Cereno Scientific reports favorable safety and tolerability after 12 months of CS1 treatment in pulmonary arterial hypertension (PAH)from the Expanded Access Program (EAP), March 31, 2026

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 […]

Cereno Scientific reports favorable safety and tolerability after 12 months of CS1 treatment in pulmonary arterial hypertension (PAH)from the Expanded Access Program (EAP), March 31, 2026 Read Post »

Detecting pulmonary hypertension earlier? US Food and Drug Administration (FDA) clears Anumana’s AI echocardiogram algorithm

Anumana has received US Food and Drug Administration (FDA) 510(k) clearance for an AI-powered algorithm that detects early signs of pulmonary hypertension using standard 12-lead echocardiograms (ECGs) — making it the first pulmonary hypertension algorithm cleared for this widely available diagnostic tool. Previously granted US Food and Drug Administration “Breakthrough Device Designation”, the algorithm integrates

Detecting pulmonary hypertension earlier? US Food and Drug Administration (FDA) clears Anumana’s AI echocardiogram algorithm Read Post »

United Therapeutics announces results for its Phase 3 ADVANCE OUTCOMES study on ralenipag for pulmonary arterial hypertension, March 2, 2026

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

United Therapeutics announces results for its Phase 3 ADVANCE OUTCOMES study on ralenipag for pulmonary arterial hypertension, March 2, 2026 Read Post »

Nippon Shinyaku reports progress on trials on NS-863 targeting pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD)

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,

Nippon Shinyaku reports progress on trials on NS-863 targeting pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) Read Post »

PF-07868489: Pfizer’s New Biologic Enters Phase 2 for Pulmonary Arterial Hypertension

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 »

Inhibikase Therapeutics Phase 3 study on IKT-001 – an anti-proliferative tyrosine kinase inhibitor – expected to be initiated in the first quarter of 2026

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

Inhibikase Therapeutics Phase 3 study on IKT-001 – an anti-proliferative tyrosine kinase inhibitor – expected to be initiated in the first quarter of 2026 Read Post »

The UK Pulmonary Hypertension Association Chair, Dr Iain Armstrong, explains what happens next with sotatercept and what will be considered when it comes to making decisions for the UK

The first-in-class pulmonary arterial hypertension drug sotatercept was approved in March 2024 by the Food and Drug Administration (FDA) in the USA and the approval of the European Medicines Agency (EMA) is expected in the next few months. The UK Pulmonary Hypertension Association, PHA UK, has put together a short video, with its Chair Dr

The UK Pulmonary Hypertension Association Chair, Dr Iain Armstrong, explains what happens next with sotatercept and what will be considered when it comes to making decisions for the UK Read Post »

The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has recommended granting a marketing authorisation for Winrevair (sotatercept)

On 28 June 2024 the European Medicines Agency has issued a press release to say that the CHMP (human medicines committee) has recommended granting a marketing authorisation in the European Union (EU) for Winrevair (sotatercept) to treat adult patients with pulmonary arterial hypertension (PAH), in combination with other specific PAH therapies, to improve exercise capacity. This is the first step

The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has recommended granting a marketing authorisation for Winrevair (sotatercept) Read Post »

The US Food and Drug Administration, FDA, approves sotatercept, Merck’s new drug for pulmonary arterial hypertension, March 26, 2024

The US Food and Drug Administration has approved sotatercept, Merck‘s new drug for pulmonary arterial hypertension. It’s commercial name is Winrevair. Read more on the FDA website at this link Sotatercept is an activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein. It was evaluated as an add-on to stable background therapy for the treatment of pulmonary

The US Food and Drug Administration, FDA, approves sotatercept, Merck’s new drug for pulmonary arterial hypertension, March 26, 2024 Read Post »

The US Food and Drug Administration, FDA, approves the single tablet combination macitentan/tadalafil for pulmonary arterial hypertension, March 22, 2024

On March 22, 2024 the Food and Drug Administration (FDA), the US drug regulatory authority, approved the single-tablet macitentan/tadalafil combination (Opsynvi) for pulmonary arterial hypertension. The application to the FDA was submitted by the Janssen Pharmaceutical Companies of Johnson & Johnson on May 30, 2023. The FDA approval is based on the results of the

The US Food and Drug Administration, FDA, approves the single tablet combination macitentan/tadalafil for pulmonary arterial hypertension, March 22, 2024 Read Post »

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 »

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 »

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 »

Info on treatments for pulmonary arterial hypertension, life style advice and patient stories on “The PAH Initiative”, by United Therapeutics

The PAH Initiative was established by United Therapeutics with the aim of providing knowledge and inspiration based on science and research in pulmonary arterial hypertension today. Here you can find interesting information on pulmonary arterial hypertension, treatments and life style advice as well as patient testimonials. The “Learning Library” section of the PAH initiative contains useful

Info on treatments for pulmonary arterial hypertension, life style advice and patient stories on “The PAH Initiative”, by United Therapeutics Read Post »

“PH Human”, a JanssenWithMe platform provides support resources for people with pulmonary arterial hypertension and features a number of real-life experiences from patients

PH Human, part of the JanssenWithMe digital platform, was created in partnership with the pulmonary hypertension patient community and is dedicated to supporting people with the condition. It has a particular focus on pulmonary arterial hypertension (Group 1 WHO classification of pulmonary hypertension). It helps share real-life experiences from people living with pulmonary arterial hypertension

“PH Human”, a JanssenWithMe platform provides support resources for people with pulmonary arterial hypertension and features a number of real-life experiences from patients Read Post »

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