A Phase 3 interventional study of Baloxavir marboxil and Placebo in Influenza, Human, Respiratory Tract Infections and Post-exposure Prophylaxis, sponsored by Hoffmann-La Roche. Recruiting at 8 sites in China. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Prevention
Among 18 studies testing baloxavir in Influenza, Human — 7 open to participants now, 7 under way, 5 of them phase 3. baloxavir · Influenza, Human.
Among the 18 studies testing baloxavir in Influenza, Human, this one is the 13th largest by planned enrollment, is one of 2 that started in 2026, is one of 12 in phase 3, and was the 18th registered.
2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
This study's planned enrollment of 325 is above the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →7 of the 18 studies testing baloxavir in Influenza, Human are open now, in 12 countries. Each count lists the studies.
baloxavir: first FDA approval 2018 (XOFLUZA), first EMA approval 2021. What it is approved for, and how studies give it, is on its page →
Of the 119 Influenza, Human studies recruiting now, 62 (52%) set no upper age limit and 47 (39%) stop at 75 or younger; 31 take children under 18; 65 take healthy volunteers.
This study: 5 Years and older · all sexes · healthy volunteers too.
The full table on the hub →18 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 2 started in 2026.
Median enrollment 483 across the 18 interventional studies. Of the 10 that completed or were terminated, 8 (80%) have results posted.
9 of 18 have an industry lead sponsor. The 10 most frequent:
Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
20 studies in Influenza, Human by Hoffmann-La Roche: 2 open now, 2 under way, 2 of them phase 3. Of 18 finished, 14 (78%) have results posted.
Among the 20 studies in Influenza, Human by Hoffmann-La Roche, this one is the 5th largest by planned enrollment of the 17 interventional ones, is the only one that started in 2026, is one of 10 in phase 3, and was the 20th registered.
Hoffmann-La Roche’s Influenza, Human studies by the year they started, since 2006.
5 of the studies testing baloxavir in Influenza, Human that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07314905Phase 3Unity Health TorontoAdaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp) | 2027-03-31 |
| NCT06653569Phase 3Dre Pauline VetterEfficacy of Baloxavir Against Influenza in Hospitalized Patients: The INFLUENT Study (INpatients inFLUENza Treatment) | 2027-04 |
| NCT07827599Phase 3Hoffmann-La RocheA Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis (PEP) of Influenza Virus Infection in Chinese Participants | 2027-04-30 |
| NCT06094010Phase 3Hoffmann-La RocheA Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts | 2027-05-11 |
| NCT05648448University of OxfordA Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza | 2027-01-01 |
Among the 18 studies testing baloxavir in Influenza, Human, from their registry updates:
Among Hoffmann-La Roche’s 20 in Influenza, Human:
The main purpose of the study is to evaluate the efficacy of a single dose of baloxavir marboxil compared with placebo in the PEP of influenza virus infection with respect to symptomatic, laboratory-confirmed influenza in participants who are household contacts (HHCs) of participants with influenza (index participants).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Index Participants (Participants With Influenza Virus Infection):
HHCs of Index Participants:
Exclusion Criteria:
HHCs of Index Participants:
Note: Other protocol-defined inclusion/exclusion criteria may apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HHCs will receive baloxavir marboxil according to their body weight as outlined in the protocol.
Drug: Baloxavir marboxil
HHCs will receive baloxavir marboxil matching placebo according to their body weight as outlined in the protocol.
Drug: Placebo
Index participants will not receive any study treatment but will continue to receive SOC treatment for influenza, as per the local guidelines.
Baloxavir marboxil will be administered to the HHCs as per the schedule specified in the protocol.
Also known as: Xofluza; RO7191686
Baloxavir marboxil matching placebo will be administered to the HHCs as per the schedule specified in the protocol.
Percentage of Participants who are Infected With Influenza Virus (Reverse Transcription - Polymerase Chain Reaction [RT-PCR] Positive), and Present With Fever and at Least one Respiratory Symptom
Time frame: From Day 1 up to Day 10
Percentage of Participants who are Infected With Influenza Virus (RT-PCR Positive), and Present With Fever or at Least one Influenza Symptom (Respiratory or Systemic)
Time frame: From Day 1 up to Day 10
Percentage of Participants who are Infected With Influenza Virus (RT-PCR Positive) Regardless of Body Temperature or Influenza Symptoms
Time frame: From Day 1 up to Day 10
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 21
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing.
Started Oct 2026 (actual). Primary completion is estimated for Apr 2027, 6 months after the start.
Of 118 industry-sponsored phase 3 interventional studies under Influenza, Human, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 14. This study's planned 6 months is below that.
Counting every sponsor, half of 153 studies reached it within 8 months; a quarter within 4 and three quarters within 15.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 22, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Baloxavir