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.




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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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