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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