Drugs / Baloxavir Marboxil
Baloxavir Marboxil
Regulatory milestones approvals, filings & regulatory actions · 14 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed influenza 6 milestones | |||||
| Filed | Other | Xofluza | influenza | 2023-07-04 | “has filed for a supplemental new drug application (sNDA) of Xofluza® (baloxavir marboxil) in Taiwan for treatment and post-exposure prophylaxis for influenza virus infection” shionogi.com ↗ |
| Filed | Other | Xofluza | influenza | 2020-03-31 | “Shionogi filed sNDA for Xofluza® in Taiwan for the post-exposure prophylaxis of influenza virus infection in adults and children 12 years of age and older on March 31, 2020” shionogi.com ↗ “also filed sNDA for Xofluza® in Taiwan for the post-exposure prophylaxis of influenza virus infection in adults and children 12 years of age and older on March 31, 2020” shionogi.com ↗ “filed sNDA for Xofluza® in Taiwan for the post-exposure prophylaxis of influenza virus infection” shionogi.com ↗ |
| Filed | US (FDA) | Xofluza | influenza | 2020-03-26 | “FDA has accepted a New Drug Application (NDA) as well as two supplemental New Drug Applications (sNDA) for Xofluza®” gene.com ↗ “The FDA also accepted an sNDA for post-exposure prophylaxis of influenza in people one year of age and older” gene.com ↗ |
| Filed | Japan (PMDA) | Xofluza | influenza | 2019-10-16 | “Shionogi submitted a sNDA for the post-exposure prophylaxis on October 16, 2019 in Japan” shionogi.com ↗ “submitted a sNDA on October 16, 2019 in Japan” shionogi.com ↗ |
| Filed | US (FDA) | XOFLUZA | influenza | 2019-03-05 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for XOFLUZA™ (baloxavir marboxil)” gene.com ↗ |
| Filed | US (FDA) | — | influenza | 2018-06-25 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for baloxavir marboxil” gene.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (6) | US (FDA) | XOFLUZA | — | 2019-10-16 – 2025-05-30 | fda.gov ↗ |
| Approved | EU (EMA) | Xofluza | — | 2021-01-07 | europa.eu ↗ |
| Approved | US (FDA) | XOFLUZA | — | 2018-10-24 | fda.gov ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT04712539 | Oct 2021 → Feb 2028 expected | hematopoietic and lymphoid cell neoplasm, influenza | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 311 trials · 3 met primary · 1 missed | ||||||
| Phase 3 | NCT07827599 | Sep 2026 → Apr 2027 expected | influenza | Hoffmann-La Roche | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06653569 | Dec 2024 → Apr 2027 expected | influenza | Dre Pauline Vetter | Recruiting | No outcome recorded |
| Phase 3 | NCT06774859 | Oct 2024 → May 2025 | influenza | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT06094010 | Nov 2023 → May 2027 expected | influenza | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 3 | NCT03969212 | Oct 2019 → May 2024 | influenza | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT03653364 | Jan 2019 → Apr 2023 | influenza | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT03684044 | Jan 2019 → Mar 2020 | influenza | Hoffmann-La Roche | Completed | Missed primary |
| Phase 3 | NCT03629184 | Nov 2018 → Apr 2019 | influenza | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT02949011 | Jan 2017 → Apr 2018 | influenza | Shionogi | Completed | Met primary |
| Phase 3 | NCT02954354 | Dec 2016 → Apr 2017 | influenza | Shionogi | Completed | Mixed |
| Phase 3 | NCT02735707 | Apr 2016 → Feb 2026 overdue | pneumonia | UMC Utrecht | Recruiting | Mixed |
| Phase 42 trials | ||||||
| Phase 4 | NCT06161454 | Dec 2023 → Apr 2025 | Coronaviridae infectious disease, disease related to transplantation, influenza | Children's Hospital of Philadelphia | Completed | No outcome recorded |
| Phase 4 | NCT04141930 | Nov 2019 → Apr 2020 | influenza | University of Washington | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT06762587 | Jan → Apr 2025 overdue | influenza, nosocomial infection | Capital Medical University | Not yet recruiting | No outcome recorded |
| — | NCT03959332 | Jun → Jul 2019 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2/3 | NCT05170009 Comparator | Apr 2022 → Jan 2024 | influenza | Weill Medical College of Cornell University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04381936 Comparator | Mar 2020 → Sep 2028 expected | pneumonia | University of Oxford | Recruiting | No outcome recorded |
| — | NCT06205641 Comparator | Jan → Jun 2024 | influenza | Capital Medical University | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 37
| Date | Issuer | Release |
|---|---|---|
