Clinical TrialJun 18, 2026, 07:16 AM
Enanta Advances Zelicapavir into Registrational Ph2b/3 RSV Trial
AI Summary
Enanta Pharmaceuticals announced the advancement of its zelicapavir clinical development program for respiratory syncytial virus (RSV). Following a successful End-of-Phase 2 meeting with the FDA, the company plans to initiate a registrational Phase 2b/3 clinical trial in high-risk adults in Q4 2026, with Phase 2b data expected in 2027. Additionally, a Phase 2b clinical trial for pediatric patients with RSV is set to begin in Q3 2026, with topline data also anticipated in 2027. This progress underscores zelicapavir's potential as the first antiviral therapy for RSV, addressing a significant global disease burden.
Key Highlights
- Enanta Pharmaceuticals is advancing zelicapavir into a registrational Phase 2b/3 clinical trial for high-risk adults with RSV.
- The Phase 2b portion of the adult trial is expected to provide topline data in 2027.
- A Phase 2b clinical trial for zelicapavir in pediatric patients with RSV will initiate in Q3 2026, with topline data expected in 2027.
- The adult Phase 2b/3 trial will enroll a minimum of 200 patients in Phase 2b and approximately 660 in Phase 3.
- The pediatric Phase 2b trial will enroll approximately 150 participants aged 28 days to 36 months.
- Enanta estimates an oral RSV antiviral market opportunity of over $2 billion globally, with a potential total addressable population of greater than 3 million patients in the U.S.
- Zelicapavir previously showed a one-week reduction in symptom resolution and reduced hospitalization in high-risk adults.
- Zelicapavir has been granted Fast Track designation by the U.S. FDA.
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