Enanta Pharmaceuticals (ENTA) has upcoming FDA regulatory milestones for EDP-978. The table below outlines estimated target dates and event types for these pending regulatory actions.
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-978, zelicapavir, and EDP-323. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
EDP-978 FDA Regulatory Events
EDP-978 is a drug developed by Enanta Pharmaceuticals for the following indication: Treatment of Urticaria.
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-978
- Announced Date:
- April 13, 2026
- Target Action Date:
- Q4 2026
- Estimated Target Date Range:
- October 1, 2026 - December 31, 2026
- Indication:
- Treatment of Urticaria
Announcement
Enanta Pharmaceuticals, Inc announced that the Topline Data Expected in Q4 2026
AI Summary
Enanta Pharmaceuticals has begun a first-in-human Phase 1 trial of EDP-978, a new drug being studied for chronic urticaria. The randomized, double-blind, placebo-controlled study plans to enroll about 98 healthy adults aged 18 to 65 to assess safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD), including serum tryptase. The design includes a single-ascending-dose (SAD) phase with a two-part food-effect cohort and a multiple-ascending-dose (MAD) phase with a 14-day treatment period.
Topline data from this Phase 1 study are expected in Q4 2026. These initial results should show whether the drug is safe in humans and how it behaves in the body, which will guide decisions about further testing and development.
If the topline findings are positive, Enanta may move EDP-978 into later-stage trials to further evaluate efficacy and longer-term safety in patients with chronic urticaria.
Read Announcement- Drug:
- EDP-978
- Announced Date:
- April 13, 2026
- Indication:
- Treatment of Urticaria
Announcement
Enanta Pharmaceuticals, Inc. announced that the first participant has been dosed in a Phase 1 clinical trial of EDP-978, an oral, once-daily KIT inhibitor in development for urticaria and other mast cell-driven diseases.
AI Summary
Enanta Pharmaceuticals announced that the first participant has been dosed in a first-in-human Phase 1 trial of EDP-978, an oral, once-daily KIT inhibitor being developed for chronic urticaria and other mast cell–driven diseases. EDP-978 is designed to block KIT, a key receptor involved in mast cell activation, with the goal of reducing symptoms driven by mast cell activity.
The randomized, double-blind, placebo-controlled study plans to enroll about 98 healthy adults ages 18 to 65 to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD). PD assessments will include measures such as serum tryptase to monitor mast cell activity.
The trial includes a single ascending dose (SAD) phase with a two-part food-effect cohort and a multiple ascending dose (MAD) phase with 14 days of dosing. Topline data are expected in the fourth quarter of 2026.
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:
- April 7, 2026
- Indication:
- For respiratory syncytial virus
Announcement
Enanta Pharmaceuticals, Inc announced that data on zelicapavir, an oral, once-daily, N-protein inhibitor, in development for the treatment of (RSV) have been accepted for two oral presentations at the European Society of Clinical Microbiology & Infectious Diseases Global 2026 (ESCMID) being held April 17-21, 2025 in Munich, Germany.
AI Summary
Enanta Pharmaceuticals announced that data on zelicapavir, an oral, once-daily N‑protein inhibitor in development for treating respiratory syncytial virus (RSV), were accepted for two oral presentations at the European Society of Clinical Microbiology & Infectious Diseases (ESCMID) Global 2026 meeting. The presentations will be part of the meeting scheduled for April 17–21, 2025, in Munich, Germany. Acceptance for two oral talks indicates the company will share substantial findings directly with clinicians and researchers at a major infectious disease conference.
Zelicapavir targets the viral N protein and aims to provide a convenient, once‑daily oral option for RSV. Presenting at ESCMID gives Enanta an opportunity to highlight clinical and scientific data to the global research community, advance peer feedback, and raise awareness of the drug’s potential role in treating RSV, especially among high‑risk patients. Further details about the presentations were not included in the announcement.
Read Announcement- Drug:
- zelicapavir
- Announced Date:
- January 8, 2026
- Indication:
- For respiratory syncytial virus
Announcement
Enanta Pharmaceuticals, Inc. highlighted upcoming key milestones for 2026.
AI Summary
Enanta highlighted its key 2026 milestones across virology and immunology programs. In RSV, the company plans to align with the FDA on an adult Phase 3 design and registration path in Q2 2026 and to prepare for a Phase 3 study of zelicapavir in high‑risk adults in the second half of 2026. Enanta is also exploring business development opportunities for its RSV assets and will present its 2026 outlook at the J.P. Morgan Healthcare Conference on January 14.
