Publications - UTHR PIPELINE

ADVANCE Studies Ralinepag (IP receptor agonist)

Advance Outcomes - A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in Subjects with Pulmonary Arterial Hypertension

Channick R, Tapson VF, Humbert M, et al.

Am J Respir Crit Care Med. 2020;201:A3819.

Safety, Tolerability, and Pharmacokinetics of the Selective Prostacyclin Receptor Agonist Ralinepag in Single and Multiple Dosing Studies of an Immediate-Release Oral Formulation in Healthy Volunteers

Grundy JS, King C, Adams J, et al.

Pulmonary Circulation. 2020.

Efficacy and safety of ralinepag, a novel oral IP agonist, in PAH patients on mono or dual background therapy: results from a phase 2 randomised, parallel group, placebo-controlled trial

Torres F, Farber H, Ristic A, et al.

European Respiratory Journal. 2019;54(4).

Interim Results from the Ongoing Open-Label Extension of the Phase 2 Trial Evaluating Ralinepag for the Treatment of Pulmonary Arterial Hypertension

McLaughlin VV, Ristic A, Jansa P, et al.

American Journal of Respiratory and Critical Care Medicine. 2019;199:A2509.

Interim Results from the Ongoing Open-Label Extension of the Phase 2 Trial Evaluating Ralinepag for the Treatment of Pulmonary Arterial Hypertension. American Journal of Respiratory and Critical Care Medicine

McLaughlin VV, Ristic A, Jansa P, et al.

Poster presented at: American Thoracic Society International Conference; May 19, 2019; Dallas, TX.

Study Design of the Phase 3 ADVANCE Program Evaluating Time-to-Clinical Events and Exercise Capacity in Patients with Pulmonary Arterial Hypertension Treated with Ralinepag

McLaughlin VV, Channick R, Tapson V, et al.

American Journal of Respiratory and Critical Care Medicine. 2019; 199:A5074.

Study Design of the Phase 3 ADVANCE Program Evaluating Time-to-Clinical Events and Exercise Capacity in Patients with Pulmonary Arterial Hypertension Treated with Ralinepag

McLaughlin VV, Channick R, Tapson V, et al.

Poster presented at: American Thoracic Society International Conference; May 19, 2019; Dallas, TX.

Ralinepag plasma levels correlate with improvements in functional and hemodynamic parameters in patients with pulmonary arterial hypertension

Farber HW, Sood N, Preston IR, et al.

The Journal of Heart and Lung Transplantation. 2019;38(4):S208.

Ralinepag plasma levels correlate with improvements in functional and hemodynamic parameters in patients with pulmonary arterial hypertension

Farber HW, Sood N, Preston IR, et al.

Presentation at: ISHLT 2019 Annual Meeting and Scientific Sessions; April 3-6,2019; Orlando, FL.

Clinical pharmacokinetic performance of a ralinepag extended-release tablet

Grundy J, Blackburn A, Tang Y, et al.

The Journal of Heart and Lung Transplantation. 2019;38(4):S207-S208.

Clinical pharmacokinetic performance of a ralinepag extended-release tablet

Grundy J, Blackburn A, Tang Y, et al.

Poster presented at: ISHLT 2019 Annual Meeting and Scientific Sessions; April 3-6,2019; Orlando, FL.

Near-term

Mid-term

Long-term

ADVANCE Studies Ralinepag (IP receptor agonist)

Advance Outcomes - A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in Subjects with Pulmonary Arterial Hypertension

Channick R, Tapson VF, Humbert M, et al.

Am J Respir Crit Care Med. 2020;201:A3819.

Safety, Tolerability, and Pharmacokinetics of the Selective Prostacyclin Receptor Agonist Ralinepag in Single and Multiple Dosing Studies of an Immediate-Release Oral Formulation in Healthy Volunteers

Grundy JS, King C, Adams J, et al.

Pulmonary Circulation. 2020.

Efficacy and safety of ralinepag, a novel oral IP agonist, in PAH patients on mono or dual background therapy: results from a phase 2 randomised, parallel group, placebo-controlled trial

Torres F, Farber H, Ristic A, et al.

European Respiratory Journal. 2019;54(4).

Interim Results from the Ongoing Open-Label Extension of the Phase 2 Trial Evaluating Ralinepag for the Treatment of Pulmonary Arterial Hypertension

McLaughlin VV, Ristic A, Jansa P, et al.

American Journal of Respiratory and Critical Care Medicine. 2019;199:A2509.

Interim Results from the Ongoing Open-Label Extension of the Phase 2 Trial Evaluating Ralinepag for the Treatment of Pulmonary Arterial Hypertension. American Journal of Respiratory and Critical Care Medicine

McLaughlin VV, Ristic A, Jansa P, et al.

Poster presented at: American Thoracic Society International Conference; May 19, 2019; Dallas, TX.

Study Design of the Phase 3 ADVANCE Program Evaluating Time-to-Clinical Events and Exercise Capacity in Patients with Pulmonary Arterial Hypertension Treated with Ralinepag

McLaughlin VV, Channick R, Tapson V, et al.

American Journal of Respiratory and Critical Care Medicine. 2019; 199:A5074.

Study Design of the Phase 3 ADVANCE Program Evaluating Time-to-Clinical Events and Exercise Capacity in Patients with Pulmonary Arterial Hypertension Treated with Ralinepag

McLaughlin VV, Channick R, Tapson V, et al.

Poster presented at: American Thoracic Society International Conference; May 19, 2019; Dallas, TX.

Ralinepag plasma levels correlate with improvements in functional and hemodynamic parameters in patients with pulmonary arterial hypertension

Farber HW, Sood N, Preston IR, et al.

The Journal of Heart and Lung Transplantation. 2019;38(4):S208.

Ralinepag plasma levels correlate with improvements in functional and hemodynamic parameters in patients with pulmonary arterial hypertension

Farber HW, Sood N, Preston IR, et al.

Presentation at: ISHLT 2019 Annual Meeting and Scientific Sessions; April 3-6,2019; Orlando, FL.

Clinical pharmacokinetic performance of a ralinepag extended-release tablet

Grundy J, Blackburn A, Tang Y, et al.

The Journal of Heart and Lung Transplantation. 2019;38(4):S207-S208.

Clinical pharmacokinetic performance of a ralinepag extended-release tablet

Grundy J, Blackburn A, Tang Y, et al.

Poster presented at: ISHLT 2019 Annual Meeting and Scientific Sessions; April 3-6,2019; Orlando, FL.

Pulmonary Arterial Hypertension (PAH) WHO Group 1