The Phase 3 clinical trial to evaluate the safety and efficacy of oral inhalation of seralutinib for pulmonary arterial hypertension is enrolling

The PROSERA Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of the oral Inhalation of seralutinib for the treatment of pulmonary arterial hypertension is currently enrolling. The PROSERA study’s objective is to understand the effect of seralutinib on specific pathways in the body that lead to the inflammation, proliferation and fibrosis […]

The Phase 3 clinical trial to evaluate the safety and efficacy of oral inhalation of seralutinib for pulmonary arterial hypertension is enrolling Read Post »

Phase 1 clinical trial on a treprostinil skin patch for pulmonary arterial hypertension due to start shortly

Corsair Pharma has developed a proprietary transdermal patch intended to provide consistent blood levels of treprostinil, a drug currently administered via a 24/7 infusion pump (sub-cutaneous or intra-venous, see this link for more details), by delivering an inactive prodrug, which crosses the skin, enters the blood, and converts rapidly to treprostinil in the liver. Since

Phase 1 clinical trial on a treprostinil skin patch for pulmonary arterial hypertension due to start shortly Read Post »

“Discovering New Pulmonary Hypertension Therapies on the Horizon”, a live webinar on February 21, 2024, organised by the US Pulmonary Hypertension Association, PHA

Join the Pulmonary Hypertension Association, PHA, for the upcoming “Discovering New Pulmonary Hypertension Therapies on the Horizon” PHA Live webinar on Wednesday, Feb. 21 at 2 pm. EST/ 7 p.m. UTC. During the webinar, Sandeep Sahay, MD, MSc, ATSF, will review: Don’t miss this opportunity to gain insights into these promising therapies that will help manage your

“Discovering New Pulmonary Hypertension Therapies on the Horizon”, a live webinar on February 21, 2024, organised by the US Pulmonary Hypertension Association, PHA Read Post »

Prof. Adam Torbicki explores access to care, Prof. Jean-Luc Vachiéry delves into drug development – watch the highlights from the PHA Europe Annual Conference online

Prof. Adam Torbicki’s presentation is titled “Access to care for pulmonary arterial hypertension and chronic thromboembolic pulmponary hypertension”. It can be viewed at this link on Vimeo (you need to register on Vimeo to see it) Prof. Jean-Luc Vachiéry’s presentation is titled “Drug development and clinical trials“. It can be viewed at this link on

Prof. Adam Torbicki explores access to care, Prof. Jean-Luc Vachiéry delves into drug development – watch the highlights from the PHA Europe Annual Conference online Read Post »

Wrapping up a successful year of pulmonary hypertension knowledge-sharing educational live web events!

The Alliance for Pulmonary Hypertension has just held the last webinar of the six-part series it launched in June 2023 exploring the innovations outlined in the 2022 joint clinical guidelines on pulmonary hypertension by the European Society of Cardiology (ESC) and the European Respiratory Society (ERS). Across these six insightful sessions, we delved into pivotal

Wrapping up a successful year of pulmonary hypertension knowledge-sharing educational live web events! Read Post »

The US Pulmonary hypertension Association, PHA, is partnering with the Fundación Contra la Hipertensión Pulmonar, Spain, to host a two-part Live webinar series, simulcast in English and Spanish

November 30, 2 pm EST The first webinar, “Hope Through Research in Pulmonary Hypertension: Emerging Developments,” will review emerging pulmonary hypertension research developments and the potential impact they’ll have on the PH community. December 14, 2 pm EST The second webinar, “Hope Through Research in Pulmonary Hypertension: Clinical Trials,” will discuss the clinical trial process,

The US Pulmonary hypertension Association, PHA, is partnering with the Fundación Contra la Hipertensión Pulmonar, Spain, to host a two-part Live webinar series, simulcast in English and Spanish Read Post »

J&J subsidiary Janssen has terminated the Phase III MACiTEPH trial of macitentan in chronic thromboembolic pulmonary hypertension (MACiTEPH)

