Winrevair Shows Promise in Advancing PAH Treatment | ACC 2025

Marc Humbert, M.D., Ph.D., professor of respiratory medicine at Université Paris-Saclay and Inserm, believes that recent clinical trials have reinforced the potential of Winrevair (sotatercept) as a breakthrough in pulmonary arterial hypertension (PAH) treatment.

Two key studies—the STELLAR and ZENITH trials—have demonstrated the drug’s effectiveness and safety, supporting its role as a new foundation of PAH therapy.

PAH affected roughly 192,000 people in 2021, globally.

Winrevair is already approved in the U.S. and 40 countries based on the STELLAR trial, which showed that adding the drug to standard PAH therapy significantly improves exercise capacity, hemodynamics, symptomatology and quality of life.

In addition, these benefits were seen in patients receiving the most intensive treatments available, suggesting that Winrevair offers advantages beyond the current standard of care.

The ZENITH trial built on these findings by evaluating the drug in patients with PAH at the most severe stages (functional class III or IV) who face a high risk of mortality.

The study met its primary endpoint by showing a statistically significant reduction in time to the first morbidity or mortality event, including death, lung transplantation, or PAH-related hospitalization, Humbert shared.

Due to the strength of these results, an independent data monitoring committee recommended stopping the trial early.

Reflecting on the significance of these studies, Humbert shared that before the “landmark, pivotal, randomized control trial” of STELLAR, “we analyzed patients with maximum therapy and with a high risk of death. So first, we showed that the drug is well tolerated even in those extreme circumstances.”

Addressing any potential inconsistencies, Humbert highlighted that the trials complement each other.

While they studied different patient populations and endpoints, both confirm Winrevair’s efficacy and manageable safety profile, reinforcing its role in PAH management.