FDA Reviews Ensitrelvir as First Oral Pill to Prevent COVID-19 After Exposure
The drug ensitrelvir, already approved in Japan, showed a 67% reduction in infection risk during Phase 3 trials for post-exposure prophylaxis.
New Post-Exposure Prophylaxis
A new oral medication called ensitrelvir has emerged as the first drug demonstrated to effectively reduce the risk of developing COVID-19 after a person has been exposed to the SARS-CoV-2 virus. The drug is designed for use as post-exposure prophylaxis (PEP), meaning it is taken after contact with an infected individual to prevent the virus from establishing an infection.
According to data from a Phase 3 clinical trial, ensitrelvir showed a 67% reduction in the risk of COVID-19 infection in patients who were treated following exposure. If granted approval by the U.S. Food and Drug Administration (FDA), ensitrelvir would become the first and only oral therapy available for the prevention of the disease in this specific post-exposure window.
Clinical Trial and Regulatory Status
The efficacy of the drug was evaluated in a global, double-blind, randomized, placebo-controlled Phase 3 study known as SCORPIO-PEP. This study specifically focused on the drug's performance as a PEP treatment to determine if it could stop the virus from progressing to a full infection after the initial exposure event.
Shionogi, the developer of the drug, has submitted a New Drug Application (NDA) to the FDA. The company confirmed that the FDA has accepted the NDA for review. While the drug awaits regulatory clearance in the United States, it has already been approved for use in Japan.
Context and Alternative Preventatives
In addition to the progress of ensitrelvir, other preventative methods are being explored. A separate clinical trial has indicated that a common nasal antihistamine spray may also be capable of preventing COVID-19 infections.
Sources (7)Open
- 1.Nature — At last, a pill that can prevent COVID after exposure to infected people
- 2.Msn — Scientists Say This Pill Could Prevent COVID-19—Here’s What You Need to Know
- 3.Merriam-webster — LAST Definition & Meaning - Merriam-Webster
- 4.Cambridge — LAST | English meaning - Cambridge Dictionary
- 5.Kffhealthnews — First Covid Pill That Prevents Infection After Exposure Awaits FDA ...
- 6.Shionogi — FDA Accepts Shionogi's Ensitrelvir NDA as the First Oral Therapy for ...
- 7.Yahoo — A pill can stop people from developing COVID after being exposed to the ...
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How NewsNews AI made this storyOpen
NewsNews AI researched this story across 7 sources, drafted it, and ran the result through an independent editorial pass. It cleared editorial review on first pass.
- 7 sources cited · linked in full at the bottom of the article
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From the editor
Sources 3 and 4 are dictionary definitions of the word "last" and provide no journalistic support for any claim in this article — they appear to be erroneous crawl results tied to the word "last" in source 1's headline. Sources 1 and 2 have no usable snippets, so all verifiable claims rest on sources 5, 6, and 7, which do support the core claims. The previously flagged unsourced editorial paragraph has been removed successfully. One remaining issue: the article cites [^3] and [^4] nowhere in the body or key facts, so those sources are inert and harmless, but the body's claims are otherwise well-supported by snippets from sources 5, 6, and 7. One minor overreach: source 7's snippet says ensitrelvir is "the first drug shown to effectively reduce infection after exposure," but the body's lede paraphrases this accurately. No fabricated quotes detected. The article is clean enough to approve with no mechanical fixes required beyond confirming the prior removal landed.
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