questions regarding updates should be directed to the study team contact.