BEYFORTUS

(Nirsevimab)

ApprovedMonoclonal antibody

Sanofi

BEYFORTUS is one of 101 small molecule programs targeting Safety and Efficacy. It is currently in Approved.

Indications

Total Trials

Active Trials

100

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Safety and EfficacyActive, not recruiting

Respiratory Tract InfectionActive, not recruiting

PregnancyNot yet recruiting

AntibodyActive, not recruiting

Respiratory Syncytial Virus (RSV)Active, not recruiting

RSV InfectionNot yet recruiting

Safety and EfficacyPhase 3

Active, not recruiting

Respiratory Tract InfectionPreclinical

Active, not recruiting

PregnancyPhase 3

Not yet recruiting

AntibodyPhase 3

Active, not recruiting

Respiratory Syncytial Virus (RSV)Approved

Active, not recruiting

RSV InfectionPhase 3

Not yet recruiting

Competition

Competitive Landscape

149 competitors in Safety and Efficacy

#DrugCompanyPhaseTrials

BEYFORTUS

Sanofi

Approved

1 2

Rituxan

Roche

Phase 3

8 3

Opdivo

Bristol-Myers Squibb

Phase 3

7 4

Avastin

Roche

Phase 3

3 5

Humira

Novartis

Phase 3

3 6

Neulasta

Amgen

Phase 3

1 7

Oncovin

Eli Lilly

Phase 3

1 8

Adriamycin

Pfizer

Phase 3

1 9

Cytoxan

BBaxter Healthcare Corporation

Phase 3

6 10

Rayos

RRoxane Laboratories

Phase 3

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

Timeline

Expected Milestones

Q4 2026

Recruiting

Effectiveness

NCT06180993

Q1 2027

Phase 1/2Not yet recruiting

Premature Infants

NCT07363837

Q2 2027

Phase 1Recruiting

Clinical Trial

NCT07106918

Q4 2028

Phase 3Not yet recruiting

Pregnancy

NCT07041190

Recruiting

Effectiveness

NCT06172660

Clinical

Trials by Indication[1]

Effectiveness3 trials

Real-World Effectiveness of Perinatal RSV Immunoprophylaxis

Recruiting·YYale University··NCT06172660·3,750 enrolled

Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization

Recruiting·FFederico Martinón Torres··NCT06180993·42,000 enrolled

Effectiveness And Impact Of Nirsevimab In Chile (NIRSE-CL)

Recruiting·IInstituto Sistemas Complejos de Ingeniería··NCT06511687·160,000 enrolled

RSV Infection2 trials

Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age.

Recruiting·MMeyer Children's Hospital IRCCS··NCT06856967·138 enrolled

Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination

Not yet recruiting·—·Phase 3·NCT07232706·1,000 enrolled

Respiratory tract infection1 trial

Real-World Effectiveness of Nirsevimab Against RSV-Related and All-Cause Respiratory Tract Infections in Chinese Infants

Completed·HHan Tongyan··NCT07382219·816 enrolled

Clinical Trial1 trial

A Clinical Trial of SIBP-A16 Injection in Healthy Adults

Recruiting·SShanghai Institute Of Biological Products·Phase 1·NCT07106918·140 enrolled

Premature Infants1 trial

Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants

Not yet recruiting·SShanghai Institute Of Biological Products·Phase 1/2·NCT07363837·36 enrolled

8 more indications

Respiratory Syncytial Virus (RSV) Infection1 trial

Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life

Completed· Sanofi logo

Sanofi·Phase 3·NCT05437510·8,057 enrolled

Safety and Efficacy1 trial

Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05110261·800 enrolled

Respiratory Syncytial Virus (RSV)1 trial

Study of Monoclonal Antibody Nirsevimab Against Respiratory Syncytial Virus (RSV) in Participants up to 24 Months of Age in India

Active, not recruiting· Sanofi logo

Sanofi·Phase 4·NCT07109297·110 enrolled

Antibody1 trial

A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06042049·33 enrolled

Pregnancy1 trial

Pregnancy and Infant PrEparedness pLatform IN Europe, RSV-International Adaptive Platform Trial to Evaluate Two Approved Prevention Options to Prevent Respiratory Syncytial Virus in Infants: Maternal Vaccine to Women in Pregnancy and Monoclonal Antibody to the Infants, Given Alone or in Combination.

Not yet recruiting·PPENTA Foundation·Phase 3·NCT07041190·1,500 enrolled

Immunocompromised1 trial

Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT04484935·100 enrolled

Adult1 trial

Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04840849·24 enrolled

Unspecified1 trial

A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea

Recruiting· Sanofi logo

Sanofi··NCT07200206·3,000 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 17, 2023

BEYFORTUS

BLA BLA761328

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Nirsevimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Nirsevimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Nirsevimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761328). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Approved[1]
Company: Sanofi

BEYFORTUS

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q4 2028

Trials by Indication[1]

Effectiveness3 trials

RSV Infection2 trials

Respiratory tract infection1 trial

Clinical Trial1 trial

Premature Infants1 trial

Respiratory Syncytial Virus (RSV) Infection1 trial

Safety and Efficacy1 trial

Respiratory Syncytial Virus (RSV)1 trial

Antibody1 trial

Pregnancy1 trial

Immunocompromised1 trial

Adult1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Related News