--- title: When Will New COVID-19 Antivirals Be Approved in the U.S.? description: COVID-19 antivirals like simnotrelvir and ensitrelvir seem to work for more people than Paxlovid. But they're not approved in the U.S. canonical: https://time.com/6588624/covid-19-antiviral-treatments-us/ author: Jamie Ducharme article:opinion: false article:content_tier: free article:published_time: 2024-01-25T20:05:44.000Z article:modified_time: 2026-02-24T17:01:09.617Z article:section: Health og:title: When Will We Get New COVID-19 Drugs? og:description: Effective antivirals are available overseas—but not in the U.S. og:url: https://time.com/6588624/covid-19-antiviral-treatments-us/ og:site_name: TIME og:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt5f8a5c833afb820b/698a4431096a94b64a6ae89d/IMG_0080.jpg?branch=production&width=3840&quality=75&auto=webp&crop=16:9 og:image:width: 1200 og:image:height: 675 og:image:alt: Ensitrelvir og:type: article twitter:card: summary_large_image twitter:title: When Will We Get New COVID-19 Drugs? twitter:description: Effective antivirals are available overseas—but not in the U.S. twitter:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt5f8a5c833afb820b/698a4431096a94b64a6ae89d/IMG_0080.jpg?branch=production&width=3840&quality=75&auto=webp&crop=16:9 ---  # COVID-19 Antiviral Drugs Promise Speedier Recoveries. But They're Not Available in the U.S. ## Video: Former U.K. Prime Minister Boris Johnson Apologizes In Front of COVID-19 Inquiry Panel [Watch (HLS stream): Former U.K. Prime Minister Boris Johnson Apologizes In Front of COVID-19 Inquiry Panel](https://cdn.jwplayer.com/manifests/TWdGwYtD.m3u8) (4:43)  _Published 2023-12-06. The U.K’s COVID-19 Inquiry into the government’s response to the pandemic picked up again on Wednesday morning. The hearings for the initial stage of the investigation were heard in London in June. Today, former U.K. Prime Minister Boris Johnson, who served as the nation’s leader from 2019 to 2022, was sworn in to give evidence in front of the panel. Shortly into his opening statement, he said that he was sorry for the suffering experienced by COVID victims and their families._  by [Jamie Ducharme](https://time.com/author/jamie-ducharme/)  ## Jamie Ducharme Ducharme is a contributor to TIME. Jan 25, 2024 8:05 PM UTC  Ensitrelvir, the COVID-19 antiviral made by the pharmaceutical company Shionogi. Ensitrelvir, the COVID-19 antiviral made by the pharmaceutical company Shionogi.Courtesy Shionogi  by [Jamie Ducharme](https://time.com/author/jamie-ducharme/)  ## Jamie Ducharme Ducharme is a contributor to TIME. Jan 25, 2024 8:05 PM UTC When a young, healthy person in the U.S. catches COVID-19, there’s not much they can do except [stay home and rest](https://time.com/6215346/covid-19-rest-helps/). The antiviral drug Paxlovid is widely available, but it’s [only approved for people at high risk of severe disease](https://time.com/6553027/paxlovid-for-young-healthy-adults/), such as older adults and people with underlying conditions. The U.S. Food and Drug Administration (FDA) hasn’t approved any drugs that can treat COVID-19 among people who are unlikely to get very sick or die, but nonetheless would like some relief from their symptoms. These drugs do exist, though. Antivirals currently available overseas seem to be effective at shortening the length and treating the symptoms of mild-to-moderate cases of COVID-19—but it’s anyone’s guess if and when they’ll make the jump to the U.S. market. [A study](https://www.nejm.org/doi/10.1056/NEJMoa2301425) published in the _New England Journal of Medicine_ in January showed promising results associated with the drug simnotrelvir, which is made by Simcere Pharmaceutical and is currently available in China under the brand name Xiannuoxin. People who took simnotrelvir within three days of developing COVID-19 recovered faster than people who took a placebo, the researchers