For immunology, Enanta expects to file an IND for EDP‑978 (a KIT inhibitor) in Q1 2026 and report Phase 1 topline data in Q4 2026. It aims to file an IND for EPS‑3903 (a STAT6 inhibitor) in H2 2026 and to nominate a development candidate for its MRGPRX2 program in H2 2026. The company says it has a strong cash position with runway into fiscal 2029 to support these plans.
Read Announcement- Drug:
- zelicapavir
- Announced Date:
- October 20, 2025
- Indication:
- For respiratory syncytial virus
Announcement
Enanta Pharmaceuticals, Inc announced that new data for zelicapavir, its oral, once-daily, N-protein inhibitor, and EDP-323, its oral, once-daily L-protein inhibitor, both in development for the treatment of respiratory syncytial virus (RSV), will be presented at IDWeek™ 2025 being held October 19 – 22, 2025, virtually and in Atlanta, Georgia.
AI Summary
Enanta Pharmaceuticals announced it will present new data for its two oral, once-daily RSV therapies—zelicapavir, an N-protein inhibitor, and EDP-323, an L-protein inhibitor—at IDWeek™ 2025, held October 19–22 in Atlanta and online.
Zelicapavir showed a shorter time to complete resolution of RSV symptoms in a Phase 2, randomized, double-blind, placebo-controlled trial of children aged 28 days to 36 months. Data will be shared in both a rapid-fire session and a poster presentation on October 20, highlighting its potential to reduce symptom duration and hospital discharge time.
EDP-323 demonstrated strong post-exposure prophylaxis effects in a human viral challenge study. Participants who received EDP-323 had significantly fewer infections and rapid reductions in symptoms and viral load compared to placebo. These results will be shared in an oral presentation on October 20 and a poster on October 22.
These findings support further clinical development and underscore Enanta’s goal to advance best-in-disease RSV treatments.
Read Announcement- Drug:
- zelicapavir
- Announced Date:
- October 7, 2025
- Indication:
- For respiratory syncytial virus
Announcement
Enanta Pharmaceuticals, Inc announced that data for zelicapavir, its oral, once-daily, N-protein inhibitor will be presented at IDWeek™ 2025 being held October 19 - 22, 2025 virtually and at the Georgia World Congress Center in Atlanta, Georgia.
Read Announcement- Drug:
- zelicapavir
- Announced Date:
- September 29, 2025
- Indication:
- For respiratory syncytial virus
Announcement
Enanta Pharmaceuticals, Inc announced positive topline data from RSVHR, a Phase 2b, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of zelicapavir in outpatient adults with acute RSV infection who are at high risk of complications including the elderly and/or those with congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) or asthma..
AI Summary
Enanta Pharmaceuticals announced positive topline results from RSVHR, a Phase 2b, randomized, double‐blind, placebo‐controlled study of zelicapavir in high‐risk adults with acute RSV infection. Participants included elderly outpatients and those with congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) or asthma.
In the subgroup of patients aged ≥75 or with CHF/COPD, zelicapavir cut the time to complete resolution of all 13 RSV symptoms by 6.7 days versus placebo. In the overall efficacy group, symptom resolution was 2.2 days faster. Patients also improved 2 days sooner on the Patient Global Impression of Severity scale.
Virology results showed a 4–5 day faster median time to undetectable viral load with zelicapavir and a higher rate of undetectable virus at end of treatment. Hospitalization rates were lower with zelicapavir (1.7%) versus placebo (5%).
Zelicapavir was well‐tolerated, with a safety profile similar to placebo and no treatment discontinuations due to adverse events.
Read Announcement- 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
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:
- October 7, 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 for EDP-323, it's oral, once-daily L-protein inhibitor, both in development for the treatment of respiratory syncytial virus (RSV), will be presented at IDWeek™ 2025 being held October 19 - 22, 2025 virtually and at the Georgia World Congress Center in Atlanta, Georgia.
AI Summary
Enanta Pharmaceuticals will present new data for EDP-323, its oral, once-daily L-protein inhibitor for respiratory syncytial virus (RSV), at IDWeek™ 2025. The conference runs October 19–22, 2025, both virtually and at the Georgia World Congress Center in Atlanta, Georgia.
An oral presentation titled “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” will be delivered on Monday, October 20, from 4:15 PM to 4:27 PM EDT. Dr. John P. DeVincenzo will discuss how EDP-323 quickly lowers symptoms and viral load in a human challenge model.
A poster presentation on Wednesday, October 22, from 12:15 PM to 1:30 PM EDT will cover post-exposure prophylaxis against RSV after high-dose viral challenge. The poster (number 2181) will be available online during and after the conference, and on Enanta’s website.
Read Announcement- 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
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