Drugs / AT-527
AT-527
Trials 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 120 trials | ||||||
| Phase 1 | NCT07272889 | Dec 2025 → Feb 2026 | — | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06911320 | Apr 2025 → May 2026 overdue | impaired renal function disease | Atea Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06921941 | Apr → Jul 2025 | — | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06356194 | Apr → May 2024 | — | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06204679 | Dec 2023 → Aug 2024 | — | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05905497 | Apr → May 2023 | — | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05905484 | Apr → May 2023 | — | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05724693 | Jan 2023 → Apr 2024 | — | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05731843 | Jan → Mar 2023 | — | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05618314 | Oct 2022 → Jun 2024 | impaired renal function disease | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05256732 | Feb → Aug 2022 | — | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05154123 | Nov → Dec 2021 | — | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05137626 | Nov → Dec 2021 | — | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05004415 | Jul → Aug 2021 | — | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04877769 | Apr → Aug 2021 | — | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04865445 | Apr → May 2021 | — | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04849299 | Apr → May 2021 | — | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04784000 | Mar → Apr 2021 | — | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04711187 | Nov 2020 → Sep 2021 | — | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03219957 | Jul 2017 → Jun 2018 | chronic hepatitis C virus infection | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04309734 | Oct 2021 → Jun 2022 | chronic hepatitis C virus infection | Atea Pharmaceuticals, Inc. | Withdrawn | No outcome recorded |
| Phase 23 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT05904470 | May 2023 → Dec 2024 | chronic hepatitis C virus infection, cirrhosis of liver | Atea Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 2 | NCT04709835 | Feb → Sep 2021 | COVID-19 | Hoffmann-La Roche | Completed | Missed primary |
| Phase 2 | NCT04019717 | Jun 2019 → Jan 2020 | chronic hepatitis C virus infection | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 33 trials · 1 missed | ||||||
| Phase 3 | NCT07037277 | Jun 2025 → Dec 2026 expected | chronic hepatitis C virus infection | Atea Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06868264 | Apr 2025 → Sep 2026 overdue | chronic hepatitis C virus infection | Atea Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05629962 | Nov 2022 → Apr 2024 | COVID-19 | Atea Pharmaceuticals, Inc. | Completed | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT04396106 Comparator | May 2020 → Jan 2022 | COVID-19 | Atea Pharmaceuticals, Inc. | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 33
| Date | Issuer | Release |
|---|---|---|
| 2026-05-27 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Presents New Drug-Drug Interaction Results Supporting Potential Best-in-Class Profile of the Regimen of Bemnifosbuvir and Ruzasvir for the Treatment of Hepatitis C Virus at EASL Congress 2026 ateapharma.com ↗
today announced Phase 1 results which further demonstrate that the fixed-dose combination regimen of bemnifosbuvir and ruzasvir (BEM/RZR) for the treatment of hepatitis C virus (HCV) has a low risk of drug-drug interaction. |
| 2026-05-13 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals to Present Three Abstracts at EASL 2026 Congress Highlighting Progress Across Viral Hepatitis Pipeline ateapharma.com ↗
Proton-pump inhibitor omeprazole did not affect the plasma pharmacokinetics of bemnifosbuvir and ruzasvir fixed-dose combination in healthy participants |
| 2025-11-12 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Reports Third Quarter 2025 Financial Results and Provides Business Update ateapharma.com ↗
New Data Show Bemnifosbuvir Has Unique Dual Mechanism Against HCV |
