Drugs / Sotatercept
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed pulmonary arterial hypertension 4 milestones | |||||
| Filed | EU (EMA) | — | pulmonary arterial hypertension | 2023-10-26 | “Merck’s submission for sotatercept to the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU) has also been completed.” merck.com ↗ |
| Filed | US (FDA) | — | pulmonary arterial hypertension | 2023-09-28 | “the U.S. Food and Drug Administration (FDA) has accepted for priority review a new Biologics License Application (BLA) for sotatercept” merck.com ↗ “Merck received priority review from the FDA for a new Biologics License Application (BLA) for sotatercept” merck.com ↗ |
| Filed | US (FDA) | — | pulmonary arterial hypertension | 2023-08-01 | “Merck submitted an application for regulatory approval of sotatercept to the U.S. Food and Drug Administration” merck.com ↗ “Merck submitted a Biologics License Application to the U.S. Food and Drug Administration (FDA) for sotatercept” merck.com ↗ |
| Filed | Japan (PMDA) | — | pulmonary arterial hypertension | — | “今年11月に日本で、STELLAR試験および日本人患者を対象とした非盲検第3相試験の結果に基づき製造販売承認申請が行われました。” msd.co.jp ↗ “ソタテルセプトは、日本国内では肺動脈性肺高血圧症治療薬として承認申請中です。” msd.co.jp ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Winrevair | — | 2024-08-22 | europa.eu ↗ |
Trials 35
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT06843460 | Nov 2023 → May 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01562405 | May 2012 → Dec 2026 expected | plasma cell myeloma | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 1 | NCT00709540 | Jan → Nov 2008 | osteoporosis | Acceleron Pharma, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01464164 | Jan 2012 → Apr 2021 | Diamond-Blackfan anemia | Northwell Health | Terminated | No outcome recorded |
| Phase 220 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT07646860 | Sep 2026 → May 2029 expected | pulmonary arterial hypertension | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT07498803 | Sep 2026 → Mar 2028 expected | Eisenmenger syndrome, congenital heart disease | Philipps University Marburg | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07266519 | Jul 2026 → Oct 2028 expected | pulmonary arterial hypertension | Philipps University Marburg | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06925750 | May 2025 → Jun 2028 expected | pulmonary arterial hypertension | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06814145 | Apr 2025 → Aug 2035 expected | pulmonary hypertension | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06664801 | Nov 2024 → Nov 2025 | pulmonary arterial hypertension | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT05587712 | Jan 2023 → Sep 2028 expected | pulmonary arterial hypertension | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT04945460 | Dec 2021 → Sep 2025 | pulmonary hypertension | Acceleron Pharma, Inc. | Completed | Met primary |
| Phase 2 | NCT03738150 | Apr 2019 → Dec 2021 | pulmonary arterial hypertension | Acceleron Pharma, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03496207 | Jun 2018 → Mar 2022 | pulmonary arterial hypertension | Acceleron Pharma, Inc. | Completed | Mixed |
| Phase 2 | NCT02230917 | Oct 2014 → Apr 2016 | plasma cell myeloma | Rebecca Silbermann | Withdrawn | No outcome recorded |
| Phase 2 | NCT01999582 | Nov 2013 → Aug 2016 | anemia, chronic renal failure syndrome | Celgene Corporation | Completed | No outcome recorded |
| Phase 2 | NCT01712308 | Feb 2013 → May 2022 | anemia, myelodysplastic/myeloproliferative neoplasm, myelofibrosis | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01736683 | Nov 2012 → Apr 2018 | anemia, chronic myelomonocytic leukemia, myelodysplastic syndrome | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT01571635 | Oct 2012 → Jul 2015 | beta-thalassemia intermedia, beta-thalassemia major | Celgene Corporation | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT01284348 | Mar 2011 → Sep 2012 | anemia, cervical cancer, head and neck cancer, non-small cell lung carcinoma +2 | Merck Sharp & Dohme LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01146574 | Jun 2010 → Mar 2016 | anemia | Celgene Corporation | Completed | No outcome recorded |