| 2026-06-29 | Lotus Pharmaceutical | Regulatory Lotus Pharmaceutical Announces U.S. FDA Approval for First Generic Baloxavir Marboxil Tablets, a Generic Version of Xofluza® lotuspharm.com ↗
Lotus Pharmaceutical Co., Ltd. (TWSE: 1795, “Lotus” or the “Company”) today announced that Norwich Pharmaceuticals, Inc. (“Norwich”), a wholly owned subsidiary of Alvogen Pharma US Inc. and part of the Lotus group, has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Baloxavir Marboxil Tablets. |
| 2025-04-25 | Hoffmann-La Roche | Results New England Journal of Medicine publishes phase III data showing single-dose Xofluza significantly reduces influenza virus transmission roche.com ↗
The trial met its primary endpoint, showing a single, oral dose of Xofluza taken by people infected with influenza reduced the odds of untreated household members contracting the virus by 32%. |
| 2025-04-24 | Genentech, Inc. | Results New England Journal of Medicine Publishes Phase III Data Showing Single-Dose Xofluza Significantly Reduces Influenza Virus Transmission gene.com ↗
The trial met its primary endpoint, showing a single, oral dose of Xofluza taken by people infected with influenza reduced the odds of untreated household members contracting the virus by 32%. |
| 2024-09-19 | Hoffmann-La Roche | Results Positive phase III results show Xofluza significantly reduces the transmission of influenza viruses roche.com ↗
The study met its primary endpoint, demonstrating that a single, oral dose of Xofluza taken by people infected with influenza significantly reduced the likelihood of others in their household contracting the virus. |
| 2024-09-18 | Genentech, Inc. | Results Positive Phase III Results Show Xofluza Significantly Reduces the Transmission of Influenza Viruses gene.com ↗
The study met its primary endpoint, demonstrating that a single, oral dose of Xofluza taken by people infected with influenza significantly reduced the likelihood of others in their household contracting the virus. |
| 2024-04-15 | Shionogi | Regulatory Shionogi Announces Approval of XOFLUZA® (Baloxavir Marboxil) in Taiwan for Pediatrics Aged 5 to <12 years for Treating and Preventing Influenza shionogi.com ↗
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced that its group company—Taiwan Shionogi & Co., Ltd. (Taiwan Shionogi)—has received approval of a supplemental New Drug Application (sNDA) for Xofluza® (baloxavir marboxil) for the treatment and postexposure prophylaxis for influenza virus infection for pediatrics aged 5 to <12 years. |
| 2023-07-04 | Shionogi | Regulatory Shionogi Filed for a Supplemental New Drug Application of XOFLUZA® (Baloxavir Marboxil) in Taiwan for Pediatrics Aged 5 to Under 12 for the Treatment and Prevention of Influenza Infection shionogi.com ↗ |
| 2023-01-12 | Hoffmann-La Roche | Regulatory Roche announces the European Commission approval of Xofluza for the treatment and prevention of influenza in children aged one year and above roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has approved Xofluza® (baloxavir marboxil) in children aged one year and above for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza. |
| 2022-08-12 | Hoffmann-La Roche | Regulatory Roche announces U.S. FDA approval of Xofluza to treat influenza in children aged five years and older roche.com ↗ |
| 2022-08-11 | Genentech, Inc. | Regulatory Genentech Announces FDA Approval of Xofluza to Treat Influenza in Children Aged Five and Older gene.com ↗ |
| 2021-01-15 | Shionogi | Regulatory Shionogi Announces European Commission Approval of XOFLUZA® (Baloxavir Marboxil) for the Treatment and Post-Exposure Prophylaxis of Influenza Virus Infection shionogi.com ↗
In addition, the EC has approved Xofluza for post-exposure prophylaxis of influenza in individuals aged 12 years and above. |
| 2021-01-15 | Shionogi | Regulatory Shionogi Announces Approval of XOFLUZA® (Baloxavir Marboxil) in Taiwan for the Post-Exposure Prophylaxis of Influenza Virus Infection shionogi.com ↗ |
| 2021-01-11 | Hoffmann-La Roche | Regulatory Roche’s Xofluza approved by the European Commission for the treatment of influenza, the first new influenza antiviral for patients in almost 20 years roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has approved Xofluza® (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged 12 years and above. |
| 2020-11-27 | Shionogi | Regulatory Shionogi Announces Supplemental New Drug Application for XOFLUZA® in Japan for the Post-Exposure Prophylaxis of Influenza Virus Infection was Approved. shionogi.com ↗
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced that Shionogi received approval for the supplemental New Drug Application (sNDA) for XOFLUZA® for the post-exposure prophylaxis of influenza virus infection. |
