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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 19 indications[4].[1]

Winrevair is one of 461 fusion protein programs targeting Beta-Thalassemia Intermedia. It is currently in Approved.

19

Indications

30

Total Trials

12

Active Trials

460

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Beta-Thalassemia IntermediaActive, not recruiting

MortalityActive, not recruiting

Kidney DiseaseActive, not recruiting

Pulmonary HypertensionUnknown

Beta-Thalassemia MajorActive, not recruiting

Anemia (phenotype)Active, not recruiting

Diamond-Blackfan AnemiaActive, not recruiting

AnemiaActive, not recruiting

MyelofibrosisActive, not recruiting

HypertensionUnknown

Beta-Thalassemia IntermediaPhase 2

Active, not recruiting

MortalityPhase 3

Active, not recruiting

Kidney DiseasePhase 2

Active, not recruiting

Pulmonary HypertensionPreclinical

Unknown

Beta-Thalassemia MajorPhase 2

Active, not recruiting

Anemia (phenotype)Phase 2

Active, not recruiting

Diamond-Blackfan AnemiaPhase 1

Active, not recruiting

AnemiaPhase 1

Active, not recruiting

MyelofibrosisPhase 2

Active, not recruiting

HypertensionPreclinical

Unknown

Showing 10 of 19 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Winrevair

Megace

Bristol-Myers Squibb

MS Contin

MS Contin

HHikma Pharmaceuticals LLC

Effexor

WWyeth-Lederle Vaccines

Sporanox

SSebela Pharmaceuticals Development LLC

Vit D

PPost Graduate Institute of Medical Education and Research, Chandigarh

Naltrexone/bupropion

Iniparib

Docetaxel-Carboplatin

NNational University Hospital, Singapore

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

Timeline

Expected Milestones

Q2 2028

Phase 3Recruiting

Pulmonary Arterial Hypertension

NCT04811092

ApprovedNot yet recruiting

Pulmonary Arterial Hypertension

NCT07600723

Post-ApprovalRecruiting

Pulmonary Arterial Hypertension

NCT07356778

Phase 2Active, not recruiting

Pulmonary Arterial Hypertension

NCT06925750

Q3 2028

Phase 2Recruiting

Pulmonary Arterial Hypertension

NCT05587712

Q4 2028

Phase 2Not yet recruiting

Pulmonary Arterial Hypertension

NCT07266519

Clinical

Trials by Indication[1]

Pulmonary Arterial Hypertension14 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

Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT05587712·42 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

Show 11 more trials

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 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 (PAH) (MK-7962-024)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT06664801·164 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

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

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

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)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT07218029·815 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

Not yet recruiting· Merck & Co. logo

Merck & Co.·Approved·NCT07600723·30 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

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

Treatment1 trial

A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT04945460·164 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

11 more indications

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

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

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

Myelofibrosis1 trial

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

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

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

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

Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT06814145·130 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

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

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 — 30 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

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