| Phase 2 | NCT01190644 | Jun 2010 → Sep 2012 | cancer | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 2 | NCT00931606 | Jun 2009 → Nov 2010 | aregenerative anemia | Merck Sharp & Dohme LLC | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT00747123 | Sep 2008 → Aug 2009 | plasma cell myeloma | Celgene Corporation | Completed | No outcome recorded |
| Phase 36 trials · 3 met primary | ||||||
| Phase 3 | NCT07839585 | Nov 2026 → Jan 2030 expected | pulmonary hypertension | Merck Sharp & Dohme LLC | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05818137 | May 2023 → Mar 2024 | pulmonary arterial hypertension | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT04811092 | Mar 2022 → Apr 2025 | pulmonary arterial hypertension | Acceleron Pharma, Inc. | Terminated | Met primary |
| Phase 3 | NCT04896008 | Dec 2021 → Jul 2024 | pulmonary arterial hypertension | Acceleron Pharma, Inc. | Completed | Met primary |
| Phase 3 | NCT07218029 | May 2021 → Dec 2028 expected | pulmonary arterial hypertension | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04576988 | Jan 2021 → Aug 2022 | pulmonary arterial hypertension | Acceleron Pharma, Inc. | Completed | Met primary |
| Phase 45 trials · 1 met primary | ||||||
| Phase 4 | NCT07600723 | Jul 2026 → Apr 2028 expected | pulmonary arterial hypertension | Merck Sharp & Dohme LLC | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07356778 | Oct 2025 → Aug 2027 expected | Eisenmenger syndrome | Kazuya Hosokawa | Recruiting | No outcome recorded |
| Phase 4 | NCT07140484 | Oct 2025 → Jan 2029 expected | pulmonary arterial hypertension | University of Alberta | Recruiting | No outcome recorded |
| Phase 4 | NCT06658522 | May 2025 → May 2026 overdue | pulmonary arterial hypertension | Amsterdam UMC, location VUmc | Recruiting | No outcome recorded |
| Phase 4 | NCT06409026 | Jul 2024 → Jan 2026 | pulmonary arterial hypertension | Mayo Clinic | Completed | Met primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT06930664 Comparator | May → Nov 2025 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| — | NCT03724227 Background | — | myelodysplastic syndrome | Celgene Corporation | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 32
| Date | Issuer | Release |
|---|---|---|
| 2026-10-07 | MSD R&D (China) Co., Ltd. | Regulatory WINREVAIR™（ソタテルセプト）、肺動脈性肺高血圧症（PAH、WHO* Group 1）と新たに診断された成人患者さんについて評価した第3相HYPERION試験のデータを 追加する添付文書の改訂について、米国FDAの承認を取得 msd.co.jp ↗
Merck & Co., Inc., Rahway, NJ, USA（米国とカナダ以外ではMSD）は本日、WINREVAIR™（ソタテルセプト）皮下注用45 mgおよび60 mgについて、第3相HYPERION試験に基づき、米国における添付文書の一部変更に関する承認を米国食品医薬品局（FDA）から取得したことを発表しました。 |
| 2026-04-22 | MSD R&D (China) Co., Ltd. | Results 第2相CADENCE試験の良好なデータにより、WINREVAIR™（ソタテルセプト）が、左室駆出率の保たれた心不全に伴う混合性毛細血管性肺高血圧症（CpcPH-HFpEF）を有する 成人患者において、明確なproof-of-concept（POC）を達成 msd.co.jp ↗
当社のWINREVAIR™が 肺血管抵抗（PVR）の変化量の主要評価項目を達成し、肺から心臓への血行動態を有意に改善 |
| 2026-03-29 | Merck Sharp & Dohme LLC | Results Positive Data from Phase 2 CADENCE Trial Provides Definitive Proof-of-Concept for WINREVAIR™ (sotatercept-csrk) in Adults With the Syndrome of Combined Post- and Precapillary Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction merck.com ↗
Merck’s WINREVAIR met primary endpoint of change in pulmonary vascular resistance (PVR), significantly improving the ability of blood to flow through the lungs to the heart |
| 2026-03-16 | Merck Sharp & Dohme LLC | Results Merck Highlights New Data from Cardio-Pulmonary Pipeline at ACC.26 Showcasing Commitment to Advance Innovative Research merck.com ↗
Positive results from the Phase 2 CADENCE trial evaluating WINREVAIR™ (sotatercept-csrk) in adults with CpcPH-HFpEF |