| 2025-11-07 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Presents New Data Supporting the Fixed-Dose Combination of Bemnifosbuvir and Ruzasvir as a Potential Best-in-Class Regimen for Treatment of Hepatitis C Virus Infection at The Liver Meeting® 2025 ateapharma.com ↗
These modeling data will be presented at The Liver Meeting ® 2025, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), taking place November 7-11 in Washington, DC. |
| 2025-05-07 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Announces Full Results from Phase 2 Study of Regimen of Bemnifosbuvir and Ruzasvir for Treatment of Hepatitis C Virus (HCV) Presented at EASL Congress 2025 ateapharma.com ↗
With a short 8-week treatment duration, the Phase 2 results showed a robust 98% (210/215) sustained virologic response rate at 12 weeks post-treatment (SVR12) with the regimen in the “Per-Protocol Treatment-Adherent Population.” |
| 2025-03-19 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Announces Presentation of Bemnifosbuvir Preclinical Data at the 38th International Conference on Antiviral Research (ICAR) 2025 ateapharma.com ↗
Metabolism of Bemnifosbuvir to its Active Triphosphate Metabolite AT-9010 is Cell-Line Dependent |
| 2024-12-04 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Announces Positive Results from Phase 2 Study of Bemnifosbuvir and Ruzasvir Regimen for Treatment of Hepatitis C Virus (HCV) ateapharma.com ↗
Primary endpoint results demonstrated a 98% (208/213) SVR12 rate in the per-protocol treatment adherent patient population after eight weeks of treatment with a regimen of bemnifosbuvir and ruzasvir. |
| 2024-09-13 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Provides Update on Global Phase 3 SUNRISE-3 Trial Evaluating Bemnifosbuvir for Treatment of COVID-19 ateapharma.com ↗
The trial did not meet the primary endpoint of a statistically significant reduction in all-cause hospitalization or death through Day 29 in the monotherapy cohort of 2,221 high-risk patients with mild to moderate COVID-19. |
| 2024-08-28 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Announces Publication of Additional Data Further Highlighting Bemnifosbuvir’s Metabolic Activation Pathway ateapharma.com ↗
Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced that data highlighting the metabolic activation pathway of bemnifosbuvir were published in the peer-reviewed journal, PLOS Biology , in an article titled, “The activation cascade of the broad-spectrum antiviral bemnifosbuvir characterized at atomic resolution.” |
| 2024-06-05 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Presents Positive Initial Phase 2 Data for Bemnifosbuvir and Ruzasvir Combination for Treatment of Hepatitis C Virus at EASL Congress 2024 ateapharma.com ↗
With an 8-week treatment duration, the Phase 2 data from the lead-in cohort of non-cirrhotic patients showed a 97% sustained virologic response rate at 12 weeks post-treatment (SVR12), which is the primary efficacy endpoint of the study. |
| 2024-04-29 | Atea Pharmaceuticals, Inc. | Results Atea Announces Presentation of Data Highlighting Favorable Safety Profile of Bemnifosbuvir at ESCMID Global 2024 ateapharma.com ↗
The results presented at ESCMID further support the favorable safety profile for bemnifosbuvir by demonstrating the lack of cardiotoxicity in healthy participants,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. |
| 2024-02-28 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update ateapharma.com ↗
I am pleased to share that the 98% SVR4 rate was confirmed in the final results from the lead-in cohort of the Phase 2 combination study. |
| 2024-01-08 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Announces Positive Initial Data from Phase 2 Study for Hepatitis C Virus (HCV) and Significant Enrollment Milestone for Phase 3 SUNRISE-3 Trial for COVID-19 ateapharma.com ↗
The Company reported positive initial data from the first 52 patients in the lead-in cohort of its Phase 2 combination 8-week study of bemnifosbuvir and ruzasvir (RZR) for the treatment of HCV. |
| 2023-11-13 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Presents Promising Bemnifosbuvir and Ruzasvir Combination Data for the Treatment of Hepatitis C Virus at AASLD The Liver Meeting 2023 ateapharma.com ↗
Phase 1 data demonstrate that coadministration of bemnifosbuvir and ruzasvir was well tolerated and not affected by food or concomitant dosing, indicating a low risk of drug-drug interactions,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. |