found. Most of the roughly 1,100 people in the study were young and fully vaccinated and half did not have any specific risk factors for serious disease, which suggests simnotrelvir could work well across much of the general population. It’s unclear whether Simcere is seeking FDA approval; representatives from the company did not respond to TIME’s requests for comment about if and when it may apply. At the moment, the drug with perhaps the best shot at cracking the U.S. market seems to be the antiviral ensitrelvir, which is made by the pharmaceutical company Shionogi & Co., Ltd., and has been approved in Japan under the brand name Xocova since 2022\. In April 2023, the drug [received “Fast Track” designation](https://www.shionogi.com/global/en/news/2023/04/20230404.html) from the FDA, a status meant to expedite the agency’s review process. ### More From TIME When taken shortly after getting sick, ensitrelvir shortens the length of time it takes for people with mild-to-moderate COVID-19 to [test negative](https://academic.oup.com/cid/article/76/8/1403/6881001#402743420) and [recover](https://www.medrxiv.org/content/10.1101/2023.07.11.23292264v1.full) from [certain symptoms](https://www.nature.com/articles/d41586-023-03244-7), research shows. Some [preliminary data](https://www.shionogi.com/us/en/news/2023/10/shionogi-presents-new-ensitrelvir-covid-19-data-supporting-effectiveness-in-real-world-and-clinical-settings-at-idweek-2023.html) also suggest people who take ensitrelvir may be less likely to have Long COVID symptoms later on. **Read More**: [_How COVID-19 Vaccines and Infections Are Tweaking Our Immunity_](https://time.com/6564464/covid-19-changing-immune-system/) The drug could be a big deal both for patients and public health, says Simon Portsmouth, head of clinical development at Shionogi Inc., Shionogi's U.S. subsidiary. The company’s research shows that people who take ensitrelvir stop shedding infectious virus sooner than people who don’t, which means “the potential for reducing infectiousness and onward transmission in the community is another benefit,” Portsmouth says. Dr. Eric Topol, director of the Scripps Research Translational Institute, says having multiple antivirals to choose from in the U.S. would also be a good insurance policy, since it’s feasible that the virus could someday [mutate to become resistant to Paxlovid](https://time.com/6265507/long-covid-antivirals-paxlovid-metformin/). Ensitrelvir also seems to have fewer side effects than Paxlovid, which is known for its bad aftertaste and long list of drug interactions, says Stefan Sarafianos, a professor at Emory University who researches antivirals. It may also come with lower chances of [“rebound” positive tests](https://time.com/6334739/paxlovid-rebound-infections/), he adds. Solving some of those problems would be an upgrade for U.S. public health, Sarafianos says, since they partially explain why Paxlovid is [underused even among people at high risk of severe disease](https://www.cdc.gov/mmwr/volumes/73/wr/mm7303a2.htm?s%5Fcid=mm7303a2%5Fw). Portsmouth declined to comment on ensitrelvir’s regulatory timeline, saying only that Shionogi needs to complete additional clinical trials before anything else can happen. (Last year, the CEO of Shiongi & Co., Ltd., [estimated the drug could be approved](https://www.reuters.com/business/healthcare-pharmaceuticals/shionogi-sees-covid-pill-reaping-2-billion-annual-sales-upon-us-approval-2023-02-27/) in the U.S. at some point in 2024.) The company has also [signed a licensing agreement](https://www.shionogi.com/us/en/news/2022/10/shionogi-and-the-medicines-patent-pool-mpp-sign-licence-agreement-for-covid-19-oral-antiviral-treatment-candidate-to-increase-access-in-low-and-middle-income-countries.html) that will allow ensitrelvir to be manufactured and distributed in 117 countries, pending appropriate regulatory approvals, to boost access in low- and