{"id":249,"date":"2023-09-06T15:47:32","date_gmt":"2023-09-06T15:47:32","guid":{"rendered":"https:\/\/www.merckconnect.com\/winrevair\/?page_id=249"},"modified":"2026-04-10T12:50:06","modified_gmt":"2026-04-10T12:50:06","slug":"now-available","status":"publish","type":"page","link":"https:\/\/www.merckconnect.com\/winrevair\/","title":{"rendered":"Home"},"content":{"rendered":"\n\n
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Actor Portrayal<\/p>\n\n\n\n

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Adding WINREVAIRTM<\/sup> (sotatercept-csrk), the first and only activin signaling inhibitor, gives patients with PAH<\/strong> the chance for more clinical improvement1<\/sup><\/strong><\/h1><\/div>\n\n\n\n
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In STELLAR, a 24-week clinical study of adults with PAH (WHO Group 1, FC II or III) on stable background therapy, patients (N=323) were randomized 1:1 to WINREVAIR (n=163) or placebo (n=160) administered by subcutaneous injection once every 3 weeks.2<\/sup><\/h4><\/div>\n\n\n\n
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Primary endpoint at 24 weeks<\/strong><\/h3><\/div>\n\n\n\n
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Improvement in 6MWD\u2028<\/mark>
+41 metersa<\/sup><\/mark><\/strong><\/strong><\/h4><\/div>\n\n\n\n
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(95% CI: 28, 54; P<\/em><0.001)\u2028
Placebo-adjusted median increase from baseline in 6MWD<\/span><\/p><\/div><\/div>\n<\/div>\n\n\n\n

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Selected secondary endpoints<\/strong> at 24 weeks<\/strong><\/h3><\/div>\n\n\n\n
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Improvement from baseline in WHO FC<\/span>\u2028<\/mark><\/strong><\/strong>
29% of patients receiving WINREVAIR<\/mark> vs 14% of patients receiving placebo (P<\/em><0.001)<\/mark><\/strong><\/strong><\/strong><\/strong><\/h4><\/div>\n<\/div>\n\n\n\n
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Time to death or the first occurrence of a PAH worsening event\u2028<\/mark>
84% relative risk reductionb<\/sup><\/mark><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/h4><\/div>\n\n\n\n
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(HR 0.16; 95% CI: 0.08, 0.35; P<\/em><0.001)\u20285.5% of patients on WINREVAIR experienced death or at least 1 PAH clinical worsening event, vs 26.3% of patients on placebo<\/p><\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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\u1d43Hodges-Lehmann location shift from placebo estimate (median of all paired differences).\u2028
\u1d47PAH clinical worsening events and death from any cause were captured until the last patient completed the week 24 visit (median duration of exposure 33.6 weeks).\u2028
6MWD = 6-minute walk distance; CI = Confidence Interval; HR = Hazard Ratio.<\/p>\n\n\n\n

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Mechanism of action<\/strong> (MOA)<\/strong><\/h4><\/div>\n\n\n\n
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Learn about the mechanism of action of WINREVAIR<\/p>\n\n\n\n

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Explore the MOA<\/a><\/div>\n<\/div>\n\n\n\n
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Dosage and administration<\/strong><\/h4><\/div>\n\n\n\n
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Review dosage and administration and the Injection Volume Calculator for WINREVAIR<\/p>\n\n\n\n

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View recommended dosage<\/a><\/div>\n<\/div>\n\n\n\n
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References:\u2028<\/strong><\/p>\n\n\n\n

1.<\/strong> DailyMed database. Advanced search: “activin signaling inhibitor” in Mechanism of Action section. National Library of Medicine. Accessed October 20, 2025. htt\u200dp\u200ds:\/\/dailymed.nlm.nih\u200d.\u200dg\u200dov\/dailymed\/advanced-search.cfm
2.<\/strong> Hoeper MM, Badesch DB, Ghofrani HA, et al; STELLAR Trial Investigators. Phase 3 trial of sotatercept for treatment of pulmonary arterial hypertension. N<\/em> Engl<\/em> J Med<\/em>. 2023;388(16):1478-1490.<\/p>\n\n\n\n

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Report exposure during pregnancy or lactation to the Merck Sharp & Dohme<\/span> LLC Adverse Event reporting line at 1-877-888-4231<\/span><\/strong><\/p><\/div><\/div>\n<\/div><\/div><\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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Actor Portrayal (95% CI: 28, 54; P<0.001)\u2028Placebo-adjusted median increase from baseline in 6MWD (HR 0.16; 95% CI: 0.08, 0.35; P<0.001)\u20285.5% of patients…<\/p>\n","protected":false},"author":446,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_trash_the_other_posts":false,"editor_notices":[],"footnotes":""},"ga4_page_audience":[911],"ga4_page_birn_id":[],"ga4_page_branding":[271],"ga4_page_businessunit":[278],"ga4_page_campaign":[],"ga4_page_content_purpose":[916],"ga4_page_customer_journey_stage":[337],"ga4_page_customer_specialty":[396],"ga4_page_experience":[],"ga4_page_indication":[507],"ga4_page_material_intent":[526],"ga4_page_product":[941],"ga4_page_region":[814],"ga4_page_therapeuticarea":[856],"user_role":[],"mhh-area-of-interest":[],"access":[],"user_status":[],"class_list":["post-249","page","type-page","status-publish"],"yoast_head":"\nWINREVAIR\u2122 (sotatercept-csrk) | Official Healthcare Professional Site<\/title>\n<meta name=\"description\" content=\"Information for HCPs about WINREVAIR\u2122 (sotatercept-csrk), including study data. 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