| 2023-11-02 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals to Present Bemnifosbuvir and Ruzasvir Data for the Treatment of Hepatitis C Virus at AASLD The Liver Meeting 2023 ateapharma.com ↗
We are encouraged by the highly potent, pan-genotypic antiviral activity of these compounds, along with the favorable drug-drug interaction and safety profile observed to-date, which supports their use in combination. |
| 2023-04-25 | Atea Pharmaceuticals, Inc. | Regulatory Atea Pharmaceuticals Announces U.S. FDA Fast Track Designation Granted to Bemnifosbuvir, an Investigational Oral Antiviral, for the Treatment of COVID-19 ateapharma.com ↗
has granted Fast Track designation (FTD) to bemnifosbuvir for the treatment of COVID-19. |
| 2023-04-12 | Atea Pharmaceuticals, Inc. | Results Atea Announces Presentation of Bemnifosbuvir Data Demonstrating Reduced Hospitalizations for COVID-19 Patients at 2023 European Congress of Clinical Microbiology & Infectious Diseases ateapharma.com ↗
The MORNINGSKY results showed that non-hospitalized adult and adolescent patients receiving bemnifosbuvir for the treatment of mild to moderate COVID-19 experienced a 71% relative reduction in risk of hospitalization, regardless of vaccination status. |
| 2023-03-14 | Atea Pharmaceuticals, Inc. | Results New Data Showcasing Favorable Profile of Bemnifosbuvir for Treatment of COVID-19 and Hepatitis C Presented at 2023 International Conference on Antiviral Research ateapharma.com ↗
In vitro results demonstrate that bemnifosbuvir is a potent inhibitor of all tested SARS-CoV-2 variants of concern as well as other human coronaviruses such as HCoV-229E, HCoV-OC43, and SARS-CoV-1. |
| 2023-03-08 | Atea Pharmaceuticals, Inc. | Results New Data Showcasing Favorable Profile of Bemnifosbuvir for Treatment of COVID-19 and Hepatitis C to be Presented at 2023 International Conference on Antiviral Research ateapharma.com ↗
Bemnifosbuvir (BEM, AT-527) a Potent Inhibitor of SARS-CoV-2 Variants of Concern (VOC), and a Promising Oral Antiviral with a High Resistance Barrier for Treatment of COVID-19 and other Coronaviruses Infections |
| 2023-02-23 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Presents Favorable Drug Interaction Profile of Bemnifosbuvir in Phase 1 Studies at CROI 2023 ateapharma.com ↗
No dosage adjustment is needed for CYP3A substrates or for drugs that are sensitive substrates of efflux and hepatic uptake transporters when co-administrated with bemnifosbuvir. |
| 2022-05-10 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Reports First Quarter 2022 Financial Results and Provides Business Update ateapharma.com ↗
These new results show a meaningful reduction in hospitalization in a broad patient population treated in the MORNINGSKY outpatient trial and suggest potential clinical benefits in the Phase 2 high-risk hospitalized trial. |
| 2022-03-28 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Reports Nonclinical Bemnifosbuvir (AT-527) Toxicology Data at Society of Toxicology 61st Annual Meeting ateapharma.com ↗
There were no AT-527-related effects on the fertility, reproduction, embryofetal and postnatal development in rats. |
| 2022-02-02 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Announces Publication of Data Supporting Bemnifosbuvir’s (AT-527) Novel Mechanism of Action Against SARS-CoV-2 in Nature Communications ateapharma.com ↗
Data show bemnifosbuvir’s unique mechanism of action increases barrier for emergence of resistance, making it an ideal candidate for treatment of COVID-19 and for combination therapy |
| 2021-11-11 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Provides Clinical and Corporate Update and Reports Third Quarter 2021 Financial Results ateapharma.com ↗
New infectious virus data from a quantitative, highly-sensitive live virus assay further demonstrate AT-527's antiviral response potential. |
| 2021-10-20 | Chugai Pharmaceutical | Results Atea Announces Update and Topline Results of MOONSONG Study Evaluating AT-527 for COVID-19 in the Outpatient Setting chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that Atea issued a press release on October 19 regarding update and topline results of MOONSONG study evaluating the RNA polymerase inhibitor AT-527 for COVID-19 in the outpatient setting. |
