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zelicapavir

Phase 2

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

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

Clinical trial landscape

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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Recent Changes (Last 90 Days)

LOWJul 20, 2026NCT07482657startDate: changed
LOWJul 20, 2026NCT07482657startDate: changed
LOWJul 10, 2026NCT07482657Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 10, 2026NCT07482657Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about zelicapavir

What is zelicapavir used for?

Zelicapavir is an investigational small molecule being developed for the treatment of respiratory syncytial virus (RSV) infection. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes zelicapavir?

Zelicapavir is being developed by Enanta Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ENTA.

What phase is zelicapavir in?

Zelicapavir is in Phase 2 clinical development for RSV infection. It is an investigational drug and has not been approved by the FDA or any other regulatory agency.

What clinical trials is zelicapavir in?

Zelicapavir has two clinical trials. A completed Phase 1 study (NCT06601192) evaluated its effects on QTc interval in healthy adults. An ongoing Phase 2 study (NCT07482657) is recruiting participants aged 28 days to 36 months with RSV infection in Thailand.

How does zelicapavir work?

Zelicapavir is a small molecule antiviral. Its specific molecular target has not been disclosed in available information, so its exact mechanism of action is not publicly detailed.

Is zelicapavir the same as EDP-938?

Yes, zelicapavir is also known as EDP-938. The Phase 1 trial title refers to zelicapavir (EDP-938), confirming that both names refer to the same investigational drug.