Drugs / zelicapavir

Trials 13

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
Phase 1 NCT06601192 Jul 2024 → Feb 2025 respiratory syncytial virus infectious disease Enanta Pharmaceuticals, Inc Completed No outcome recorded
Phase 1 NCT04927793 May → Jul 2021 respiratory syncytial virus infectious disease Enanta Pharmaceuticals, Inc Completed No outcome recorded
Phase 1 NCT04871724 Mar 2021 respiratory syncytial virus infectious disease Enanta Pharmaceuticals, Inc Completed No outcome recorded
Phase 1 NCT04498741 Jul 2020 → May 2021 respiratory syncytial virus infectious disease Enanta Pharmaceuticals, Inc Completed No outcome recorded
Phase 1 NCT03755778 Nov 2018 → Jan 2019 respiratory syncytial virus infectious disease Enanta Pharmaceuticals, Inc Completed No outcome recorded
Phase 1 NCT03750383 Nov 2018 respiratory syncytial virus infectious disease Enanta Pharmaceuticals, Inc Completed No outcome recorded
Phase 1 NCT03384823 Dec 2017 → Jul 2018 respiratory syncytial virus infectious disease Enanta Pharmaceuticals, Inc Completed No outcome recorded
Phase 26 trials · 1 met primary
Phase 2 NCT07482657 Jul → Dec 2026 expected respiratory syncytial virus infectious disease Enanta Pharmaceuticals, Inc Recruiting No outcome recorded
Phase 2 NCT05568706 Nov 2022 → Jun 2025 respiratory syncytial virus infectious disease Enanta Pharmaceuticals, Inc Completed No outcome recorded
Phase 2 NCT04816721 Apr 2022 → Aug 2024 respiratory syncytial virus infectious disease Enanta Pharmaceuticals, Inc Completed No outcome recorded
Phase 2 NCT04633187 Jul 2021 → May 2023 respiratory syncytial virus infectious disease Enanta Pharmaceuticals, Inc Terminated No outcome recorded Stop: Business
Phase 2 NCT04196101 Jan 2020 → Jan 2022 respiratory syncytial virus infectious disease Enanta Pharmaceuticals, Inc Completed No outcome recorded
Phase 2 NCT03691623 Oct 2018 → Sep 2019 respiratory syncytial virus infectious disease Enanta Pharmaceuticals, Inc Completed Met primary

News releases announcing trial results or a regulatory action · 14

DateIssuerRelease
2026-05-04 Enanta Pharmaceuticals, Inc Results Enanta Pharmaceuticals to Present Data for its Respiratory Syncytial Virus and STAT6 Inhibitor Programs at the American Thoracic Society International Conference 2026 enanta.com ↗
Zelicapavir Reduces Symptom Duration and Hospitalization in a Randomized, Double-Blind, Placebo-Controlled, International, Phase 2 Trial
2026-04-07 Enanta Pharmaceuticals, Inc Results Enanta Pharmaceuticals to Present Data for Zelicapavir, an Oral, Once-Daily, N-Protein Inhibitor, in Development for the Treatment of Respiratory Syncytial Virus, at ESCMID Global 2026 enanta.com ↗
The second oral presentation will highlight new data confirming zelicapavir’s high clinical and functional barrier against antiviral resistance, generated from the Phase 2 study in pediatric patients, which was announced in September 2024.
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 ↗
Zelicapavir (EDP-938) Antiviral Treatment is Associated with Shortened Duration of RSV Symptoms in a Randomized, Double-Blind, Placebo-Controlled, Clinical Trial in Children 28 Days to 36 Months of Age
2025-09-29 Enanta Pharmaceuticals, Inc Results Enanta Pharmaceuticals Reports Positive Topline Results from its Phase 2b Study of Zelicapavir for the Treatment of Respiratory Syncytial Virus (RSV) in High-Risk Adults enanta.com ↗
2024-12-09 Enanta Pharmaceuticals, Inc Results Enanta Pharmaceuticals Announces Positive Topline Results from First-in-Pediatrics Phase 2 Study Evaluating Zelicapavir for the Treatment of Respiratory Syncytial Virus (RSV) enanta.com ↗
The primary endpoint in Part 2 of the study, which focused on virology, showed a pronounced antiviral effect with a 1.4 log decline in viral load at Day 5 compared to placebo.
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 ↗
EDP-938 and EDP-323 displayed potent anti-RSV activity with EC50s below 30 nM and 1 nM, respectively.
2022-05-18 Enanta Pharmaceuticals, Inc Results Enanta Pharmaceuticals Reports Topline Data from the RSVP Study of EDP-938 in Otherwise Healthy Adults with Community-Acquired Respiratory Syncytial Virus (RSV) enanta.com ↗
In this low-risk patient population which had mild, self-resolving upper respiratory tract infection, EDP-938 did not meet the primary endpoint of reduction in total symptom score compared to placebo, or the secondary antiviral endpoints.
2022-02-17 Enanta Pharmaceuticals, Inc Results Enanta Pharmaceuticals Announces Publication in The New England Journal of Medicine of Data from the Phase 2a Human Challenge Study of EDP-938 for the Treatment of Respiratory Syncytial Virus (RSV) enanta.com ↗
Overall, EDP-938 was generally safe and well-tolerated.
2019-10-03 Enanta Pharmaceuticals, Inc Results New Data from Enanta’s Phase 2a Human Challenge Study of EDP-938 for RSV Demonstrates Highly Statistically Significant Reductions (p<0.001) in Total Symptom Score, Mucus Weight and RSV Viral Load as Measured by RT-PCR Assay and by Plaque Assay enanta.com ↗
2019-06-14 Enanta Pharmaceuticals, Inc Results Enanta Pharmaceuticals Announces Topline Results Showing EDP-938 Achieved its Primary and Secondary Endpoints in its Phase 2a Human Challenge Study in Healthy Adults Infected with Respiratory Syncytial Virus (RSV) enanta.com ↗
EDP-938 achieved highly statistically significant (p<0.001) reductions in viral load and in resolution of clinical symptoms compared to placebo
2018-10-23 Enanta Pharmaceuticals, Inc Results Enanta Pharmaceuticals Announces Positive Phase 1 Results and Initiation of Phase 2a Clinical Study of EDP-938 for Respiratory Syncytial Virus enanta.com ↗
In the MAD phase, half-life ranged from 12.9 to 17.6 hours, and at doses comparable to those under study in the Phase 2a trial, mean trough levels were approximately 30x higher than the EC90 of EDP-938 against RSV-infected human cells.

All press releases naming this drug 22 releases

DateIssuerRelease

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 15 sources stand behind the page.

FieldValueCited text
Known as zelicapavir ClinicalTrials.gov intervention name — accepted as the source's own label NCT06601192 ↗
1

NCT07482657 ↗

Known as EDP-938 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05568706 ↗
10

NCT04927793 ↗

NCT04633187 ↗

NCT04816721 ↗

NCT03755778 ↗

NCT04498741 ↗

NCT03691623 ↗

NCT04871724 ↗

NCT03384823 ↗

NCT04196101 ↗

NCT03750383 ↗

Action Inhibit “EDP-938, a nonfusion replication inhibitor of RSV, acts by modulating the viral nucleoprotein.” PMID 35172056 ↗ Feb 2022
Modality Small molecule — CHEMBL4475481 ↗
Route Oral “EDP-938 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, and Dose 6 oral suspension, once daily in one single administration” NCT03384823 ↗