| 2021-10-19 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Provides Update and Topline Results for Phase 2 MOONSONG Trial Evaluating AT-527 in the Outpatient Setting ateapharma.com ↗
Topline Phase 2 MOONSONG trial results did not meet the primary endpoint in the overall population of patients with mild or moderate COVID-19, who were mostly low-risk with mild symptoms |
| 2021-08-12 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Provides Clinical and Corporate Update and Reports Second Quarter 2021 Financial Results ateapharma.com ↗
In healthy volunteers, AT-527’s active metabolite achieved target antiviral levels in lining fluid of the lungs, where SARS-CoV-2 virus replicates. |
| 2021-06-30 | Atea Pharmaceuticals, Inc. | Results Atea’s AT-527, an Oral Antiviral Drug Candidate, Reduces Viral Replication in Hospitalized Patients with COVID-19 in Phase 2 Interim Analysis ateapharma.com ↗
Interim virology results indicated that AT-527 rapidly reduced viral load levels. |
| 2021-03-06 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Presents Favorable Phase 1 Results for AT-527 at 28th Annual Conference on Retroviruses and Opportunistic Infections ateapharma.com ↗
today presented results from the Phase 1 study of AT-527 in healthy volunteers at the 28th Annual Conference on Retroviruses and Opportunistic Infections (CROI) in a Science Spotlight presentation. |
| 2021-02-08 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Announces Publication of Preclinical Data Highlighting Potent Activity of AT-527 Against SARS-CoV-2 ateapharma.com ↗
The results demonstrated in several in vitro assays that AT-527 has highly potent antiviral activity against several human coronaviruses, including SARS-CoV-2, the causative agent of COVID-19. |
| 2020-05-20 | Atea Pharmaceuticals, Inc. | Regulatory Atea Pharmaceuticals Announces IND Clearance of AT-527 for COVID-19 and $215 Million Financing ateapharma.com ↗ |
| 2018-11-09 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals to present positive clinical data with AT-527 for the treatment of chronic Hepatitis C in patients with cirrhosis at The Liver Meeting® 2018 ateapharma.com ↗
AT-527 shows profound and equivalent pan-genotypic antiviral activity in cirrhotic and non-cirrhotic (NC) hepatitis C virus (HCV) infected patients |
| 2018-04-12 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals reports positive proof of concept clinical data with AT-527 for the treatment of chronic Hepatitis C ateapharma.com ↗ |
All press releases naming this drug 56 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 29 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AT-527 | “Bemnifosbuvir (AT-527)” NCT05724693 ↗ |
| Known as | AT-527 is also know as R07496998 | “AT-527 is also know as R07496998” NCT05154123 ↗ |
| Known as | BEM | “A co-administered dose of Bemnifosbuvir (BEM)/Ruzasvir (RZR) as separate formulations and Biktarvy (BIK)” NCT06356194 ↗7“A Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR)” NCT06204679 ↗ “Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination” NCT06911320 ↗ “Drug: single dose Bemnifosbuvir (BEM)” NCT05724693 ↗ “Bemnifosbuvir (BEM; AT-527) Tablets” NCT05904470 ↗ “Bemnifosbuvir (BEM)” NCT05629962 ↗ “Bemnifosbuvir (BEM)” NCT05905484 ↗ “Bemnifosbuvir (BEM)” NCT05905497 ↗ |
| Known as | Bemnifosbuvir | “A Phase 1, Open-Label, Two-Part Study to Evaluate the Effect of a Single Oral Dose of Bemnifosbuvir/Ruzasvir Fixed Dose Combination on the Pharmacokinetics of Digoxin and...” NCT06921941 ↗12“A Phase 1, Open-Label Study to Evaluate the Potential Drug-Drug Interaction Between Bemnifosbuvir and Ruzasvir and Food-Drug Interaction in Healthy Adult Subjects” NCT05731843 ↗ |
| Known as | R07496998 | “Other Names: AT-527 is also known as R07496998” NCT04849299 ↗3“Other Names: AT-527 is also know as R07496998” NCT04865445 ↗ “AT-527 Formulation 1 (R07496998)” NCT04711187 ↗ “AT-527 (R07496998)” NCT05004415 ↗ |
| Action | Inhibit | “inhibitor of the hepatitis C virus (HCV) NS5B polymerase” PMID 31570394 ↗ Sep 2019 |
| Modality | Other / unclassified | “AT-527 is a novel modified guanosine nucleotide prodrug inhibitor” PMID 31570394 ↗ Sep 2019 |
| Route | Oral | “Ascending doses of AT-527 administered orally.” NCT03219957 ↗ |