Clinical Trials

Bemnifosbuvir hemisulfate has been evaluated across multiple clinical trials ranging from Phase 1 to Phase 3, sponsored by industry partners including Atea Pharmaceuticals Inc. and Hoffmann-La Roche. These studies assess the safety, antiviral activity, and pharmacokinetic profile of the compound in healthy subjects, individuals with renal or hepatic impairment, and patient cohorts with COVID-19, Long COVID, or chronic Hepatitis C virus infection. Trial recruitment statuses across these investigations vary, encompassing completed, actively recruiting, terminated, and withdrawn protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05618314 COMPLETED
Healthy Volunteer; Renal Impairment
Atea Pharmaceuticals, Inc.
 2022-10-17 PHASE1
NCT05724693 COMPLETED
Healthy Volunteer; Hepatic Impairment
Atea Pharmaceuticals, Inc.
 2023-01-30 PHASE1
NCT05618314 Recruiting
Healthy Volunteer|Renal Impairment
Atea Pharmaceuticals Inc.
 2022-10-17 Phase 1
NCT05256732 COMPLETED
Healthy Volunteer Study
Atea Pharmaceuticals, Inc.
 2022-02-22 PHASE1
NCT04309734 WITHDRAWN
Hepatitis C; Hepatitis C, Chronic; Chronic Hepatitis C; Hepatitis C Virus Infection; HCV Infection
Atea Pharmaceuticals, Inc.
 2021-10 PHASE1; PHASE2
NCT04396106 TERMINATED
COVID-19
Atea Pharmaceuticals, Inc.
 2020-05-26 PHASE2
NCT05154123 COMPLETED
Healthy Volunteer Study
Atea Pharmaceuticals, Inc.
 2021-11-16 PHASE1
NCT05137626 COMPLETED
Healthy Volunteers Study
Atea Pharmaceuticals, Inc.
 2021-11-03 PHASE1
NCT04889040 TERMINATED
COVID-19
Hoffmann-La Roche
 2021-04-28 PHASE3
NCT05137626 Completed
Healthy Volunteers Study
Atea Pharmaceuticals Inc.|Hoffmann-La Roche
 2021-11-03 Phase 1
NCT04309734 Withdrawn
Hepatitis C|Hepatitis C Chronic|Chronic Hepatitis C|Hepatitis C Virus Infection|HCV Infection
Atea Pharmaceuticals Inc.
 2021-10 Phase 1|Phase 2
NCT04709835 COMPLETED
COVID-19
Hoffmann-La Roche
 2021-02-03 PHASE2
NCT04711187 COMPLETED
Healthy Volunteer Study
Atea Pharmaceuticals, Inc.
 2020-11-02 PHASE1
NCT04877769 COMPLETED
Healthy Volunteer Study
Atea Pharmaceuticals, Inc.
 2021-04-25 PHASE1
NCT05004415 COMPLETED
Healthy Volunteer Study
Atea Pharmaceuticals, Inc.
 2021-07-28 PHASE1
NCT04865445 COMPLETED
Healthy Volunteer Study
Atea Pharmaceuticals, Inc.
 2021-04-22 PHASE1
NCT04849299 COMPLETED
Healthy Volunteer Study
Atea Pharmaceuticals, Inc.
 2021-04-18 PHASE1
NCT04784000 COMPLETED
Healthy Volunteer Study
Atea Pharmaceuticals, Inc.
 2021-03-01 PHASE1
NCT04877769 Completed
Healthy Volunteer Study
Atea Pharmaceuticals Inc.|Hoffmann-La Roche
 2021-04-25 Phase 1
NCT04019717 COMPLETED
Hepatitis C; Hepatitis C, Chronic; Chronic Hepatitis C; Hepatitis C Virus Infection; HCV Infection
Atea Pharmaceuticals, Inc.
 2019-06-20 PHASE2
NCT03219957 COMPLETED
Chronic Hepatitis C; Hepatitis C; Hepatitis C, Chronic
Atea Pharmaceuticals, Inc.
 2017-07-06 PHASE1

(data from https://clinicaltrials.gov, updated on 2024-07-31)

Check the Bemnifosbuvir Hemisulfate (AT-527) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bemnifosbuvir hemisulfate acts as a nucleotide prodrug that inhibits viral RNA-dependent RNA polymerase, leading to premature RNA chain termination and the suppression of intracellular viral replication. By blocking viral genomic synthesis, this targeted action prevents viral propagation, supporting its clinical investigation for viral infectious diseases such as COVID-19 and chronic Hepatitis C.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.