The trial was evaluating efficacy and safety of Macitentan 75 mg in Inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. It was a prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 Study. The decision to drop the study is in line with the recommendation of an independent data monitoring committee, which found during a

J&J subsidiary Janssen has terminated the Phase III MACiTEPH trial of macitentan in chronic thromboembolic pulmonary hypertension (MACiTEPH) Read Post »

KEROS Therapeutics announces launch of a Phase 2 trial, TROPOS, to assess the effectiveness of KER-012 as add-on treatment in pulmonary arterial hypertension

Keros Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug application to conduct a Phase 2 clinical trial of KER-012, TROPOS, in combination with background therapy in patients with pulmonary arterial hypertension. KER-012 KER-012 is designed to normalize blood vessel thickness and heart function in pulmonary hypertension.

KEROS Therapeutics announces launch of a Phase 2 trial, TROPOS, to assess the effectiveness of KER-012 as add-on treatment in pulmonary arterial hypertension Read Post »

Update on Merck Phase 2/3 INSIGNIA-PAH clinical trial investigating inhaled treatment MK-5475 in pulmonary arterial hypertension

Merck’s investigational inhaled soluble guanylate cyclase (sGC) stimulator MK-5475 was well-tolerated and showed promise among adults with pulmonary arterial hypertension (PAH) in a Phase 1 clinical trial (see our article on this topic at this link). Merck is sponsoring a Phase 2/3 study. Learn more about the INSIGNIA-PAH trial at this link on the Merck website

Update on Merck Phase 2/3 INSIGNIA-PAH clinical trial investigating inhaled treatment MK-5475 in pulmonary arterial hypertension Read Post »

EVOLVE, a study by United Therapeutics to evaluate real-world use of next generation pumps for Remodulin was enrolling, August 15, 2023

The aim of the EVOLVE study is to observe and assess drug administration activities, time spent on drug administration activities, and patient-reported outcomes (PROs) including quality of life, treatment satisfaction, and patient perception of devices related to use of United Therapeutics Corporation (UTC)-developed next-generation infusion pumps to administer Remodulin in patients with pulmonary arterial hypertension.

EVOLVE, a study by United Therapeutics to evaluate real-world use of next generation pumps for Remodulin was enrolling, August 15, 2023 Read Post »

Aerami Therapeutics prepares for initiation of uniPHied, a Phase 2 study trial of AER-901, inhaled imatinib, in pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), June 1, 2023

Aerami Therapeutics has announced new additions to its management team as the company prepares for the imminent initiation of the planned “uniPHied” Phase 2 trial of AER-901 (inhaled imatinib), in pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH). AER-901 is a drug-device combination delivered via a high-performance, handheld nebulizer that

Aerami Therapeutics prepares for initiation of uniPHied, a Phase 2 study trial of AER-901, inhaled imatinib, in pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), June 1, 2023 Read Post »

ARTISAN Phase 4 study to assess effect of early and rapid treprostinil therapy in mean pulmonary artery pressure (mPAP) reduction and reverse right ventricle remodeling in pulmonary arterial hypertension patients, June 3, 2023

ARTISAN (Afterload Reduction To Improve Right Ventricular Structure And Function) is a Phase 4, Prospective, Multi-center, Single-Arm Study to assess the effect of early and rapid treprostinil therapy to reduce mean pulmonary artery pressure (mPAP, improve right ventricular (RV) function, and reverse RV remodeling, in patients with pulmonary arterial hypertension (PAH). Estimated enrolment is 50

ARTISAN Phase 4 study to assess effect of early and rapid treprostinil therapy in mean pulmonary artery pressure (mPAP) reduction and reverse right ventricle remodeling in pulmonary arterial hypertension patients, June 3, 2023 Read Post »

Zambon Pharma completes enrolment in Phase 3 clinical trial evaluating new inhaled treatment for the treatment of Bronchiolitis Obliterans Syndrome (BOS) following single or double lung transplant, May 1, 2023

