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Lagevrio
Published
Product name
Lagevrio
Active ingredient
Molnupiravir
Submission type
New chemical entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Lagevrio (molnupiravir) was approved for the following therapeutic use:
Lagevrio (molnupiravir) has provisional approval for the treatment of adults with COVID 19 who do not require initiation of oxygen due to COVID-19 and who are at increased risk for hospitalisation or death (see section 5.1 Pharmacodynamic properties - Clinical trials).
The decision to approve this indication has been made on the basis of the analysis of efficacy and safety data from a Phase 3 trial. Continued approval of this indication depends on additional data.
How this medicine works
Lagevrio is a prodrug that is metabolized to the ribonucleoside analogue n-hydroxycytidine (NHC). NHC distributes into cells where it is phosphorylated to form the pharmacologically active ribonucleoside triphosphate (NHC‑TP). NHC‑TP incorporation into viral ribonucleic acid (RNA) by the viral RNA polymerase, results in an accumulation of errors in the viral genome leading to inhibition of replication. This mechanism of action is known as viral error catastrophe.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Lagevrio was considered favourable for the therapeutic use approved.