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zelicapavir

Phase 2

RSV Infection | Small molecule | Infectious Disease |Enanta Pharmaceuticals, Inc.|Trials Updated: Jul 20, 2026

zelicapavir development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Mar 2026

zelicapavir target and mechanism

Molecular targetRSV N-protein
ModalitySmall molecule

Also known as zelicapavir (therapeutic dose)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment222

FDA Designations

No designations recorded

zelicapavir clinical trials

zelicapavir · 2 trials · 4 indications

Phase 2 1Phase 1 1
NCT07482657A Phase 2 Study to Investigate the Efficacy and Safety of Zelicapavir in Participants Aged ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial VirusRSV Infection
RECRUITING150 Analytics
PHASE2RECRUITING
A Phase 2 Study to Investigate the Efficacy and Safety of Zelicapavir in Participants Aged ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial Virus
RSV InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to complete resolution of clinical signs of RSV as measured by RESOLVE-P
Day 1 through Day 14
Time-matched, placebo-corrected change-from-baseline QTc based on the Fridericia correction QTcF (ΔΔQTcF) after TD and SD of Zelicapavir
Up to 24 hours post dose

Secondary Endpoints

Time to sustained resolution of clinical signs of RSV as measured by RESOLVE-P
Day 1 through Day 14
Change in severity of clinical signs of RSV from Baseline to D7 as measured by RESOLVE-P
Day 1 through Day 7
Proportion of participants with Lower Respiratory Tract Infection (LRTI)
D1 through D14
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
zelicapavirEXPERIMENTALzelicapavir, oral suspension, once daily for 7 days
PlaceboPLACEBO_COMPARATORMatching placebo, orally, once daily for 7 days
zelicapavir Dose 1 (therapeutic dose)EXPERIMENTALAll participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25.
zelicapavir Dose 2 (supratherapeutic dose)EXPERIMENTALAll participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25.
moxifloxacinEXPERIMENTALAll participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25.

Interventions

NameTypeDescription
zelicapavirDRUGOral suspension
PlaceboDRUGPlacebo oral suspension to match zelicapavir
zelicapavir (therapeutic dose)DRUGSubjects will receive zelicapavir (TD) once per treatment period.
zelicapavir (supratherapeutic dose)DRUGSubjects will receive zelicapavir (SD) once per treatment period.
moxifloxacinDRUGSubjects will receive moxifloxin once per treatment period.
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Eligibility Criteria

Age Range28 Days to 36 Months
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Participants diagnosed with RSV infection using an approved diagnostic assay, without known and/or documented coinfection with SARS-CoV-2 or influenza * Participant has signs of RSV infection with onset ≤3 days (72 hours) at the time of randomization * In the Investigator's op...

Countries:ThailandUnited States
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Frequently asked questions about zelicapavir

What is zelicapavir?

Zelicapavir is an investigational small molecule antiviral being developed by Enanta Pharmaceuticals, Inc. for the treatment of respiratory syncytial virus, or RSV, infection. It is given as a therapeutic dose and is currently in Phase 2 clinical development. It is not yet approved for any indication.

What is zelicapavir used for in RSV infection?

Zelicapavir is being studied for the treatment of respiratory syncytial virus infection. Development includes a Phase 2 trial in participants from 28 days to 36 months of age who are infected with RSV, and a completed Phase 1 study in healthy adults. It remains investigational and has not been approved for use.

What does zelicapavir target?

Zelicapavir targets the RSV N-protein, a viral nucleoprotein. By binding this target, the small molecule is designed to interfere with the virus rather than act on a human host protein. This mechanism underlies its development as an antiviral for respiratory syncytial virus infection.

Who is developing zelicapavir?

Zelicapavir is being developed by Enanta Pharmaceuticals, Inc., which trades under the ticker ENTA. The company is the sponsor of the clinical program evaluating the drug in respiratory syncytial virus infection, including a Phase 2 trial in young children and a completed Phase 1 study in healthy adults.

What phase is zelicapavir in?

Zelicapavir is in Phase 2 clinical development. One Phase 2 trial is currently recruiting, and one Phase 1 trial has been completed. The drug is investigational and has not been approved by the FDA or any other regulatory authority for the treatment of RSV infection.

What clinical trials is zelicapavir in?

Zelicapavir has been studied in two trials. NCT07482657 is a recruiting Phase 2 study of zelicapavir in participants aged 28 days to 36 months infected with RSV, conducted in Thailand. NCT06601192 is a completed Phase 1 study evaluating the effects of zelicapavir, also known as EDP-938, on the QTc interval in healthy adults in the United States.

Is zelicapavir the same as EDP-938?

Yes. Zelicapavir is also known as EDP-938, and the two names refer to the same investigational antiviral compound. The completed Phase 1 QTc study used the EDP-938 designation, while current development refers to the drug as zelicapavir. Both names describe the same small molecule targeting the RSV N-protein.