Winrevair

(Sotatercept)

ApprovedProtein / enzyme

Sotatercept is used to treat a rare blood disorder called beta-thalassemia, where the body doesn't make enough healthy red blood cells, causing anemia and fatigue.[2] Winrevair is currently approved and in use across 5 indications[4].[1]

Winrevair is one of 105 fusion protein programs targeting Pulmonary Hypertension. It is currently in Approved.

Indications

Total Trials

Active Trials

104

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Pulmonary HypertensionUnknown

HypertensionUnknown

Pulmonary Arterial HypertensionRecruiting

Hypertension, PulmonaryNot yet recruiting

Pulmonary Artery HypertensionRecruiting

Pulmonary HypertensionPreclinical

Unknown

HypertensionPreclinical

Unknown

Pulmonary Arterial HypertensionApproved

Recruiting

Hypertension, PulmonaryApproved

Not yet recruiting

Pulmonary Artery HypertensionApproved

Recruiting

Competition

Competitive Landscape

161 competitors in Hypertension

#DrugCompanyPhaseTrials

Winrevair

Merck & Co.

Approved

34 2

Foundayo

Eli Lilly

Phase 3

3 3

Nitrostat

VViatris Specialty LLC

Phase 3

5 4

Alka-Seltzer

AAbbott

Phase 3

1 5

HCP1803-3

Hanmi Pharmaceutical Company Limited

Phase 3

1 6

Avastin

Roche

Preclinical

1 7

Alphagan

AbbVie

Preclinical

—8

Deltavit

HHyundai Pharmaceutical Co., LTD.

Preclinical

2 9

Nipride

EExela Pharma Sciences, LLC.

Preclinical

1 10

Ultiva

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2028

ApprovedActive, not recruiting

Pulmonary Arterial Hypertension

NCT05825417

ApprovedNot yet recruiting

Hypertension, Pulmonary

NCT07899905

Q2 2028

Phase 3Recruiting

Pulmonary Arterial Hypertension

NCT04811092

ApprovedRecruiting

Pulmonary Arterial Hypertension

NCT07600723

Post-ApprovalRecruiting

Pulmonary Arterial Hypertension

NCT07356778

Phase 2Active, not recruiting

Pulmonary Arterial Hypertension

NCT06925750

Clinical

Trials by Indication[1]

Pulmonary Arterial Hypertension16 trials

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT03738150·21 enrolled

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-031/LIGHTRAY EXTENSION)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT06925750·130 enrolled

A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT05818137·46 enrolled

Show 13 more trials

Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension

Active, not recruiting·MMayo Clinic·Phase 4·NCT06409026·30 enrolled

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT06664801·164 enrolled

SIRIUS - Initial Combination Therapy With an Endothelin Receptor Antagonist, a Phosphodiesterase-5 Inhibitor and Sotatercept in Patients With Newly Diagnosed Pulmonary Arterial Hypertension

Not yet recruiting·PPhilipps University Marburg·Phase 2·NCT07266519·25 enrolled

Right Ventricular Compensation With Sotatercept: A Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effects of Sotatercept on Right Ventricular Function in Pulmonary Arterial Hypertension (RECOMPENSE)

Recruiting·AAmsterdam UMC, location VUmc·Phase 4·NCT06658522·20 enrolled

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT03496207·106 enrolled

A Study of Sotatercept for Patients With Eisenmenger Syndrome or Unrepaired Shunt-Associated Pulmonary Arterial Hypertension Resistant to Vasodilator Therapy

Recruiting·KKazuya Hosokawa·Phase 4·NCT07356778·36 enrolled

A Phase 4, Prospective, Open-label, Single-Arm Study to Evaluate the Safety of Sotatercept in Adults With Pulmonary Arterial Hypertension (PAH) in India

Recruiting· Merck & Co. logo

Merck & Co.·Approved·NCT07600723·30 enrolled

A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children From 1 to Less Than 18 Years of Age With PAH on Standard of Care

Recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT05587712·42 enrolled

An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT07218029·815 enrolled

A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotatercept (MK-7962) in Japanese Children From 1 to Less Than 18 Years of Age With PAH on Standard of Care.

Recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT07646860·6 enrolled

A Multicentre Randomised Cross-over Trial of Disease Specific Therapy in Patients With Pulmonary Arterial Hypertension (PAH) Implanted With Pulmonary Artery Pressure and Cardiac Rhythm Monitoring Devices (CardioMEMS/ConfirmRx)

Active, not recruiting·SSheffield Teaching Hospitals NHS Foundation Trust·Approved·NCT05825417·70 enrolled

VOYAGER-PAH: Sotatercept Long-Term Extension

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT04811092·600 enrolled

STELLAR: Sotatercept in Pulmonary Arterial Hypertension

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT04576988·323 enrolled

Hypertension, Pulmonary3 trials

An Open-Label, Single-Arm, Multi-Center, Post-Marketing Study to Evaluate the Efficacy and Safety of Sotatercept (MK-7962) Add-on to Background Therapy in Chinese Participants With Pulmonary Arterial Hypertension (PAH)

