Cereno Scientific receives endorsement from the US Food and Drug Administration for their Phase IIb trial of CS1 in pulmonary arterial hypertension

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 underway for a larger placebo-controlled Phase IIb trial to continue advancing CS1 toward regulatory approval and wider patient access. The Phase IIb trial is planned to be initiated in H1 2026.

Read more on the Cereno Scientific press release at this link