Gossamer Bio has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for seralutinib in pulmonary arterial hypertension (PAH). A New Drug Application is the formal application requesting that the Food and Drug Administration review a medicine to determine whether it may be approved for use in patients. To be […]
The pipeline VLR199 (the lead candidate): works in the same way as sotatercept (Winrevair), by trapping proteins of the activin family that drive the abnormal growth of cells in the lung vessels. The aim is to improve on aspects of sotatercept that may not be “fully optimised”. First clinical results showing whether it works are
EPIMODE is a global, randomized and placebo-controlled Phase IIb trial designed to evaluate efficacy, safety and tolerability, determine the optimal dose for further development, and provide additional insight into CS1’s potential disease-modifying effects in patients with pulmonary arterial hypertension (PAH). CS1 is being developed by Cereno Scientific as an oral, once-daily, potentially disease-modifying treatment for
The US Food and Drug Administration (FDA) has approved an update to the US label for WINREVAIR (sotatercept-csrk), Merck’s activin signaling inhibitor for pulmonary arterial hypertension, to include efficacy and safety data from the Phase 3 HYPERION trial. The trial specifically evaluated adults newly diagnosed with pulmonary arterial hypertension — within 12 months of screening,
The findings of the Pulmovant Phase 2 PHocus trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD, Group 3 of the World Health Organisation, WHO, pulmonary hypertension classification) were presented on September 8, 2026, at the European Respiratory Society (ERS) International Congress 2026 by Marc Humbert, MD, PhD, Professor of Respiratory Medicine
Pulnovo Medical‘s PADN-HF-PH trial results were presented at European Society of Cardiology (ESC) Congress 2026 in Munich, Germany, and published simultaneously in a New England Journal of Medicine article. The multicenter, randomized trial enrolled 264 patients with pulmonary hypertension associated with left heart disease (pulmonary hypertension associated with left heart disease (PH-LHD), World Health Organisation
The US Food and Drug Administration (FDA) has accepted for review a New Drug Application from United Therapeutics Corporation for ralinepag, an investigational prostacyclin IP receptor agonist intended to treat pulmonary arterial hypertension (PAH). The filing rests on results from the Phase III ADVANCE OUTCOMES study See our previous article on this topic here. Read more at
Tenax Therapeutics, Inc. announced today the topline results of its Phase 3 LEVEL trial, which evaluated TNX-103 (oral levosimendan) in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF), Group 2 of the World Health Organisation (WHO) pulmonary hypertension classification. The trial did not meet its primary endpoint — improvement in
Insmed announced on July 16 positive 12-Month data from the ongoing open-label extension (OLE) study evaluating treprostinil palmitil inhalation powder (TPIP), administered once daily in patients with pulmonary arterial hypertension (PAH, World Health Organization Group 1). The OLE study is a non-placebo-controlled trial and was designed to evaluate the long-term safety, tolerability, and effectiveness of
A review recently published in Pulmonary Circulation brings together academic and industry researchers (via the PVRI Innovative Drug Discovery Initiative) to consolidate current knowledge on activin signaling inhibitors (ASIs), the role of specific Bone morphogenetic protein (BMP) ligands, efficacy/safety data, and considerations for developing next-generation activin signaling inhibitors. Key points: Open questions remain about: the
ADVANCE OUTCOMES is a phase 3, randomised, double-blind trial tested oral ralinepag against placebo in pulmonary arterial hypertension patients, measuring time to first clinical worsening (death, hospitalisation, need for parenteral/inhaled prostacyclin therapy, disease progression, or unsatisfactory clinical response). Patients were enrolled between Jan 24, 2019, and June 20, 2025. Of 1037 patients screened for eligibility,
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to IKT-001, an experimental formulation of imatinib that Inhibikase Therapeutics is developing to treat pulmonary arterial hypertension (PAH). Orphan drug designation is granted to investigational medications aimed at treating rare diseases — conditions affecting fewer than 200,000 people in the U.S. The designation is meant to give
An article recently published in Open PR notes that inhaler devices are seeing broadening use for managing several respiratory conditions, with pulmonary arterial hypertension listed alongside asthma and COPD as one of the areas of application. The report is about the respiratory inhaler devices market overall — smart/connected inhalers, market size projections (forecast to reach
Pulmonary Hypertension associated with Heart Failure with Preserved Ejection Fraction (PH-HFpEF) is classified as Group 2 pulmonary hypertension by the World Health Organization (WHO). It is a type of heart failure in which the heart still pumps normally but becomes too stiff to fill properly with blood between heartbeats. This can cause pressure to build
GSK has confirmed it will discontinue Flolan, a drug used to treat pulmonary arterial hypertension, in the UK from 2028 — having already pulled it from the US (see our article on this topic here), and other markets. Around 150 UK patients, including children, currently rely on the drug. With production ending in April 2028
A Yale study, published in Pulmonary Circulation, examined links between pharmaceutical industry payments and prescribing patterns among physicians treating pulmonary arterial hypertension (PAH) — a field chosen because therapies are costly and prescribing is concentrated among a small group of specialists. Using CMS Open Payments data, researchers found that physicians receiving drug-specific industry payments were
Earlier this month, Liquidia Corporation presented four posters at the US Pulmonary Hypertension Association (PHA)’s International Conference in Dallas, sharing 24‑week ASCENT study data and broader insights on YUTREPIA (treprostinil) inhalation powder in pulmonary hypertension. Beyond clinical outcomes, the company highlighted patient‑reported cough data, the mental health strain on caregivers and the evolving role of
GLP-1 receptor agonists (GLP-1RAs) are drugs originally developed for diabetes and obesity. In experimental models of pulmonary arterial hypertension GLP-1RA’s administration attenuates the severity of pulmonary hypertension. Additional studies highlight their ability to protect against lung fibrosis and preserve endothelial function. No clinical trials have yet tested GLP-1RAs specifically in pulmonary arterial hypertension, though observational
Corsair Pharma‘s experimental skin patch designed to deliver treprostinil, an approved treatment for pulmonary arterial hypertension (PAH), appears to be working as intended, according to newly announced data from an early clinical trial in healthy volunteers. Several treprostinil formulations are already approved for pulmonary arterial hypertension: subcutaneous 24/7 infusion (Remodulin and generics), oral (Orenitram, not
Regeneron Pharmaceuticals, a U.S. biotech, is running a Phase 2 trial of REGN13335, an Anti-PDGF-B monoclonal antibody, in adults with pulmonary arterial hypertension who are already on standard treatment. It’s a randomized, placebo-controlled, quadruple-blind study (patients, doctors, investigators, and assessors are all kept in the dark during the main phase) to gauge what extra benefit