| 2025-12-12 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Positive EU CHMP Opinion for Expanded Use of WINREVAIR™ (sotatercept) in Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1 Pulmonary Hypertension) merck.com ↗ |
| 2025-11-18 | Merck Sharp & Dohme LLC | Results Merck’s WINREVAIR™ (sotatercept-csrk) Met Primary Endpoint in Phase 2 CADENCE Study in Adults With Combined Post- and Precapillary Pulmonary Hypertension (CpcPH) due to Heart Failure With Preserved Ejection Fraction (HFpEF) merck.com ↗
CADENCE met its primary endpoint, showing a statistically significant and clinically meaningful reduction in pulmonary vascular resistance (PVR) from baseline at 24 weeks compared to placebo. |
| 2025-11-17 | MSD R&D (China) Co., Ltd. | Regulatory WINREVAIR™（ソタテルセプト）、第3相ZENITH試験に基づき、肺動脈性肺高血圧症（PAH、WHO* Group 1 PH）の成人患者さんに対する治療薬としてFDAから適応症更新の承認を取得 msd.co.jp ↗
WINREVAIR™は、本日、臨床的悪化のイベント項目として、PAHによる入院、肺移植、死亡を追加する適応拡大が承認されました。 |
| 2025-10-27 | Merck Sharp & Dohme LLC | Regulatory U.S. FDA Approves Updated Indication for WINREVAIR™ (sotatercept-csrk) in Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1 Pulmonary Hypertension) Based on Phase 3 ZENITH Study merck.com ↗
Today’s approval expanded the indication of WINREVAIR to include components of the clinical worsening events: hospitalization for PAH, lung transplantation and death. |
| 2025-10-20 | MSD R&D (China) Co., Ltd. | Results WINREVAIR™（ソタテルセプト）、新たにPAHと診断され、バックグラウンド治療を受けている患者さんを対象とした第3相HYPERION試験において、プラセボと比較して臨床的悪化のイベントリスクを76%低下 msd.co.jp ↗
この試験で、WINREVAIR™は臨床的悪化イベントのリスクを76%低下させました（ハザード比［HR］0.24［95%信頼区間［CI］0.14-0.41］; p<0.0001）。 |
| 2025-09-30 | Merck Sharp & Dohme LLC | Results WINREVAIR™ (sotatercept-csrk) Reduced the Risk of Clinical Worsening Events by 76% Compared to Placebo in Patients Recently Diagnosed With PAH on Background Therapy in Phase 3 HYPERION Trial merck.com ↗
HYPERION results were presented today at ERS 2025 and simultaneously published in the New England Journal of Medicine |
| 2025-07-02 | Merck Sharp & Dohme LLC | Regulatory FDA Grants Priority Review for WINREVAIR™ (sotatercept-csrk) to Update Label Based on Results From ZENITH Trial merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval to update the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR™ (sotatercept-csrk). |
| 2025-06-23 | Merck Sharp & Dohme LLC | Results Merck Announces Phase 3 HYPERION Study of WINREVAIR™ (sotatercept-csrk) Met Primary Endpoint in Recently Diagnosed Adults with Pulmonary Arterial Hypertension (PAH) merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 HYPERION study evaluating WINREVAIR™ (sotatercept-csrk) versus placebo (both in combination with background therapy) in recently diagnosed adults with pulmonary arterial hypertension (PAH, WHO* Group 1) functional class (FC) II or III at intermediate or high risk of disease progression. |
| 2025-05-16 | Merck Sharp & Dohme LLC | Results Merck to Present New Clinical and Outcomes Research Data at The American Thoracic Society’s (ATS) 2025 International Conference Demonstrating Commitment to Advancing Research in Pulmonary Arterial Hypertension merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced new clinical and outcomes research data on pulmonary arterial hypertension (PAH) to be presented at the American Thoracic Society’s (ATS) 2025 International Conference in San Francisco from May 16-21. |
| 2025-04-15 | MSD R&D (China) Co., Ltd. | Results WINREVAIR™（ソタテルセプト）、第3相ZENITH試験において複合エンドポイント（全死亡、肺移植、肺動脈性肺高血圧症［PAH］による入院）のリスクをプラセボと比較して76%低下 msd.co.jp ↗
中央値10.6カ月のフォローアップ期間（範囲：0.3〜26.1カ月）において、WINREVAIR™は重要な疾患状態の悪化／死亡イベント（全死亡、肺移植、およびPAH悪化に関連する24時間以上の入院の複合イベント）の相対リスクをプラセボと比較して76%低下させました（HR=0.24 [95% CI, 0.13-0.43]; p<0.0001［片側］）。 |
| 2025-03-31 | Merck Sharp & Dohme LLC | Results WINREVAIR™ (sotatercept-csrk) Reduced the Risk of a Composite of All-Cause Death, Lung Transplantation and Hospitalization for Pulmonary Arterial Hypertension (PAH) by 76% Compared to Placebo in the Phase 3 ZENITH Trial merck.com ↗ |
