Enrollment is now complete — with nearly 400 participants with pulmonary arterial hypertension (PAH) — in the Phase 3 PROSERA clinical trial that’s testing the PAH treatment candidate seralutinib against a placebo in adults. Top-line results from PROSERA are expected in February 2026, according to Gossamer Bio, which is…
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The U.S. Food and Drug Administration (FDA) has accepted Gradient Denervation Technologies, a company that makes an ultrasound-based catheter to treat pulmonary hypertension (PH), into a program to facilitate development of medical devices. Acceptance into the FDA’s Total Product Life Cycle Advisory Program (TAP) pilot will give…
Beyond Air has submitted a supplement application to the U.S. Food and Drug Administration (FDA) for its LungFit PH 2, a second-generation device for administering nitric oxide (NO) to treat persistent pulmonary hypertension of the newborn (PPHN). LungFit PH 2 is a smaller, lightweight, transport-ready version of the…
A Phase 2b clinical trial of Insmed’s treprostinil palmitil inhalation powder (TPIP) suggested daily doses of the inhaled dry powder are well tolerated and may improve blood flow and exercise capacity in adults with pulmonary arterial hypertension (PAH). “The statistically significant and clinically meaningful results shown with TPIP…
The first participant has been dosed in a Phase 1 trial testing F230, an investigational oral therapy for pulmonary arterial hypertension (PAH). This clinical study (NCT06899815) seeks to enroll about 116 healthy individuals in China, ages 18 to 45. Around 68 participants will be randomly assigned to receive a…
A Phase 2a study of HB-1614, an oral therapy candidate, suggested the medication is safe and may improve exercise capacity and quality of life in adults with pulmonary hypertension associated with interstitial lung disease (PH-ILD). This is according to Halo Biosciences, developer of HB-1614, which announced the publication of…
Adding more lines of treatment may reduce the risk of rehospitalization among adults with pulmonary arterial hypertension (PAH) who are taking only one medication, a study reports. “Our results suggest that a shift away from monotherapy towards a greater reliance on combination therapy might help to reduce the risk…
People with pulmonary arterial hypertension (PAH) have abnormalities in their gut microbes that may play a role in their disease, a study reports. Transplanting gut microbes from healthy rats into the digestive tract of a rat model of PAH led to a reduction in disease severity, suggesting that targeting…
Soon after Yutrepia (treprostinil) was approved by the U.S. Food and Drug Administration (FDA) to treat some forms of pulmonary hypertension, the therapy’s maker, Liquidia, scheduled its first commercial shipment to specialty pharmacies. “We have moved with exceptional speed to provide a new and differentiated therapeutic alternative to the…
Low-dose metformin, a medication for type 2 diabetes, delivered to the pulmonary arteries using lipid-based nanocapsules, safely eased signs of pulmonary arterial hypertension (PAH) in rats, a study reports. “Administration of [metformin] nanocapsules is a safe and innovative therapeutic approach for PAH,” the researchers wrote. “This method could improve…
Plans for a Phase 2b clinical trial that will test CS1, Cereno Scientific‘s experimental treatment for pulmonary arterial hypertension (PAH), have been endorsed by the U.S. Food and Drug Administration (FDA). The FDA’s endorsement comes just a few weeks after a meeting between Cereno and the FDA…
The U.S. Food and Drug Administration (FDA) has approved Yutrepia, Liquidia’s inhaled dry powder formulation of treprostinil, for improving exercise capacity in people with pulmonary hypertension (PH) associated with interstitial lung disease, known as PH-ILD, and pulmonary arterial hypertension, or PAH. Yutrepia had previously held tentative approvals…
