A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (Core OLE)

Summary

The purpose of this study is to assess the safety and efficacy of Rodatristat Ethyl in pulmonary arterial hypertension (PAH) patients.

Timeline

Start

2021-03-15

Primary completion

2023-06-05

Completion

2023-08-28

Outcome

Missed primary endpoint

paper Least-squares mean percent change in PVR from baseline to week 24 favoured placebo PMID 39307144 ↗

Publications

• Lachant DJ, Sahay S, Block R, Ossip D, Denning J, Lazarus HM, Parsley E, White RJ. Rodatristat ethyl decreases activity in pulmonary arterial hypertension: results from the ELEVATE-2 trial. Ann Am Thorac Soc. 2026 May 1;23(5):754-761. doi: 10.1093/annalsats/aaoaf066.
• Sitbon O, Skride A, Feldman J, Sahay S, Shlobin OA, McLaughlin V, Ghofrani HA, Langleben D, Parsley E, D'Souza G, Marmon T, Kamau-Kelley W, Jones R, Grewal R, Wring S, Palacios M, Naik H, Denning J, Lazarus HM, Humbert M. Safety and efficacy of rodatristat ethyl for the treatment of pulmonary arterial hypertension (ELEVATE-2): a dose-ranging, randomised, multicentre, phase 2b trial. Lancet Respir Med. 2024 Nov;12(11):865-876. doi: 10.1016/S2213-2600(24)00226-1. Epub 2024 Sep 19.

Drugs

Indications