Enanta advances zelicapavir into registrational Phase 2b/3 trial
Enanta Pharmaceuticals is advancing zelicapavir into a registrational Phase 2b/3 clinical trial for high-risk adults with RSV in 4Q 2026, following a successful FDA meeting, with topline data expected in 2027.
*this image is generated using AI for illustrative purposes only.
Enanta Pharmaceuticals, Inc. is advancing zelicapavir into a registrational Phase 2b/3 clinical trial for adults at high risk of severe outcomes from respiratory syncytial virus (RSV) infection in 4Q 2026. The decision follows a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). The company also announced plans to initiate a Phase 2b clinical trial of zelicapavir in pediatric patients with RSV in 3Q 2026. Topline data for both the adult and pediatric trials are expected in 2027.
Clinical Trial Timeline
The Phase 2b portion of the registrational trial in adults will confirm the treatment effect. Enanta outlined the schedule for its upcoming clinical studies involving zelicapavir.
| Trial Phase | Patient Population | Initiation Date | Topline Data Expected |
|---|---|---|---|
| Phase 2b/3 | High-risk adults | 4Q 2026 | 2027 |
| Phase 2b | Pediatric patients | 3Q 2026 | 2027 |
Regulatory Progression
The advancement to the registrational stage comes after the End-of-Phase 2 meeting with the FDA. Enanta Pharmaceuticals focuses on developing small molecule drugs for viral infections and immunological diseases.
How will the competitive landscape for RSV treatments evolve by the time zelicapavir reaches the market in 2027?
What are the potential market size and commercial opportunities for zelicapavir in high-risk adult and pediatric populations?
What regulatory challenges could arise during the Phase 2b/3 trial, and how might they impact the approval timeline?
16
Create Custom Screeners 
Access 200+ Pre-built Filters 
Use 50+ Readymade Screener 