| 2020-11-24 | Shionogi | Regulatory Shionogi Announces FDA Approval of XOFLUZA® (Baloxavir Marboxil) for the prevention of Influenza following contact with an infected person shionogi.com ↗
Xofluza® is the first single-dose influenza medicine approved for post-exposure prophylaxis. |
| 2020-11-24 | Hoffmann-La Roche | Regulatory Roche announces FDA approval of Xofluza for the prevention of influenza following contact with an infected person roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza® (baloxavir marboxil) as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis). |
| 2020-11-23 | Genentech, Inc. | Regulatory Genentech Announces FDA Approval of Xofluza for the Prevention of Influenza Following Contact With an Infected Person gene.com ↗ |
| 2020-11-13 | Hoffmann-La Roche | Regulatory CHMP recommends EU approval of Roche’s Xofluza® (baloxavir marboxil) for the treatment of influenza roche.com ↗
Basel, 13 November 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Xofluza® (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged 12 years and above. |
| 2020-07-09 | Shionogi | Results BLOCKSTONE Study of Xofluza® (Baloxavir Marboxil) for the Prevention of Influenza in Household Contacts Published in The New England Journal of Medicine shionogi.com ↗
In the BLOCKSTONE1 study, following exposure to a person with confirmed influenza, preventive treatment with Xofluza® significantly reduced the proportion of household contacts who developed clinical influenza, compared with placebo. |
| 2020-06-09 | Shionogi | Results CAPSTONE-2 study of Xofluza® (Baloxavir Marboxil) for the Treatment of Influenza Published in The Lancet Infectious Diseases shionogi.com ↗
In all patients in the study (those infected with influenza types A and B), the TTIIS in patients treated with Xofluza was similar to oseltamivir, but was significantly shorter versus oseltamivir in patients infected with influenza type B. |
| 2020-03-26 | Genentech, Inc. | Regulatory FDA Accepts Genentech’s New Drug Application for Xofluza for the Treatment of Influenza In Children gene.com ↗
The FDA accepted a NDA for a new formulation of Xofluza as one-dose granules for oral suspension (2 mg/mL), potentially offering a more convenient option for children and those who have difficulty swallowing. |
| 2019-10-18 | Hoffmann-La Roche | Regulatory Roche announces FDA approval of Xofluza (baloxavir marboxil) for people at high risk of developing influenza-related complications roche.com ↗
Basel, 18 October 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza™ (baloxavir marboxil) for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications. |
| 2019-10-17 | Genentech, Inc. | Regulatory Genentech Announces FDA Approval of Xofluza (Baloxavir Marboxil) for People at High Risk of Developing Influenza-Related Complications gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza™ (baloxavir marboxil) for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications. |
| 2019-09-02 | Hoffmann-La Roche | Results Positive phase III results show Xofluza reduces risk of developing flu after contact with an infected person by 86% roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III BLOCKSTONE study showed preventive treatment with XofluzaTM (baloxavir marboxil) after exposure to an infected household member significantly reduced the risk of people developing flu by 86% versus placebo. |
| 2019-09-02 | Hoffmann-La Roche | Results Roche presents positive phase III study results for one-dose Xofluza in children with flu roche.com ↗
The study met its primary endpoint, which evaluated the proportion of patients with adverse events (AEs) or severe AEs up to study day 29, demonstrating results consistent with the safety profile of Xofluza. |
| 2019-09-01 | Genentech, Inc. | Results Positive Phase III Results Show Xofluza (Baloxavir Marboxil) Reduces Risk of Developing the Flu After Contact With an Infected Person by 86 Percent gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III BLOCKSTONE study showed preventive treatment with XofluzaTM (baloxavir marboxil) after exposure to an infected household member significantly reduced the risk of people developing the flu by 86 percent versus placebo. |
| 2019-09-01 | Genentech, Inc. | Results Genentech Presents Positive Phase III Study Results for One-Dose Xofluza (Baloxavir Marboxil) in Children With the Flu gene.com ↗
today announced that the Phase III MINISTONE-2 study showed that one-dose Xofluza TM (baloxavir marboxil) was a well-tolerated and effective potential treatment for the flu in otherwise healthy children aged one to less than 12 years old. |
