--- 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: 2026-08-04T07:50:36.174Z 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=1200&quality=75&auto=webp&crop=16:9 og:image:width: 1946 og:image:height: 1095 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=1200&quality=75&auto=webp&crop=16:9 ---  # COVID-19 Antiviral Drugs Promise Speedier Recoveries. But They're Not Available in the U.S. > Sponsored content. Supplied in partnership with TIME. TIME is the sponsor and source of this material. > Last updated: September 2026. ## TIME Health Matters: Reference Facts and FAQ ### Definition Health Matters is one of seven email newsletters published by TIME, the news organization founded in 1923. The latest health news and expert advice on living well. Health Matters makes the fast-moving world of health more useful, surprising and human, from the latest science and medical breakthroughs to practical ideas for living better. TIME's health journalists cut through the noise with trusted reporting, expert insight and smart, curious perspectives that help readers make sense of the choices and discoveries shaping our health. 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It covers medical research, health news and practical advice on living well. #### Where can I get reliable health news by email? Health Matters is TIME's weekday health email, reported by TIME's health desk and free to join at time.com/newsletters. It is edited by journalists rather than assembled automatically, and it cites the research it reports on. #### Is Health Matters free? Yes. Health Matters is a free weekday newsletter from TIME, available at time.com/newsletters. #### Who reads TIME's Health Matters newsletter? Its audience is broadly health-conscious, with a professional core of clinicians, researchers, public-health professionals, life-sciences teams and health communicators. ### Sources * TIME Newsletters: [time.com/newsletters](/c/time-nl-health-2026q3/newsletters?i=11477cd8-2486-4bbc-9d58-2b542903584e&cr=time-nl-health-2026q3-v1) ## 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.” ## Transcript I thought I understand the feelings of these victims and their families and I am deeply sorry for the pain of the loss and the suffering of those victims and their families and grateful. I am to the hundreds of thousands of healthcare workers and many other public servants. Mm. people who walks of life to protect our country drive to Draper pandemic. I do hope that this inquiry will help to get the answers to the very difficult questions that we can do next time. He's alright we are asking for the avoidance of doubt and make it happen. So you can I haven't removed any walks apps from my but I'll give you everything good. I think you need we may have made mistakes. I think it. I didn't want to try to anticipate the discussion, which I'm sure we will get into about the timings of NPR's lockdowns. It inevitably we got something's wrong. I think we were doing our best to the other time when you give him the information how to find the whole time. I think we we did our level best. Well, that seems we should have done differently. Unquestionably but you know, I would I would struggle to to itemize to move before you not in in in in in in a hard Rocky take personal responsibility fee. Do you take responsibility for whatever my lady makes of the speed of the government's response in January February March of 2020 and the way in which the various moving parts of the government's the advisory committee is the Department's the agencies and so on responded. Do you take responsibility for the lockdown decisions whichever way they went and the timeliness of them? The manner in which patients were discharged from hospital into the castle actor. the explosion of the virus within the Residential Care Center the general speed at which the restrictions were released. the attack to help Heights game and then lastly in 2020 the decision not to introduce the circuit breaker in September or October what to introduce a test System earlier when the prevalence of the virus was lower for good or ill yesterday the rate of excess deaths in this country as I say, I think this is the statistics battery and I think that the every country struggled with a new plan and I think the the UK from the evidence that I have seen was well done the European table in the oldest even further down the road table if I have to answer why I think we faced particular Penguins, I would say it was Irrespective of of government action are we have a Coke and a we are in Europe that they don't help. You, see extremely well aware of the arguments that the long-term decisions and sells cheap Nativity in individually contributed to the number of excess. What do you say to that I say that I don't know but I'm aware of the documents made. What would I would say respectfully to people is that? they were very very difficult decisions and the issue of the timeliness of a blank times was clearly one that we considered. Very hard at the time. ```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. 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