Phase 2 clinical trial of sotatercept for Group 2 PH succeeds
- PHA Canada
- Nov 19, 2025
- 1 min read
Pulmonary hypertension (PH) due to heart failure -- Group 2 PH -- has, until now, been treated by treating the underlying heart failure. However, a recent Phase 2 clinical trial, called CADENCE, tried treating PH due to heart failure with preserved ejection fraction (HFpEF) with sotatercept. Phase 2 trials are small trials which look at the safety of a drug and at whether it seems to work.
Full data have not been published yet, but CADENCE successfully met its primary endpoint -- participants who took sotatercept showed a significant reduction in pulmonary vascular resistance after 24 weeks of treatment, compared to participants who received a placebo. Lower pulmonary vascular resistance means the heart needs to use less energy to pump blood through the lungs.
Because this Phase 2 trial was successful, a Phase 3 trial is planned. Phase 3 trials are larger trials which look at whether or not a drug treatment is better than the current standard treatment and whether the drug is reasonably safe. They are the last clinical trials before a manufacturer applies for drug approval.
While much work remains, the CADENCE results offer a welcome sign that new options for Group 2 PH may finally be within reach.
Traditionally, this type of PH has been managed only by treating the underlying heart failure. The CADENCE trial demonstrated that sotatercept significantly reduced pulmonary vascular resistance over 24 weeks compared to a placebo, indicating improved efficiency of blood flow through the lungs and reduced Retro Bowl strain on the heart.
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