Zambon, a multinational pharmaceutical company, announced today that it has completed enrollment in its two pivotal Phase 3 studies. The trials are designed to evaluate the safety and efficacy of Liposomal Cyclosporine A for Inhalation (L-CsA-i) for the treatment of BOS in adults following single lung (BOSTON-1) or double lung (BOSTON-2) transplantation.  BOS is a

Zambon Pharma completes enrolment in Phase 3 clinical trial evaluating new inhaled treatment for the treatment of Bronchiolitis Obliterans Syndrome (BOS) following single or double lung transplant, May 1, 2023 Read Post »

Currently enrolling: HYPERION Phase 3 clinical trial to evaluate Sotatercept on top of background pulmonary arterial hypertension therapy in newly diagnosed intermediate-and high-risk patients

This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate sotatercept when added to background pulmonary arterial hypertension therapy in newly diagnosed intermediate- or high risk pulmonary arterial hypertension participants. The estimated enrolment is participants is 662 and the estimated completion date is August 31, 2028. The sponsor is Acceleron Pharma, Inc., a wholly-owned

Currently enrolling: HYPERION Phase 3 clinical trial to evaluate Sotatercept on top of background pulmonary arterial hypertension therapy in newly diagnosed intermediate-and high-risk patients Read Post »

IMPAHCT, a Phase 2b/3 study investigating a potential new medication, AV-101, developed by aerovate therapeutics, for patients with pulmonary arterial hypertension, April 30, 2023

AV-101 is an investigational, proprietary dry powder inhaled formulation of imatinib which is intended to address the underlying hyperproliferation of cells within the narrowed arteries of the lungs. It is designed to deliver antiproliferative therapy directly to the lungs, allowing more of the drug to access the diseased tissues directly while simultaneously reducing systemic exposure

IMPAHCT, a Phase 2b/3 study investigating a potential new medication, AV-101, developed by aerovate therapeutics, for patients with pulmonary arterial hypertension, April 30, 2023 Read Post »

Effects of an inhaled soluble guanylate cyclase (sGC) stimulator MK-5475 in pulmonary arterial hypertension (PAH), in Respiratory Medicine, January 2023

This Phase 1 study evaluated efficacy/safety of inhaled single-dose MK-5475, an investigational, small-molecule stimulator of soluble guanylate cyclase designed for inhaled delivery via a dry-powder inhaler device, in participants with pulmonary arterial hypertension. The findings reveal that treatment with inhaled single-dose MK-5475 reduced pulmonary vascular resistance and increased pulmonary blood volume. Compared to the placebo, MK-5475 was

Effects of an inhaled soluble guanylate cyclase (sGC) stimulator MK-5475 in pulmonary arterial hypertension (PAH), in Respiratory Medicine, January 2023 Read Post »

Gossamer Bio announces seralutinib meets primary endpoint in phase 2 TORREY study in pulmonary arterial hypertension, December 6, 2022

On December 6, 2022, Gossamer Bio, Inc. announced topline results for the TORREY Phase 2 study of seralutinib in patients with pulmonary arterial hypertension. Seralutinib is a tyrosine kinase inhibitor targeting PDGFRα/β, CSF1R, and c-KIT, specifically designed to be delivered via dry powder inhaler for the treatment of pulmonary hypertension. Read more about the TORREY

Gossamer Bio announces seralutinib meets primary endpoint in phase 2 TORREY study in pulmonary arterial hypertension, December 6, 2022 Read Post »

Want to find out more about sotatercept, a potential new pulmonary arterial hypertension treatment? Check out this interview with Dr. Mark Tushner, care of the Pulmonary Hypertension Association UK (PHA UK), November 2022

the Pulmonary Hypertension Association UK (PHA UK) has recently posted a very informative interview with Dr Mark Toshner, pulmonary hypertension Specialist and Associate Professor, about sotatercept, a promising new pulmonary arterial hypertension drug (results for the STELLAR study were announced recently) which is the first to target the root cause of the disease. The video

Want to find out more about sotatercept, a potential new pulmonary arterial hypertension treatment? Check out this interview with Dr. Mark Tushner, care of the Pulmonary Hypertension Association UK (PHA UK), November 2022 Read Post »

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