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EV25 is an investigational chemical substance developed by Eradivir, Inc. It is currently being studied as a nasal spray for the treatment of influenza virus infections.[1] The substance has no marketing authorisation in the product records, meaning it is not yet approved as a medicine.[1] EV25 belongs to the therapeutic area of virus diseases, specifically influenza virus infections.[1] A larger Phase 2b trial is being planned in both the United States and Europe in conjunction with the 2026-2027 influenza season.[2]
The registered clinical data do not describe the exact mechanism of action of EV25. The completed Phase 1/2 trial measured the effect of single doses of EV25 on viral area under the curve (AUC), which is a measure of how much virus is present in the body over time, compared to placebo in participants exposed to influenza H3N2.[1] This suggests that EV25 is intended to reduce the amount of influenza virus in the body, but the precise way it does so has not been disclosed in the available registry records.
EV25 is given intranasally, meaning it is administered through the nose. The pharmaceutical form used in the clinical trial is a nasal spray solution in a single-dose container.[1] The trial tested single doses of EV25 given via the nose.[1]
One clinical trial with EV25 is registered in the EU Clinical Trials Information System. It is a Phase 1/2 interventional study that enrolled 122 healthy adult participants and has been completed.[1] The trial was divided into two parts. Part I assessed the safety and tolerability of a single dose of EV25 intranasal administration in healthy participants and determined the single-dose pharmacokinetic (PK) profile, which describes how the drug is absorbed, distributed, and eliminated by the body over time.[1] Part II assessed the safety and tolerability of a single dose of EV25 in healthy participants exposed to influenza H3N2 and evaluated the effect of single doses of EV25 on viral AUC compared to placebo in participants with positive predose values.[1] The primary outcomes measured included adverse events, laboratory safety assessments, 12-lead ECG findings, vital signs, physical examination findings, and intranasal administration site examination findings.[1] The trial also included a placebo arm in which participants received a placebo nasal spray, and a group exposed to wild-type influenza A virus A/Belgium/4217/2015 (H3N2) given intranasally.[1] A larger Phase 2b trial is currently in planning, with the company announcing that it will be conducted in the United States and Europe during the 2026-2027 influenza season.[2]
The available sources do not report specific side effects of EV25. The completed Phase 1/2 trial measured adverse events as a primary outcome, but the results of that measurement have not been published in the registry record.[1] No side effect information is available from the supplementary source.[2]
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