| 2019-07-02 | Genentech, Inc. | Results Genentech Announces Positive Results for First Global Phase III Study Investigating One-dose XOFLUZA (Baloxavir Marboxil) in Children With the Flu gene.com ↗
today announced that the Phase III MINISTONE-2 study met its primary endpoint, demonstrating that XOFLUZA™ (baloxavir marboxil) was well-tolerated in children with the flu. |
| 2019-06-03 | Genentech, Inc. | Results Phase III Study Showed XOFLUZA (Baloxavir Marboxil) is Effective at Preventing Influenza Infection gene.com ↗
Compared with placebo, XOFLUZA treatment significantly reduced the likelihood of people developing influenza (flu) after exposure to an infected household member |
| 2019-03-05 | Genentech, Inc. | Regulatory FDA Accepts Genentech’s Supplemental New Drug Application for Xofluza (baloxavir marboxil) for the Treatment of Influenza in People at High Risk of Complications gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for XOFLUZA™ (baloxavir marboxil) as a single-dose, oral treatment for people at high risk of complications from the flu. |
| 2018-10-24 | Hoffmann-La Roche | Regulatory Roche announces FDA approval of Xofluza (baloxavir marboxil) for influenza roche.com ↗
Basel, 24 October 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Xofluza (TM) (baloxavir marboxil) for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older. |
| 2018-10-24 | Genentech, Inc. | Regulatory Genentech Announces FDA Approval of XOFLUZA (Baloxavir Marboxil) for Influenza gene.com ↗ |
| 2018-10-04 | Hoffmann-La Roche | Results Positive phase III results for baloxavir marboxil in people at high risk of complications from influenza to be presented at IDWeek 2018 roche.com ↗
In the subpopulation of patients with influenza type B, a subgroup where some antiviral treatments have shown only limited efficacy or inconclusive data, baloxavir marboxil was significantly more efficacious than oseltamivir in reducing the time to improvement of symptoms (median time of 74.6 hours versus 101.6 hours; p<0.05). |
| 2018-10-03 | Genentech, Inc. | Results Positive Phase III Results for Baloxavir Marboxil in People at High Risk of Complications From Influenza to be Presented at IDWeek 2018 gene.com ↗
CAPSTONE-2 showed that baloxavir marboxil significantly reduced time to improvement of influenza symptoms versus placebo |
| 2018-07-17 | Hoffmann-La Roche | Results Phase III CAPSTONE-2 study showed that baloxavir marboxil reduced symptoms in people at high risk of complications from the flu roche.com ↗
Baloxavir marboxil also demonstrated superior efficacy compared to placebo and oseltamivir for important secondary endpoints, including reducing the time that the virus continued to be released (viral shedding) and reducing viral levels in the body. |
| 2018-07-16 | Genentech, Inc. | Results Phase III CAPSTONE-2 Study Showed That Baloxavir Marboxil Reduced Symptoms in People at High Risk of Complications From the Flu gene.com ↗
Baloxavir marboxil also demonstrated superior efficacy compared to placebo and oseltamivir for important secondary endpoints, including reducing the time that the virus continued to be released (viral shedding) and reducing viral levels in the body. |
| 2018-06-25 | Genentech, Inc. | Regulatory FDA Grants Priority Review to Genentech’s Baloxavir Marboxil for the Treatment of Influenza gene.com ↗ |
All press releases naming this drug 39 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Baloxavir Marboxil | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03684044 ↗ |
| Known as | baloxavir | “I. To compare the efficacy of baloxavir marboxil (baloxavir) in combination with oseltamivir to oseltamivir monotherapy as measured by changes in influenza viral loads at day 1...” NCT04712539 ↗3“BACKGROUND: Baloxavir marboxil (baloxavir) rapidly reduces influenza virus shedding, which suggests that it may reduce transmission.” PMID 40267424 ↗ Apr 2025 “Baloxavir marboxil (hereafter baloxavir), a selective inhibitor of influenza cap-dependent endonuclease” PMID 32526195 ↗ Jun 2020 “Baloxavir marboxil (baloxavir) is a novel, cap-dependent endonuclease inhibitor” PMID 32516282 ↗ Aug 2020 |
| Known as | Xofluza | “Xofluza® (Baloxavir Marboxil), FDA approved in 2018 for the treatment of acute Influenza, has been shown to have improved outcome characteristics versus Tamiflu® (Oseltamivir),...” NCT06161454 ↗ |
| Action | Inhibit | “a selective inhibitor of influenza cap-dependent endonuclease” PMID 32526195 ↗ Jun 2020 |
| Route | Oral | “Tablets taken orally” NCT02949011 ↗ |