Respiratory Syncytial Virus

Respiratory
8
Pipeline Programs
5
Companies
11
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
0
3
0
2
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

RNA Therapeutic
778%
Monoclonal Antibody
111%
Small Molecule
111%
+ 2 programs with unclassified modality

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Moderna
ModernaCAMBRIDGE, MA
7 programs
2
2
2
mRNA-1345Phase 3RNA Therapeutic1 trial
mRNA-1345Phase 3RNA Therapeutic1 trial
mRNA-1345Phase 2RNA Therapeutic1 trial
mRNA-1345Phase 2RNA Therapeutic1 trial
mRNA-1345Phase 1RNA Therapeutic1 trial
+2 more programs
Active Trials
NCT05572658Completed10,994Est. Sep 2023
NCT05743881Active Not Recruiting186Est. Sep 2026
NCT04528719Completed651Est. Jul 2024
+4 more trials
GS
Gilead SciencesFOSTER CITY, CA
1 program
1
PresatovirPhase 2Small Molecule1 trial
Active Trials
NCT02254408Completed189Est. Jul 2017
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
1 program
1
VRC-RSVRGP084-00-VPPhase 11 trial
Active Trials
NCT03049488CompletedEst. Oct 2019
Pfizer
PfizerNEW YORK, NY
1 program
ABRYSVON/A1 trial
Active Trials
NCT06647654Active Not Recruiting1Est. Oct 2026
Sanofi
SanofiPARIS, France
1 program
NirsevimabN/AMonoclonal Antibody1 trial
Active Trials
NCT06325332Completed49,680Est. Jun 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
ModernamRNA-1345
ModernamRNA-1345
ModernamRNA-1345
ModernamRNA-1345
Gilead SciencesPresatovir
ModernamRNA-1345
ModernamRNA-1345
Allergy TherapeuticsVRC-RSVRGP084-00-VP
PfizerABRYSVO
SanofiNirsevimab
ModernamRNA-1345

Clinical Trials (11)

Total enrollment: 64,067 patients across 11 trials

NCT07117487ModernamRNA-1345

A Study of mRNA-1345 Following a Primary Dose of a Licensed Protein Subunit Respiratory Syncytial Virus (RSV) Vaccine in Adult Participants ≥60 Years of Age

Start: Aug 2025Est. completion: Apr 2026507 patients
Phase 3Active Not Recruiting
NCT06067230ModernamRNA-1345

A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in High-risk Adults

Start: Oct 2023Est. completion: Jul 20261,153 patients
Phase 3Active Not Recruiting
NCT06143046ModernamRNA-1345

A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers

Start: Nov 2023Est. completion: May 2026360 patients
Phase 2Active Not Recruiting
NCT06097299ModernamRNA-1345

A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus

Start: Oct 2023Est. completion: Jun 2025346 patients
Phase 2Completed
NCT02254408Gilead SciencesPresatovir

Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract

Start: Jan 2015Est. completion: Jul 2017189 patients
Phase 2Completed
NCT05743881ModernamRNA-1345

A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months

Start: Feb 2023Est. completion: Sep 2026186 patients
Phase 1Active Not Recruiting
NCT04528719ModernamRNA-1345

A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive

Start: Sep 2020Est. completion: Jul 2024651 patients
Phase 1Completed
NCT03049488Allergy TherapeuticsVRC-RSVRGP084-00-VP

Dose, Safety, Tolerability and Immunogenicity of a Stabilized Prefusion RSV F Subunit Protein Vaccine, VRC-RSVRGP084-00-VP (DS-Cav1), Alone or With Alum Adjuvant, in Healthy Adults

Start: Feb 2017Est. completion: Oct 2019
Phase 1Completed
NCT06647654PfizerABRYSVO

Impact and Effectiveness of ABRYSVO® Vaccination During Pregnancy

Start: Aug 2024Est. completion: Oct 20261 patients
N/AActive Not Recruiting
NCT06325332SanofiNirsevimab

BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study)

Start: Apr 2024Est. completion: Jun 202549,680 patients
N/ACompleted
NCT05572658ModernamRNA-1345

Moderna Vaccine mRNA-1345 Observational Respiratory Syncytial Virus (RSV) Study

Start: Sep 2022Est. completion: Sep 202310,994 patients
N/ACompleted

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
RNA Therapeutic is the dominant modality (78% of programs)
5 companies competing in this space

Related Indications

Asthma(378)Pulmonary Disease, Chronic Obstructive(263)Chronic Obstructive Pulmonary Disease(123)Idiopathic Pulmonary Fibrosis(90)COPD(74)Chronic Obstructive Pulmonary Disease (COPD)(38)Pulmonary Embolism(27)Respiratory Syncytial Virus Infections(26)Severe Asthma(21)Lung Diseases, Interstitial(19)