middle-income nations. In a statement provided to TIME, an FDA spokesperson said the agency “remains committed to providing product-specific advice to drug developers to facilitate the development of new drug products to treat or prevent COVID-19.” But it did not comment on the likelihood or timing of simnotrelvir, ensitrelvir, or other COVID-19 antivirals receiving approval. It would be good for Americans to have antiviral choices, Topol says, but the regulatory process for new drugs can be long and winding. “If \[other antivirals\] do come here,” he says, “it’s probably not going to be imminent.” ```json [{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://time.com/6588624/covid-19-antiviral-treatments-us/","mainEntityOfPage":{"@type":"WebPage","@id":"https://time.com/6588624/covid-19-antiviral-treatments-us/"},"headline":"COVID-19 Antiviral Drugs Promise Speedier Recoveries. But They're Not Available in the U.S.","datePublished":"2024-01-25T20:05:44.000Z","dateModified":"2026-02-24T17:01:09.617Z","description":"Effective antivirals are available overseas—but not in the U.S.","url":"https://time.com/6588624/covid-19-antiviral-treatments-us/","keywords":["COVID-19","healthscienceclimate"],"thumbnailUrl":"https://static.time.com/v3/assets/bltea6093859af6183b/blt5f8a5c833afb820b/698a4431096a94b64a6ae89d/IMG_0080.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","author":[{"@type":"Person","name":"Jamie Ducharme","jobTitle":"Ducharme is a contributor to TIME.","url":"https://time.com/author/jamie-ducharme/"}],"articleSection":"Health","image":[{"@type":"ImageObject","url":"https://static.time.com/v3/assets/bltea6093859af6183b/blt5f8a5c833afb820b/698a4431096a94b64a6ae89d/IMG_0080.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","width":1200,"height":675,"headline":"Ensitrelvir","caption":"Ensitrelvir, a COVID-19 antiviral made by the pharmaceutical company Shionogi.","creditText":"Courtesy Shionogi","representativeOfPage":true}],"publisher":{"@type":"Organization","name":"Time","url":"https://time.com/","logo":{"@type":"ImageObject","url":"https://time.com/images/logo.png","width":528,"height":156},"foundingDate":"March 3, 1923","sameAs":["https://www.facebook.com/time","https://www.instagram.com/time/?hl=en","https://twitter.com/time","https://www.pinterest.com/timemagazine"]}},{"@context":"https://schema.org","@type":"BreadcrumbList","itemListElement":[{"@type":"ListItem","position":1,"item":{"@id":"/section/health/","name":"Health"}},{"@type":"ListItem","position":2,"item":{"@id":"/tag/covid-19/","name":"COVID-19"}},{"@type":"ListItem","position":3,"item":{"@id":"https://time.com/6588624/covid-19-antiviral-treatments-us/","name":"COVID-19 Antiviral Drugs Promise Speedier Recoveries. But They're Not Available in the U.S."}}]},{"@context":"https://schema.org","@type":"VideoObject","name":"Former U.K. Prime Minister Boris Johnson Apologizes In Front of COVID-19 Inquiry Panel","description":"The U.K’s COVID-19 Inquiry into the government’s response to the pandemic picked up again on Wednesday morning. The hearings for the initial stage of the investigation were heard in London in June. Today, former U.K. Prime Minister Boris Johnson, who served as the nation’s leader from 2019 to 2022, was sworn in to give evidence in front of the panel. Shortly into his opening statement, he said that he was sorry for the suffering experienced by COVID victims and their families.","thumbnailUrl":"https://cdn.jwplayer.com/v2/media/TWdGwYtD/poster.jpg?width=720","uploadDate":"2023-12-06T15:17:39.000Z","contentUrl":"https://cdn.jwplayer.com/manifests/TWdGwYtD.m3u8","embedUrl":"https://time.com/6588624/covid-19-antiviral-treatments-us/","duration":"PT4M43S","potentialAction":{"@type":"SeekToAction","target":"https://time.com/6588624/covid-19-antiviral-treatments-us/?jw_start={seek_to_second_number}","startOffset-input":"required name=seek_to_second_number"}}] ```