The PROSERA study for seralutinib in pulmonary arterial hypertension findings were released yesterday and report that it did not meet its primary endpoint in the full population. It appears that unexpected placebo results in some geographical areas may have been responsible for this happening. While this is disappointing news for the patient community the program […]
SCOTLAND: It was announced last week (9th February) that sotatercept, the ‘first in class’ pulmonary arterial hypertension treatment, will not be commissioned for use by NHS Scotland at this stage. Our fellow patient advocates at the PHA UK note that whilst this is disappointing news initial refusal is common for new and specialised drugs, and
The February 9 2026 edition of Pulmonary Hypertension News reports that enrollment has been completed in under a year for the PHocus Phase 2 clinical trial testing mosliciguat, a once-daily inhaled therapy for pulmonary hypertension associated with interstitial lung disease (PH-ILD)—a condition where current treatment options remain limited and often poorly tolerated. Developed by Pulmovant,
This multicenter, open-label, single-arm phase 3 study aimed to assess the efficacy and safety of sotatercept in Japanese patients with PAH. Forty-six adult Japanese patients with pulmonary arterial hypertension receiving stable background therapy were enrolled in a multicenter, open-label, single-arm phase 3 study to assess the efficacy and safety of sotatercept in Japanese patients. They
Current joint European Society of Cardiology and European Respiratory Society pulmonary hypertension clinical practice guidelines recommend double oral therapy for intermediate-risk pulmonary arterial hypertension patients . They recommend upfront triple combination therapy for high-risk patients only, but retrospective data suggests triple therapy including parenteral prostacyclins may be better. The phase IV, multicentre, prospective, randomised, two-arm,
Research published in Respiratory Medicine on January 12, 2026, explored adherence to pulmonary arterial hypertension-specific therapies across different therapeutic classes, identified factors associated with non-adherence and evaluated its impact on clinical outcomes. Adherence was measured by proportion of days covered (PDC) during the treatment period, defined as 60 days after first therapy until treatment discontinuation/censor.
A retrospective cohort study using data from 103 healthcare organizations compared 454 pulmonary arterial hypertension patients receiving sotatercept to 963.386 pulmonary arterial hypertension patients not receiving sotatercept. After propensity score matching to balance baseline characteristics, 346 patients per group were analyzed over an average follow-up of approximately 6-8 months. The sotatercept group demonstrated dramatically lower
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
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
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
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
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
