A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension

Summary

The purpose of this study to confirm the selexipag starting dose(s), selected based on pharmacokinetic (PK) extrapolation from adults, that leads to similar exposure as adults doses in children from greater than or equal to (\>=) 2 to less than (˂) 18 years of age with Pulmonary Arterial Hypertension (PAH), by investigating the PK of selexipag and its active metabolite ACT-333679 in this population.

Timeline

Start

2018-07-23

Primary completion

2022-03-28

Completion

2026-12-31

Publications

• Beghetti M, Axelsen LN, Borissoff JI, Farhan M, Grill S, Leng S, Russu A, Lesage C, Remenova T, Hsu Schmitz SF, Moledina S. A Prospective, Multicenter, Open-Label, Single-Arm Phase 2 Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Exploratory Efficacy of Selexipag in Children With Pulmonary Arterial Hypertension. Chest. 2026 May;169(5):1330-1344. doi: 10.1016/j.chest.2025.12.013. Epub 2025 Dec 20.

Drugs

Indications