Sotatercept: A New Frontier in Pulmonary Arterial Hypertension Treatment

Abstract

Objective:

To review the pharmacology, pharmacokinetics, safety, and efficacy of sotatercept for the management of pulmonary arterial hypertension (PAH).

Data Sources:

A literature search in PubMed, EMBASE, and the National Institutes of Health Clinical Trials Registry (http://www.clinicaltrials.gov) was conducted from January 2009 to June 2025 using the keyword “sotatercept.”

Study Selection and Data Extraction:

Phase II and III trials assessing sotatercept’s safety and efficacy were included. Initially, 796 trials were yielded, and 4 trials were included after application of inclusion criteria.

Data Synthesis:

The findings from this review indicate that sotatercept is an overall safe and effective option for improving PAH outcomes when added to established PAH pharmacotherapy. Trials found improvement in outcomes such as pulmonary vascular resistance, 6-minute walk distance, and a reduction in a composite outcome of all-cause death, lung transplantation, and hospitalization for worsening PAH.

Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:

Sotatercept targets a new pathway in PAH that directly addresses inappropriate cellular proliferation and the underlying pathophysiology in PAH. The benefit with sotatercept was found when added to background PAH therapy, but limitations for use include cost and need for reconstitution by the patient or caregiver.

Conclusion and Relevance:

Sotatercept offers a novel and effective approach to management of patients with PAH on background therapy. Additional data regarding long-term outcomes is needed—studies evaluating this are in progress.