BEYFORTUS

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

PregnancyRespiratory Tract InfectionRespiratory Syncytial Virus (RSV)AntibodyRSV Infection

45 competitors in Pregnancy

#DrugCompanyPhaseTrials

1

Femara

Novartis

Approved

132

Bayer Aspirin

Bayer

Approved

73

Marinol

Jazz Pharmaceuticals

Approved

14

Rayos

RRoxane Laboratories

Approved

75

BEYFORTUS

Sanofi

Approved

16

Pifeltro

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

17

Dihydroartemisinin-Piperaquine

GSK

Phase 3

48

Monoferric

PPharmacosmos A/S

Phase 3

19

Cimzia

UCB

Phase 2

110

Sulfadoxine Pyrimethamine

Pfizer

Phase 3

4Show 21 more competitors

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

RSV Infection3 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

Real-World Effectiveness of Perinatal RSV Immunoprophylaxis

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

Effectiveness2 trials

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

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

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

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

Respiratory Syncytial Virus (RSV)2 trials

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

Active, not recruiting·Sanofi·Phase 4·NCT07109297·110 enrolled

Passive Immunisation With RSV-specific Monoclonal Antibody (RSV-SMA) to Prevent RSV Respiratory Infections Among Aboriginal and Torres Strait Islander Children in the Northern Territory: a Pragmatic Randomised Controlled Trial.

Recruiting·MMenzies School of Health Research·Approved·NCT07578298·1,000 enrolled

Adult1 trial

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

Completed·AstraZeneca·Phase 1·NCT04840849·24 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

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·Phase 3·NCT05437510·8,057 enrolled

Immunocompromised1 trial

Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children

Completed·AstraZeneca·Phase 2·NCT04484935·100 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·Phase 3·NCT06042049·33 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

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

Lower Respiratory Tract Infection1 trial

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Nirsevimab, a Monoclonal Antibody With Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm and Term Infants in China

Completed·AstraZeneca·Phase 3·NCT05110261·800 enrolled

Unspecified1 trial

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

Recruiting·Sanofi··NCT07200206·3,000 enrolled

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

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