This section highlights FDA-related milestones and regulatory updates for drugs developed by Enanta Pharmaceuticals (ENTA).
Over the past two years, Enanta Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
EDP-323 and zelicapavir. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
EDP-323 - FDA Regulatory Timeline and Events
EDP-323 is a drug developed by Enanta Pharmaceuticals for the following indication: Eduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EDP-323
- Announced Date:
- April 8, 2025
- Indication:
- Eduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B
Announcement
Enanta Pharmaceuticals, Inc announced that data from the Company's Phase 2a human challenge study of EDP-323 in healthy adults infected with respiratory syncytial virus (RSV) has been accepted for an oral presentation as an ePoster at the European Society of Clinical Microbiology & Infectious Diseases Global 2025 (ESCMID, formerly ECCMID) being held April 11-15, 2025 in Vienna, Austria.
AI Summary
Enanta Pharmaceuticals announced that data from its Phase 2a human challenge study of EDP-323 in healthy adults infected with respiratory syncytial virus (RSV) has been accepted for an oral presentation at the European Society of Clinical Microbiology & Infectious Diseases Global 2025 in Vienna, Austria. The study evaluated EDP-323, a first-in-class, oral, non-nucleoside small molecule that targets the RSV polymerase, and showed promising results by reducing respiratory mucus production and speeding up viral clearance.
The ePoster, scheduled for April 13, 2025, during a session on Novel Approaches to Antiviral Therapy, will highlight key findings from the clinical challenge study. This acceptance underlines the potential of EDP-323 as a new treatment option for RSV infections.
Read Announcement - Drug:
- EDP-323
- Announced Date:
- November 25, 2024
- Indication:
- Eduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B
Announcement
Enanta Pharmaceuticals, Inc provides clinical updates
AI Summary
Enanta Pharmaceuticals provided an update on its clinical programs for treating respiratory syncytial virus (RSV). In its RSV portfolio, the company is evaluating two promising antiviral candidates. Zelicapavir, an oral N-protein inhibitor, is being studied in the RSVPEDs Phase 2 trial. This trial involves infants and children aged between 28 days and three years, and topline results are expected in December 2024, offering hope for a new treatment option for the youngest patients affected by RSV.
Meanwhile, the company's second candidate, EDP-323—an oral L-protein inhibitor—delivered positive topline results in a Phase 2a human challenge study involving healthy adults. The study showed significant reductions in viral load and clinical symptoms, along with a favorable safety profile. These advances underscore Enanta’s commitment to expanding its RSV treatment strategies and may provide multiple options for patients at high risk for severe RSV infection.
Read Announcement- Drug:
- EDP-323
- Announced Date:
- September 26, 2024
- Indication:
- Eduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B
Announcement
Enanta Pharmaceuticals, Inc. announced positive topline results from a Phase 2a human challenge study of EDP-323 in healthy adults infected with respiratory syncytial virus (RSV).
AI Summary
Enanta Pharmaceuticals, Inc. announced positive topline results from a Phase 2a human challenge study of EDP-323 in healthy adults with respiratory syncytial virus (RSV). The study showed that EDP-323 met its primary and secondary endpoints, demonstrating strong antiviral activity. The drug reduced viral load by 85-87% as measured by qRT-PCR and decreased infectious viral load by 97-98% through viral culture, both with high statistical significance. In addition, clinical symptoms were reduced by 66-78% compared to a placebo group. The results highlight the rapid and sustained reduction in viral load and symptom relief provided by the once-daily oral treatment. EDP-323 also showed favorable pharmacokinetics and a good safety profile during the study. These promising findings support further development of EDP-323 as an effective treatment for RSV and have earned it Fast Track designation from the FDA.
Read Announcement
zelicapavir - FDA Regulatory Timeline and Events
zelicapavir is a drug developed by Enanta Pharmaceuticals for the following indication: For respiratory syncytial virus.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- zelicapavir
- Announced Date:
- May 22, 2025
- Indication:
- For respiratory syncytial virus
Announcement
Enanta Pharmaceuticals, Inc announced that data from the Company's Phase 2 study of zelicapavir in young children infected with respiratory syncytial virus (RSV) will be available as an E-Poster at the 43rd Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID) 2025, being held May 26-30, 2025 at the Bucharest International Conference Centre in Bucharest, Romania and online.
AI Summary
Enanta Pharmaceuticals, Inc. announced that data from its Phase 2 study of zelicapavir, an experimental oral treatment for respiratory syncytial virus (RSV), will be featured as an E-Poster at the 43rd Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID) 2025. The study focuses on young children with RSV and provides new insights into the drug’s population PK/PD as well as the time needed to achieve viral load negativity. The E-Poster, titled "Antiviral Treatment of RSV in Children: Virology and PK Results of a Randomized Double-Blind Placebo-Controlled International Trial of Zelicapavir (EDP-938)," will be available starting May 26, 2025, both in Bucharest, Romania, and online. This presentation highlights Enanta’s ongoing efforts to develop small molecule drugs targeting viral infections, and it represents a step forward in exploring new treatment options for children affected by RSV.
Read Announcement- Drug:
- zelicapavir
- Announced Date:
- December 9, 2024
- Indication:
- For respiratory syncytial virus
Announcement
Enanta Pharmaceuticals, Inc announced positive topline results from the first-in-pediatrics Phase 2 study evaluating zelicapavir in hospitalized and non-hospitalized children aged 28 days to 36 months with respiratory syncytial virus (RSV).
AI Summary
Enanta Pharmaceuticals, Inc. announced positive topline results from its first pediatric Phase 2 study of zelicapavir in children aged 28 days to 36 months with RSV. The study showed a clear antiviral effect, with patients in Part 2 of the trial experiencing a 1.4 log decline in viral load after five days of treatment compared to placebo. Additionally, a subgroup of children treated within three days of symptom onset saw a 1.2 log reduction in viral load at Day 5.
The study involved both hospitalized and non-hospitalized patients and reported that zelicapavir was well-tolerated with a favorable safety profile. These positive findings support further clinical evaluation of zelicapavir as a promising once-daily oral treatment for RSV, addressing a significant need for safe and effective therapies in this young and vulnerable population.
Read Announcement- Drug:
- zelicapavir
- Announced Date:
- December 6, 2024
- Indication:
- For respiratory syncytial virus
Announcement
Enanta Pharmaceuticals, Inc announced the company will hold a conference call and webcast on Monday, December 9 at 8:30 a.m. ET to share topline results from RSVPEDs, a first-in-pediatrics Phase 2 study evaluating zelicapavir in hospitalized and non-hospitalized children aged 28 days to 36 months with respiratory syncytial virus (RSV).
AI Summary
Enanta Pharmaceuticals, Inc. announced that it will host a conference call and webcast on Monday, December 9 at 8:30 a.m. ET. During this session, the company will share topline results from RSVPEDs, a first-in-pediatrics Phase 2 study. The study is evaluating zelicapavir, Enanta’s lead N-protein inhibitor, in both hospitalized and non-hospitalized children aged 28 days to 36 months who have respiratory syncytial virus (RSV). The study aims to assess the treatment's effect on RSV, a major cause of respiratory illness in young children. Interested parties can watch the live webcast or register to join the call by phone. For those who cannot attend the live event, the webcast will be available on Enanta’s website for approximately 30 days after December 9.
Read Announcement
