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Oral drug to prevent COVID-19 after exposure reaches US market

Oral drug to prevent COVID-19 after exposure reaches US market

New Capabilities

Shionogi's ensitrelvir (XOCOVA) is the first pill cleared in the US to cut infection risk in people exposed to the virus.

Yesterday: XOCOVA goes on sale in the US

Overview

For years, the only move after a close COVID-19 exposure was to wait and watch for symptoms. Now there is a pill for that.

Shionogi's ensitrelvir, sold as XOCOVA, is the first oral drug cleared in the US to prevent COVID-19 after contact with an infected person. In its main trial, a five-day course cut the chance of symptomatic illness by 67 percent. The list price is about $1,400, so insurance coverage may decide who actually gets it.

Why it matters

Anyone exposed to COVID-19 now has a pill that can lower the odds of getting sick, if they start it within three days.

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Key Indicators

67%
Drop in symptomatic COVID-19
Relative risk reduction versus placebo through day 10 in the SCORPIO-PEP trial.
76%
Reduction in high-risk group
Effect was larger in a prespecified subgroup of high-risk participants.
$1,400
List price per course
Price before insurance for the five-day, once-daily regimen.
2,387
Trial participants
Household contacts aged 12 and up enrolled in the global Phase 3 study.

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People Involved

Organizations Involved

Timeline

April 2022 July 2026

9 events Latest: Yesterday
Tap a bar to jump to that date
  1. XOCOVA goes on sale in the US

    Latest Launch

    Shionogi announced US availability of the five-day pill regimen, priced at about $1,400 before insurance.

  2. FDA approves ensitrelvir for prevention

    Regulatory

    The FDA cleared XOCOVA to prevent COVID-19 in people 12 and older after exposure. It is the first oral drug with that use.

  3. New England Journal of Medicine publishes the data

    Publication

    The journal published SCORPIO-PEP results: symptomatic COVID-19 hit 2.9 percent on ensitrelvir versus 9.0 percent on placebo, a 67 percent reduction.

  4. Japan approves the prevention use

    Regulatory

    Japan added post-exposure prevention as an approved use for ensitrelvir, ahead of the US decision.

  5. Prevention results shown at CROI

    Trial Result

    Shionogi presented SCORPIO-PEP data at a scientific conference, the first oral antiviral to prevent COVID-19 after exposure in a Phase 3 study.

  6. Japan upgrades to standard approval

    Regulatory

    Japan converted the emergency clearance into full standard approval for treating SARS-CoV-2 infection.

  7. SCORPIO-PEP prevention trial begins

    Trial

    Shionogi launched a global Phase 3 study testing ensitrelvir in household contacts of infected people. Enrollment ran through September 2024.

  8. Japan grants emergency approval for treatment

    Regulatory

    Japan's health ministry cleared ensitrelvir (Xocova) to treat SARS-CoV-2 infection under its emergency approval system.

  9. Paxlovid falls short as a prevention drug

    Trial Result

    Pfizer's EPIC-PEP trial failed to show a statistically significant benefit for Paxlovid as post-exposure prevention. The result left a gap in the market.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

April 2022

Paxlovid EPIC-PEP trial (2022)

Pfizer tested its oral antiviral Paxlovid as a way to prevent COVID-19 in people exposed by a household member. The pill cut symptomatic infection by 32 to 37 percent, but the results were not statistically significant.

Then

Pfizer dropped the prevention use and kept Paxlovid as a treatment.

Now

The failure left no oral option for people who wanted protection right after an exposure.

Why this matters now

Ensitrelvir succeeded where Paxlovid did not, which is why it can claim a first.

November 2000

Tamiflu approved for flu prevention (2000)

The FDA cleared oseltamivir (Tamiflu) to prevent influenza in people exposed to a sick household member, not just to treat those already ill. A short course taken after contact lowered the chance of coming down with flu.

Then

Doctors began prescribing Tamiflu to families and nursing homes during outbreaks.

Now

Post-exposure antiviral use became a standard tool in managing seasonal flu clusters.

Why this matters now

It shows the same treat-and-prevent playbook that ensitrelvir now brings to COVID-19.

January 2023

Evusheld loses its authorization (2023)

Evusheld, an antibody shot from AstraZeneca, was authorized to prevent COVID-19 in people with weak immune systems. New Omicron subvariants slipped past the antibodies, and the FDA pulled its authorization.

Then

Immunocompromised patients lost their main preventive option overnight.

Now

It exposed how fast the evolving virus can defeat prevention tools tied to specific variants.

Why this matters now

Ensitrelvir targets a viral protein that mutates less than the spike antibodies aim at, a point Shionogi stresses for durability.

Sources

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