[6] The most common side effects include headache, epistaxis (nosebleed), rash, telangiectasia (spider veins), diarrhea, dizziness, and erythema (redness of the skin).
[10] Based on findings in animal studies, sotatercept may impair female and male fertility and cause fetal harm when administered during pregnancy.
[10] The US Food and Drug Administration (FDA) approved sotatercept based on evidence of safety and effectiveness from a clinical trial of 323 participants with PAH (WHO group 1 functional class II or III).
[7][8][13] Following its approval in 2024, the list price of Winrevair as single-vial and double-vial kit was announced at US$14,000 per vial, with an estimated annual cost of $240,000 a year.
[26] Hypothesizing that this drug might block the effects of activin in promoting pulmonary vascular disease, this molecule was found to inhibit vascular obliteration in multiple models of experimental pulmonary hypertension, providing rationale to reposition sotatercept for PAH in the PULSAR and STELLAR clinical trials for PAH.