Clinical Trials

Molnupiravir (EIDD-2801) has been evaluated across numerous Phase I, Phase II, and Phase III clinical trials investigating viral infections including COVID-19, SARS-CoV-2, pneumonia, human influenza, and dengue. Sponsored by pharmaceutical organizations and academic institutions such as Merck Sharp & Dohme, Ridgeback Biotherapeutics, and the University of Oxford, these recruiting, terminated, and completed studies evaluate key endpoints such as viral shedding and disease prevention.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06667700 RECRUITING
Coronavirus Disease (COVID-19)
Merck Sharp & Dohme LLC
 2024-12-02 PHASE3
NCT06551844 RECRUITING
Dengue; Antiviral Drugs
Oxford University Clinical Research Unit, Vietnam
 2026-04-20 PHASE2
NCT04381936 RECRUITING
Pneumonia
University of Oxford
 2020-03-19 PHASE3
NCT04746183 RECRUITING
Covid19
University of Liverpool
 2020-07-03 PHASE1; PHASE2
NCT05648448 RECRUITING
Influenza; Influenza, Human
University of Oxford
 2023-02-22 PHASE2
NCT06488300 RECRUITING
Respiratory Syncytial Virus; Respiratory Syncytial Virus, Human
University of Oxford
 2024-07-25 PHASE2
NCT05041907 RECRUITING
COVID-19
University of Oxford
 2021-09-30 PHASE2
NCT05818124 COMPLETED
Influenza Infection
Merck Sharp & Dohme LLC
 2023-08-21 PHASE1
NCT05459532 COMPLETED
COVID-19
University of Witwatersrand, South Africa
 2022-08-12 PHASE2; PHASE3
NCT05559905 COMPLETED
Respiratory Syncytial Virus
Merck Sharp & Dohme LLC
 2022-11-02 PHASE2
NCT06615869 COMPLETED
Healthy
Merck Sharp & Dohme LLC
 2023-01-20 PHASE1
NCT05386758 COMPLETED
Renal Impairment
Merck Sharp & Dohme LLC
 2022-06-29 PHASE1
NCT05386589 COMPLETED
Hepatic Impairment
Merck Sharp & Dohme LLC
 2022-06-14 PHASE1
NCT04939428 COMPLETED
Coronavirus Disease (COVID-19)
Merck Sharp & Dohme LLC
 2021-08-11 PHASE3
NCT04730206 TERMINATED
Covid19; SARS-CoV Infection
KU Leuven
 2021-06-15 PHASE3
NCT05412173 COMPLETED
Viral Infection; COVID-19
Valenta Pharm JSC
 2022-04-22
NCT04575597 COMPLETED
Coronavirus Disease (COVID-19)
Merck Sharp & Dohme LLC
 2020-10-19 PHASE2; PHASE3
NCT05595824 COMPLETED
COVID-19
Promomed, LLC
 2021-12-01 PHASE3
NCT04405739 COMPLETED
SARS-CoV 2
Ridgeback Biotherapeutics, LP
 2020-06-16 PHASE2
NCT04575584 TERMINATED
Coronavirus Disease (COVID-19)
Merck Sharp & Dohme LLC
 2020-10-19 PHASE2; PHASE3
NCT04405570 COMPLETED
SARS-CoV-2 Infection, COVID-19
Ridgeback Biotherapeutics, LP
 2020-06-19 PHASE2
NCT04392219 COMPLETED
Coronavirus
Ridgeback Biotherapeutics, LP
 2020-04-10 PHASE1
NCT04405739 Completed
SARS-CoV 2
Ridgeback Biotherapeutics LP|Merck Sharp & Dohme LLC
 2020-06-16 Phase 2

(data from https://clinicaltrials.gov, updated on 2026-08-28)

Check the Molnupiravir (EIDD-2801) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Molnupiravir (EIDD-2801) is an oral prodrug metabolized into the active ribonucleoside analog β-D-N4-hydroxycytidine, which is incorporated by viral RNA-dependent RNA polymerase to induce widespread mutagenesis during viral genome synthesis. This accumulation of lethal errors throughout the viral genome impairs viral replication and reduces viral load, mediating its clinical application in treating viral respiratory infections such as COVID-19 and influenza.

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.