Drugs / EDP-323
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT06917508 | Mar → Jun 2025 | respiratory syncytial virus infectious disease | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT06847464 | Jan → May 2025 | respiratory syncytial virus infectious disease | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT05587478 | Sep 2022 → Mar 2023 | respiratory syncytial virus infectious disease | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT06170242 | Nov 2023 → Jun 2024 | respiratory syncytial virus infectious disease | Enanta Pharmaceuticals, Inc | Completed | Met primary |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2025-10-20 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Presents New Data for Zelicapavir, its N-Protein Inhibitor, and EDP-323, its L-Protein Inhibitor, Both in Development for the Treatment of Respiratory Syncytial Virus (RSV) at IDWeek™ 2025 enanta.com ↗
The results presented demonstrate zelicapavir’s ability to shorten symptom duration in children aged 28 days to 36 months, while another presentation underscores EDP-323’s promise in post-exposure prophylaxis of RSV infection, |
| 2025-10-07 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals to Present Data for Zelicapavir and EDP-323, Two Candidates in Development for the Treatment of Respiratory Syncytial Virus (RSV) at IDWeek™ 2025 enanta.com ↗
EDP-323, a First-in-Class, Oral, RSV-Specific, Non-Nucleoside L-Protein Inhibitor Antiviral Rapidly Reduces Total RSV Symptoms, Lower Respiratory Tract RSV Symptoms and Viral Load After Human Viral Challenge |
| 2024-09-26 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Announces Positive Topline Results for EDP-323 in a Phase 2a Human Challenge Study of Healthy Adults Infected With Respiratory Syncytial Virus (RSV) enanta.com ↗
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating best-in-class small molecule drugs for virology and immunology indications, today announced positive topline results from a Phase 2a human challenge study of EDP-323 in healthy adults infected with respiratory syncytial virus (RSV). |
| 2023-06-20 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Announces Positive Data From a Phase 1 Clinical Study of EDP-323, an Oral, L-Protein Inhibitor in Development for the Treatment of Respiratory Syncytial Virus enanta.com ↗
Data from the Phase 1 study demonstrated favorable safety, tolerability, and PK supportive of once-daily dosing, with good exposure multiples, thereby supporting further clinical advancement of EDP-323. |
| 2023-04-17 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Presents Data for its COVID-19 and Respiratory Syncytial Virus Programs at the 33rd European Congress of Clinical Microbiology and Infectious Diseases enanta.com ↗
Additionally, preclinical data presented showcase EDP-323’s favorable preclinical pharmacokinetic (PK) properties, excellent bioavailability with low plasma clearance, and favorable target tissue distribution, supporting a once-daily oral dosing regimen for RSV. |
| 2023-04-06 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Pharmaceuticals Receives FDA Fast Track Designation for EDP-323, its Oral, L-Protein Inhibitor in Development for the Treatment of Respiratory Syncytial Virus enanta.com ↗
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDP-323, Enanta’s L-protein inhibitor in development for the treatment of respiratory syncytial virus (RSV). |
| 2022-09-29 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Presents Preclinical Data for its Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (hMPV) Programs at the 12th International RSV Symposium enanta.com ↗
Results demonstrate potent inhibition of RSV replication and associated pathology in a rodent infection model, supporting continued advancement of EDP-323 as an oral therapy for RSV. |
All press releases naming this drug 9 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | EDP-323 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06917508 ↗ |
| Route | Oral | “Oral administration” NCT05587478 ↗ |