On October 11, 2025, the Alliance for Pulmonary Hypertension launched the inspiring “Wheels of Hope” campaign, following Czech cyclist and chef Lukáš Jakovec as he embarked on an extraordinary journey across Europe to raise awareness about organ donation and transplantation—all while cycling through some of Europe’s most challenging terrain. Key Numbers Route Highlights Starting from […]
After 30 years on the market, Flolan (epoprostenol) was discontinued in November 2025, marking the end of an era for pulmonary arterial hypertension treatment. Healthcare professionals worked throughout 2025 to transition patients to alternative therapies. Veletri, a room temperature-stable version of epoprostenol, remains available. A recent article in the News section of the US Pulmonary
Professor Marc Humbert, one of the world’s leading specialists in pulmonary arterial hypertension (PAH), has been awarded the prestigious Inserm Grand Prize in recognition of his extraordinary career dedicated to understanding and treating this life-threatening disease. Inserm is the French National Institute of Health and Medical Research. From Orphan Disease to Hope When Prof. Humbert
A very interesting article by Prof. Werner Seeger recounts the discovery and development of inhaled prostanoids for pulmonary hypertension at the Giessen Pulmonary Hypertension center (Germany) in the late 1980s-1990s (§). Initially researching acute lung injury/Acute Respiratory Distress Syndrome (ARDS), researchers at Giessen observed that while intravenous vasodilators worsened ventilation/perfusion mismatch, aerosolized prostacyclin (PGI2) reduced
Parenteral prostacyclin therapy remains the cornerstone for high-risk pulmonary arterial hypertension (PAH) patients but is limited by complications and reduced quality of life. A case series of eight high-risk patients demonstrated that adding sotatercept successfully enabled transition from intravenous to oral prostacyclin therapy. All patients received background dual therapy with endothelin receptor antagonists and phosphodiesterase-5
The European Medicines Agency’s Committee for Human Medicinal Products (CHMP) has recommended expanding WINREVAIR™ (sotatercept) approval for pulmonary arterial hypertension (PAH) treatment to include World Health Organisation (WHO) Functional Class II, III, and IV patients (previously only II-III). The recommendation is based on the Phase 3 ZENITH trial, which showed a 76% reduction in risk
The Food and Drug Administration (FDA)’s recent clearance for a Cereno Scientific Phase IIb trial on CS1 builds on the favourable safety, tolerability and encouraging disease-modifying signals observed in the Phase IIa study. CS1, an HDACi that acts through epigenetic modulation, has also been granted Orphan Drug Designation and Fast Track designation in the US. The
This is a small study but it addresses a very important but often overlooked issue, that of injection site pain for pulmonary arterial hypertension patients being treated with sub-cutaneous treprostinil, which can significantly affect quality of life. The researchers found that topical 10% lidocaine gel provided rapid and effective relief of injection site pain, facilitating
Pfizer has a new study ongoing on PF-07868489, a recombinant human IgG1 antibody that targets bone morphogenetic protein 9 (BMP9) and is administered through subcutaneous route for the treatment of PAH. PF-07868489 is currently in Phase 2 development and has received Orphan Drug designation in the US. The study (NCT06137742) has two parts: Part A: An
PF-07868489: Pfizer’s New Biologic Enters Phase 2 for Pulmonary Arterial Hypertension Read Post »
A review recently published in the European Respiratory Journal Open Research provides the latest evidence on drug- and toxin-associated pulmonary arterial hypertension, offering clinicians updated guidance on recognition, diagnosis, and management of this pulmonary arterial hypertension subtype (see below for the most recent pulmonary arterial hypertension classification, at 1.3) The first World Health Organization (WHO)
Pulmonary arterial hypertension (PAH) is a progressive, life-threatening disease where early detection is strongly encouraged to prevent irreversible vascular and cardiac damage. However, a fundamental paradox exists: while clinicians are urged to diagnose pulmonary arterial hypertension early, treatment is restricted to symptomatic patients (New York Heart Association (NYHA) functional class II or higher), leaving asymptomatic
Inhibikase Therapeutics, Inc., a clinical-stage pharmaceutical company has announced that it expects to advance IKT-001 to a global pivotal Phase 3 clinical study in pulmonary arterial hypertension The Phase 3 study, named IMPROVE-PAH, is expected to be initiated in the first quarter of 2026. IKT-001 is an investigational novel pro-drug of imatinib mesylate. Imatinib is
The European Medicines Agency (EMA) has published a new booklet on the safety monitoring of medicines in the European Union. It provides an overview of how the European Medicines Agency and European Union Member States work to ensure that medicines used across Europe remain safe throughout their lifecycle. The booklet is published on a new
Pulmonary arterial hypertension patients face unique challenges in lung transplantation. Unlike patients with other lung diseases, they often have relatively normal lung function tests but are in critical condition due to heart failure. This means they receive low priority scores in the standard Lung Allocation Score (LAS) system, which was designed primarily for patients with
Access to specialized care may differ between urban and rural patients, potentially influencing outcomes. A study conducted at the at the University of Utah Pulmonary Hypertension Center compared 263 pulmonary arterial hypertension patients from urban versus rural areas treated in the period 2020-2024. Similar at baseline: Important differences emerged: Conclusion: Despite similar care delivery and
CM5480 is an experimental therapy being developed by Calcimedica, a US clinical-stage biopharmaceutical company. The findings of a new study titled “Combination of Orai1 inhibitor CM5480 with specific therapy mitigates pulmonary hypertension and its cardiac dysfunction” reveals that CM5480 was helpful in rat models when used on its own and provided additional benefits when combined
The Council of Europe’s EDQM (European Directorate for the Quality of Medicines and HealthCare) Newsletter Transplant provides regular updates on transplantation-related developments across Europe. It covers policy, regulation, quality standards, and best practices related to organ donation, allocation, and transplant safety, ensuring harmonisation across European Union member states. Additionally, the newsletter shares news on scientific
Vallerie McLaughlin, MD, the Kim A. Eagle M.D. Endowed Professor of Cardiovascular Medicine and Professor of Internal Medicine at the University of Michigan Medical School, presented the results of a pooled analysis of the PULSAR, STELLAR, and ZENITH trials of sotatercept in pulmonary arterial hypertension at the 2025 American Heart Association Scientific Sessions, held in
Cereno Scientific has submitted the clinical trial protocol for the planned global Phase IIb trial of its lead drug candidate CS1 to the U.S. Food and Drug Administration (FDA). CS1 is an oral histone deacetylase inhibitor (HDACi) intended as a disease-modifying therapy for pulmonary arterial hypertension (PAH), working through epigenetic modulation to target underlying mechanisms
The first clinical site is now active for a global Phase 3 study that will evaluate Gossamer Bio’s therapy candidate seralutinib for people with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The study, titled SERANATA, aims to enroll around 480 patients aged 18 to 80, randomised to receive either 90 mg or 120 mg