Not yet recruiting· Merck & Co. logo

Merck & Co.·Approved·NCT07899905·40 enrolled

A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of Sotatercept Versus Placebo for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT04945460·165 enrolled

A Phase 2, Multicenter, Open-label Extension Study to Evaluate the Effects of Sotatercept for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) With Heart Failure With Preserved Ejection Fraction (HFpEF)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT06814145·440 enrolled

Anemia2 trials

Safety and Efficacy Study of Sotatercept in Adults With Transfusion Dependent Diamond Blackfan Anemia

Terminated·NNorthwell Health·Phase 1/2·NCT01464164·19 enrolled

A Phase 2a Study To Evaluate The Pharmacokinetics, Safety, Efficacy, Tolerability, And Pharmacodynamics of Sotatercept (ACE-011) for the Correction of Anemia in Subjects With End-stage Renal Disease on Hemodialysis.

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01146574·50 enrolled

Plasma Volume1 trial

Study to Evaluate Effect of a Single Dose of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Participants With Solid Tumors

Terminated· Merck & Co. logo

Merck & Co.·Phase 2·NCT01190644·5 enrolled

ART1 trial

A Clinical Study of MK-7962 in Healthy Chinese Participants (MK-7962-021)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06843460·24 enrolled

11 more indications

Kidney Disease1 trial

A Phase 2 Study of Intravenous or Subcutaneous Dosing of Sotatercept (ACE-011) in Patients With End-Stage Kidney Disease on Hemodialysis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01999582·50 enrolled

Multiple Myeloma1 trial

A Phase IIa Study of Sotatercept on Bone Mass and Turnover in Patients With Multiple Myeloma

Withdrawn·RRebecca Silbermann·Phase 2·NCT02230917

Thalassemia1 trial

Study to Determine the Safety and Tolerability of Sotatercept (ACE-011) in Adults With Beta( β)- Thalassemia.

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01571635·46 enrolled

Myelofibrosis1 trial

Sotatercept in Treating Patients With Myeloproliferative Neoplasm-Associated Myelofibrosis or Anemia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01712308·56 enrolled

Breast Cancer1 trial

Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)

Terminated· Merck & Co. logo

Merck & Co.·Phase 2·NCT00931606·30 enrolled

Mortality1 trial

A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT04896008·173 enrolled

Chronic Myelomonocytic Leukemia1 trial

Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01736683·74 enrolled

Female1 trial

A Study of Sotatercept (MK-7962) in Healthy Females Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation (MK-7962-027)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06930664·146 enrolled

Non-Small Cell Lung Cancer1 trial

To Determine Safe and Effective Dose of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Participants With Advanced Non-small Cell Lung Cancer

Terminated· Merck & Co. logo

Merck & Co.·Phase 2·NCT01284348·26 enrolled

Pulmonary Hypertension1 trial

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sotatercept in Adults With Combined Postcapillary and Precapillary Pulmonary Hypertension (CpcPH) and Heart Failure With Preserved Ejection Fraction (HFpEF)

Not yet recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT07839585·352 enrolled

Pulmonary Artery Hypertension1 trial

A Single-arm, Open-label Phase IV Study to Evaluate the Effectiveness of Sotatercept in Improving Pulmonary Vascular Recruitment in Patients With Pulmonary Arterial Hypertension (PAH)

Recruiting·UUniversity of Alberta·Approved·NCT07140484·27 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 26, 2024

WINREVAIR

BLA BLA761363

Sources

References

[1]
ClinicalTrials.gov — 34 trial records for Sotatercept. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Winrevair drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Sotatercept compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Sotatercept. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (BLA BLA761363). U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Sotatercept. U.S. National Library of Medicine.
[7]
SEC EDGAR — Merck & Co. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Activin Receptor Ligand Trap[3]
Modality: Protein / enzyme[3]
Highest Phase: Approved[1]
Company: Merck & Co.

Key Publications[6]

Sotatercept for Pulmonary Arterial Hypertension: STELLAR Phase 3

N Engl J MedApr 27, 2023DOI: 10.1056/NEJMoa2213558

Winrevair

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2028

Q2 2028

Trials by Indication[1]

Pulmonary Arterial Hypertension16 trials

Hypertension, Pulmonary3 trials

Anemia2 trials

Plasma Volume1 trial

ART1 trial

Kidney Disease1 trial

Multiple Myeloma1 trial

Thalassemia1 trial

Myelofibrosis1 trial

Breast Cancer1 trial

Mortality1 trial

Chronic Myelomonocytic Leukemia1 trial

Female1 trial

Non-Small Cell Lung Cancer1 trial

Pulmonary Hypertension1 trial

Pulmonary Artery Hypertension1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Key Publications[6]

Related News