drugset
Drugs / Baloxavir
last change Jan 2026 re-read 2 minutes ago

Baloxavir

also known as XOFLUZA
Developed for
influenza
Investigated by
Genentech, Inc. · Bassett Healthcare · Brown University · Canadian Institutes of Health Research (CIHR) · Case Western Reserve University · Health Canada
+5 more · Insight Therapeutics, LLC · Unity Health Toronto · University of Oxford · University of Washington · Viroclinics Biosciences B.V.

Trials 5 · a red edge is where a trial was stopped

today NCT07314905 · Ph 3 NCT05648448 · Ph 2 NCT05012189 · Ph 4 NCT04327791 · Ph 2/3 NCT04141917 · Ph 4
20202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT05648448 Feb 2023 → Jan 2027 expected influenza University of Oxford Recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT04327791 Apr 2020 → Jul 2024 influenza Bassett Healthcare Completed No outcome recorded
Phase 31 trial
Phase 3 NCT07314905 Jan 2026 → Mar 2027 expected COVID-19, influenza Unity Health Toronto Not yet recruiting No outcome recorded
Phase 42 trials
Phase 4 NCT05012189 Aug 2021 → Dec 2023 influenza Insight Therapeutics, LLC Unknown No outcome recorded
Phase 4 NCT04141917 Nov 2019 → Mar 2021 influenza University of Washington Terminated No outcome recorded

Press releases naming this drug 13 releases

DateIssuerRelease
2025-04-25 Roche Global Development New England Journal of Medicine publishes phase III data showing single-dose Xofluza significantly reduces influenza virus transmission roche.com ↗
2024-09-19 Roche Global Development Positive phase III results show Xofluza significantly reduces the transmission of influenza viruses roche.com ↗
2023-01-12 Roche Global Development Roche announces the European Commission approval of Xofluza for the treatment and prevention of influenza in children aged one year and above roche.com ↗
2022-08-12 Roche Global Development Roche announces U.S. FDA approval of Xofluza to treat influenza in children aged five years and older roche.com ↗
2021-01-11 Roche Global Development 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 ↗
2020-11-24 Roche Global Development Roche announces FDA approval of Xofluza for the prevention of influenza following contact with an infected person roche.com ↗
2020-11-13 Roche Global Development CHMP recommends EU approval of Roche’s Xofluza® (baloxavir marboxil) for the treatment of influenza roche.com ↗
2019-10-18 Roche Global Development Roche announces FDA approval of Xofluza (baloxavir marboxil) for people at high risk of developing influenza-related complications roche.com ↗
2019-09-02 Roche Global Development Positive phase III results show Xofluza reduces risk of developing flu after contact with an infected person by 86% roche.com ↗
2019-09-02 Roche Global Development Roche presents positive phase III study results for one-dose Xofluza in children with flu roche.com ↗
2018-10-24 Roche Global Development Roche announces FDA approval of Xofluza (baloxavir marboxil) for influenza roche.com ↗
2018-10-04 Roche Global Development Positive phase III results for baloxavir marboxil in people at high risk of complications from influenza to be presented at IDWeek 2018 roche.com ↗

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 5 sources stand behind the page.

FieldValueCited text
Known as Baloxavir “antiviral treatment with baloxavir for those aged ≥12 years” NCT04141917 ↗
4

NCT05012189 ↗

NCT04327791 ↗

NCT05648448 ↗

NCT07314905 ↗
Known as XOFLUZA “Baloxavir (XOFLUZA®)” NCT05648448 ↗
Route Oral “administered PO once” NCT04327791 ↗