Inhibikase Therapeutics has enrolled the first patient in its global pivotal Phase 3 IMPROVE-PAH trial of IKT-001 for pulmonary arterial hypertension. The trial uses a two-part adaptive design: the first part evaluates change in pulmonary vascular resistance in approximately 140 patients over 12 weeks, followed by a second part focusing on six-minute walk distance in […]
AllRock Bio has dosed the first patients in its Phase 2a ROCSTAR trial, evaluating ROC-101 — a potential first-in-class oral pan-rho-associated protein kinase (ROCK) inhibitor — in patients with pulmonary arterial hypertension and pulmonary hypertension with interstitial lung disease. The open-label, multicenter, exploratory study will evaluate the safety, tolerability, and efficacy of ROC-101 in both
Cereno Scientific has reported initial findings from a 12-month Expanded Access Program (EAP) with its oral drug candidate CS1 in pulmonary arterial hypertension (PAH), enrolling ten patients who had completed the previous Phase IIa trial. The results confirm a favourable safety and tolerability profile over long-term use, consistent with earlier findings, with no unexpected safety
To date sotatercept has only been studied in patients with prevalent pulmonary arterial hypertension receiving stable background therapy, not as part of the initial treatment regimen in newly diagnosed patients. A case report, published recently on the ERJ Open Research, describes a 25-year-old woman who developed severe high-risk idiopathic pulmonary arterial hypertension (IPAH) shortly after
United Therapeutics reported positive results from TETON-1, its second Phase III trial testing nebulised Tyvaso (treprostinil) in idiopathic pulmonary fibrosis (IPF). The trial, involving 598 patients over 52 weeks, showed that nebulised Tyvaso was superior to placebo in improving forced vital capacity (FVC) by 130.1 mL, and also achieved statistical significance in reducing the risk
The Phase 2 CADENCE randomised controlled trial tested sotatercept in patients with combined post- and pre-capillary pulmonary hypertension in heart failure with preserved ejection fraction (CpcPH-HFpEF) — a serious condition with high mortality and no proven treatments (Group 2 WHO pulmonary hypertension classification). 164 patients received either sotatercept (at one of two doses) or placebo
Swedish biotech Cereno Scientific has received approval from the Swedish Medical Products Agency to begin a Phase I study of its experimental drug CS014, a new HDAC inhibitor being developed for pulmonary hypertension associated with interstitial lung disease (PH-ILD). The study, designed in line with FDA guidance, will compare CS014’s pharmacokinetics to valproic acid (VPA),
Martine Aliana Rothblatt (born 1954) is an American lawyer, author, and entrepreneur. She founded United Therapeutics in 1996, to make medicines for her daughter who suffered from pulmonary arterial hypertension, and is now developing genetically modified pig organs for human transplant. On the latter topic she has written a book titled “Your life or mine
Since sotatercept received Food and Drug Administration (FDA) approval for pulmonary arterial hypertension in March 2024, knowing when and how to use it has become an essential part of managing this serious condition — so say the authors of a recently published article in CHEST, who offer a practical guide for clinicians navigating this new
This review covers the full clinical picture of pulmonary arterial hypertension (PAH) — from its pathophysiology and diagnosis through to current and emerging treatments. Understanding the Disease Pulmonary arterial hypertension is driven by progressive structural remodelling of the pulmonary arteries, creating a vicious cycle of vasoconstriction, inflammation, and uncontrolled cell growth that ultimately leads to
A Japanese study has confirmed that sotatercept works just as well in Asian patients, even though pulmonary arterial hypertension presents somewhat differently in the Asian population: patients tend to have longer disease duration, more severe baseline profiles, and are more frequently on intensive triple therapy including parenteral prostacyclin. This was a regional Phase 3, open-label
United Therapeutics has announced promising results from its pivotal Phase 3 ADVANCE OUTCOMES study of ralinepag, a new oral treatment for pulmonary arterial hypertension (PAH). Ralinepag is a highly selective prostacyclin (IP) receptor agonist that works through multiple pathways — vasodilatory, anti-proliferative, and anti-inflammatory. It is taken once daily orally, yet achieves sustained receptor activity
A consensus document featuring 10 statements, the main focus of which was the use of parenteral prostanoids, was developed by eight experts in pulmonary arterial hypertension during in-person and web-based meetings. Forty-six Italian physicians were invited online to rate each statement, indicating their agreement, neutrality or disagreement. These consensus statements are intended to support physicians
Nippon Shinyaku recently reported progress on two Phase 2 trials of its oral candidate NS-863, targeting pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), both serious cardiopulmonary conditions with high unmet need. By advancing NS-863 across two related indications, the company is signaling a deeper push into rare cardiopulmonary therapeutics,
GSK, a UK pharmaceutical multinational, has agreed to acquire 35Pharma, a private Canadian clinical-stage biopharmaceutical company, for $950m in cash. The transaction will provide GSK with full ownership of 35Pharma and its lead investigational medicine, HS235, an activin receptor signalling inhibitor currently positioned for studies in pulmonary arterial hypertension (PAH) and pulmonary hypertension due to
AI translation of article on MedUni, Vienna, Austria news, available in German at this link Vienna, February 25, 2026 – In January 2026, eight lung transplant recipients and their companions from five nations, together with a medical team from MedUni Vienna, climbed Aconcagua (6,961 meters) in Argentina – the highest peak in the Americas. During
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
