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
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
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
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.
INCREASE – Phase 3 clinical trial with Tyvaso® (treprostinil) for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Please click here to see important safety information
Status
Devices / FDA Approved*
Implantable System for intravenous delivery of Remodulin® (treprostinil).
*FDA requires that certain conditions of Medtronic’s PMA approval of the Implantable System for Remodulin must be satisfied prior to launch or sale of the Implantable System for Remodulin; accordingly, Implantable System for Remodulin labeling may be revised in the process of satisfying such conditions of approval.
Pulmonary Hypertension (PH) WHO Group 1 (PAH)Pulmonary Hypertension (PH) WHO Group 3
Status
Phase 3
Dry Powder Inhaled (DPI) treprostinil in a small handheld device for the treatments of pulmonary arterial hypertension (PAH), and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Patients with Chronic Fibrosing Interstitial Lung Disease.
An IP receptor agonist that is a next-generation, once-a-day oral therapy that targets the prostacyclin pathway for patients with pulmonary arterial hypertension (PAH).
Phase 2 clinical trial to establish the efficacy and safety of repeat dosing of autologous endothelial progenitor cells (EPCs) transfected with human endothelial nitric oxide synthase (eNOS) and expanded ex-vivo in patients with PAH on top of conventional treatments.
The TAL is a biomedical device that is being developed to provide respiratory assistance for patients who cannot receive a tissue-based lung, or who need partial or short-term lung support.
WHO Group 1 pulmonary hypertension is also known as pulmonary arterial hypertension (PAH) and is distinguished by high blood pressure that specifically occurs in the vessels that supply the lungs. This is distinct from more generalized hypertension which is characterized by high blood pressure in vessels throughout the body. In PAH, the blood vessels in the lung stiffen and become narrower, which increases the pressure in the arteries and causes the heart to pump harder in order to pass blood through them. Over time, the added stress from heightened blood pressure in the lungs can cause the heart to weaken. Patients with PAH commonly experience symptoms such as shortness of breath, fatigue, chest pain, dizziness and/or fainting. These patients can also experience difficulties in completing normal activities such as climbing stairs.