Cereno Scientific announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to CS1, its lead pulmonary arterial hypertension (PAH) drug candidate.
The FDA Fast Track program is designed to accelerate the review of therapies for serious conditions where unmet medical needs remain. For Cereno Scientific, the designation marks an important milestone in advancing CS1 as a potential new treatment option for PAH.
Pulmonary arterial hypertension is a rare and progressive disease that causes high blood pressure in the arteries of the lungs. It often leads to heart failure and reduced life expectancy.
Current PAH treatments focus mainly on symptom management. Cereno Scientific’s PAH drug CS1 has shown potential disease-modifying effects, offering a new therapeutic approach for patients.
Clinical Progress Of CS1
Cereno Scientific’s PAH drug CS1 is an oral histone deacetylase inhibitor (HDACi) with a novel mechanism of action based on epigenetic modulation.
In a Phase IIa trial, CS1 met safety and tolerability endpoints while also showing early signals of efficacy. Improvements were observed in functional class, REVEAL risk scores, patient quality of life, and right heart function.
The company is now preparing for a global Phase IIb trial, scheduled to begin in the first half of 2026. The FDA has endorsed the development pathway following a Type C meeting earlier this year.
Fast Track status provides drug developers with more frequent interactions with the US FDA, eligibility for rolling review, and the potential for priority review. These regulatory advantages are designed to bring promising therapies to patients faster.
Rahul Agrawal, MD, Chief Medical Officer at Cereno Scientific, said the FDA Fast Track designation will help accelerate CS1’s progress. “It enables timely feedback as we prepare for our global Phase IIb trial,” he noted.
CEO Sten R. Sörensen said the FDA Fast Track designation validates CS1’s potential and strengthens the company’s competitive position. “This milestone creates opportunities for strategic collaborations while advancing access to new therapies for PAH patients,” he said.
In addition to its PAH drug program, Cereno Scientific is developing CS014, another HDAC inhibitor targeting idiopathic pulmonary fibrosis (IPF). A successful Phase I trial supports plans to initiate Phase II in 2026.
