Drugs / EDP-235
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05594602 | Oct → Dec 2022 | COVID-19 | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT05594615 | Oct → Nov 2022 | COVID-19 | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT05246878 | Jan → Jul 2022 | COVID-19 | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05616728 | Nov 2022 → Feb 2023 | COVID-19 | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2023-05-08 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Reports Positive Topline Results from Phase 2 SPRINT Trial Evaluating EDP-235 in Standard Risk Patients with COVID-19 enanta.com ↗
EDP-235 met the primary endpoint of the trial and was generally safe and well-tolerated. |
| 2023-05-08 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter with Conference Call and Webcast Today at 4:30 p.m. ET enanta.com ↗
This vision is supported by positive topline data from our SPRINT Phase 2 study announced today. |
| 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 ↗
Preclinical data presented demonstrate EDP-235’s preferential target tissue distribution and cell penetration, enabling EDP-235 to reach potential sites of persistent viral replication, which may impact progression of long COVID-19. |
| 2023-03-14 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals to Present New Data for EDP-235, its 3CL Protease Inhibitor, in Development as an Oral, Once-Daily Treatment for COVID-19, at the 36th International Conference on Antiviral Research enanta.com ↗
Phase 1 data presented continue to highlight EDP-235’s promising overall safety, tolerability and pharmacokinetic (PK) profile, and preclinical data demonstrate EDP-235’s ability to suppress viral replication and transmission in an animal model. |
| 2023-01-06 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals to Provide Updates on its Research and Development Programs and 2023 Outlook at the 41st Annual J.P. Morgan Healthcare Conference enanta.com ↗
We are also excited to present new preclinical in vivo data demonstrating EDP-235’s robust antiviral treatment effect and its ability to prevent the transmission of COVID-19 in a ferret model. |
| 2022-10-19 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Presents New Preclinical Data for EDP-235, its Oral, Direct-Acting Antiviral Protease Inhibitor Specifically Designed for the Treatment of COVID-19 at IDWeek™ 2022 enanta.com ↗
Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced new preclinical data supporting the potential of EDP-235 for the treatment of COVID-19, which are being presented at IDWeek 2022 in Washington, DC. |
| 2022-07-29 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Announces Positive Data from a Phase 1 Clinical Study of EDP-235, its Oral 3CL Protease Inhibitor Designed for the Treatment of COVID-19 enanta.com ↗
Data from the Phase 1 study demonstrated favorable safety, tolerability, and PK with strong exposure multiples over the EC90, thereby supporting the advancement of EDP-235 into a Phase 2 study using once-daily dosing, without ritonavir. |
| 2022-03-29 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Pharmaceuticals Receives FDA Fast Track Designation for EDP-235, its Oral 3CL Protease Inhibitor Specifically Designed for the Treatment and Prevention of COVID-19 enanta.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDP-235, its coronavirus 3CL protease inhibitor (also known as the main coronavirus protease, or Mpro) specifically designed as a once-daily, oral treatment for COVID-19. |
| 2021-10-19 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Presents New Data for EDP-235, its Lead Oral Protease Inhibitor Designed for the Treatment of COVID-19, at the ISIRV–WHO Virtual Conference 2021 enanta.com ↗
EDP-235 potently blocked the replication of SARS-CoV-2 in multiple cellular models, including primary human airway epithelial cells, where an EC90 of 33 nM was observed. |
All press releases naming this drug 15 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-235 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05594615 ↗ |
| Route | Oral | “Oral administration” NCT05246878 ↗ |