| 2025-01-30 | Merck Sharp & Dohme LLC | Results Merck Announces Decision to Stop Phase 3 HYPERION Trial Evaluating WINREVAIR™ (sotatercept-csrk) Early and Move to Final Analysis merck.com ↗
The program’s external steering committee and Merck made this decision in light of these data, which will enable all study participants to have the opportunity to access WINREVAIR. |
| 2024-12-09 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Rahway, NJ, USA、WINREVAIR™（ソタテルセプト）を評価する検証的第3相ZENITH試験の中間解析で主要エンドポイントを達成したことを発表 msd.co.jp ↗
ZENITH試験は、最初の疾患状態の悪化／死亡イベント（全死亡、肺移植、またはPAH悪化に関連する24時間以上の入院）が発現するまでの時間を検討した主要エンドポイントを達成しました。 |
| 2024-11-25 | Merck Sharp & Dohme LLC | Results Merck Announces Pivotal Phase 3 ZENITH Trial Evaluating WINREVAIR™ (sotatercept-csrk) Met Primary Endpoint at Interim Analysis merck.com ↗
ZENITH met its primary endpoint of time to first morbidity or mortality event (all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥ 24 hours). |
| 2024-08-26 | Merck Sharp & Dohme LLC | Regulatory Merck Receives European Commission Approval for WINREVAIR™ (sotatercept) in Combination With Other Pulmonary Arterial Hypertension (PAH) Therapies, for the Treatment of PAH in Adult Patients With Functional Class II-III merck.com ↗
WINREVAIR is the first and only activin signaling inhibitor therapy for PAH approved in all 27 member states of the EU, as well as Iceland, Liechtenstein and Norway. |
| 2024-06-28 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Positive EU CHMP Opinion for WINREVAIR™ (sotatercept) in Pulmonary Arterial Hypertension (PAH) merck.com ↗
This positive opinion marks the first step toward expanding access to our first-in-class activin signaling inhibitor therapy, WINREVAIR, for eligible adults with PAH in Europe. |
| 2024-04-03 | MSD R&D (China) Co., Ltd. | Regulatory WINREVAIR™（sotatercept）、肺動脈性肺高血圧症（PAH、WHO Group 1）の 成人患者に対するファーストインクラスの治療薬としてFDAの承認を取得 msd.co.jp ↗
sotatercept（米国における商品名：WINREVAIR™注射用45 mg、60 mg）が、肺動脈性肺高血圧症（PAH、世界保健機関［WHO］ Group 1）の成人患者さんの運動耐容能を向上させ、WHO機能分類（FC）を改善し、臨床的悪化イベントのリスクを減少させる治療薬として米国食品医薬品局（FDA）の承認を取得したことを発表しました。 |
| 2024-03-26 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s WINREVAIR™ (sotatercept-csrk), a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1) merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved sotatercept-csrk (U.S. Brand Name: WINREVAIR™, for injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events. |
| 2023-09-28 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Priority Review from FDA for New Biologics License Application for Sotatercept, an Activin Signaling Inhibitor to Treat Adults with Pulmonary Arterial Hypertension (PAH) merck.com ↗
The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of March 26, 2024. |
| 2023-09-11 | Merck Sharp & Dohme LLC | Results MSD Presents New Analyses Supporting the Promising Potential of Sotatercept, its Investigational Medicine for Adults with Pulmonary Arterial Hypertension (PAH) msd.com ↗
A new exploratory post-hoc analysis of right heart catheterization and echocardiography data from patients in the Phase 3 STELLAR study showed treatment with sotatercept for 24 weeks on top of background therapy reduced right heart size and improved right-ventricular (RV) function and hemodynamic status. |
| 2023-09-11 | Merck Sharp & Dohme LLC | Results Merck Presents New Analyses Supporting the Promising Potential of Sotatercept, its Investigational Medicine for Adults with Pulmonary Arterial Hypertension (PAH) merck.com ↗
Interim results from SOTERIA open-label extension study represent longest safety and efficacy analysis of sotatercept to date; safety profile of sotatercept consistent with previous studies and efficacy improvements maintained after one year of therapy |
| 2023-03-22 | MSD R&D (China) Co., Ltd. | Results アクチビンシグナル伝達阻害剤のsotaterceptが、基礎療法を実施中の肺動脈性肺高血圧症の成人患者への追加療法としてプラセボと比較して24週時の6分間歩行距離を40.8メートル延長 副次評価項目においても、臨床的な悪化または死亡のリスクの低下を含む9項目中8項目で統計学的に有意な改善が示される 本日、ACC.23/WCCで発表、The New England Journal of Medicineにも掲載 msd.co.jp ↗
