An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)

Inclusion Criteria:

• Male and female participants who completed end of treatment study visit in StudyINS1009-201, INS1009-202, or any other lead-in PAH TPIP study. Participants for whomthe OLE study was not available at the time of their completion of the lead-in studyare eligible for enrolment within one year of their lead-in end of treatment visit.

• Complete baseline screening assessments to confirm eligibility to participate ifmore than 30 days have elapsed since the end of the study visit in StudyINS1009-201, 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 TPIPstudies. 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 drugadministration.

• Any new ventricular or supraventricular tachyarrhythmia except for paroxysmal atrialfibrillation and any new symptomatic bradycardia.

• New-onset of heart disease including left ventricular ejection fraction (LVEF) ≤40%or clinically significant valvular, constrictive, or symptomatic atheroscleroticheart 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 previoussevere 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 thecervix and completely treated non-metastatic squamous or basal cell carcinoma of theskin.

• Use of any investigational drug/device or participation in any investigational studywithin 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 orher lifetime, who smokes either every day or some days.

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

Note: Other inclusion/exclusion criteria may apply.