Gossamer Bio, Inc. today announced enrollment completion for the ongoing, global registrational Phase 3 PROSERA Study evaluating seralutinib in Functional Class II and III pulmonary arterial hypertension patients. Gossamer Bio and the Chiesi Group are jointly developing seralutinib under a global collaboration agreement. See also our previous article about the PROSERA study at this link […]
The investigational drug CS1 aims to reverse the pathological vascular remodeling of the small pulmonary arteries. A successful Phase IIa trial was concluded in 2024 (see our article here). Insights into the long-term use of CS1 are being gathered in an expanded access program with 10 patients from the Phase IIa trial. Preparations are currently
Yutrepia is a dry powder formulation of treprostinil, a prostacyclin analog. It is designed to enhance deep-lung delivery with an easy-to-use device requiring low inspiratory effort. Yutrepia was was tentatively approved by the Food and Drug Administration last year (see our article here), but the agency was waiting for regulatory exclusivity of a competing product
A very important update on the phase 3 ZENITH trial for Winrevair (sotatercept) in pulmonary arterial hypertension was presented today at the American College of Cardiologists Annual Scientific Session in Boston, USA. The ZENITH trial evaluated Winrevair compared to placebo in adults with PAH, WHO Group 1, functional class III or IV, at high risk
Link: Liquidia Corporation announced on March 28, 2025, that the US Food and Drug Administration has accepted its resubmitted new drug application for YUTREPIA (treprostinil) inhalation powder. The treatment targets pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The FDA had previously granted tentative approval for both indications (see our
Cereno Scientific has received approval to initiate a sub-study within its Expanded Access Program (EAP) for CS1, a drug candidate aimed at treating pulmonary arterial hypertension. The study will use Functional Respiratory Imaging (FRI) technology, developed by Fluidda, to monitor changes in small pulmonary arteries over a 12-month period. This innovative approach aims to explore
Gossamer Bio, Inc. presented clinical and preclinical data related to its investigational drug seralutinib at the Pulmonary Vascular Research Institute (PVRI) 2025 Annual Congress that took place January 29th through February 1st in Rio de Janeiro, Brazil. Of particular interest the data on sustained benefit of seralutinib over nearly 1.5 years, and the evidence, from preclinical
Merck/MSD announced today that the Phase 3 HYPERION trial on pulmonary arterial hypertension patients (Group 1 World Health Organisation) in functional class II-III was suspended. Patients in the study will be offered the option of receiving WINREVAIR through the Phase 3 SOTERIA open-label extension study. Findings from the HYPERION study will be available later this
ALG-801 is a next-generation ligand trap targeting type IIA/IIB activin receptors that selectively sequesters a specific set of molecules that activate the Smad2/3 pathway, known to be involved in pulmonary arterial hypertension. Smad2/3 is implicated in the growth of pulmonary artery smooth muscle cells, which contributes to blood vessel remodeling, essentially structural alterations, and narrowing
Tiakis Biotech has received positive scientific advice from the US Food and Drug Administration (FDA) for a planned Phase 2 ATHENA clinical trial of tiprelestat in pulmonary arterial hypertension. The therapy has been granted orphan designation in the U.S. and in Europe for pulmonary arterial hypertension. Dr. Roham Zamanian, Professor of Medicine at Stanford University and
MK-5475 is an experimental soluble guanylate cyclase stimulator which is administered via dry powder inhalation and is designed to potentially mitigate the side effects associated with systemic vasodilation. The results of the INSIGNIA-PAH study published in the Respiratory Journal suggest that MK-5475 reduced pulmonary vascular resistance (PVR) and was well tolerated in patients with pulmonary
Janssen-Cilag International NV, a Johnson & Johnson company, announced on September September 30, 2024, that the European Commission has approved Yuvanci®, a single tablet macitentan 10 mg and tadalafil 40 mg combination therapy for the long-term treatment of adult pulmonary arterial hypertension patients in WHO Functional Class II-III, who are treated with macitentan and tadalafil
CS1 is a HDAC, Histone Deacetylase inhibitor, that works through epigenetic modulation and is being developed by Cereno Scientific as a disease modifying treatment for pulmonary arterial hypertension. CS1 targets the root cause of the disease, aiming to reverse the pathological vascular remodeling of the small lung arteries. The Phase IIa trial evaluated the safety,
Merck, known as MSD outside of the US and Canada, announced on August 26, 2024 that the European Commission has approved WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of pulmonary arterial hypertension in adult patients with World Health Organization (WHO) Functional Class (FC) II to III, to improve
Liquidia Corporation announced on August 20, 2024, that the US Food and Drug Administration (FDA) has granted tentative approval for YUTREPIA™ (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The approval is supported by the Phase 3 INSPIRE trial, which demonstrated YUTREPIA’s safety and tolerability.
Oral treprostinil is a prostacyclin analogue approved to treat pulmonary arterial hypertension (PAH). A study analysing the practical management of oral treprostinil in patients with pulmonary arterial hypertension has been published on “Respiratory Medicine” Volume 231, 107734, September 2024. The article is based on results of the ADAPT and EXPEDITE trials and expert consensus. The
The US Food and Drug Administration (FDA) has granted orphan drug designation to ZMA001,a first-in-class therapeutic monoclonal antibody designed to control or inhibit inflammation responses in pulmonary blood vessels. ZMA001 could potentially improve both the survival rates and the quality of life of patients by addressing the underlying cause of pulmonary arterial hypertension. The placebo-controlled
Selexipag shows promise for treating pulmonary arterial hypertension associated with connective tissue disease (CTD). The ongoing EXPOSURE (EUPAS19085) study sheds light on the real-world management of PAH-CTD patients in Europe and Canada. For more detailed insights, check out the full study results at this link on PubMed Citation Gaine S, Escribano-Subias P, Muller A, Fernandes
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
A recent article in “Pulmonary Hypertension News” reports on the tentative approval of Alembic Pharmaceuticals’ generic selexipag as pulmonary arterial hypertension treatment for pulmonary arterial hypertension. Alembic’s generic selexipag contains the same chemical substance as an approved treatment, Uptravi for injection, sold by Johnson & Johnson. Selexipag is a prostacyclin receptor agonist that leads to