Sotaterceptはこの試験の主要評価項目であるベースラインから24週時の6分間歩行距離（6MWD）を40.8メートル延長し、運動耐容能を有意に改善しました（95% CI, 27.5-54.1; p<0.001）。 |
| 2023-03-06 | Merck Sharp & Dohme LLC | Results MSD’s Investigational Activin Signaling Inhibitor Sotatercept Improved Six-Minute Walk Distance by 40.8 Meters at Week 24 Versus Placebo in Adults with Pulmonary Arterial Hypertension on Background Therapy msd.com ↗
Sotatercept significantly improved exercise capacity, increasing 6-minute walk distance (6MWD) by 40.8 meters (95% CI, 27.5-54.1; p<0.001) from baseline at week 24, the study’s primary endpoint. |
| 2023-03-06 | Merck Sharp & Dohme LLC | Results Merck’s Investigational Activin Signaling Inhibitor Sotatercept Improved Six-Minute Walk Distance by 40.8 Meters at Week 24 Versus Placebo in Adults with Pulmonary Arterial Hypertension on Background Therapy merck.com ↗
Sotatercept significantly improved exercise capacity, increasing 6-minute walk distance (6MWD) by 40.8 meters (95% CI, 27.5-54.1; p<0.001) from baseline at week 24, the study’s primary endpoint. |
| 2022-10-27 | Merck Sharp & Dohme LLC | Results Merck Announces Third-Quarter 2022 Financial Results merck.com ↗
Announced Positive Top-line Results From Pivotal Phase 3 STELLAR Trial Evaluating the Safety and Efficacy of Sotatercept |
| 2022-10-18 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Rahway, N.J., USA 肺動脈性肺高血圧症（PAH）の成人患者の治療薬としてのSotaterceptを評価する 第3相STELLAR試験の良好なトップラインデータを公開 msd.co.jp ↗
この試験の主要評価項目であるベースラインから24週時の6分間歩行距離（6MWD: 6-minute walking distance、6分間に歩ける距離を測定）は、統計学的に有意かつ臨床的に意味のある改善を示しました。 |
| 2022-10-11 | Merck Sharp & Dohme LLC | Results MSD Announces Positive Top-line Results from Pivotal Phase 3 STELLAR Trial Evaluating Sotatercept for the Treatment of Adults with Pulmonary Arterial Hypertension (PAH) msd.com ↗
The trial met its primary efficacy outcome measure, demonstrating a statistically significant and clinically meaningful improvement in 6-minute walk distance (6MWD, which measures how far patients can walk in 6 minutes) from baseline at 24 weeks. |
| 2022-10-10 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Top-line Results from Pivotal Phase 3 STELLAR Trial Evaluating Sotatercept for the Treatment of Adults with Pulmonary Arterial Hypertension (PAH) merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive top-line results from the pivotal Phase 3 STELLAR trial evaluating the safety and efficacy of sotatercept, an investigational activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein being evaluated as an add-on to stable background therapy for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1). |
All press releases naming this drug 33 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 39 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sotatercept | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01464164 ↗ |
| Known as | ACE-001 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743073 ↗ |
| Known as | ACE-011 | “Sotatercept (ACE-011) in Adults With Red Blood Cell Transfusion- Dependent Diamond Blackfan Anemia” NCT01464164 ↗ |
| Known as | hActRIIA-IgG1 | “ACE-011 (hActRIIA-IgG1)” NCT00747123 ↗ |
| Known as | Sotatercept-csrk | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743073 ↗ |
| Known as | Winrevair | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743073 ↗ |
| Action | Inhibit | “acts as a ligand trap to neutralise negative regulators of late-stage erythropoiesis” PMID 29331635 ↗ Jan 20181“Inhibin beta A chain inhibitor” CHEMBL1743073 ↗ |
| Modality | Protein / enzyme biologic | “ACE-011 (ActRIIA-IgG1)” NCT00709540 ↗ |
| Route | Subcutaneous | “ACE-011 given subcutaneously” NCT00709540 ↗ |
| Target | BMPR2 | “Sotatercept is a novel medication which targets the BMPR2/TGF-β pathway” NCT06658522 ↗ |
| Target | INHBA | “Inhibin beta A chain inhibitor” CHEMBL1743073 ↗ |