NCT07482657

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

Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zelicapavir in Participants ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial Virus

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Enanta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 28 Days – 36 Months
• Healthy volunteers: Not accepted

Summary

Zelicapavir is a novel, orally administered, nonfusion replication inhibitor of RSV. It is being investigated in this Phase 2 study (EDP 938-203) as a potential treatment for RSV infection in both hospitalized and non-hospitalized children aged ≥28 days to ≤36 months who present with symptomatic RSV infection.

Conditions

• RSV Infection
• RSV
• Respiratory Syncytial Virus (RSV)

Interventions

Type	Name	Description
DRUG	zelicapavir	Oral suspension
DRUG	Placebo	Placebo oral suspension to match zelicapavir

Timeline

• Start date: 2026-07-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2026-03-19
• Last updated: 2026-03-19

Regulatory

• FDA-regulated drug study