ENFLONSIA

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

5 competitors in RSV Infection

#DrugCompanyPhaseTrials

1

BEYFORTUS

Sanofi

Phase 3

22

ENFLONSIA

Merck & Co.

Approved

13

Rsvpref

Pfizer

Phase 3

14

ABRYSVO

Pfizer

Phase 3

15

AK0529

SShanghai Ark Biopharmaceutical Co., Ltd.

Phase 3

26

Zelicapavir

EEnanta Pharmaceuticals, Inc

Phase 2

1

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Respiratory Syncytial Virus (RSV)2 trials

Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)

Completed·Merck & Co.·Phase 3·NCT04938830·1,003 enrolled

Phase 2a Respiratory Syncytial Virus (RSV) Human Challenge Study of Clesrovimab (MK-1654) in Healthy Participants (MK-1654-005)

Completed·Merck & Co.·Phase 2·NCT04086472·80 enrolled

Infants1 trial

Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)

Completed·Merck & Co.·Phase 1/2·NCT03524118·183 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)

Completed·Merck & Co.·Phase 2/3·NCT04767373·3,632 enrolled

RSV Infection1 trial

Longitudinal Serum and Mucosal RSV Antibodies Following Clesrovimab (Enflonsia™, Merck) Administration in Infants During Their First Respiratory Season or [The EMBRACE Study: Enflonsia™ Monoclonal in Babies - RSV Antibody Concentration Evaluation]

Not yet recruiting·EEmory University·Approved·NCT07824167·24 enrolled

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

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